HIV Infection and AIDS (Acquired Immunodeficiency Syndrome) (1)

exp date isn't null, but text field is

Acquired Immunodeficiency Syndrome (AIDS) is a condition of reduced immunity as a result of infection with the Human Immunodeficiency Virus (HIV). HIV should be confirmed with an HIV test.

Test and Treat policy: Uganda has adopted the “Test and Treat Policy”, which involves providing lifelong antiretroviral therapy (ART) to ALL people living with HIV irrespective of CD4 count or clinical staging.Causes

  • Human Immunodeficiency Virus

Modes of transmission

  • Sexual intercourse with an HIV-infected person
  • Transfusion with HIV-infected blood
  • Mother-To-Child Transmission during pregnancy, delivery, or through breastfeeding
  • HIV-contaminated sharp instruments, g. dental and surgical equipment, needles, scalpels, razors, hair shaving equipment, nail cutters, and other sharp objects
  • Exposure to HIV-infected materials through an open wound or cut

Epidemiological risk factors for HIV

  • Present or past high-risk behaviour (multiple sexual partners)
  • Loss of a spouse or partner from HIV disease
  • Having sexually transmitted infections, especially Herpes simplex virus type 2
  • Being an uncircumcised man
  • Being in an HIV-discordant sexual relationship or marriage
  • History of blood transfusion between 1975 and 1986

 

Clincal Features of HIV

The WHO Clinical Staging of HIV for adults and children in the tables below shows the typical clinical features of HIV infection. The staging is based on demonstration of one or more opportunistic infections or key findings and correlates with disease progression and prognosis. Clinical staging should be performed at HIV diagnosis, on entry into HIV care, at ART initiation and at every visit hereafter to help guide patient care and monitor disease progress.

WHO Staging for HIV Infection and Disease in Adults and Adolescents

Clinical Stage I: Asymptomatic

  1. Asymptomatic
  2. Persistent generalised lymphadenopathy

Performance Scale 1: asymptomatic, normal activity

Clinical Stage II: Mild

  1. Moderate weight loss (< 10% of presumed or measured body weight)
  2. Minor mucocutaneous manifestations (seborrheic dermatitis, popular pruritic eruptions, fungal nail infections, recurrent oral ulcerations, angular cheilitis)
  3. Herpes zoster
  4. Recurrent upper respiratory tract infections (e.g. bacterial sinusitis, tonsillitis, otitis media, and pharyngitis)

And/or performance scale 2: symptomatic but normal activity

Clinical Stage III: Advanced

  1. Severe weight loss (more than 10% of presumed or measured body weight)
  2. Unexplained chronic diarrhoea for longer than 1 month
  3. Unexplained persistent fever (intermittent or constant for longer than 1 month)
  4. Persistent oral candidiasis
  5. Oral hairy leukoplakia
  6. Pulmonary tuberculosis
  7. Severe bacterial infections (such as pneumonia, pyomyositis, empyema, bone or joint infection, bacteraemia, meningitis)
  8. Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
  9. Unexplained anaemia (< 8 g/dl), neutropenia (< 0.5×109 per litre), or chronic thrombocytopenia (< 50× 109 per litre)

And/or performance scale 3: Bed ridden for less than 50% of the day during the last month

Clinical Stage IV: Severe

  • HIV wasting syndrome
  • Pneumocystis jirovecii pneumonia (PCP)
  • Recurrent severe bacterial pneumonia (>2 episodes within 1 year)
  • Toxoplasmosis of the brain
  • Cryptosporidiosis with diarrhoea for longer than 1 month
  • Chronic isosporiasis
  • Extrapulmonary cryptococcosis including meningitis
  • Cytomegalovirus infection (retinitis or infection of other organs other than liver, spleen or lymph nodes)
  • Chronic oro-labial, genital or ano-rectal herpes simplex virus (HSV) infection of >1 month
  • Progressive multifocal leukoencephalopathy (PML)
  • Any disseminated endemic mycosis such as histoplasmosis, coccidioidomycosis
  • Candidiasis of the oesophagus, trachea, bronchi, or lungs
  • Disseminated non-tuberculous mycobacterial infection
  • Recurrent septicaemia (including non-typhoid salmonella)
  • Extrapulmonary tuberculosis
  • Lymphoma (cerebral or B-cell non-Hodgkin)
  • Invasive cancer of the cervix
  • Kaposi sarcoma
  • HIV encephalopathy 
  • Atypical disseminated leishmaniasis
  • Symptomatic HIV-associated nephropathy or symptomatic HIV associated cardiomyopathy

And/or performance scale 4: Bed-ridden for more than 50% of the day during the last month

Differential diagnosis

  • TB
  • Untreated diabetes mellitus
  • Malnutrition
  • Cancer
  • Other chronic diseases

Diagnosis and Investigations of HIV

HIV testing is the point of entry into comprehensive care HIV services. The aim of HIV Testing Services (HTS) is to promptly identify HIV status to ensure early linkage to prevention, treatment, and support services. Early diagnosis is fundamental for early treatment, good prognosis and reduction in transmission. HTS should be availed to all persons at risk of HIV infection using cost-effective and high impact approaches. HTS should be differentiated to subpopulations and geographical locations because less than 20% of PLWHIV aged 15 years and above do not know their status. Uganda is currently implementing targeted HIV testing to optimize HIV case identification and linkage to care. People at high risk of HIV acquisition include: being in a sexual relationship with multiple concurrent partners; belonging to a key/priority/vulnerable population (e.g., children, adolescent girls and young women, pregnant or breastfeeding women); being a sexual contact to an index client; being a biological child to an HIV positive client; not knowing your partner's HIV status; or being in a sero-discordant relationship.

1. The following approaches are utilized in targeted HIV testing:

  • Screening for HIV testing eligibility for children, adolescents and adults.
  • Index Client Testing (ICT), including Assisted Partner Notification (APN) and testing for biological children / Know Your Child Status (KYCS)
  • Social Network Strategy (SNS)
  • HIV Self-Testing (HIVST)

2. Pre and post counselling and consent are needed except in the following situations:

  • Diagnostic testing: test carried out on very sick, unconscious, symptomatic or mentally ill by attending health care team for the purpose of better patient management
  • Routine testing: for individuals likely to pose a risk of HIV infection to others e.g. pregnant and breastfeeding mothers, sexual offenders and survivors, blood or body tissue or organ donors. Individuals tested using this approach must be given an opportunity to know their status

If a patient is positive, he/she must be IMMEDIATELY connected to HIV care services.

In adults and children >18 months, testing is based on serological (antibody) testing.

Due to the window period between infection and production of detectable levels of antibodies, patients who are negative should be re-tested after three months if they had a possible exposure in the 3 months before the test.

Serial HIV Testing Algorithm for testing persons above 18 months of age in Uganda.

HIV Testing Algorithm using the HIV-Syphilis Duo Kit in MCH Settings

 

Serological testing is available from HC2 level.

In children below 18 months, testing is virological, that is based on direct detection of viral DNA (DNA-PCR).

Virological testing (DNA-PCR and viral load) is done on DBS (dried blood spots) samples which can be collected from HC2 and are sent to a central national laboratory through the hub system.

HIV testing in children less than 18 months

The recommended test for children <18 months is virological (DNA-PCR) testing, since antibody tests will detect antibodies passed to the child from the mother (so the test can give a false positive).

If the mother is HIV negative:

  • The child is classified as HIV negative

If the mother if positive:

  • Do DNA PCR at 6 weeks of age or at an earlier opportunity thereafter
    • Start cotrimoxazole prophylaxis and Niverapine syrup  till HIV status is confirmed
  • If PCR is positive, enroll child for ART
  • If PCR is negative and child never breastfed: child is negative
    • Stop cotrimoxazole and Niverapine syrup
    • Follow up every 3 months and do HIV rapid test (serological) at 18 months
  • If PCR is negative BUT child is breastfeeding/has breastfed in the last 6 weeks, re-check PCR 6 weeks after cessation of breastfeeding

If mother’s status is unknown:

  • Test the mother and continue management according to the result

If mother unavailable:

  • Perform rapid antibody testing on the child. The result will give indication on the mother’s status:
    • If the test is negative: child negative
    • If the test is positive, follow algorithm for managing a child from an HIV positive mother

Other tests in HIV management

TEST

DESCRIPTION

LOC

CD4

It measures the level of CD4 T lymphocytes, a subtype white blood cell. It reflects the level of compromise of the immune system. It is used for initial assessment pre ART and for monitoring of ART effect.

HC2

Viral Load

It measures the quantity of virus in the blood. It is used to monitor the effect of ARVs. It is currently done by DBS (Dried Blood Spot)

HC2

Genotype Testing

HIV genotypic resistance test is a qualitative test that detects mutations associated with ARV drug resistance. The test evaluates if the HIV strain infecting the individual has developed resistance to one or more ARV drugs. This is useful in identifying a combination of ARVs to which the HIV strain is susceptible

 

 

If an infant with a Negative previous PCR is symptomatic while still breastfeeding, take off a PCR sample at that point in time. If negative, another PCR sample must be taken according to the algorithm either 9 months or 6 weeks after breastfeeding. 

If mother's status cannot be ascertained, may use rapid test in babies to determine HIV exposure status, should perform DNA PCR for baby who is symptomatic, malnourished or has TB as routine. 

If breastfeeding is stopped before 9 months then a final DNA PCR can be done at any point 6 weeks after cessation of breastfeeding. 

For infants whose mothers are filling on any regimen: take off 2 DBS at the time of confirming the positive test- one for confirmation and one for HIVDR testing. 

Management of HIV Infection

Measures before ARV Treatment

Even without the use of specific ARV treatment, there are many ways in which good HIV management can help patients:

TREATMENT

LOC

Prophylaxis against opportunistic infections

The following groups have been prioritized for cotrimox- azole preventive therapy:

  1. All PLHIV newly initiating on ART.
  2. Those having a current WHO stage 3 or 4 event or other symptoms of advanced disease.
  3. Pregnant and breast-feeding women   

Note: Additional intermittent preventive treatment for malaria using Sulfadoxine-Pyrimethamine (SP) is not required for pregnant women on CPT.

      d. Children and adolescents aged 0-15 years. Patients suspected to have treatment failure

  • Cotrimoxazole: 960 mg once daily for adults and children >30 kg, Child <5 kg: 120 mg once daily,  Child 5-14.9 kg: 240 mg once daily,  and Child 15-29.9 kg: 480 mg once daily

Contraindications: known allergies, severe anaemia and neutropenia

Guidance for when to stop CPT in stable PLHIV

  1. Patient should be older than 15 years of age.
  2. Patient should not be pregnant.
  3. Patient should have been on ART for at least one year.
  4. Patient’s last VL should be suppressed.
  5. Patient should not have a current WHO stage 3 or 4 event or other symptoms of advanced HIV disease at the time of stopping CPT.

