About the Author(s)


Pippa Macdonald symbol
The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

Gonasagrie Nair symbol
The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

Camilla Wattrus Email symbol
Southern African HIV Clinicians Society (SAHCS), Johannesburg, South Africa

Saiqa Mullick symbol
Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Melanie Pleaner symbol
Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Elzette Rousseau symbol
The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

Hasina Subedar symbol
National Department of Health, Pretoria, South Africa

Dvora Joseph-Davey symbol
Division of Infectious Diseases, University of California Los Angeles, Los Angeles, United States of America

Department of Epidemiology and Biostatistics, University of Cape Town, Cape Town, South Africa

Johan Hugo symbol
Anova Health Institute, Cape Town, South Africa

Sinead Delany-Moretlwe symbol
Wits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Linda-Gail Bekker symbol
The Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa

Citation


Macdonald P, Nair G, Wattrus C, et al. Southern African HIV Clinicians Society guideline on pre-exposure prophylaxis to prevent HIV. S Afr J HIV Med. 2025;26(1), a1713. https://doi.org/10.4102/sajhivmed.v26i1.1713

Guideline

Southern African HIV Clinicians Society guideline on pre-exposure prophylaxis to prevent HIV

Pippa Macdonald, Gonasagrie Nair, Camilla Wattrus, Saiqa Mullick, Melanie Pleaner, Elzette Rousseau, Hasina Subedar, Dvora Joseph-Davey, Johan Hugo, Sinead Delany-Moretlwe, Linda-Gail Bekker

Received: 18 Feb. 2025; Accepted: 19 Feb. 2025; Published: 11 Apr. 2025

Copyright: © 2025. The Author(s). Licensee: AOSIS.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Introduction

This guideline is an update to the Southern African HIV Clinicians Society (SAHCS) 2020 recommendations on HIV pre-exposure prophylaxis (PrEP).1 Previous SAHCS guidance was limited to the provision of oral emtricitabine/tenofovir disoproxil fumarate (F/TDF) PrEP. This update includes newer PrEP modalities, including the monthly dapivirine vaginal ring (DVR) and the long-acting cabotegravir intramuscular injection (CAB-LA). It also introduces upcoming modalities such as the long-acting lenacapavir subcutaneous injection (LEN).

Background

Significant progress has been made to control the HIV epidemic in South Africa. Since 2010, AIDS-related deaths have decreased by 66%, and new HIV infections have decreased by 58%.2 Despite this progress, about 150 000 new HIV cases were reported in South Africa in 2023, which equates to 410 new infections per day.2 With no imminent cure, prevention remains the key to epidemic control, hence the significant role of PrEP.

Since 2016, when oral PrEP was initially made available to select sites in South Africa, the provision of PrEP has been scaled up and, as of December 2024, 1 780 919 individuals were initiated on oral PrEP across 4291 facilities.3,4 The DVR and CAB-LA were approved for use by the South African Health Products Regulatory Authority (SAHPRA) in 2022, and the South African National Department of Health (NDoH) released guidelines for both products shortly thereafter.5,6 However, as of April 2025, they have not been included in the South African Essential Medicines List, are not yet considered standard of care in the public sector, and implementation is limited to a few select study and pilot sites. In the private sector, access to the DVR is steadily increasing, but the introduction of CAB-LA is likely to depend on demand, cost, and willingness of medical aids to reimburse. At present, widescale use of CAB-LA in the private sector may only occur once generic equivalents are approved.

Expanding access to PrEP and newer PrEP modalities, particularly for individuals who are disproportionately affected by and at higher risk of acquiring HIV (including pregnant and lactating people [PLP], people who engage in sex work, transgender and gender diverse [TGD] people, adolescent girls and young women [AGYW], people who use drugs [PWUD] including people who inject drugs [PWID], and gay, bisexual and other men who have sex with men [GBMSM]), could help reduce the number of new HIV infections.

This guideline aims to increase accessibility to PrEP within the South African context. Key updates are detailed in Box 1.

BOX 1: Key updates to the Southern African HIV Clinicians Society HIV pre-exposure prophylaxis guidance.

The NDoH PrEP guideline7 provides valuable guidance for the South African public sector; however, in settings with greater resources and more PrEP options, this guideline provides additional information to enhance the implementation of HIV prevention modalities.

Initiating pre-exposure prophylaxis

PrEP should be offered as part of an integrated sexual and reproductive health (SRH) package that includes options for HIV prevention to all individuals with a negative HIV test result, and who are likely to be exposed to HIV or who request PrEP. Figure 1 details how to initiate PrEP.

