Master HIV prevention strategies, counselling, and ethical issues with targeted questions and detailed explanations (50 questions): Through targeted clinical questions and in-depth answer explanations, this section helps you master key HIV prevention strategies, including PEP, PrEP and safe exposure management. You will also test your understanding of HIV counselling and ethical challenges around confidentiality and disclosure, strengthening your ability to support HIV-negative individuals in real-world settings.

📓 HIV PREVENTION IN ADULTS AND CHILDREN

POST EXPOSURE PROPHYLAXIS

Post-exposure prophylaxis (PEP) is used not only for preventing HIV transmission, but also for the prevention of HBV and HCV. In this section, we will focus on HIV prevention.  The first step is to assess the exposure by determining:

1. the type of fluid involved, and
2. the nature of the exposure to the potentially infectious body fluids.

Types of fluid: 

• Infectious fluids: blood, intimate fluids (semen, vaginal sections), tissue/wound fluids, CSF, synovial, pleural, peritoneal, pericardial, amniotic fluid and breast milk
• Non-infectious fluids: tears, non-bloodstained saliva, sweat, urine or stool.

Nature of exposure to infectious body fluids: 

• Occupational: needle-stick injuries, splashes, exposure of non-intact skin to blood or body fluids 
• Sexual: assault involving vaginal or rectal penetration, unprotected consensual sex, broken condoms. All must be provided PEP despite clinical findings, and ensure adequate documentation. All cases of suspected or alleged assault involving children must be reported to the relevant authorities. 
• Inadvertent: needle sharing, accidental injury of improperly disposed sharps or medical waste, blood exposure via contact sport, contact with body fluids at accident scenes (e.g., MVA), tattooing, violent assaults (e.g., same knife or bullet injuring multiple people)

PEP after exposure  Key considerations to assess PEP eligibility include:

• time since exposure (within 72 hours of exposure)
• mechanisms of exposure
• type of fluid exposure
• pre-existing medical conditions
• immune status (e.g., against HBV)
• pregnancy status. 

When is PEP not indicated? 

• Exposed individual is HIV positive 
• Source is confirmed HIV negative and the window period has been excluded 
• Exposure to low risk non-infectious bodily fluids 

Baseline investigations for the source and exposed individual: 

• HIV: HIV rapid and ELISA for both source and exposed individual 
• HepB: HBsAg for source individual, and HBsAb for the exposed individual 
• HepC: HCV antibody for the source, and only for the exposed individual if the risk of exposure is high or if the source is positive or HCV status is unknown 
• Pregnancy: Beta-HCG for women of child-bearing potential (WOCBP) if a sexual exposure occurred
• Creatinine for exposed individuals if TDF will be used for PEP, and FBC if AZT will be used. 

HIV PEP regimens (28 days)

• Children <10 years old and <30 kg: AZT + 3TC + DTG
  (Aligned with SAHCS 2023 PEP recommendations — updated to replace AZT + 3TC + LPV/r with DTG due to its higher genetic barrier to resistance, improved tolerability, and once-daily dosing.)
• Children ≥10 years old or ≥30 kg + Adults: TDF + 3TC + DTG

Note: The NDoH 2020 PEP Guideline recommended AZT + 3TC + LPV/r for children <10 years old and <20 kg, but this has now been replaced by AZT + 3TC + DTG according to the updated evidence and recommendations in the SAHCS 2023 guidelines Secondary Prevention during PEP  remember to add practical reminders:

• consistent condom use whilst on PEP
• Avoid pregnancy, breastfeeding, and donating blood/organs until final HIV testing at 12 weeks post-exposure

HIV test follow-up timeline on PEP

• Test HIV status at week 0 (baseline), week 4, and week 12 post-exposure

PrEP FOR HIV NEGATIVE PERSONS

Pre-Exposure Prophylaxis (PrEP)

PrEP is a highly effective intervention for preventing HIV acquisition. Importantly, it should be offered to any individual who requests it, regardless of clinician perceived risk. This person-centred approach helps reduce stigma and improve access. That said, certain groups are considered higher risk and may particularly benefit from PrEP.  

This includes: 

• Patients who have taken repeated courses of PEP
• men who have sex with men (MSM)
• sex workers
• people with multiple sexual partners
• individuals with a recent or concurrent sexually transmitted infection (STI)
• IV drug users
• adolescents and young adults
• serodiscordant couples
• pregnant or breastfeeding women who are at risk of HIV.

Oral PrEP

The standard PrEP regimen consists of two antiretroviral drugs: Tenofovir disoproxil fumarate plus emtricitabine (TDF + FTC). The fixed-dose combination (FDC) containing TDF and FTC is called Truvada.