When to re-start CPT in PLHIV

CPT can be restarted in the following scenarios:

  1. New pregnancy
  2. Suspected treatment failure

 

New Treatment WHO stage 3 or 4 condition

  • Alternative: dapsone

Adults and child >12 years: dapsone 100 mg daily

Children below 12 years: dapsone 2 mg/kg daily

 

HC2

TPT (TB Preventive treatment)

such as; isoniazid + rifapentine(3HP) weekly for 3 months in all adults, adolescents and children >12 months living with HIV and in whom TB disease has been excluded (other medications for TPT refer to the current HIV/TB guidelines)

If child <12 months, give only if history of contact with TB case and no active disease (one-month daily rifapentine and isoniazid (1HP).)

– Dose: (see section 5.3.2.1 )

HC3

Prompt and appropriate medical care

  • By treating opportunistic infections as they occur
  • By treating symptoms, such as pain, diarrhoea, and skin problems, as they develop
  • Going for treatment promptly if unwell

HC3

Positive health, dignity, and prevention intervention

Intervention

Description

Preventing HIV trans- mission

PLHIV should be encouraged to adopt safer sexual practices including abstinence, correct and consistent condom use. Condom use prevents HIV transmission, reduces risk of other STIs, and prevents unintended pregnancies.

Disclosure and partner testing

PLHIV should actively explore ways of disclosing their HIV status to sexual partners, family members and significant others. Offer provider and/or counselor-mediated or supported disclosure as options for those who do not feel comfortable disclosing on their own.

Family planning

Encourage PLHIV to discuss their reproductive choices and support them to adopt those which do not compromise their health. For women who choose to conceive, link them to eMTCT services.

Alcohol and other risk reduction

Educate on risks of alcohol abuse leading to poor treatment adherence resulting in disease progression, and the likelihood of engaging in risky sexual behaviours, placing themselves at increased risk for acquiring STIs and placing their negative partners at risk for infection.

General Principles of Antiretroviral Treatment (ART)

Initial evaluation checklist for patients starting ART

Before initiating ART, a full evaluation of the patient must be done. This includes:

  • Assessment of the history, physical exam and baseline laboratory tests to assess disease progression and any other conditions
  • Staging the patient’s stage using WHO clinical staging
  • Counselling and assessing patient’s readiness to start ART

Assessment of patient’s history

  • Level of understanding of HIV/AIDS
  • Length of time since the diagnosis of HIV infection
  • Demographics and lifestyle: whether employed and nature of work
  • History of previous ART
  • Pregnancy risks: contraception options and choices, current or planned pregnancy, access to contraceptive services
  • Sexual risks and disclosure: willingness to practice safer sex, disclosure of HIV serostatus, use of condoms, HIV counselling, and testing of sex partners and children
  • Symptoms of chronic pain and depression
  • History of opportunistic infections and other significant illnesses g. TB and STIs, hospitalisations, and surgeries
  • Current medications (including anti-TB drugs, traditional therapies, )

Physical exam

  • Weight
  • Nutritional status
  • Functional capacity and level of disability
  • Vital signs, skin, eyes, oropharynx (presence of thrush), lymph nodes, lungs, heart, abdomen, genital tract (STIs), extremities, nervous system

Baseline laboratory tests to assess immunosuppression and disease aggressiveness

  • Confirming HIV serostatus
  • CD4 testing
  • Pregnancy test
  • Full blood count particularly for patients starting on a AZT-containing regimen

Baseline Labs to assess general health and diagnose any pre-existing HIV complications

  • Sputum smear for AFB for patients who have coughed for > 2-3 weeks and a chest X-ray for patients who have unproductive cough or whose AFB smears are negative
  • Urine analysis for proteinuria, particularly for patients starting on TDF-containing regimen
  • Syphilis and Hepatitis B screening
  • Liver and renal function tests if available
  • Cryptococcal antigen and urine LAM screening for patients whose CD4 count is < 200 cells/ml
  • Symptom-directed lab tests to diagnose pre-existing illnesses

Staging of disease

  • Using WHO clinical criteria (see tables above)
  • Counselling and assessment of patient’s readiness to start therapy
  • Assess for education, information or counselling support needs
  • Develop an adherence plan

Goals of treatment with antiretroviral medicines are to:

  • Inhibit viral replication as reflected in plasma HIV concentration to as low as possible and for as long as possible. This promotes restoration of the immune system.
  • Preserve or enhance the immune function (CD4 restoration), which prevents/delays the clinical progression of HIV disease
  • Minimise toxicities and side effects associated with the medicines
  • Improve quality of life and reduce HIV-related morbidity and mortality
  • Promote growth and neurological development in children

Tools to achieve the goals of therapy

  • Maximisation of adherence to ART: adequate support to patient to adhere to treatment and/or access to community/facility level adherence counselling
    • Disclosure of HIV serostatus reinforces patient’s adherence to ART
  • Rational sequencing of medicines to preserve future treatment options
  • Use of ARV medicine resistance testing when appropriate and available
  • Use of viral load estimates for monitoring

Principles of ART

Antiretroviral therapy is part of comprehensive HIV care. The guiding principles of good ART include:

  • Efficacy and durability of the chosen medicine regimens
  • Freedom from serious adverse effects; low toxicity
  • Ease of administration including no food restrictions, better palatability, and lower pill burden
  • Affordability and availability of medicines and medicine combinations
  • Organised sequencing – spares other available formulations for use in second line while allowing for harmonisation of regimens across age and population
  • Ongoing support of the patient to maintain adherence

Limitations of ART

  • Antiretroviral medicines are not a cure for HIV but greatly improve quality of life when used appropriately
  • ARVs are relatively expensive, require an adequate infrastructure, and knowledgeable healthcare workers
  • Medicine interactions and resistance may decrease the potency of ARVs
  • Patients may develop adverse medicine reactions
  • Patients have to take at least 95% of their pills in order to respond well (adherence is key to successful therapy)
  • The medications have to be taken for life
  • Some patients may not respond (benefit) to treatment and continue to regress in spite of high adherence
  • Children are dependent on adults for adherence to ART

Available agents for ART

At present, antiretroviral medicines come in six classes, which attack different sites and stages of the HIV life cycle, thereby interfering with its reproduction.

CLASS

EXAMPLES

Nucleoside reverse transcriptase inhibitors (NtRTIs) incorporate themselves into the DNA of the virus, thereby stopping the building process

Tenofovir (TDF) Zidovudine (AZT) Lamivudine (3TC) Abacavir (ABC)

Non-nucleoside reverse transcriptase inhibitors (NNRTIs) stop HIV production by binding directly onto the reverse transcriptase enzyme, and prevent the conversion of RNA to DNA

Efavirenz (EFV) Nevirapine (NVP) Etravirine (ETV)

Integrase inhibitors interfere with the HIV DNA’s ability to insert itself into the host DNA and copy itself.

Dolutegravir (DTG) Raltegravir (RAL)

Protease inhibitors (PIs) prevent HIV from being successfully assembled and released from the infected CD4 cell. Boosted PIs  are combinations of low-dose ritonavir (RTV) with a PI for pharmaco-enhancement

Atazanavir (ATV) Lopinavir (LPV) Darunavir (DRV) Ritonavir (RTV, abbreviated as ”r” if boosting other PIs, e.g. ATV/r, LPV/r)

Entry inhibitors (HIV fusion inhibitors) prevent the HIV virus particle from infecting the CD4 cell

Enfuvirtide (T-20)

CCR5 antagonists block the CCR5 co-receptor molecules that HIV uses to infect new target T-cells. Some forms of HIV use a different co-receptor and thus, some patients may not benefit from maraviroc

Maraviroc

Initiation of ART

It is recommended to initiate ART at the earliest opportunity in all documented HIV-infected adults, adolescents and children regardless of CD4 count and WHO clinical staging (Test and Treat)

Evidence and programmatic experience have shown that early initiation of ART results in reduced mortality, morbidity and HIV transmission outcomes. However, priority should be given to patients with lower CD4 counts as well as those who are symptomatic.

A CD4 count is not necessary for initiation but it can be useful to assess risk of opportunistic infections.

ART in children

The vast majority (about 90%) of infants and children with HIV acquire the infection through mother-to-child transmission.

HIV infection follows a more aggressive course among infants and children than among adults; 30% die by age 1 year and 50% die by age 2 years without access to life-saving medicines, including ART and preventive interventions, such as cotrimoxazole prophylaxis.

Early HIV diagnosis and ARV treatment is critical for infants. A significant number of lives can be saved by initiating ART for HIV-positive infants immediately after diagnosis within the first 12 weeks of life.

General principles

  • ARV doses need to be adjusted from time to time as the children grow quickly and thus, their weight
  • Before a child begins ART, the following assessments must be made:
    • Readiness of parents/caretakers or child (if older) to start ART
    • Complete pre-treatment baseline assessment (see previous sections)

Process of Initiating ART

Health workers should do the following before initiating ART:

Assess all clients for any evidence of Opportunistic Infections (OIs). If the patient has TB or cryptococcal meningitis, ART should be referred and initiated after starting treatment of these OIs. 

For patients without TB or cryptococcal meningitis, offer ART on the same day through an opt-out approach. In this approach, patients should be prepared and assessed for readiness to start ART on the same day. 

If a client is ready, ART should be initiated on the same day. If a client is not ready, or opts-out of the same day initiation, a timely ART preparation plan should be agreed upon with the aim of initiating ART within seven days for children and pregnant women, and within one month for adults. 

Recommended First Line Regimens in Adults, Adolescents, Pregnant Women and Children

HIV management guidelines are constantly being updated according to evidence and public policy decisions. Always refer to the latest official guidelines. 

The 2022 guidelines recommend DOLUTEGRAVIR (DTG) an integrase inhibitor as the anchor ARV in the preferred first and second-line treatment regimens for all HIV infected clients; children, adolescents, men, women (including pregnant women, breastfeeding women, adolescent girls and women of child bearing potential)

ART regimens in children are age and weight dependent. When children grow, doses and regimens have to be changed according to guidelines below. 

Recommended first-line ARV regimens in adults, adolescents, pregnant or breastfeeding women and children

Patient Category

Preferred regimens

Alternative regimens

Adults And Adolescents

Adults (including pregnant women and breast feeding mothers and adolescents 30Kg

TDF +3TC+ DTG

If DTG is contraindicated1 use: ;: TDF + 3TC + EFV400

If TDF is contraindicated use: TAF-

+FTC+ DTG

If TDF or TAF is contraindicated, use ABC + 3TC +DTG

If TDF or TAF and DTG are contraindicated: ABC +3TC +EFV400

If EFV and DTG are contraindicated: TDF +3TC + ATV/r or + 3TC + ATV/r
Children

Children 20Kg-<30Kg

A BC + 3T C + DTG

If DTG is contraindicated:

ABC + 3TC + LPV/r (tablets) If ABC is contraindicated:

TAF+FTC+ DTG (For Children >6 years and

>25kgs)

if ABC and TAF are contraindicated AZT + 3TC + DTG

Children <20Kg

A BC + 3T C + DTG

If intolerant or appropriate DTG formulations are not available:

ABC +3TC + LPV/r Granules. If intolerant to LPV/r:

ABC + 3TC + EFV (in children > 3 years and

>10Kg)

If ABC is contraindicated: AZT + 3TC + DTG or LPV/r

 

Contraindications for DTG (use DTG screening tool prior to DTG initiation) including: known diabetics, patients on anticonvulsants (carbamazepine, phenytoin, phenobarbital)

Contraindications for TDF and TAF: Renal disease and/or GFR <60ml/min, weight<30Kg

3 TAF can be used in sub populations with bone density anomalies.

4. Children will be assessed individually for ability to correctly take the different formulations of LPV/r.

Important drug interactions

Drug Family

ARV Drug

Interaction

Action

Anti-TB medicines

NVP

Rifampicin decreases NVP concentrations in blood.

