Journal Of The International AIDS Society[JOURNAL]
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200 papers
Finally, PrEP choices! But will clients ever have a choice?
Green KE, Ngure K, Eakle R … +2 more , Phanuphak N, Reed J
J Int AIDS Soc · 2025 Jul · PMID 40600475 · Full text
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HIV-1 testing in the context of expanding PrEP modalities.
Parikh UM, Jacobs JL, Njuguna N … +2 more , Torjesen K, Mellors JW
J Int AIDS Soc · 2025 Jul · PMID 40600472 · Full text
INTRODUCTION: Multiple effective antiretroviral-based pre-exposure prophylaxis (PrEP) modalities for HIV-1 prevention are now available or under investigation but their safe rollout requires implementable HIV-1 testing s...
INTRODUCTION: Multiple effective antiretroviral-based pre-exposure prophylaxis (PrEP) modalities for HIV-1 prevention are now available or under investigation but their safe rollout requires implementable HIV-1 testing strategies that accurately identify rare cases of HIV-1 acquisition. Current PrEP testing guidelines and testing algorithms in PrEP studies are varied, using single or combinations of rapid antibody-based diagnostic testing, qualitative or quantitative nucleic acid testing, and/or sample collection for retrospective analyses with sensitive research assays for HIV-1 nucleic acid detection. The objective of this commentary is to summarize current and alternative HIV testing approaches for PrEP implementation to guide best practices for individual programmes. DISCUSSION: Diagnosing HIV-1 in PrEP users is challenging because (1) rarity of breakthrough HIV-1 in individuals on PrEP that increases the risk of a false-positive test; (2) modification of acute HIV infection by PrEP; and (3) PrEP delivery in community settings with inadequate testing infrastructure. Current best practices indicate the use of rapid diagnostic tests or self-testing as recommended by national testing algorithms and the World Health Organization (WHO). The use of nucleic acid testing such as plasma HIV-1 RNA polymerase chain reaction may allow earlier detection of HIV-1 but feasibility and risk of false positive are downsides. Sensitive tests to detect single-copy HIV-1 RNA in plasma and integrated proviral DNA in blood mononuclear cells may be important methods to resolve ambiguous HIV-1 diagnosis in research settings. Delayed diagnoses could lead to drug resistance emergence under long-acting PrEP selection, whereas single unconfirmed false-positive tests could create diagnostic challenges in users of long-acting PrEP. The cost, feasibility and positive predictive value of HIV tests are important considerations for PrEP programmes. CONCLUSIONS: Optimal strategies to detect HIV-1 acquisition among users of different PrEP modalities are evolving. While new guidance from the WHO recommends HIV-1 testing by serological assays or self-testing with PrEP use, feasible plans for clinical management of rare cases of breakthrough on PrEP and ambiguous diagnoses are still needed. The data from PrEP studies and scale-up will help us assess the value of different tests and testing approaches for their inclusion in HIV detection algorithms across PrEP modalities.
Feasibility and acceptability of persons on long-acting cabotegravir for HIV prevention in the SEARCH Dynamic Choice HIV Prevention trial extension in rural Kenya and Uganda: a longitudinal cohort study.
Kakande ER, Balzer LB, Kabami J … +15 more , Ayieko J, Chamie G, Sutter N, Sunday H, Nyabuti M, Litunya J, Camlin C, Johnson-Peretz J, Temple J, Lavoy G, Koss C, Czarnogorski M, Petersen ML, Kamya MR, Havlir DV
J Int AIDS Soc · 2025 Jul · PMID 40600471 · Full text
INTRODUCTION: Injectable cabotegravir (CAB-LA) is highly effective for HIV prevention, but real-world implementation studies in Africa are ongoing. We assessed feasibility and acceptability among participants who used CA...