It is important to counsel individuals that PrEP requires at least 7 days of daily dosing before it becomes effective. 

Contraindications and renal thresholds

Oral PrEP should not be used in people living with HIV or in those with significant renal impairment:

• Adults and adolescents over 16 years with eGFR <50 mL/min
• Adolescents aged 10–16 years with eGFR <80 mL/min
• Pregnant people with serum creatinine >85 µmol/L
• Specialist input is required if PrEP is indicated despite renal impairment.

Baseline investigations before starting PrEP

Before initiating PrEP, several baseline investigations are required. These include an HIV test to confirm negative status, creatinine and eGFR to assess renal function, hepatitis B surface antigen (HBsAg), STI screening, and a pregnancy test when applicable.

• If HBsAg is negative: assess eligibility for hepatitis B vaccination
• If HBsAg is positive: perform liver function tests.

Renal monitoring requirements depend on age, comorbidities, and pregnancy status. 

• < 30 years: no routine monitoring required
• ≥ 30 years: baseline creatinine required
• History of diabetes or hypertension: baseline and annual creatinine
• Pregnancy: creatinine at baseline, 3 months, and 6 months

Transitioning from PEP to PrEP

• Important for patient who have taken repeated courses of PEP (i.e. recurrent PEP needs)→ transition to PrEP
• Confirm HIV negative status after PEP course → if negative: start PrEP 
• Do not delay PrEP if there is an ongoing risk

Long-Acting and Alternative PrEP Modalities

Cabotegravir long-acting (CAB-LA)

• injectable integrase strand transfer inhibitor
• Route of administration: intramuscular injection
• Dosing schedule: 0 months, 1 month, then every 2 months thereafter
• Onset of protection: Protection starts approximately 1 week after the first injection. 
• Registered by SAHPRA since late 2022
• Limitation: Costly – Public sector rollout limited. Widespread private sector use only expected once generics become available
• Side effects: 
• • Injection site reactions are common and include pain, swelling, induration, and erythema
  • Systemic effects may include headache, fatigue, fever, and myalgia
  • Generally mild to moderate and self-limiting
  • Rare risk of integrase resistance if started during undiagnosed acute HIV infection

Dapivirine vaginal ring (DVR)

• NNRTI
• Route of administration: Intravaginal
• Dosing schedule: slow-release formulation designed for use over 1 month.
• Mechanism: Acts locally in the vaginal mucosa
• Limitation: Provides protection only against HIV acquisition during vaginal sex, not other forms of exposure. Currently available only in the private sector in South Africa
• Side effects: 
• • Local vaginal irritation, discharge, or discomfort
  • Minimal systemic side effects due to low systemic absorption
  • No renal or bone toxicity

Lenacapavir (LEN)

• First-in-class capsid inhibitor
• Route of administration: Subcutaneous injection
• Dosing schedule: 6 monthly injections
• Approved by SAHPRA for HIV prevention in adults and adolescents weighing at least 35 kg
• Initiation regimen: 
• Oral Loading dose:
  • Day 1 and 2: 600mg Lenacapavir orally daily (i.e. two 300mg tablets each day)
  • Day 8: 300mg Lenacapavir (one tablet )
• Injection phase:
  • Day 15: 927 mg subcutaneous lenacapavir, administered as two injections on the same day
• Maintenance regimen: 
  • 927 mg subcutaneously every 6 months (26 weeks)
  • Next dose should be given no later than 28 weeks after previous injection

• Side effects: 
  • Injection site reactions are the most common adverse effect, including nodules and induration
  • Mild gastrointestinal symptoms such as nausea may occur during oral lead-in
  • No significant renal or bone toxicity
  • Long half-life raises concern for resistance if HIV is acquired during sub-therapeutic drug tail

• Lenacapavir Trials:
  • PURPOSE 1 trial showed 100 percent efficacy in cisgender women aged 16–25 years
  • PURPOSE 2 showed a 96 percent reduction in HIV acquisition across diverse populations

HIV testing while on PrEP

• Before initiation
• One month after starting
• Thereafter at every follow-up before repeat PrEP is issued

Testing intervals:

• Oral PrEP and dapivirine vaginal ring: every 3 months
• CAB-LA: every 2 months
• LEN: at every 6-monthly injection visit
• If acute HIV infection is suspected, delay follow up PrEP and perform additional testing where available

For CAB-LA, HIV RNA or NAAT testing may be considered if available to reduce the risk of initiating long-acting PrEP during acute HIV infection and subsequent integrase resistance. This must be balanced against delays in PrEP initiation.

PrEP in Pregnancy and Lactation

Pregnancy and the postpartum period are associated with a more than two-fold increased risk of HIV acquisition, and new maternal infection carries a high risk of vertical transmission. PrEP is therefore recommended for all pregnant and lactating people at risk of HIV.