Could cause liver toxicity

Do not co-administer NVP and rifampicin

See Table 30 and Table 31 for TB/ARV co-management

 

DTG

 Rifampicin lowers DTG levels Adjust DTG dose to twice daily

A T V / r , LPV/r, DRV and RTV

Rifampicin boosts metabolism of PIs

If given together with LPV/r increase the dose of RTV to achieve 1:1 ratio

Combined oral contraceptive pills, hormonal implants (etonogestrel)

EFV or AT-

V/r, LPV/r, DRV and RTV

Risk of contraceptive failure due to increased metabolism of contraceptives

Use additional barrier method or

Use Depo-Provera or IUDs

Anxiolytics,

e.g. midazolam, diazepam

A T V / r , LPV/r, DRV

and RTV

Risk of respiratory depression(midazolam)

Increased sedation (diazepam)

Reduce dose of midazolam or diazepam

Simvastatin, rosuvastatin, atorvastatin

A T V / r , LPV/r, DRV

and RTV

Inhibition of CYP450 3A4 (reduced metabolism of statins)

Use atorvastatin with lowered dose and monitor for side effects like muscle pains

Anti-epileptics, e.g. carbamazepine, phenobarbital, and phenytoin.

EFV, DTG,

Etravirine

Carbamazepine decreases DTG levels by 30-70%

Use valproic acid

Drugs for acid reflux or ulcers, e.g. omeprazole,

esomeprazole, lansoprazole, pantoprazole

ATV/r

Reduced concentrations of Atazanavir

Use alternatives like ranitidine, cimetidine, etc.

Polyvalent cation products containing Mg, Al, Fe, Ca, Zn (e.g. vitamin supplements and antacids)

DTG

Reduce DTG levels

Use DTG 2 hours before or 6 hours after the product to avoid interaction

Antimalarial drugs: artemether/ lumefantrine, halofantrine

ATV

Both could prolong QT interval

When given with artemether/ lumefantrine monitor closely for undesired effects

Halofantrine: do not give together (contraindicated)

Metformin

DTG

DTG increases metformin levels. May increase risk of hypoglycaemia and metabolic acidosis

Close follow-up (routine electrolytes, BUN

and Creatinine, Random Blood Sugar tests) recommended

 

Monitoring of ART

The purpose of monitoring patients on ART is to assess:

  • Response to ART and early detection of treatment failure
  • Side effects and toxicity
  • Adherence

The schedule of monitoring visits follow a pre-set calendar for the 1st one year after initiation of ART, i.e:

  • At 1, 2 and 3 months from start of ART
  • At 6, 9, 12 months

After 12 months from initiation of ART, the Differentiated Model of Care Delivery is followed, in which schedule and modalities of periodic checks are based on individual needs and characteristics of the patient.

The aim of this model is:

  • A client centered approach, so that stable patients have spaced checks and fast tracks drug pick ups
  • More efficient use of resources by avoiding overcrowding and long waiting times
  • More focus on unstable/complex patients

(Refer to MOH HIV/ART guidelines for more details).

TYPE OF MONITORING

 

COMPONENTS

Clinical Monitoring
  • Screen for and manage opportunistic infections (OI) and STI
  • Assess for pregnancy, and/or use or need of FP
  • Screen and manage co-morbidities including depression
  • Weight and nutritional assessement
  • Disclosure

For children and adolescents:

  • Growth and development, school attendance, behavioural issues, sexual awareness

Laboratory Monitoring

Viral load

Is preferred method to monitor response to ART and treatment failure:

  •  Children and adolescents under 19 years of age: first VL at 6 and 12 months from initiation, if suppressed; every 6 months thereafter.
  • Adults: First VL at 6 months after initiation. Second VL following sup- pressed viral load at 12 months , then every 12 months if suppressed

  • HIV positive pregnant and breast- feeding women: If newly initiated on ART at ANC, conduct a VL test at 3 months on ART. If VL suppressed repeat VL every 3 months throughout pregnancy and until cessation of breastfeeding.

  • HIV-positive pregnant and breast- feeding women already on ART at ANC1 or MBCP: conduct a VL test at first ANC or MBCP visit. If VL is suppressed repeat VL every 3 months throughout pregnancy until cessation of breastfeeding

If unsuppressed in the above, refer to the algorithm below.

  • After every switch in treatment (after failure): VL at 6 months after a switch to second- and third-line ART.
  • Third line ART patients: VL every 6 months. If VL is un-suppressed, then genotype testing is recommended.

CD4 monitoring

  • Recommended at baseline to screen for risk of opportunistic infections
  • In patients who are suppressed but are in clinical stage 3-4
  • In patients on prophylaxis for cryptococcus to inform decision on when to stop fluconazole

Other tests

  • According to clinical findings

 

 

 

Time

Before ART

During ART

 

DSD from 6 months

After 12 months on ART

Base- line

1

month

2

months

3

months

6

months

9

months

12

months

3

monthly

6

month- ly

12

month- ly

Clinical assessment

Comprehensive clinical assessment

X

X

X

x

X

X

x

X

X

x

Prepare for ART

X

 

 

 

 

 

 

 

 

 

Assess readiness for ART

X

 

 

 

 

 

 

 

 

 

Provide CTX

X

X

X

x

X

X

x

x**

x**

x**

Provide FP if required

X

 

 

 

 

 

 

 

 

 

Assess for drug intolerance, side effects/ toxicities

 

X

X

x

X

X

x

X

X

x

Adherence assessment, monitoring, and support

 

X

X

x

X

X

x

X

X

x

Assess for Immune re- constitution inflammatory syndrome (IRIS)

 

X

X

x

X

 

 

 

 

 

Adherence asseessment, monitoring, and support

 

X

X

X

X

X

X

X

X

X

ART and CTX refill (in children adjust dose based on weight)

 

X

X

x

X

X

x

X

X

x

FP refill

 

X

X

x

X

X

x

X

X

x

TB Screening

X

 

 

 

 

 

 

X

X

x

Follow up review: If the patient is clinically well:

Give ONE month refill and appointment

 

X

X

x

 

 

 

 

 

 

Give THREE months refill and appointment

 

 

 

 

X

X

x

X

 

 

Laboratory tests

Viral Load

 

 

 

 

x*

 

x*

 

x**

x

CD 4

X

 

 

 

 

 

 

 

 

 

HBsAg,

X

 

 

 

 

 

 

 

 

 

CrAg if CD4 <200,

X

 

 

 

 

 

 

 

 

 

TB LAM if CD4 <200,

X

 

 

 

 

 

 

 

 

 

FBS/RBS (especially adults at risk on DTG)

X

 

 

x

X

X

X

 

X

 

Give ONE month refill and appointment

 

X

X

x

 

 

 

 

 

 

LFTs

X

 

 

 

 

 

 

 

 

 

Do other lab tests if clinically indicated (Table 58)

X

X

X

x

X

X

X

X

X

x

Cervical cancer screening

 

 

 

 

 

 

 

 

 

x

 

Routine Viral Load Monitoring

Routine Viral Load Monitoring

ARV Toxicity

ARV drugs can cause a wide range of toxicities, from mild to life threatening.

Active monitoring and management of toxicities and side effects is important not only to avoid negative medical outcome but also to ensure that they do not negatively affect adherence.

CATEGORY

ACTION

Severe Life-Threatening Reactions (e.g. SJS/TEN, severe hepatitis)

Immediately discontinue all ARV drugs (possibly all drugs in general), manage the medical event and substitute the offending drug when the patient is stabilised

Severe Reactions (e.g. Hepatitis, anaemia) 

Stop the offending drug and substitute it without stopping the ART (if clinically possible)

Moderate Reactions (Gynaecomastia, lipodystrophy)

Substitute with a drug in the same ARV class but with a different toxicity profile, or with a drug in a different class

Do not discontinue ART. Continuation of ART as long as feasible. If the patient does not improve on symptomatic therapy, consider single- drug substitution

Mild Reactions (Headache, minor rash, nausea)

Do not discontinue or substitute ART.

Reassure the patient or caregiver that while the reaction may be bothersome, it does not require a change in therapy and often it subsides in few weeks.

Provide support to mitigate the adverse reactions as well as counseling about the events

 

 

Major Adverse/ Toxicity Events

PRESENTING SIGNS/SYMPTOMS

SUGGESTED MANAGEMENT

REGIMENS FOR ADULTS AND ADOLESCENTS

 

 DTG
  1. Hyperglycaemia
  2. Insomnia
  3. Hepatotoxicity
  4. Hypersensitivity reactions
  1. Excessive drinking/eating, excessive urination
  2. Difficulty falling asleep
  3. Nausea, vomiting, right upper quadrant abdominal pain, yellow urine or eyes
  4. Skin itching (localized or diffuse), dizziness, faintness, difficulty breathing, nausea, vomiting, diar- rhoea, and abdominal cramping
  • Do RBS to confirm hyperglycaemia then substitute with EFV
  • Insomnia: Ensure patient is taking DTG during the day if it persists then substitute with EFV
  • If EFV is contraindicated: Substitute with ATV/r

 

ETG
  1. Persistent central nervous system toxicity
  2. Convulsions
  3. Hepatotoxicity
  4. Severe skin and hypersensitivity reactions
  5. Gynecomastia
  1. Dizziness, insomnia, abnormal dreams or mental symptoms (anxiety, depression, mental confusion, suicidality)
  2. New-onset seizures
  3. Nausea, vomiting, right upper quad- rant abdominal pain, yellow urine or eyes
  4. New-onset skin rash
  5. Breast enlargement in men

In case on EFV 600mg

  • Lower the dose of EFV to 400mgs

In case on EFV 400, Reassure.

If symptoms persist

•Substitute EFV with DTG

If DTG is contraindicated: substitute with ATV/r

TDF

 

  1. Chronic kidney disease, acute kidney injury and Fanconi syndrome
  2. Decreased bone mineral density
  3. Lactic acidosis or
  4. severe Hepatomegaly with steatosis
  1.  Lower back pain, change in urine volume
  2. Bone aches, spontaneous fractures
  3. Exhaustion or extreme fatigue, muscle cramps or pain, headache.
  4. Abdominal pain or discomfort, decrease in appetite.