FIGURE 1: Steps to follow when initiating HIV pre-exposure prophylaxis.

Selecting an HIV testing strategy

HIV testing recommendations in the context of PrEP include the following:

  • HIV testing is one part of the recommended three-step process to exclude HIV infection (Figure 1, Step 1).
  • Test at initiation, 1 month after initiation, and at each follow-up visit thereafter, before PrEP is provided – every 3 months for oral PrEP and DVR, and every 2 months for CAB-LA.
  • Follow the NDoH HIV testing algorithm (Figure 2) which recommends three tests to ensure the reliability of positive HIV rapid diagnostic test (RDT) results – a screening test, confirmatory test 1 and confirmatory test 2, with three different HIV assays. This will ensure that a 99% positive predictive value is maintained and aid in avoiding false-positive diagnoses.
  • Either a third-generation (HIV antibody) and/or a fourth-generation (HIV antigen/antibody) pre-qualified HIV RDT can be used.
  • Individuals with inconclusive RDT results should receive confirmatory testing with a lab-based HIV enzyme-linked immunosorbent assay.
  • If resources allow and to reduce the risk of initiating CAB-LA during acute HIV infection, before HIV antibodies can be detected, an HIV nucleic acid antigen test (NAAT) or HIV RNA-1 viral load test can be considered. NAAT assays prior to the initiation of CAB-LA can help prevent the risk of integrase strand transfer inhibitor (INSTI) resistance associated with undiagnosed HIV infection in the context of CAB-LA exposure. If point-of-care NAAT testing is not available, the risk of delaying PrEP initiation should be weighed against the risk of HIV acquisition, while waiting for the result. The impact of these resistance mutations on the effectiveness of the current first-line antiretroviral therapy (ART) treatment regimen of tenofovir/lamivudine/dolutegravir (TLD) is currently unknown.
  • If resources allow, NAAT assays can also be considered during follow-up on CAB-LA, in addition to an HIV RDT, to help detect HIV within the context of the Long-acting Early Viral Inhibition (LEVI) syndrome. It is worth noting that, in a recent analysis from HPTN083,8 false-positive results have been uncommonly reported, suggesting that NAAT results should be used with caution.
  • HIV self-testing (HIVST) may be used instead of provider testing when initiating or continuing oral PrEP or the DVR, but is not currently recommended for use with CAB-LA. In the event of a positive test result obtained through HIVST, this should be confirmed by a trained healthcare provider as soon as possible.
FIGURE 2: South African National Department of Health HIV testing algorithm.

Pre-exposure prophylaxis choice counselling

Comprehensive counselling on PrEP choice is essential when multiple PrEP products and modalities are available.

Choice counselling should ideally be conducted by a trained healthcare provider, after HIV counselling and testing has been performed, and HIV-negative status confirmed. Counselling should always be person centred, considering the user’s personal preferences alongside eligibility for one or other choice. Figure 3 details a suggested process. Box 2 provides general messages on PrEP choice counselling, and Box 3 provides more information on PWUD.

FIGURE 3: How to provide comprehensive choice counselling for pre-exposure prophylaxis.

BOX 2: General messages on pre-exposure prophylaxis choice counselling.
BOX 3: A note on pre-exposure prophylaxis for people who use drugs, including those who inject drugs.

Individuals who are pregnant, lactating or planning to conceive, and who are at risk of HIV exposure should be encouraged to consider PrEP because (1) there is a higher infection risk, especially in the third trimester and postpartum period12,13; (2) the benefits of PrEP extend to protecting the infant by protecting the mother; and (3) the risks to the infant are likely to be minimal. Counselling should cover the risks and benefits of using oral PrEP and CAB-LA, depending on their level of risk of HIV exposure, preference and ability to adhere to a daily pill or injection. Please see Pre-exposure prophylaxis in pregnant and lactating people for more detail on PLP.

Currently available pre-exposure prophylaxis options

Table 1 details available PrEP options in the South African setting, and Table 2 details appropriate safety screening and monitoring.

TABLE 1: Approved pre-exposure prophylaxis products in South Africa.
TABLE 2: Safety screening and monitoring.

Integrated HIV prevention and sexual and reproductive health package

PrEP should be offered as part of an integrated HIV prevention and SRH package to all individuals with a negative HIV test, and who are likely to be exposed to HIV or who request PrEP. Box 4 outlines the recommended core services, along with additional services to consider or for which to establish referral pathways.

BOX 4: Components of an integrated HIV prevention and sexual and reproductive health package.