Approved options in South Africa as of 2025

• Daily oral PrEP
• CAB-LA after risk benefit counselling

Safety highlights

• Oral PrEP: Extensive data show no increase in adverse pregnancy or infant outcomes. Mild side effects such as nausea or fatigue may occur and often overlap with early pregnancy symptoms.
• CAB-LA: Well tolerated in pregnancy, with no increase in congenital abnormalities or pregnancy loss. Drug levels decline in late pregnancy but remain protective. No dose adjustment is currently required.
• DVR: Not approved for pregnancy by SAHPRA, but emerging data suggest safety in pregnancy and breastfeeding, with minimal infant exposure.
• LEN: not yet approved for use in pregnancy in South Africa. Data from the PURPOSE studies show no safety signals in participants who became pregnant, but these data are still considered insufficient for formal approval.

Counselling principles

PrEP choice during pregnancy and lactation should be individualised, weighing HIV risk against potential side effects. Anticipatory counselling and reassurance improve adherence and continuation.

HIV PREVENTION: INFANT PROPHYLAXIS

Infants born to mothers with HIV require timely and appropriate prophylaxis to reduce the risk of vertical transmission. At birth, all neonates are treated as “high risk” and started on dual prophylaxis with AZT and NVP while awaiting the mother’s delivery VL result. Ongoing management is determined by a risk stratification process that considers maternal VL at delivery, whether the mother is on antiretroviral therapy (ART), her feeding method (breastfeeding or formula), and whether the infant has been abandoned. Risk stratification

• Low Risk: Mother on ART with VL < 50 copies/mL at delivery
• High Risk – Breastfeeding: Mother on ART with VL ≥ 50 copies/mL at delivery, or mother not on ART or diagnosed HIV positive during breastfeeding or after a history of breastfeeding.
• High Risk – Formula Feeding: Mother on ART with VL ≥ 50 copies/mL at delivery, mother not on ART, and/or an abandoned baby (with positive HIV antibody test indicating exposure)
• Undefined Risk: Mother diagnosed HIV positive after the baby is born and never breastfeed or stopped breastfeeding more than 1 week ago

Management based on risk category 

• Low Risk: Stop AZT and complete 6 full weeks of once-daily NVP
• High Risk – Breastfeeding: Give 12 weeks of NVP (minimum) and continue until the maternal VL is suppressed (<50 copies/mL) or 4 weeks after breastfeeding stops, whichever is later; and 6 weeks twice-daily AZT
• High Risk – Formula Feeding: 6 weeks of once-daily NVP and 6 weeks of twice-daily AZT
• Undefined Risk: No Infant ARV prophylaxis required 

If a birth PCR is positive, indicating HIV infection, infant prophylaxis should be stopped and full antiretroviral therapy (ART) should be initiated immediately. A confirmatory PCR must be performed on a new sample. Do not wait for confirmatory PCR results before initiating ART. Co-trimoxazole prophylaxis (CPT) should be started no earlier than six weeks of age and is now only recommended in confirmed HIV positive infants not HIV-exposed infants due to rising concerns about antibiotic resistance and its benefit being less clear in HIV-exposed, uninfected infants. It is essential that all HIV-exposed infants have a birth PCR performed within the first 7 days of life, regardless of risk category.

Counselling: Prevention 

When counselling about PEP or PrEP the following should be addressed: 

• Potential conditions that the individual may be exposed to
• Testing and consent (all those >12 years of age can consent to testing, if less than 12 will need to consider if they are ‘sufficiently mature’ otherwise will require consent from the caregiver or provincial head of the Department of Social Development.
• Risk, benefits, and efficacy of PEP/PrEP 
• How to take PEP/PrEP – start as soon as possible, adhere to daily doses and complete the full course as prescribed

Legal and ethical considerations

• Health care professionals 
  • Consent for disclosure of HIV status is required. Consent from a child can be given if older than 12 or if of sufficient maturity. Disclosure without consent may be justified in specific cases, for example if it is done for the public’s interest, or has been court-ordered. 
  • HCPs should encourage HIV positive patients to voluntarily disclose their status to their partners. If they persistently refuse, at the HCPs carefully considered discretion, they may choose to disclose a patient’s HIV status to their sexual partner and encourage VCT. Risks include HIV infection of the partner and risk of violence towards the partner. 
• Patient: Currently no law in SA states that it is an offence to withhold, transmit, or reveal one’s HIV status to consenting adult partner during a sexual activity. However, cases exist highlighting potential criminal liability for those who knowingly expose their partners. Health care professionals have the responsibility to counsel and educate about voluntary disclosure and safe practices