Do LFTs and RFTs. If deranged (elevated liver enzymes and/or GFR is < 60mls/min) then substitute with ABC

If ABC is contraindicated: substitute with AZT

ABC

1. Hypersensitivity reaction

1. Skin itching (localized or diffuse) dizziness, faintness, difficulty breathing, nausea, vomiting, diarrhoea, and abdominal cramping

Substitute with TDF

If TDF is contraindicated: substitute with AZT

AZT
  1. Severe anaemia, neutropenia
  2. Lactic acidosis or severe hepatomegaly with steatosis
  3. Lipoatrophy, lipodystrophy, myopathy
  4. Severe vomiting
  1. Easy fatigability, breathlessness, recurrent infections
  2. Exhaustion or extreme fatigue, muscle cramps or pain, headache.
  3. Abdominal pain or discomfort decrease in appetite.
  4. Persistent vomiting resulting in severe dehydration

Do Hb (if < 8mg/dl): Substitute with TDF

If TDF is contraindicated: substitute with ABC

 

Recommended Second Line Regimens in Adults, Adolescents, Pregnant Women and Children

Patients may need to be swiched to second line regimens in case of treatment failure, and to third line if they fail on second line drugs. Third line regimens require resistance testing to inform the choice of appropriate drugs, and needs referral to specialised ART centres.

Factors involved in treatment failure are poor adherence, inadequate drug levels or prior existing drug resistance.

Before switching therapy, it is essential to assess and address adherence issues, and provide intensive adherence counselling if necessary.

Criteria for defining treatment failure are presented in the following table:

DEFINITION

COMMENT

VIROLOGICAL FAILURE

Two consecutive viral loads >1000 copies/ml, done at three to six months apart, with intensive adherence support following the 1st VL test

 

Patient should have been on ART for at least six months

CLINICAL FAILURE

Adults and adolescents:

New or recurrent WHO clinical stage 3 or 4 (with exception of TB) in a patient who has been on effective ART regimen for at least six months

Children:

New or recurrent WHO clinical stage 3 or stage 4 event (with the exception of TB) in a patient who has been on effective ART regimen for at least six months

The condition must be differentiated from Immune Reconstitution Inflammatory Syndrome (IRIS) occurring after initiating ART

Criteria for defining treatment failures are presented in the following table: 

Population

Failing first line regimens

Recommended second line regimen

Alternative second line regimen

Third line regimens1,2

Adults and adolescents above 30Kg, including pregnant and breast- feeding women

 

 

TDF + 3TC+EFV

TDF+3TC+NVP

TAF + FTC +EFV

AZT+3TC+DTG

AZT+3

TC++DRV/r or ATV/r

All third line regimens to be guided by HIV drug resistance testing.

In case of susceptibility to all drugs, use the table to guide the preferred or alternative choices.

 

NOTE: For details on the third-line ART, Please see the third-line ART implementation guides.

 

 

 

 

TDF+3TC+DTG or TAF + FTC + DTG

AZT+3TC+DRV/r

AZT+3TC+ATV/r

AZT+3TC+NVP

AZT+3TC+EFV ABC/3TC/NVP

ABC+ 3TC+ EFV

TDF+3TC+DTG or TAF + FTC + DTG

TDF+3TC+ATV/r or TAF + FTC +ATV/r

AZT+3TC+DTG

ABC+3TC+DTG

TDF+3TC+DRV/r or TAF+ FTC + DRV/r

TDF+3TC+ATV/r or TAF + FTC +ATV/r

Children 20Kg -

<30Kg

 

 

 

 

ABC+3TC+EFV ABC+3TC+NVP

AZT+3TC+DTG

AZT+3TC+LPV/r

ABC+3TC+LPV/r

AZT+3TC+DTG

AZT+3TC+DRV/r

ABC+3TC+DTG

AZT+3TC+DRV/r

AZT+3TC+LPV/r

AZT+3TC+EFV AZT+3TC+NVP

ABC+3TC+DTG or

TAF+ FTC + DTG

ABC+3TC+LPVr or

TAF+ FTC +LPV/r

AZT+3TC+LPV/r

ABC+3TC+DTG or

TAF+ FTC + DTG

ABC+3TC+DRV/r or TAF + FTC + DRV/r

AZT+3TC+DTG

ABC+3TC+DRV/r or

TAF+ FTC + DRV/r

ABC+3TC+LPV/r or TAF + FTC + LPV/r

Children

<20Kg

 

 

 

 

ABC+3TC+EFV ABC+3TC+NVP

AZT+3TC+DTG

AZT+3TC+LPV/r

AC+3TC+LPV/r

AZT+3TC+DTG

AZT+3TC+DRV/r

AZT+3TC+EFV AZT+3TC+NVP

ABC+3TC+DTG

ABC+3TC+LPV/r

AT+3TC+LPV/r

ABC+3TC+DTG

ABC+3TC+DRV/r

AZT+3TC+DTG

ABC+3TC+DRV/r

ABC+3TC+LPV/r

All PLHIV should receive resistance testing to inform the prescription of 2nd and 3rd-line medicines.

Since all 3rd-line PLHIV will have prior PI Exposure, DRV/r will be taken twice a day.

For recipients of care on NNRTI-based First Line regimen whose VL is not suppressed, switch without a second VL but conduct IAC to improve adherence to new regimen.

For all PLHIV failing first-line ART, optimize the second-line ART using HIVDR test

 ARV Dosing Tables

 

Formulations and strengths

3.0–

5.9kg

6.0–

9.9kg

10.0–

13.9kg

14.0–

19.9kg

20.0–

24.9kg

25.0–

34.9kg

Adolescents and adults

>35kg

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

 

TDF/3TC/DTG 300/300/50mg

-

-

-

-

-

-

-

-

-

-

-

-

1

-

TAF/FTC/DTG

25/200/50mg

-

-

-

-

-

-

-

-

-

-

1

-

1

-

ABC/3TC/DTG

600/300/50mg

-

-

-

-

-

-

-

-

-

-

1

-

1

-

ABC/3TC/DTG

60/30/5mg

2

-

3

-

4

-

5

-

6

-

-

-

-

--

ABC/3TC/LPV/r

30/15/40/10mg

2

2

3

3

4

4

5

5

6

6

-

-

-

-

 

 

 

 

Formulations and strengths

3.0–

5.9kg

6.0–

9.9kg

10.0–13.9kg

14.0–19.9kg

20.0–24.9kg

25.0–34.9kg

Adolescents and adults >35kg

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

AM

PM

Fixed Dose

Combination Tablets/ Granules

 

 

 

 

 

 

 

 

DTG 50mg

-

-

-

-

-

-

-

-

1

-

1

-

1

-

DTG 10mg

1

-

1.5

-

2

-

2.5

-

3

-

-

-

-

-

EFV 200mg

-

-

-

-

 

1

 

1.5

 

1.5

 

2

-

-

LPV/r 40/10mg1

Oral Granules

2

2

3

3

4

4

5

5

6

6

 

 

-

-

LPV/r

100/25mg2

-

-

-

-

2

1

2

2

2

2

-

-

-

-

LPV/r 200

/50mg

-

-

-

-

-

-

-

-

-

-

2

1

2

2

DRV/r 400/50mg

-

-

-

-

-

-

-

-

-

-

-

-

2

-

ATV/r

300/100mg

-

-

-

-

-

-

-

-

-

-

-

-

 

1

Raltegravir 25mg Chewable Tablet

-

-

-

-

3

3

-

-

-

-

-

-

-

-

Raltegravir 100mg Chewable tablet

-

-

-

-

-

-

1

1

1.5

1.5

-

-

-

-

Raltegravir 400mg

-

-

-

-

-

-

-

-

-

-

1

1

1

1

DRV 75mg Tablets 3

-

-

-

-

3+RTV 0.5ml

3+RTV 0.5m

5+RTV 50mg

5+RTV 50mg

5+RTV 50mg

5+RTV 50mg

-

-

-

-

DRV 150mg

-

-

-

-

-

-

-

-

-

-

4 + RTV 100mg 

4 + RTV 100mg

4 + RTV 100mg

4 + RTV 100mg

DRV 600mg4

-

-

-

-

-

-

-

-

-

-

1 + RTV 100mg

1 + RTV 100mg

1 + RTV 100mg

1 + RTV 100mg

RTV 25mg

 -

-

-

-

-

-

2

2

2

2

-

-

-

-

RTV 100mg

-

-

-

-

-

-

-

-

-

-

1

1

1

1

RTV 200 mg

-

-

-

-

-

-

-

-

-

-

-

-

1

1

For children 10kg that are able to swallow tablets, give LPV/r 100/25mg tablet.

Tablets of LPV/r 100/25mg can be substituted with 1 tablet of LPV/r 200/50mg in order to reduce the pill burden. These tablets should be administered fully intact/whole i.e. not cut or crushed.

DRV must be administered with 0.5mL of RTV 80mg/mL oral suspension in children <15kg, with 2 tab of RTV 25mg in children 15 to 25kg and 3 tab of RTV 25mg in children above 25kg. DRV is always taken with food.

DRV 600mg must be co-administered with RTV 100mg.

 

Mother-to-Child Transmission of HIV

Approximately one-third of the women who are infected with HIV can pass it to their babies.

Cause

Time of transmission

  • During pregnancy (15-20%)
  • During time of labour and delivery (60%-70%)
  • After delivery through breast feeding (15%-20%)

Pre-disposing factors

  • High maternal viral load
  • Depleted maternal immunity (e.g. very low CD4 count)
  • Prolonged rupture of membranes
  • Intra-partum haemorrhage and invasive obstetrical procedures
  • If delivering twins, first twin is at higher risk of infection than second twin
  • Premature baby is at higher risk than term baby
  • Mixed feeding carries a higher risk than exclusive breastfeeding or use of replacement feeding

Investigations

  • Blood: HIV serological test
  • HIV DNA PCR testing of babies (see Diagnosis and Investigation of HIV above)
  • Viral load testing every 6 months

Management

All HIV services for pregnant mothers are offered in the MCH clinic. After delivery, mother and baby will remain in the MCH postnatal clinic till HIV status of the child is confirmed, then they will be transferred to the general ART clinic.