INTRODUCTION: Injectable cabotegravir (CAB-LA) is highly effective for HIV prevention, but real-world implementation studies in Africa are ongoing. We assessed feasibility and acceptability among participants who used CAB-LA in the SEARCH Dynamic Choice HIV Prevention extension study in rural Uganda and Kenya. METHODS: From January 2023 to December 2024, we followed females and males who were aged ≥ 15 years, with self-assessed risk for HIV acquisition, in the intervention arm of the SEARCH Dynamic Choice HIV Prevention extension study, and received at least one CAB-LA injection during the first 48 weeks. To assess the feasibility and acceptability of CAB-LA, we designed quantitative surveys based on the Theoretical Framework for Acceptability. Surveys were administered at CAB-LA initiation, after 24 and 48 weeks of use, and discontinuation of CAB-LA. RESULTS: Of 487 intervention arm participants, 274 (56%) started CAB-LA (183 females; 91 males; 79 youth aged 15-24 years). Of whom, 264 completed the survey at initiation, 206 after 24 weeks on CAB-LA, 201 after 48 weeks on CAB-LA and 69 at discontinuation of CAB-LA. Most participants (65%; 171/264) reported choosing CAB-LA because it was easier to take than pills, and nearly all (99%; 261/264) had limited knowledge of CAB-LA prior to the study. Concerns for side effects were the largest anticipated and experienced barrier to CAB-LA. Overall and with subgroups, satisfaction with CAB-LA was high at 24 weeks (97%; 200/206) and 48 weeks (96%; 193/201). Nearly all participants reported that taking CAB-LA was easy at 24 weeks (95%; 195/206) and 48 weeks (99%; 198/201). At CAB-LA discontinuation, 83% (57/69) were likely to extremely likely to recommend CAB-LA to a friend: 80% (20/25) of males, 84% (37/44) of females, 100% (19/19) of youth and 76% (38/50) of older adults. CONCLUSIONS: In rural Uganda and Kenya, over half of participants in the SEARCH trial who were offered choice of oral PrEP/PEP or CAB-LA chose and started CAB-LA during the first 48 weeks. For both males and females and younger and older adults, CAB-LA was both feasible and acceptable to deliver with satisfaction remaining high throughout the study, and nearly all reporting ease of use. CLINICAL TRIAL NUMBER: 05549726.
Awareness and intention to use event-driven and long-acting injectable pre-exposure prophylaxis among adolescent and young men who have sex with men and transgender women in Brazil: a cross-sectional study.
Magno L, Leite BO, Grangeiro A … +3 more , Dezanet L, Soares F, Dourado I
J Int AIDS Soc · 2025 Jul · PMID 40600470 · Full text
INTRODUCTION: New pre-exposure prophylaxis (PrEP) options, including event-driven and long-acting injectable, may enhance HIV prevention strategies among adolescents and youth. This study examined awareness and intention...
INTRODUCTION: New pre-exposure prophylaxis (PrEP) options, including event-driven and long-acting injectable, may enhance HIV prevention strategies among adolescents and youth. This study examined awareness and intention to use event-driven and long-acting injectable PrEP, along with associated factors, among adolescent and young men who have sex with men and transgender women. METHODS: A cross-sectional study was conducted between December 2020 and February 2022 among men who have sex with men and young transgender women aged 15-20 years, who participated in a daily oral PrEP cohort study in Salvador and São Paulo, Brazil. Binomial logistic regression models analysed factors associated with the intention to use event-driven and long-acting injectable PrEP. RESULTS: A total of 1221 participants were enrolled in the cohort at the time of this analysis, with 597 responding to the survey. Awareness of event-driven and long-acting injectable PrEP was reported by 15.3% and 18.0% of participants, respectively. Intention to use event-driven PrEP was reported by 56.4% of participants, while 81.5% expressed intention to use long-acting injectable PrEP. Participants with lower and moderate adherence to daily oral PrEP were more likely to intend to use event-driven PrEP (OR = 1.79; 95% CI: 1.04-3.08), whereas those who reported always or often using condoms in insertive anal sex with steady or casual partners were less likely to intend to use event-driven PrEP (OR = 0.37; 95% CI: 0.15-0.90). For long-acting injectable PrEP, participants with middle (OR = 1.93; 95% CI: 1.05-3.53) or low socio-economic status (OR = 3.13; 95% CI: 1.30-7.51) and those reporting three or more casual partners in the past 3 months (OR = 2.25; 95% CI: 1.30-3.89) were more likely to intend to use long-acting injectable PrEP. Conversely, participants who had never used daily oral PrEP were less likely to intend to use long-acting injectable PrEP (OR = 0.31; 95% CI: 0.11-0.92). CONCLUSIONS: Adolescents and young people in Brazil demonstrated a stronger preference for long-acting injectable over event-driven PrEP, with sexual behaviour patterns significantly influencing choices. Expanding prevention options may enhance PrEP uptake and adherence, improving HIV prevention strategies among adolescents and young adults.