Differentiated service delivery

To improve PrEP uptake and persistence within an integrated HIV prevention and SRH service, and recognising that PrEP users are generally healthy, a differentiated service delivery model has been proposed.14 This model leverages existing platforms and introduces alternative delivery options outside traditional public health services, including private practice clinicians, mobile clinics, pharmacies, schools, and courier services. Task shifting of PrEP provision from doctors to nurses, and other trained and authorised providers such as pharmacists and counsellors, is encouraged. The simplification of PrEP provision aims to make access easier while maintaining quality of care. One example is multi-month dispensing, which allows for the provision of up to 6 months’ supply of oral PrEP or the DVR at follow-up visits, combined with HIVST kits. This approach reduces the need for frequent visits to a healthcare facility or a clinician, streamlining access to the service.14,15,16

Follow-up visits

Figure 4 details what should be done at PrEP follow-up visits.

FIGURE 4: HIV pre-exposure prophylaxis follow-up visits.

Cycling on and off pre-exposure prophylaxis

It is important that individuals who choose to start, stop and restart PrEP do so safely, and that they are well educated about:

  • The lead-in time until protection against HIV, when starting or restarting PrEP.
  • How to safely stop the PrEP method after their last potential exposure, and the need to use alternative HIV prevention methods, if necessary.

Cycling on and off CAB-LA intermittently is not recommended, because of the long tail, and the need to cover with other HIV prevention methods (usually oral PrEP), to prevent INSTI resistance if HIV infection occurs during the period of subtherapeutic tissue levels.

Switching between pre-exposure prophylaxis products

Individuals may choose to switch between PrEP products, depending on their preferences, changing circumstances, and the availability of certain PrEP products. If there is ongoing potential exposure to HIV, providers should support an individual to choose an alternative PrEP method and support them to switch correctly and safely to maintain optimal protection against HIV.

Both the lead-in time to effectiveness of the new product, and the waning effectiveness of the current product, need to be considered when switching. Simultaneous use of the two products for a limited period, to cover their lead-in and tail periods, may be considered.19 For example, an individual may be on both CAB-LA and oral PrEP for 7 days when stopping oral PrEP and starting CAB-LA. There are limited data on the safety of using more than one PrEP product at once, but no serious concerns are anticipated.

Table 3 details how to safely switch between PrEP products.

TABLE 3: Switching between pre-exposure prophylaxis products.

Post-exposure prophylaxis to pre-exposure prophylaxis (and pre-exposure prophylaxis to post-exposure prophylaxis) transitions

PEP is the administration of a short course of ART to an individual who has an HIV-negative test and who may have been exposed to HIV, in order to prevent acquisition of the virus. PEP can effectively prevent infection in a person exposed to HIV when initiated as soon as possible, ideally within 24 h, and at least within 72 h post-exposure. The global recommendation for PEP is a three-drug regimen involving, whenever possible, an integrase inhibitor (usually dolutegravir).25 Table 4 details how to safely transition between PEP and PrEP.

TABLE 4: Transitioning from post-exposure prophylaxis to pre-exposure prophylaxis and pre-exposure prophylaxis to post-exposure prophylaxis.

Managing missed pre-exposure prophylaxis doses

There are many reasons why PrEP users may miss a dose or more, and PrEP providers should be supportive and non-judgemental when this happens. This is often a good time to discuss different PrEP options, choices and the effective use of PrEP, within an integrated HIV prevention and SRH context. Table 5 details how to manage a missed PrEP dose.

TABLE 5: Managing missed pre-exposure prophylaxis doses.

Managing HIV seroconversion

HIV seroconversion while on PrEP is very unlikely if it is used effectively, but can occur if:

  • PrEP is initiated in an individual with pre-existing HIV infection that is missed.
  • PrEP is not used effectively, and HIV exposure occurs after starting PrEP (break through infections).

If HIV seroconversion occurs, PrEP should be stopped and ART started immediately, or as soon as possible after the diagnosis of HIV is confirmed.

If the individual is using oral PrEP (daily or intermittently) or the DVR before HIV seroconversion, first-line ART (TLD) can be started, as the risk of developing HIV drug resistance with oral PrEP and the DVR is low.

If the individual is using CAB-LA, there is a possibility that drug resistance may develop to dolutegravir as both cabotegravir and dolutegravir are INSTIs. There are three possible scenarios to consider when HIV seroconversion occurs in the context of CAB-LA use:

  • Undiagnosed HIV infection at CAB-LA initiation.
  • Breakthrough HIV infection while on CAB-LA.
  • HIV infection acquired after stopping CAB-LA, while levels of CAB-LA are waning in the 12-month tail period.