The current policy aims at elimination of Mother-to-Child Transmission (eMTCT) through provision of a continuum of care with the following elements:

  • Primary HIV prevention for men, women and adolescents
  • Prevention of unintended pregnancies among women living with HIV
  • Prevention of HIV transmission from women living with HIV to their infants
  • Provision of treatment, care and support to ALL women infected with HIV, their children and their families

Management of HIV Positive Pregnant Mother

Key Interventions for eMTCT

eMTCT Services for Pregnant Women

Service Description
Provide HTS and syphilis testing in ANC
  • Offer routine HTS and testing for syphilis to pregnant women and their partner(s) with same-day results using the SD- Bioline duo HIV/syphilis test according to algorithm. If found positive treat for syphilis in order to reduce HIV transmission from mother to child using the following:
  • Pregnant women/girls with early syphilis: give Benzathine Penicillin G 2.4 million units intramuscularly once. Early syphilis for this guideline is: (primary, secondary and early latent syphilis of not more than two years’ duration).
  • In late syphilis or unknown stage of syphilis: give Benzathine Penicillin G 2.4 million units intramuscularly once weekly for three consecutive weeks. Late syphilis for this guideline is defined as infection of more than two years’ duration without evidence of treponemal infection.
Note: Adequate maternal treatment for prevention of congenital syphilis is defined as at least one injection of 2.4 million units of intramuscular Benzathine Penicillin at least 30 days prior to delivery.
  •  Alternative treatment with Procaine Penicillin or Erythromycin, Azithromycin and Ceftriaxone if allergic to penicillin
  • Offer syphilis screening using syphilis rapid tests for mothers who are already on ART.
  • Offer HTS (including PITC, VCT and couple testing) and support mutual disclosure.
  • Link all HIV-positive seroconcordant couples as well as HIV-positive individuals in serodiscordant relationships to ART.
  • Offer PrEP to all pregnant and breast- feeding mothers at substantial risk of HIV acquisition as well as negative partners in the discordant couples.
  • For HIV-negative pregnant women, re- test in the third trimester, during labor, or shortly after delivery, because of the
    high risk of acquiring HIV infection during pregnancy.
  • Re-test HIV-negative pregnant women in a discordant relationship every three months.
  • Re-test the following HIV negative pregnant women within four weeks of the first test:
    STI, HBV or TB-infected pregnant women.
  • Those with a specific incident of HIV-exposure within the past three months
    Provide risk reduction counseling to HIV-negative women.
  • Test pregnant women/girls and their partners for Hepatitis B during antenatal
  • For patients who are HBsAg positive, assess the HBeAg and HBV viral load. Patients who are HBeAG negative with a HBV VL of <200,000 IU/ml should be monitored with CBC, LFTs and VL at 6 and 12 months.
  • For patients who are HBsAg positive assess the HBeAg and HBV viral load. Patients who are HBeAg positive with HBV VL of >200,000 IU/ml should initiate prophylactic treatment at 24 weeks gestation or at the earliest contact. Discontinue medication 3 months after delivery. After starting treat- ment, LFTs should be monitored at 4, 8, 12 and 24 weeks and thereafter annually.
  • Monitor HBV viral load at 6 and 12 months
Antenatal care package for all pregnant women (regardless of HIV status)

General care: 

  • All pregnant women/girls should have at least eight ANC visits: encourage and support mothers to start ANC in the first trimester
  • Routinely provide iron, folic acid, and multi- vitamin supplements
  • Deworm in the 2nd trimester using Mebendazole
  • Provide nutrition assessment, counseling and support. Counsel and encourage women to deliver at the health facility
  • Screen for TB and take appropriate action
  • Take weight and BP at every visit

Laboratory services:

  • Screen and treat for syphilis, HIV, hepatitis B, other STIs and anemia. Use syndromic approach to treating STIs
  • Perform urinalysis to detect a urinary tract infection (UTI), protein in the urine (proteinuria), or blood in the urine (hematuria) indicating kidney damage, or sugar in urine suggesting diabetes
  • Do a blood slide for malaria for all pregnant women.
  • Perform a blood group test in anticipation of blood transfusion and check for hereditary conditions if suspected (sickling test)
Laboratory investigations specific to HIV-positive pregnant women
  • For HIV-positive women, perform a baseline CD4 count. The test result is not required for ART initiation.
  • Do Hb test for women/girls beginning AZT-based ART at baseline and four weeks after initiating ART.
  • For HIV-positive pregnant women/girls already on ART, do VL test at first ANC visit, then follow the VL testing algorithm for pregnant and breast feeding women.
  • For newly diagnosed HIV-positive pregnant women/girls, do VL test 3 months after initiating ART and then every 3 months until end of MTCT period
Comprehensive care for pregnant women with HIV

At each visit provide:

  • Comprehensive clinical evaluation
  • Pregnant women on CPT should not be given Sulphadoxine-Pyrimethamine (Fansidar) for intermittent preventive treatment for malaria (IPTp)
  • Screen for TB and take appropriate action
  • INH for eligible women/girls
  • Screening and management of opportunistic infections (OIs)
Assess risk of unborn baby among pregnant women with HIV at ANC 1 Conduct a risk assessment of the unborn baby at 1st ANC among all HIV positive pregnant women and at every visit and flag those at high-risk including:
  • Newly initiated on ART in the 3rd trimester or breastfeeding period
  • Most recent VL is non-suppressed
  • Mothers testing HIV positive later in pregnancy or during breastfeeding
  • Closely monitor all high-risk pregnancies
ART
  • All women/girls living with HIV identified during pregnancy, labour and delivery or while breastfeeding should be started on lifelong ART
  • ART should be initiated on the same day, and adherence counseling should be initiated and sustained intensively for the first three months then maintained for life.
  • Initiate mother on once-daily FDC of TD-F+3TC+DTG with pharmacovigilance
  • The mothers initiated on TDF + 3TC+EFV400 shall be transitioned to TDF + 3TC + DTG at 6-9 months post-partum if VL within past 6 months is suppressed.
  • If mother is already on ART >6 months with TDF/3TC/EFV, do VL test. If she is virally suppressed, maintain her on TDF/3TC/EFV400 until 6-9 months after delivery and then substitute EFV with DTG if VL within the past 6 months is suppressed.
  • If she is already on a DTG-based 1st-line regimen and virally suppressed, maintain on the same regimen.

note: If she is already on ART and VL is not suppressed, manage as treatment failure and switch to DTG-based 2nd line regimen (if no previous exposure to DTG).

  • If she is on 2ndline ART with ATV/r or LPV/r and virally suppressed, maintain on the same regimen until 6-9 months after delivery and then substitute PI with DTG if VL within the past 6 months is suppressed and no previous exposure to DTG.
  • All women should receive Pre-ART adherence counseling before initiating ART and ongoing adherence support after that
  • ART should be initiated and maintained in mother-baby care point in MCH.

What to do if mum refuses ART or if you know adherence is poor:

Maternal VL suppression is key for preventing breastfeeding transmission, so if VL suppression is not certain infant prophylaxis may serve as a “back up” to prevent MTCT - similar to “Option A”. Clinical providers should continue infant prophylaxis with NVP for these specific scenarios. Continuation of prophylaxis should be seen as an interim measure while maternal adherence is improved
Risk reduction, counselling and support

Encourage consistent and correct condom use

Encourage women to deliver at the health facilities

For negative pregnant women, offer other prevention services like SMC to partner and mitigate or manage GBV
Visit schedules for HIV-infected pregnant women

HIV-positive pregnant woman/ girl already on ART and stable:

  1. Stable pregnant and breastfeeding mother
  2. Viral suppression
  3. Adherence above 95%
  4. On ART for more
    than one-year Stage T1 and no active OIs
  5. Not due for vital lab
    tests in the next two months, e.g., viral load
  6. Has disclosed to significant other/ household member/ family member

• 8 ANC visits
• Synchronize ART refills and adherence support with the ANC visits

HIV-positive pregnant woman/girl initiating ART in ANC (new clients):

  1. Unstable pregnant and breastfeeding women/ adolescent girl
  2. Recently initiated on ART (less than one year on ART)
  3. Poor viral suppression: most recent VL
  4. Adherence less than 95%
  5. Stage T3,4 and active OIs (Comorbidities/ co-infection, CD4 less than 500)
  6. Due for vital lab tests in the next two months, e.g., viral load
  7. Has not disclosed to significant other/ household member/ family member
  • Two weeks after initiating ART
  • After that, monthly until delivery
  • Follow routine MCH schedule after delivery together with the exposed infant visit schedule

HIV exposed infant care services

Service Description
Identification of HIV-exposed infants
  • Identify all HIV-exposed infants; document the HIV status of the mother in the child card and mothers’ passport.
  • Infants whose HIV status
    is not documented or is unknown should be offered rapid HIV testing; including those whose mothers did not receive eMTCT services or have become newly infected after pregnancy.

-Rapid diagnostic tests for HIV serology can be used to assess HIV exposure among infants younger than four months of age.

-HIV-exposure status among infants and children 4–18 months of age should therefore be ascertained by HIV serological testing the mother.

-The mother should be tested every 3 months until end of breastfeeding. The entry points for identification of HIV-ex- posed infants include YCC, OPD pediatric/ Nutrition/TB wards and outreaches.

-Special attention should be paid during immunization both at static and outreach areas to ensure that all
children have their exposure status ascertained
HIV testing for infants 

Follow the infant testing algorithm in to test and interpret the test results:
• Provide 1st PCR within 4-6 weeks or the earliest opportunity thereafter.
• Provide 2nd PCR at 9months thereafter
• Provide 3rdPCR 6 weeks after cessation of breastfeeding
• Do DBS for confirmatory DNA PCR for all infants who test positive on the day they start ART
• Do a DNA PCR test for all HEI who develop signs/symptoms suggestive of HIV during follow-up, irrespective of breastfeeding status.
• Conduct rapid HIV test at 18 months for all infants who test negative at 1st, 2nd and 3rd PCR
*** Where available Point-of-care nucleic acid testing should be used to diagnose HIV among infants and children younger than 18 months of age
• 8 ANC visits

  • ART for mothers and ePNP causing low viral particles difficult to detect, sometimes below cycle threshold.

An indeterminate range of viral copy equivalents should be used to improve the accuracy of all nucleic acid–based early infant diagnosis assays

  • Indeterminate range: a range of viral copy equivalents that would be too low to be accurately diagnosed as HIV infected. The indeterminate range suggested is currently estimated to be approximately equivalent to a cycle threshold of 33 on the Roche COBAS® Ampliprep/COBAS® TaqMan® HIV-1 Qualitative Test v2.0 assay

•Indeterminate range: a range of viral copy equivalents that would be too low to be accurately diagnosed as HIV infected. The indeterminate range suggested is currently estimated to be approximately equivalent to a cycle threshold of 33 on the Roche COBAS® Ampliprep/COBAS® TaqMan® HIV-1 Qualitative Test v2.0 assay

Guidance for indeterminate test:

  • Take off whole blood and test at CPHL and transport within 2 days
  • Hold off ART until results of whole blood.
  • Communicating results to caregiver
  • Testing intervals for infants with repeated discordant results 4 weeks, 4 months, 8 months
Routine immunization HIV-infected children are more susceptible to diseases preventable by immunization than their HIV-uninfected counterparts.
• HIV-infected infants and children can safely receive most childhood vaccines if given at the right time. All HIV-infected and exposed children should be immunized as per EPI immunization schedule.
• Health workers should review child immunization status at every visit
• Some special considerations/modifications for HIV-exposed children:
  1.  BCG: When considering BCG vaccination at a later age (re-vaccination for no scar or missed earlier vaccination), exclude symptomatic HIV infection. Children with symptomatic HIV infection should not receive BCG.
  2. Measles: Although the measles vaccine is a live vaccine, it should be given at six and nine months even when the child has symptoms of HIV. The measles illness from the vaccine is milder than that from the wild measles virus, which is more severe and likely to cause death.
  3. Yellow Fever: Do not give yellow fever vaccine to symptomatic HIV-infected children; asymptomatic children in endemic areas should receive the vaccine at nine months of age
Growth  monitoring and nutritional assessment 
  • Growth and child nutrition should be monitored using weight, length/height, and MUAC at all encounters with a child, and recorded on the growth monitoring card
  • MUAC should only be measured starting at six months of age.
  • Failure to gain weight or height, slow weight or height gain, and loss of weight may be an indication of HIV infection in an infant/young child. Failure to thrive affects as many as 50% of HIV-infected infants and children. HIV-infected infants and children who are failing to thrive have a significantly increased risk of mortality.
  • Counsel the mother/caregiver on the child’s growth trend and take appropriate action where necessary.
Development monitoring
  •  At each visit assess the infant’s age-specific developmental milestones.
  • Infants are at high risk for HIV encephalopathy and severe neurologic disease
  • Early identification of developmental delay can facilitate intervention and these children can improve with treatment.
  • Some forms of development delay are

The child may reach some developmental milestones but not others.