Exploring perceptions and preferences for PrEP choice and of an mHealth intervention: insights from the ImPrEP CAB-Brasil study.
Pimenta C, Mann CG, Hoagland B … +18 more , Carvalheira E, Jalil C, Benedetti M, Fernandes N, Coutinho C, Jalil EM, Secco Torres Silva M, Trefiglio R, Farias A, Mourão MPG, Madruga JV, de Lima JN, Zonta R, O'Malley G, Veloso VG, Grinsztejn B, Torres TS, ImPrEP CAB‐Brasil Study
J Int AIDS Soc · 2025 Jul · PMID 40600468 · Full text
INTRODUCTION: Although the efficacy of long-acting injectable cabotegravir (CAB-LA) for pre-exposure prophylaxis (PrEP) is well-known from clinical trials, research is needed to guide effective strategies for its impleme...
INTRODUCTION: Although the efficacy of long-acting injectable cabotegravir (CAB-LA) for pre-exposure prophylaxis (PrEP) is well-known from clinical trials, research is needed to guide effective strategies for its implementation. We describe a qualitative study to assess perceptions and preferences for PrEP choice and acceptability of an mHealth intervention within the ImPrEP CAB Brasil study. METHODS: ImPrEP CAB Brasil is an implementation study of same-day delivery of CAB-LA for young sexual and gender minorities (SGM; 18-30 years) in oral PrEP public health clinics in six Brazilian cities. At enrolment, participants received counselling on HIV prevention (SOC) or SOC+mHealth tool to choose between oral or injectable PrEP. The mHealth tool consisted of five videos describing HIV combined prevention including PrEP options. A subset of participants from each site were invited to participate in the qualitative study (October 2023-July 2024). Semi-structured interviews were conducted, recorded and transcribed. Data were fed into ATLAS.ti.24 software. Conventional content analysis was used for coding categories based on an inductive reasoning process. RESULTS: We conducted 120 interviews (48 SOC and 72 SOC+mHealth; 107 CAB-LA and 13 oral PrEP). Participants reported not knowing about CAB-LA before enrolment; some recently heard from a partner or friend. Reasons for choosing CAB-LA were perceived convenience, practicality, easier adherence to bimonthly injections and higher efficacy compared to oral PrEP. Reasons for not choosing CAB-LA were fear of injections and pain. Reasons for choosing oral PrEP included perspective of less appointments, easiness of daily adherence, access in case of travel and the option to stop immediately if desired or needed. Reasons for not choosing oral PrEP included forgetfulness of daily intake, gastrointestinal side effects, fear of inadvertent exposure and judgement by family. Participants found the mHealth educational tool useful and adequate for PrEP education and decision-making. CONCLUSIONS: Perceptions for PrEP choice among SGM underscore the importance of providing comprehensive information and support towards decision-making processes, so users can have an accurate understanding of each PrEP option, as well as their clinical and social benefits. The mHealth tool was perceived as highly desirable and useful for PrEP education, having the potential to be implemented in HIV prevention services. CLINICAL TRIAL NUMBER: NCT05515770.
"People have options": a qualitative study of experiences and influences of PrEP choice among women in South Africa.
Dada S, Musvipwa FM, Cholo FA … +5 more , Pleaner M, Kutywayo A, Butler V, Martin CE, Mullick S
J Int AIDS Soc · 2025 Jul · PMID 40600466 · Full text
INTRODUCTION: Long-acting injectable cabotegravir and dapivirine vaginal ring were recently introduced in South Africa through demonstration projects, providing additional HIV prevention options to oral pre-exposure prop...