The diagnosis of HIV might be delayed due to the suppression and inhibition of the HIV virus by CAB-LA, resulting in false-negative HIV tests. This is known as the LEVI syndrome, and if ongoing CAB-LA injections continue (as HIV infection is masked), then the monotherapy may result in the development of INSTI resistance.26

When HIV seroconversion occurs in the context of CAB-LA in any of the above three scenarios, TLD should be started immediately, and an HIV drug-resistance test done. Consultation with an experienced clinician is also recommended.

Pre-exposure prophylaxis in pregnant and lactating people

PrEP is recommended for all PLP who are at risk of HIV exposure, because pregnancy is a time when the risk of HIV infection and transmission to the infant is higher, with the risk more than doubling during pregnancy and the postpartum period.12,13

Women who acquire HIV during pregnancy or lactation have a higher chance of transmitting HIV to their infants. Consequently, primary HIV prevention for PLP has emerged as a key global health and South African HIV prevention priority.

As of April 2025, PrEP options for PLP in South Africa include daily oral PrEP and CAB-LA following risk-benefit counselling. The DVR is not approved for use in PLP, although evidence suggests that it is safe to use in pregnancy, and SAHPRA approval is pending.

Oral PrEP: Studies have shown that exposure to TDF and FTC during pregnancy among women living with HIV is safe and well tolerated. A recent systematic review27 identified 14 studies that evaluated or will evaluate maternal and/or infant outcomes following oral PrEP exposure during pregnancy or lactation. None of the completed studies found differences in pregnancy or perinatal outcomes associated with oral PrEP exposure. Most pregnant people do not experience significant side effects from oral PrEP; however, about one in 10 may have side effects such as nausea, abdominal cramps, or headache. These are usually mild and resolve in the first few weeks. Some side effects of oral PrEP may also be confused with symptoms of early pregnancy (e.g. nausea, vomiting, and fatigue).

CAB-LA is well tolerated in pregnant women. Maternal, pregnancy, and immediate infant outcomes (as defined by WHO recommended endpoints) are comparable to F/TDF, with expected background rates. Pharmacokinetic (PK) analyses showed a decline in concentrations, particularly in the third trimester, although these declines were above target thresholds, and no HIV infections occurred during pregnancy.28,29 Currently, no dose adjustment is required; however, analyses are ongoing to confirm this. Regarding infant outcomes, the use of CAB-LA has not been associated with an increase in spontaneous abortions or congenital abnormalities.28,29,30 Details regarding CAB exposure in infants who breastfeed is unknown. It is expected that transmission through breastmilk is minimal and similar to levels seen for dolutegravir, but this will be confirmed in ongoing studies.

The DVR has not yet been approved by SAHPRA for use in PLP; however, there is now data to indicate its safety for use in both pregnant and lactating people,17,18 with pregnancy and infant outcomes being similar to or lower than local background rates.18,27,31 Dapivirine exposure to infants during breastfeeding is safe, and the quantity of dapivirine in breastmilk from a DVR is minimal.29,32,33

When choosing PrEP during pregnancy and lactation, it is important to consider all potential risks and benefits, making decisions on a case-by-case basis. Common (and temporary) side effects, such as nausea and fatigue, which can occur in both early pregnancy and early PrEP use, should be discussed during counselling, and reassurance provided to encourage PrEP use and support ongoing adherence.

Upcoming modalities

The HIV prevention pipeline has many products in pre-clinical and clinical development, including preventive vaccines, broadly neutralising antibodies (BNAbs), monthly oral pills, vaginal rings, vaginal and rectal gels, vaginal films, long-acting injectable antiretrovirals, and multi-purpose prevention technologies (MPTs) designed to reduce the risk of HIV and sexually transmitted infections and/or provide effective contraception for women.34

Most relevant, and within reach is lenacapavir (a 6-monthly subcutaneous long-acting PrEP injection), a monthly pill with the nucleoside reverse transcription translocation inhibitor (MK8527), the three-monthly DVR, and a dual prevention pill combining oral PrEP and the oral contraceptive, levonorgestrel.