The child may reach some milestones but lose them after some time.
The child may fail to reach any developmental milestones at all.

  • Test children with developmental delay for HIV and, if infected, initiate on ART.
  • Measure the infant’s head circumference.
Early Childhood Development
  •  The first two years of life are the most critical for brain development and influences during this period significantly contribute to longer-term developmental outcomes.
  • ECD therefore comprises all the essential care and support a young child needs to survive and thrive in life and spans the period from prenatal to eight years of age across multiple domains consisting of physical, cognitive, language and communication, social and emotional and spiritual development. Years 0-8 most critical stage of life because the brain undergoes most dramatic growth
  • It is well established that infants and young children exposed or affected by HIV have poorer health and developmental outcomes compared to their non-HIV affected peers. Prevention of mother- to-child transmission (PMTCT) services, which focus on mothers and infants throughout the exposure period provide an ideal platform during a period of life that affects both longer-term health and developmental potential, moreover, the services along the PMTCT cascade are well aligned with intervention points for ECD.
  • ECD services and messages will therefore be well integrated into PMTCT/HEI services to improve outcomes of HEI
ARV prophylaxis
  • Provide NVP syrup to HEI from birth until six weeks of age.
  • For high-risk infants, give NVP syrup from birth until 12 weeks of age.
  • High-risk infants are breastfeeding infants whose mothers:

Have received ART for four weeks or less before delivery; or

Have VL >1000 pies in four weeks before delivery; or

Diagnosed with HIV during 3rd trimester or breastfeeding period (postnatal).

What to do if baby presents after 6 weeks:
a. Do first PCR
b. Give ART (First Line Paed regimen; give weight appropriate dose) for 6weeks
c. If PCR results are negative, give NVP for 6 weeks (after completing the 6 weeks of ART)
d. If PCR results are positive, continue with ART first line ART.
Irrespective of timing, the mother should be started on ART as soon as possible for her own health and to decrease risk of transmission to breastfeeding baby.
Opportunistic infection prophylaxis

Cotrimoxazole prophylaxis
Cotrimoxazole (CTX) prophylaxis significantly reduces the incidence and severity of Pneumocystis Jiroveci pneumonia. It also offers protection against common bacterial infections, Toxoplasmosis and Malaria.
• Provide CTX prophylaxis to all HIV-exposed infants from six weeks of age until they are proven to be uninfected.
• Infants who become HIV-infected should continue to receive CTX prophylaxis for life.
• If CTX is contraindicated, offer Dapsone at dose of 2mg/kg once daily (up to 100mg).


TB Preventive Treatment (TPT)
• Give INH for six months to HEI who are ex- posed to TB after excluding TB disease.
• For newborn infants, if the mother has TB disease and has been on anti-TB drugs for at least two weeks before delivery, INH prophylaxis should not be given.


Malaria prevention:
• All HEI and HIV-infected children should receive insecticide treated nets and CTX. Using both reduces risk of malaria by 97%.

Actively look for and treat infections early

HEI are susceptible to common infections and OIs.

Counsel caregivers to seek care to receive timely treatment.

At every visit, assess HEI for signs and symp- toms of common childhood illnesses using the Integrated Maternal, New-born and Childhood Illnesses Guidelines and provide treatment.
Counseling and feeding advice  Provide infant feeding counseling and advice according to guidance.
Educate the caregiver and family
  • HEI depend on their caregivers to receive
  • Provide information to the caregivers and family about the care plan including what to expect and how to provide care for the
  • Caregivers should participate in making decisions and planning care for the child, including decisions about therapy and where the child should receive
  • Empower caregivers to be partners with the health
  • Provide key aspects of home-based care for the child, including:
  • Dispensing prophylaxis and treatment
  • Maintaining adherence
  • Complying with the follow-up schedule
  • Ensuring good personal and food hygiene to pre- vent common infections
  • Seeking prompt treatment for any infections or other health-related problem

The most important thing for the child is to have a healthy mother. Ensure the mother/infected caregiver is receiving their care. If the mother is sick, the infant will not receive care.

When members of the same family such as mother-baby pair are in care, their appointments should be on the same day.
Referrals and Linkage Link the caregiver and HEI to appropriate services like OVC care, psychosocial support including FSG and other community support groups.
ART for infected infants Initiate ART in infants who become infected according to guidance

Care of HIV Exposed Infant

HIV-exposed infants should receive care at the mother-baby care point together with their mothers until they are 18 months of age. The goals of HIV-exposed infant care services are:

  • To prevent the infant from being HIV infected
  • Among those who get infected: to diagnose HIV infection early and treat
  • Offer child survival interventions to prevent early death from preventable childhood illnesses

The HIV Exposed Infant and the mother should consistently visit the health facility at least nine times during that period.

The visits are synchronised with the child’s immunisation schedule (i.e., at 6, 10 and 14 weeks, then at 5, 6, 9, 12, 15 and 18 months).

Management

TREATMENT LOC

Nevirapine prophylaxis

  • Provide NVP suspension from birth for 6 weeks
  • Give NVP for 12 weeks for babies at high risk, that is breastfeeding infants who mothers:
    - Have received ART for 4 weeks or less before
    - delivery; or
    - Have VL >1000 copies in 4 weeks before delivery; or
    - Diagnosed with HIV during 3rd trimester or breastfeeding period (Postnatal)
  • Do PCR at 6 weeks (or at first encounter after
    this age) and start cotrimoxazole prophylaxis
    - If PCR positive, start treatment with ARVs and
    - cotrimoxazole and repeat PCR (for confirmation)
    - If PCR negative and baby never breastfed, child is confirmed HIV negative. Stop cotrimoxazole,
    - continue clinical monitoring and do HIV serology test at 18 months.
    - If PCR negative but baby has breastfed/is breastfeeding, start/continue cotrimoxazole prophylaxis and repeat PCR 6 weeks after stopping breastfeeding
  •  Follow up any exposed child and do PCR if they develop any clinical symptom suggestive of HIV at any time and independently of previously negative results
  • For negative infants, do serology at 18 months before final discharge

Dosages of nevirapine

- Child 0-6 weeks, 2-2.5 Kg: 10 mg once daily (1 ml of syrup 10 mg/ml)
- Child 0-6 weeks, >2.5 kg: 15 mg once daily (1.5 ml of syrup 10 mg/ml)
- Child 6 weeks – 12 weeks: 20 mg once daily (2 ml)

 HC3

Cotrimoxazole prophylaxis

  • Provide cotrimoxazole prophylaxis to all HIV- exposed infants from 6 weeks of age until they are proven to be uninfected.

Dosages:
Child <5 kg: 120 mg once daily Child 5-14.9 kg: 240 mg once daily

  • Infants who become HIV infected should continue to receive cotrimoxazole prophylaxis for life
  • If cotrimoxazole is contraindicated, offer dapsone at a dose of 2 mg/kg once daily ( up to 100 mg max)
 HC2

TB preventive therapy (TPT)

  • Give INH for six months to HIV-exposed infant who are exposed to TB (close contact with PTB case) after excluding TB disease

Dose: Isoniazid 10 mg/kg + pyridoxine 25 mg daily

  • For newborn infants, if the mother has TB disease and has been on anti-TB drugs for at least two weeks before delivery, INH prophylaxis is not required.
 HC3

Immunisation

  •  Immunize HIV exposed children as per national immunisation schedule
  •  In case of missed BCG at birth, do not give if child has symptomatic HIV
  • Avoid yellow fever vaccine in symptomatic HIV
  • Measles vaccine can be given even in symptomatic HIV
  

 

Counselling on infant feeding choice

  • Explain the risks of HIV transmission by breastfeeding (15%) and other risks of not breastfeeding (malnutrition, diarrhoea)
  • Mixed feeding may also increase risk of HIV transmission and diarrhoea
  • Tell her about options for feeding, advantages, and risks
  • Help her to assess choices, decide on the best option, and then support her choice

Feeding options

  • Recommended option: Exclusive breastfeeding then complementary feeding after child is 6 months old
  • Exclusive breastfeeding stopping at 3-6 months old if replacement feeding possible after this
  • If replacement feeding introduced early, mother must stop breastfeeding
  • Replacement feeding with home-prepared formula or commercial formula and then family foods (provided this is acceptable, feasible, safe, and sustainable/ affordable)

If mother chooses breastfeeding

  • The risk may be reduced by keeping the breasts healthy (mastitis and cracked nipples raise HIV infection risk)
  • Advise exclusive breastfeeding for 3-6 months

If mother chooses replacement feeding

  • Counsel and teach her on safe preparation, hygiene, amounts, times to feed the baby
  • Follow up within a week from birth and at any visit to health facility.

Tuberculosis and HIV Co-Infection

Tuberculosis and HIV Co-Infection

Active TB may be present when ART needs to be initiated or it may develop during treatment.

TB and HIV care for co-infected patients should be provided in an integrated manner under one roof by one care team (one-stop-shop).

Co-management of TB and HIV is complicated by:

  • Drug interactions between rifampicin and both the NNRTI and PI classes
  • Immune reconstitution inflammatory syndrome (IRIS)
  • Pill burden, overlapping toxicities and adherence

Management

ART should be initiated in all TB/HIV co-infected people irrespective of their clinical stage or CD4 count. However, the timing of initiation of treatment may differ based on whether the patient is diagnosed with TB before or after initiating ART.

SITUATION

RECOMMENDATIONS

TB patients diagnosed with HIV

Start anti-TB medicines immediately, THEN start ARVs 2 weeks later (see table below)

Patient already on ART, diagnosed with TB

Start anti-TB medicines immediately, adjust regimen as per guidelines below
ADULT TB patients diagnosed with TB but with CD4 <50

 

Start anti-TB medicines immediately, start ARVs before completing 2 weeks

ARV regimen in ART-naive patients on TB treatment

AGE GROUP

RECOMMENDED REGIMEN

Adults, Pregnant and Breastfeeding Women, and Adolescents

TDF+3TC+EFV

Children aged 3 - < 12 years

ABC+3TC+EFV

Children 0 - < 3 years

ABC+3TC+AZT

ARV regimen substitution for patients initiating TB treatment while on ART

 

AGE GROUP

REGIMEN WHEN DIAGNOSED WITH TB

 

RECOMMENDED ACTION/ SUBSTITUTION

Adults, Pregnant and Breastfeeding Women and Adolescents

 

If on EFV- based regimen

Continue with the same regimen but double the dose of DTG (give DTG twice daily)

If on NVP based regimen

Substitute NVP with EFV. If EFV is contraindicated, give DTG as above. If DTG not available, give a triple NRTI regimen (ABC+3TC+AZT).