INTRODUCTION: Long-acting injectable cabotegravir and dapivirine vaginal ring were recently introduced in South Africa through demonstration projects, providing additional HIV prevention options to oral pre-exposure prophylaxis (PrEP). PrEP choice marks a pivotal moment in HIV prevention, potentially increasing PrEP uptake and use by offering women a choice of methods best suited to their individual needs. Understanding experiences of PrEP choice in real-world settings is critical to informing the introduction of PrEP choice at scale. This study, embedded within an implementation science study introducing new PrEP methods, explores women's experiences of PrEP choice counselling, and factors influencing PrEP choice. METHODS: Between April and May 2024, we conducted 12 focus group discussions with a sub-set of 126 women (18-57 years) enrolled in a parent cohort study delivering PrEP choice at six fixed and three roving mobile clinics in three areas of South Africa. Cohort participants are HIV-negative men and women ≥ 15 years interested in HIV prevention services. At the time of data collection, non-pregnant and lactating women ≥ 18 years enrolled in the cohort were provided PrEP choice counselling and offered a choice of oral PrEP or dapivirine vaginal ring. Discussions explored women's experiences of PrEP choice counselling and influences of PrEP choice. They were audio recorded, transcribed verbatim and translated into English for thematic analysis. RESULTS: Women reported positive choice counselling experiences, particularly when it was supplemented by pamphlets, demonstration rings and pelvic models. Participants valued learning about alternative PrEP methods and appreciated friendly healthcare providers who answered their questions. Privacy and emotional support were also crucial. However, negative experiences included the use of complex scientific jargon and insufficient information on PrEP's potential drawbacks. PrEP choices were mainly influenced by concerns about intravaginal products, distrust of new methods, prior oral PrEP experiences, and partner and family opinions. CONCLUSIONS: These findings will guide strategies for PrEP delivery, emphasizing provider training, effective counselling tools and tailored communication. Women valued clear, jargon-free information, visual aids and a welcoming environment, which supported open dialogue. The influence of prior oral PrEP experiences on PrEP choice highlights the need for counselling that addresses specific concerns and preferences.
The science at HIVR4P 2024: The era of choice in biomedical HIV prevention.
Grinsztejn B, Appay V, Bekker LG … +24 more , Beyrer C, Donnell D, Sanchez J, Canagasabey D, Coutinho C, Ganor Y, Muturi-Kioi V, Ortblad KF, Cooney E, Devisich G, Ellenberg P, Ghiglione Y, K'Orimba K, Ssemambo PK, Ludwig-Barron NT, Mielke DK, Mullick R, Muthui MK, Radusky PD, Sendaula E, Tirmizi SRH, Sanchez AVM, Vega J, Pebody R
J Int AIDS Soc · 2025 Jul · PMID 40598755 · Full text
INTRODUCTION: HIVR4P 2024, the 5th HIV Research for Prevention Conference, took place in Lima, Peru, 6-10 October 2024. The conference focused on new developments in HIV prevention from basic research to new product deve...
INTRODUCTION: HIVR4P 2024, the 5th HIV Research for Prevention Conference, took place in Lima, Peru, 6-10 October 2024. The conference focused on new developments in HIV prevention from basic research to new product development and implementation science. METHODS: Sessions were assigned to one of five tracks: basic science; pre-exposure prophylaxis (PrEP) and antiretroviral (ARV)-based prevention; vaccines and broadly neutralizing antibodies (bNAbs); applied and implementation science; and other prevention modalities and cross-cutting issues. A team of rapporteurs covered each track and identified conference highlights. RESULTS: Strategies to elicit bNAb responses by vaccination are advancing to clinical trials, while combination bNAbs show promise as an alternative to ARV-based products. There is promising diversity in the PrEP product pipeline and twice-yearly lenacapavir has demonstrated exceptional efficacy, but barriers to widespread access and implementation remain, compounded by new challenges from the significant policy changes and funding reductions of the new US administration. Innovative ways of delivering PrEP to vulnerable communities that could benefit are being explored and, in some cases, have been successfully implemented. DISCUSSION: Choice in HIV prevention products and differentiated delivery models that enable clients to select options that meet their preferences and changing needs is essential. Additionally, the involvement of the community throughout the design, implementation and dissemination process is necessary to maximize the impact of HIV prevention. Ensuring equitable access in a rapidly changing context will involve policy changes, partnerships with local organizations and addressing social determinants that impact health outcomes. CONCLUSIONS: We are in an era with more tools than ever before to prevent HIV acquisition; now, we need to facilitate collaborations between diverse stakeholders, including researchers, community members, policymakers, healthcare providers and funders. The future of HIV prevention should lie in a holistic approach that respects individual choice, enhances service accessibility and is flexible to meet evolving challenges and opportunities. However, policy changes since the conference ended have profoundly altered the HIV prevention landscape and threaten the advances described in this report.