Lenacapavir (LEN) is a first-in-class multi-stage capsid inhibitor that can be administered every six months via subcutaneous injection. The FDA is expected to approve LEN for HIV prevention soon, following the promising results of the PURPOSE 135 and PURPOSE 236 studies. PURPOSE 1 evaluated the efficacy and safety of LEN for HIV prevention in cisgender women from South Africa and Uganda, aged 16-25 years. Among the 2134 cisgender women receiving twice-yearly LEN, none acquired HIV, demonstrating 100% effectiveness. LEN was also safe for women who became pregnant while using it. Participants and infants continue to be followed in the open-label extension phase and will contribute to pharmacokinetic (PK) data.35 PURPOSE 2 showed that LEN reduced the risk of acquiring HIV by 96% compared to background HIV incidence among 2183 participants, including cisgender men, transgender men, transgender women, and nonbinary individuals aged 16 years and older.36 PURPOSE 1 also assessed the protection against HIV of daily oral tenofovir alafenamide, but this did not differ from background HIV infection rates or the standard oral F/TDF.35 A matched control study of drug levels confirmed this was likely due to inadequate adherence by the women in the oral PrEP arms.

MK8527 is a long-acting nucleoside reverse transcriptase translocation inhibitor which due to its antiretroviral potency can be administered monthly as a small pill. Phase 2 dose finding studies are completed and phase 3 trials will be commencing in 2025. It is hoped efficacy data may be available in 2027.

A three-monthly DVR is also in development, and offers several advantages over the monthly DVR, including reductions in cost, waste and replacement frequency, and acceptibility.37 Recent data suggest that the efficacy of the 3-month ring will be at least equal to that of the 1-month DVR, and provide an extended-use option.38,39

The dual prevention pill: This MPT is the first to contain PrEP. An application for regulatory approval of this combination of two already approved products (TDF/FTC) and oral contraception (ethinyl estradiol and levonorgestrel) was made in 2024, and it is anticipated that approvals will be received in late 2025. Bioequivalence studies have confirmed that available concentrations of active drugs in the MPT are the same as for each individual product.40

Tenofovir/levonorgestrel (TFV/LNG) vaginal ring: A phase 2a study conducted among Kenyan women showed that the TFV/LNG ring was safe and well tolerated. PK studies indicated that clinical efficacy for prevention of HIV-1, HIV-2 infections and pregnancy were highly likely.41

BNAbs administered as infusions or subcutaneous injections are also being considered as a type of immune-based prophylaxis.42 This is based on the proof-of-concept studies that showed that the BNAbs were protective if it matched the circulating HIV.43

Quick-start oral PrEP for women for intermittent use is also being discussed, and inclusion in guidelines is contingent on the availability of supportive efficacy data. This is also known as the 2:7 method, as opposed to the 2:1:1 method for men. Two tablets are taken 2–24 h before exposure and then 1 tablet is taken every day for 7 days after possible exposure.

Conclusion

More than 10 years after TDF-based oral PrEP was first approved for use for HIV prevention, two novel long-acting modalities have been approved within a relatively short space of 2 years of each other (DVR and CAB-LA). Six-monthly LEN shows great promise, and regulatory approval is eagerly awaited. Additional long-acting methods and MPTs and devices are set to enter clinical trials, or have shown promise in early clinical development. Several mechanisms have been proposed to increase accessibility and guidelines developed to allow providers to confidently offer and manage individuals who choose PrEP. Advances toward holistic, person-centred, preference-based PrEP provision will bring us closer to realising our goal to end HIV.

Acknowledgements

Competing interests

The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article. The author, L.-G.B., serves as an editorial board member of this journal. The peer review process for this submission was handled independently, and the author had no involvement in the editorial decision-making process for this manuscript. The author has no other competing interests to declare.

Authors’ contributions

P.M., G.N., C.W., S.M., M.P., E.R., H.S., D.J-D. and J.H. contributed to the writing of the original draft. P.M., C.W. and G.N. finalised the content with oversight and input from L.-G.B., S.D.-M. and H.S.

Ethical considerations

This article followed all ethical standards for research without direct contact with human or animal subjects.

Funding information

This guideline received no grant from any funding agency in the public, commercial, or not-for-profit sectors.

Data availability

Data sharing is not applicable to this article as no new data were created or analysed in this study.

Disclaimer

To the fullest extent permitted by law, the Southern African HIV Clinicians Society and the authors of this guideline cannot be held liable for any aspect of healthcare administered using this information or any other use, including any use (or misuse) that is not in accordance with any guidelines. Specific recommendations provided here are intended only as a guide to clinical management based on expert consensus and best current evidence at the date of first publication. Management decisions for clients should be made by their responsible clinicians, with due consideration for individual circumstances and various contexts. The information provided in this guideline should not be considered as a substitute for such professional judgement. The most current version of this guideline should always be consulted.

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