If on LVP/r based regimen

Continue the same regimen but double the dose of DTG (give DTG twice daily)

If on ATV/r based regimen

Continue the same regimen and give Rifabutin for TB treatment

Children aged 3 - <12 years

 

 

If on EFV- based regimen

Continue the same regimen

If on NVP or based regimen

Substitute NVP with EFV.

If EFV is contraindicated, give a triple NRTI regimen (ABC+3TC+AZT)

LPV/r

Continue the same regimen and give Rifabutin for TB treatment

Children 0 -

<3 years

If on LPV/r or NVP based regimen

Give triple NRTI regimen ABC+3TC+AZT

Second line ART for patients with TB

  • There are significant drug interactions with PIs and rifampicin. 
  • If rifabutin is available, it may be used in place of rifampicin with ATV/r or LPV/r, but it is contraindicated in patients with WBC counts below 1000/mm3.
  • Maintaining PI in second line regimens while switching from Rifampicin to Rifabutin (if available) is ideal

TB prevention

  • BCG immunisation: it protects children against severe forms of TB. It can be given at birth. If delayed, avoid in symptomatic HIV
  • IPT (Isoniazid Preventive Treatment) see Tuberculosis

Cryptococcal Meningitis

Crytococcal meningitis is an opportunistic infection caused by a fungus Cryptococcus neoformans.

In Uganda, cryptococcal meningitis (CM) associated mortality is up to 39%. Patients with a CD4 cell count of <100 are at the highest risk, so early screening and management is critical.

Screening In ART-Naive Patients

  • Screen routinely for Cryptococcal Meningitis with the cryptococcal antigen (CrAg) test (a bedside finger prick test):
    • All ART naive individuals with CD4 <100 cells/µL
    • Patients on ART with viral load (VL >1000 copies/ml) or clinical (stage 3 or 4 disease) failure
  • If serum CrAg negative and no signs of meningitis: start ART immediately (or switch regimen)
  • If CrAg positive and/or signs or symptoms of meningitis (headache, presence of seizures, altered consciousness, photophobia, neck stiffness, and a positive Kernigs’ sign)
    • Perform lumbar puncture and test for CSF CrAg (culture if possible)
  • If CSF CrAg positive, diagnose and treat for Cryptococcal Meningitis
  • If CSF CrAg negative but blood CrAg positive, give pre emptive treatment for asymptomatic cryptococcal disease or non CNS cryptococcal disease

Cryptococcal screening algorithm

 

ART timing with CCM

Decision on which ART regimen to restart should be made according to patient’s history, ART guidelines, HIV viral and genotypic resistance testing if possible. If it is considered likely that the patient has developed resistance to 1st line ARVs, then restart with 2nd line containing boosted PI or DTG is possible. ** Unless documented to have a suppressed viral load at time of admission or within the month prior to admission, in which case continue ART

Management of CCM

Phase Drug Comments LOC
Newly Diagnosed Patient
Induction Phase (2 weeks)

Recommended:
• Amphotericin B liposomal single high dose (10mg/ kg) + Flucytosine
(100mg/kg/day in four divided doses) + Fluconazole 1200mg/ day for 14 days

OR
• Amphotericin B deoxycholate (1mg/kg/day) + Flucytosine (100mg/kg/
day in four divided doses) for 1 week, followed by 1 week of fluconazole
(1200 mg/day for
adults, 12 mg/kg/ day for children and adolescents).

OR

Fluconazole (1200 mg daily for adults, 12 mg/kg/day for children and
adolescents) + Flucytosine (100 mg/kg/ day, divided into four doses per day.

OR
• Amphotericin B deoxycholate (1mg/kg/day) + high-dose Fluconazole
1200mg/day

Preventing Amphotericin toxicity: 

To prevent nephrotoxicity and hypokalemia, for patients on amphotericin deoxycholate do the following:
•Pre-hydration with 1L normal saline before starting the daily Amphotericin B dose.
• Monitor serum potassium and creatinine levels at initiation and at least twice weekly to detect changes in renal function.
• Routine administration of 40 mEq/day (mixed in 500ml NS over 4 hours) of potassium chloride or 1 tablet of 600mg twice daily while on amphotericin B can decrease the incidence of Amphotericin B-related hypokalemia.

• For electrolyte supplementation, two tablets daily of Magnesium Chloride 310 mg or slow Magnesium Chloride 535mg or Magnesium trisilicate 250mg while on amphotericin B
• Consider alternate day Am- photericin B if creatinine is
>3mg/dl.
• To monitor for flucytosine (5FC) toxicity, CBC with differential counts at least twice weekly is recommended

HRRH

H4

HRR
Consolidation phase
(8 weeks)

Fluconazole 800mg/day

OR

(6-12mg/kg/ day in children and adolescents)

 Initiate ART 4–6 weeks after starting CM treatment and there is clinical response to antifungal therapy. H4

Maintenance

Phase (18 months)

Fluconazole 200mg/day

OR

(6 mg/kg/day up to 200mg in children and adolescents)

 Criteria to stop after a minimum of 18 months of maintenance phase:
Adults: VL<1,000 copies/mm3 & CD4 200 or CD4 200 (if
viral load not available) after 12 and 18 months
Children: If CD4>25% or viral suppressed		 h4
Relapse disease  
Presents with a recurrence of symptoms of Meningitis and have a positive cerebrospinal fluid culture following a prior confirmed diagnosis of Cryptococcal Meningitis.  
Evaluate for drug resistance: Send CSF to Central Public Health Laboratory (CPHL) for culture and sensitivity testing, if there are no drug resistance results, re-initiate the induction therapy for two weeks and complete other phases of treatment  
Adequate control of elevated CSF pressure  
• Control of increased intracranial pressure improves survival by 25% in persons with Cryptococcal Meningitis.
• All patients with a CSF Pressure >250mm H2O will need a therapeutic LP the following day to reduce the CSF pressure to <200 mm.
• In the absence of a manometer, one may use an IV giving set to create an improvised manometer measuring the height with a meter stick.
Removing 20-30mL of CSF (even in the absence of a manometer) may be adequate to decrease CSF pressure. Most patients will need 2-3LPs during the induction phase.		  

 

Hepatitis B and HIV Co-Infection

  • Hepatitis B virus (HBV) is the leading cause of chronic liver disease among HIV patients. In Uganda, the prevalence of Hepatitis B among HIV patients is estimated to be at 17%. (see Chronic Hepatitis B Infection for more details)
  • All HIV-infected patients initiating and those failing ART should be routinely screened for HBV infection using Hep B surface Antigen (HBsAg)
  • People living with HIV with a positive HBsAg should have other complementary tests at baseline and repeated every 6 months and these include:
    • A complete blood count
    • Liver function tests: ALT, AST, albumin, bilirubin, PT-INR
    • Liver ultrasound scan: to assess stage of liver fibrosis
  • Repeat tests every 6 months since patients with chronic HBV infection are at increased risk for hepatocellular carcinoma

Management of HBV/HIV co-infection

The goal of HBV/HIV treatment is to prevent dual disease progression and to reduce HBV-related morbidity and mortality.

Treatment

Preferably ART regimen containing:

  • TDF 300 mg + 3TC 300 mg PO once daily for life
  • After 6 months of treatment, patients should be evaluated for HBV treatment failure

If jaundice, malaise and abdominal right upper quadrant pain are present or if liver function tests are abnormal

  • Do HBV DNA (hepatitis viral load) if any of the above is present

Treatment Failure

  • Patients with HB VL >2000 IU/ml at 24 weeks of therapy should be referred for further evaluation and management

Prevention of HBV infection

  • Counseling: emphasize sexual transmission as well as the risks associated with sharing needles and syringes, tattooing or body-piercing
  • Advise patients with chronic HBV disease to avoid alcohol consumption
  • All household members and sexual partners of people living with HIV with HBV should be screened for HBsAG
  • HBV Vaccination is the most effective way to prevent HBV infection and its consequences
    • All HIV-infected patients who test negative on HBsAg should be vaccinated with HBV vaccine
    • All sexual partners and contacts should receive HBV vaccination regardless of whether they are HIV-infected or not

Pneumocystis Pneumonia

Interstitial pneumonitis caused by the parasite Pneumocystis jirovecii (formerly carinii). It is common in severely immunosuppresed patients (e.g. in HIV).

Clinical features

  • Fever
  • Dry cough
  • Shortness of breath (significant hypoxemia)

Investigations

  • Chest x-ray shows characteristic bilateral interstitial infiltrates

Management

Pre-emptive treatment for cryptococcal disease

TREATMENT LOC
Pneumocystis Jirovecii pneumonia
  • Give oxygen if SpO2 <94%
  • Cotrimoxazole 120 mg/kg/daily in 2-4 divided doses for 21 days
- For example cotrimoxazole 480 mg tablets:
- If patient is < 60 kg: give 3 tablets If patient >60 kg: give 4 tablets
  • Plus prednisolone 2 mg/kg daily in 3 divided doses for 5 days, then reduce dose to complete 21 days of treatment

Or (in patients who cannot tolerate or do not respond to cotrimoxazole)

  • Pentamidine 4 mg/kg by IV infusion daily for 21 day

- Reduce dose in renal impairment

-Reduce dose in renal impairment
- Avoid direct bolus injections whenever possible but if unavoidable, never give rapidly
Alternative regimen (21-day course) if above not avail- able/ tolerated
- Clindamycin 600 mg every 8 hours
- Plus dapsone 100 mg daily

HC4

RRH
 

Prophylaxis
Give to all patients with history of PCP infection and consider also for severely immunocompromised patients
- Cotrimoxazole 960 mg daily

or
- Dapsone 100 mg daily
- Continue until immunity recovers sufficiently

  

 

Other Diseases

People living with HIV are at higher risk of acquiring any other infection and diseases, including non-communicable diseases, due to HIV itself and drug side effects.

  • Treat any other infection (e.g. malaria, STI) as per guidelines for the general population
  • Screen regularly for NCD (diabetes, hypertension and depression)
  • Screen women at enrolment in HIV care and then annually for cervical cancer using Visual Inspection with Acetic Acid (VIA)

Prevention of HIV

Behavioural change

  • Always follow safe sex practices (e.g. use condoms; avoid multiple sexual partners)
  • Never share used needles, syringes, razors, hair shavers, nail cutters, and other sharp objects
  • Avoid tattooing, body-piercing, and scarification unless carried out under strictly hygenic conditions in properly controlled premises
  • Delay start of sexual activity in adolescence
  • Discourage cross generational and transactional sex
  • Avoid violence and abuse

Biomedical prevention interventions

  • PMTCT
  • Safe Male Circumcision
  • ART with viral suppression
  • PEP (Post Exposure Prophylaxis)
  • PrEP (Pre Exposure Prophylaxis)
  • Blood transfusion safety
  • STI screening and treatment
  • Safe infusion and injection practices
  • Adherence to infection control procedures

Post-Exposure Prophylaxis  Post-exposure prophylaxis (PEP) is the short-term use of ARVs to reduce the likelihood of acquiring HIV infection after potential occupational or non-occupational exposure.