Low sensitivity of the fourth-generation antigen/antibody HIV rapid diagnostic test Determine™ HIV Early Detect for detection of acute HIV infection at the point of care in rural Eswatini: a diagnostic accuracy study.
Ciglenecki I, Ntshalintshali N, Mukooza E … +13 more , Lekelem S, Mavimbela M, Dlamini S, Dube L, Mabuza N, Haile M, Ellman T, Flores A, Keiser O, Matse S, de la Tour R, Calmy A, Kerschberger B
J Int AIDS Soc · 2025 Jul · PMID 40579874 · Full text
INTRODUCTION: The diagnosis of acute HIV infection (AHI) is challenging in routine settings because it cannot be detected by routine third-generation antibody rapid diagnostic tests (RDTs). The current fourth-generation...
INTRODUCTION: The diagnosis of acute HIV infection (AHI) is challenging in routine settings because it cannot be detected by routine third-generation antibody rapid diagnostic tests (RDTs). The current fourth-generation antibody/antigen RDT, Determine™ HIV Early Detect, has demonstrated high sensitivity in laboratory studies, but field evaluations at the point of care are lacking. We nested a diagnostic accuracy study within a larger study of the burden of sexually transmitted infections in rural Eswatini. METHODS: Adults were enrolled at six routine HIV testing sites (HTS) in the Shiselweni region between June 2022 and April 2023. Determine™ HIV Early Detect was performed by HTS counsellors in parallel with routine HIV testing using a finger-prick blood sample. The reference test was HIV viral load (VL) in the plasma sample, performed on the Xpert platform in the central laboratory. AHI was defined as a negative or discordant HIV test result according to the national serial RDT algorithm and an HIV VL >10,000 copies/ml, or two consecutive HIV VL measurements between the lower limit of detection (40 copies/ml) and 10,000 copies/ml. Established HIV infection was defined as a positive serial RDT test, and overall HIV infection as either established HIV infection or AHI. RESULTS: One thousand one hundred and sixty-three participants had all test results available; 49 (4.2%) were diagnosed with HIV (39 with established HIV according to the serial RDT algorithm and 10 with AHI). AHI prevalence among participants with HIV negative or discordant routine RDT results was 0.9% (10/1124). The sensitivity of Determine™ HIV Early Detect to detect overall HIV infection was 83.7% (95% CI 70.3-92.7) and to detect AHI was 20% (95% CI 2.5-55.6%); the specificity was equally high for both 99.8% (95% CI 99.4-100). CONCLUSIONS: The low sensitivity of Determine™ HIV Early Detect to detect AHI when performed at the point of care using finger-prick blood samples in our study contrasts with other published evaluations from laboratory settings and highlights the importance of field evaluations of the commonly used diagnostic tests.
Cost and effectiveness of differentiated ART service delivery strategies in Zambia: a modelling analysis using routine data.
Lekodeba NA, Rosen S, Phiri B … +11 more , Masuku SD, Govathson C, Kamanga A, Haimbe P, Shakwelele H, Mwansa M, Lumano-Mulenga P, Huber AN, Pascoe SJS, Jamieson L, Nichols BE
J Int AIDS Soc · 2025 Jul · PMID 40579870 · Full text
INTRODUCTION: Differentiated service delivery (DSD) models for antiretroviral treatment (ART) have been scaled up in many settings in sub-Saharan Africa to improve client-centred care and increase service delivery effici...