Types of Exposure:

  • Occupational exposures: Occur in health care settings and include sharps and needlestick injuries or splashes of body fluids to the skin and mucous membranes
  • Non-occupational exposures: Include unprotected sex, exposure following assault like in rape & defilement, road traffic accidents and injuries at construction sites where exposure to body fluids occur

Steps in providing PEP

TREATMENT LOC
Step 1: Rapid assessment and first aid
Conduct a rapid assessment of the client to assess exposure and risk and provide immediate care
Occupation exposure:
After a needle stick or sharp injury:
  • Do not squeeze or rub the injury site
  • Wash the site immediately with soap or mild disinfectant (chlorhexidine gluconate solution) or, use antiseptic hand rub/ gel if no running water (do not use strong irritating antiseptics (like bleach or iodine)
After a splash of blood or body fluids in contact with intact skin/broken:
  • Wash the area immediately or use antiseptic hand rub/ gel if no running water (don’t use strong irritating antiseptics)
After a splash of blood or body fluids contact with mucosae:
  • Wash abundantly with water
 HC2

Step 2: Eligibility assessment

Provide PEP when:
- Exposure occurred within the past 72 hours; and
- The exposed individual is not infected with HIV;
and
- The ‘source’ is HIV-infected or has unknown HIV status or high risk
Do not provide PEP when:
- The exposed individual is already HIV positive;
- When the source is established to be HIV negative;

– Exposure to bodily fluids that do not pose a
significant risk: e.g. to tears, non-blood-stained saliva, urine, and sweat, or small splashes on intact skin
– Exposed people who decline an HIV test

  
Step 3: Counseling and support
  • Counsel on:
- The risk of HIV from the exposure
- Risks and benefits of PEP
- Side effects of ARVs
- Provide enhanced adherence counseling if PEP is prescribed
- Link for further support for sexual assault cases (see below)		  

Step 4: Prescription

  • PEP should be started as early as possible, and not beyond 72 hours from exposure
  • Recommended regimens:
    • Adults : TDF+3TC+ATV/r
    • Children: ABC+3TC+LPV/r
  • A complete course of PEP should run for 28 days
  • Do not delay the first doses because of lack of baseline HIV Test
  

Step 5: Follow up

  • To monitor adherence and manage side effects
  • Discontinue PEP after 28 days
  • Perform follow-up HIV testing 6-week, 3 and 6 months after exposure
    • If HIV infected, provide counseling and link to
    • HIV clinic for care and treatment
    • If HIV uninfected, provide HIV prevention education/risk reduction

 

  

 

Post-rape care (see also Sexual Assault/Rape)

Health facilities should provide the following clinical services as part of post-rape care:

  • Initial assessment of the client
  • Rapid HIV testing and referral to care and treatment if HIV-infected
  • Post-exposure prophylaxis (PEP) for HIV
  • STI screening/testing and treatment
  • Forensic interviews and examinations
  • Emergency contraception – if person reached within the first 72 hours
  • Counselling

The health facility should also identify, refer and link clients to non-clinical services

  • Some of the services include the following:
  • Long term psycho-social support
  • Legal counseling
  • Police investigations, restraining orders
  • Child protection services (e.g. emergency out of family care, reintegration into family care or permanent options when reintegration into family is impossible)
  • Economic empowerment
  • Emergency shelters
  • Long-term case management

Reporting: Health facilities should use HMIS 105 to report Gender Based Violence (GBV)

 

Pre-Exposure Prophylaxis (PrEP)

Oral Pre-Exposure Prophylaxis (PrEP)

Definition: PrEP is the use of ARV drugs by HIV uninfected persons to prevent the acquisition of HIV before exposure to HIV. Table below describes processes involved in offering PrEP.

The process of providing pre-exposure prophylaxis (PrEP)

Process Description
Screening for risk of HIV

PrEP provides an effective additional biomedical prevention option for HIV-negative people at substantial risk of acquiring HIV infection. These include people who:

  1. Live in discordant sexual relationships
  2. Have had unprotected vaginal sexual intercourse with more than one partner of unknown HIV status in the past six months
  3. Have had anal sexual intercourse in the past six months
  4. Have had sex in exchange for money, goods or a service in the last six months
  5. Use or abuse of drugs especially injectable drugs in the last six months
  6. Have had more than one episode of a STI within the last twelve months
  7. Are part of a discordant couple, especially if the HIV-positive partner is not on ART or has been on ART for less than six months or not virally
  8. Recurrent post-exposure prophylaxis (PEP) (Re- current implies PEP use more than 3 times a years).
  9. Are members of key or priority populations who are unable or unwilling to achieve consistent use of condoms

NB: Eligibility is likely to be more prevalent in populations such as discordant couple, sex workers, fisher folk, long-distance truck drivers, men who have sex with men (MSM), uniformed forces, and adolescents and young women including pregnant and lactating AGYW at substantial risk.
Screening for PrEP eligibility

After meeting the substantial risk for HIV criteria:

  • Confirm HIV-negative status using the national HTS algorithm
  • Rule out signs and symptoms of acute HIV infection
  • Assess for hepatitis B infection: if negative, patient is eligible for PrEP; if positive, refer patient for Hepatitis B management.

Note:

HEP B positive test is not a contraindication for initiating PrEP, however precaution needs to be taken when making a decision to stop PrEP to avoid HEP B viral load flare.
  • Creatinine test and creatinine clearance calculation using GFR formula is Do not offer PrEP if Creatinine clearance is less than 1.2mg/dl.

Note: Absence of this should not delay PrEP initiation in persons with no signs and symptoms of renal impairment. If available, creatinine test can be done at initiation and repeated every 6 months.

 
Steps to initiation of PrEP
  • Assess for contraindications to TDF/FTC or TDF/3TC.
  • Provide risk-reduction and PrEP medication adherence counseling
  • Provide condoms and education on their use
  • Initiate a medication adherence plan
  • Prescribe a once-daily pill of TDF (300mg) and FTC (200mg) or TDF (300mg)/ 3TC (300mg)
  • Initially, provide a 1-month TDF/FTC or TDF/3TC prescription (1 tablet orally, daily) together with a 1-month follow-up date
  • Counsel client on side effects of TDF/FTC or TDF/3TC
Follow-up/ monitoring clients on PrEP
  • After the initial visit, the patient should be given a two- month follow-up appointment and thereafter quarterly appointments
  • Perform an HIV antibody test using the national HTS algorithm and every three months. Note: Blood based HIVST is an alternative for PrEP refill in case of absence of the national HTS standard recommended in patients on PrEP.
  • For women, perform a pregnancy test if there is history of amenorrhea.
  • Review the patient’s understanding of PrEP, any barriers to adherence, tolerance to the medication as well as any side effects.
  • Review the patient’s risk exposure profile and perform risk-reduction
  • Evaluate and support PrEP adherence at each clinic
  • Evaluate the patient for any symptoms of STIs at every visit and treat according to current STI treatment Guidelines.
Guidance on dis- continuing PrEP
  • Acquisition of HIV infection
  • Suspected signs and symptoms of acute HIV infection following a recent exposure within 4 weeks
  • Changed life situations resulting in lowered risk of HIV acquisition (no longer at substantial risk of HIV acquisition)
  • Intolerable toxicities and side effects of ARVs
  • Chronic non-adherence to the prescribed regimen despite efforts to improve daily pill-taking.
  • Personal choice
  • HIV-negative in a sero-discordant relationship when the positive partner on ART for >6months has achieved sustained viral load suppression (condoms should still be used consistently). The HIV negative partner can be allowed to continue PrEP even if the positive partner is virally suppressed if they choose to.
For detailed guidance on the provision of PrEP, please refer to the Technical Guidance on Pre-Exposure Prophylaxis for Persons at High Risk of HIV in Uganda, 2022.

 

The PrEP Ring

The PrEP ring is a long-acting HIV prevention method developed specifically for clients who are unable or do not want to take oral PrEP or when oral PrEP is not available. The ring is made of a flexible silicone material containing 25 mg of an ARV drug called dapivirine. It is inserted into the vagina and should remain in place for one month. Dapivirine belongs to a class of ARVs called non-nucleoside reverse transcriptase inhibitors (NNRTI) that reduce the ability of HIV to replicate itself inside a healthy cell. The ring delivers the drug directly to the site of potential infection over the course of one month, with low absorption elsewhere in the body, lowering the likelihood of systemic side effects.

Possible Side Effects of the PrEP Ring

Possible side effects of the ring are typically mild and include urinary tract infections (UTIs – experienced by about 15% of users), vaginal dis- charge (experienced by about 7% of users), vulvar itching (experienced by about 6% of users), and pelvic and lower abdominal pain (experienced by about 6% of users).

Contraindications for PrEP Ring Use

The ring should not be provided to people with:

  • An HIV-positive test result according to the national HIV testing algorithm
  • Known exposure to HIV in the past 72 hours (because such clients may derive more benefit from post-exposure prophylaxis (PEP) if the potential for HIV exposure was high)
  • Signs of AHI (Box 1) AND potential exposure within the past 14 days
  • Inability to commit to effectively using the ring and attend scheduled follow-up visits
  • Allergy or hypersensitivity to active substance or other substances listed in the product information sheet

                                                                                          

Long acting injectable cabotegravir (CAB-LA)

The long acting injectable cabotegravir: Is a long acting injectable drug containing Cabotegravir, an integrase inhibitor, is effective in preventing HIV among people at high risk of acquiring HIV.

It is indicated in all HIV negative persons at high risk of HIV.

Before initiation, individuals must be screened for HIV using the national HTS algorithm and rule out signs of Acute HIV infection as for oral PrEP.

  • Administration: Its administrated in the buttock once every 8 weeks
  • Side effects: The injectable cabotegravir is safe and well-
  • Efficacy/Effectiveness: The injectable cabotegravir was found to be over 95% effective
  • Safety: No safety concerns have been associated
  • Acceptability and barriers: In a study setting it was highly acceptable
  • Contraindications: Hypersensitivity to active substance

Note: For detailed guidance on the provision of CAB-LA, please refer to the Technical Guidance on Pre-Exposure Prophylaxis for Persons at High Risk of HIV in Uganda, 2022.

Psychosocial Support for HIV Positive Persons

HIV positive persons benefit greatly from the following support after the first impact of the test result is overcome:

  • Provide of emotional support
  • Help the person understand the social, medical, and psychological implications for him/herself, the unborn child (in the case of a pregnant woman), and any sexual partners
  • Connect the person with support services, including (religious) support groups, orphan care, income- generating activities, home care and others
  • Help the person find strategies to involve his/her partner and extended family in sharing responsibility
  • Help the person identify someone from the community to support and care for him/her
  • Discuss with HIV positive mothers how to provide for the other children in the family
  • Help him/her identify a person from the extended family or community who will provide support
  • As appropriate, confirm and support information given in HIV counselling and testing on mother-to-child transmission, possibility of ARV treatment, safer sex, infant feeding and FP advice
  • Help the person to understand and develop strategies to apply new information within daily life.