INTRODUCTION: Differentiated service delivery (DSD) models for antiretroviral treatment (ART) have been scaled up in many settings in sub-Saharan Africa to improve client-centred care and increase service delivery efficiency. However, given the multitude of models of care currently available, identifying cost-effective combinations of DSD models that maximize benefits and minimize costs remains critical for guiding their expansion. METHODS: We developed an Excel-based mathematical model using retrospective retention and viral suppression data from a national cohort of ART clients (≥15 years) in Zambia between January 2018 and March 2022 stratified by age, sex, setting (urban/rural) and model of ART delivery. Outcomes (viral suppression and retention in care), provider costs and costs to clients were estimated from the cohort and published data. The base case reflects the outcomes observed in 2022 for all DSD models for each population sub-group. For different combinations of nine DSD models and over 1-year time horizon from the provider perspective, we evaluated the incremental cost-effectiveness ratio (ICER) per additional client virally suppressed compared to the 2022 base case. Deterministic sensitivity analyses were conducted on key input parameters. RESULTS: Among 125 scenarios evaluated, six were on the cost-effectiveness frontier: (1) 6-month dispensing (6MMD)-only; (2) 6MMD and adherence groups (AGs); (3) AGs-only; (4) fast track refills (FTRs) and AGs; (5) FTRs-only; and 6) AGs and home ART delivery. 6MMD-only was cost-saving compared to the base case, increasing retention by 1.2% (95% CI: 0.7-1.8), viral suppression by 1.6% (95% CI: 1.0-2.7) and reducing client costs by 12.0% (95% CI: 10.8-12.4). The next cost-effective scenarios, 6MMD + AGs and AGs-only, cost $245 per additional person virally suppressed, increased viral suppression by 2.8% (95% CI: 2.2-3.3) and 4.0% (95% CI: 3.5-4.0) and increased client costs by 20.1% (95% CI: 9.5-28.1) and 52.3% (95% CI: 29.868.7), respectively. ART cost and laboratory test costs were the most influential parameters on provider costs and the ICERs. CONCLUSIONS: Mathematical modelling using existing data can identify cost-effective DSD model mixes while ensuring all client sub-populations are considered. In Zambia, scaling up 6MMD to all eligible clients is likely cost-saving, with further health gains achievable by targeting sub-populations with selected DSD models.
The following article for this Supplement was published before the original collection was released. It can be found in its respective issue.
J Int AIDS Soc · 2025 Jun · PMID 40569967 · Full text
Kennedy CE, Dawit R, Yeh PT, Rodolph M, Ford N, Schmidt HMA, Schaefer R, Baggaley R, and Macdonald V. HIV post-exposure prophylaxis in community settings and by lay health workers or through task sharing: a systematic re...
Kennedy CE, Dawit R, Yeh PT, Rodolph M, Ford N, Schmidt HMA, Schaefer R, Baggaley R, and Macdonald V. HIV post-exposure prophylaxis in community settings and by lay health workers or through task sharing: a systematic review of effectiveness, case studies, values and preferences, and costs. J Int AIDS Soc. 2025;28(5):e26448. https://doi.org/10.1002/jia2.26448 This article was intended for this Supplement issue, 28:S1, but was inadvertently published in an earlier issue of Journal of the International AIDS Society, issue 28:5 https://onlinelibrary.wiley.com/toc/17582652/2025/28/5. This article has also been included in the final version of J Int AIDS Soc issue 28:S1 as presented below for completeness. The publisher apologizes for this error and any confusion it may cause. When citing this article, please cite it as per its original publication in issue 28:5 as shown below: Kennedy CE, Dawit R, Yeh PT, Rodolph M, Ford N, Schmidt HA, et al. HIV post-exposure prophylaxis in community settings and by lay health workers or through task sharing: a systematic review of effectiveness, case studies, values and preferences, and costs. J Int AIDS Soc. 2025;28(5):e26448. https://doi.org/10.1002/jia2.26448.
Research designs to generate evidence of HIV post-exposure prophylaxis effectiveness for new long-acting agents.
Ortblad KF, Brown ER, Heffron R … +3 more , Ngure K, Mujugira A, Donnell D
J Int AIDS Soc · 2025 Jun · PMID 40569916 · Full text
INTRODUCTION: New longer-acting antiretroviral (ARV) drugs-that is single doses with antiviral activity for at least a month-are being utilized for HIV treatment and pre-exposure prophylaxis (PrEP) but have not been expl...
INTRODUCTION: New longer-acting antiretroviral (ARV) drugs-that is single doses with antiviral activity for at least a month-are being utilized for HIV treatment and pre-exposure prophylaxis (PrEP) but have not been explored for post-exposure prophylaxis (PEP). A "one-and-done" simplification of PEP has the potential to serve the HIV prevention needs of individuals not being met with traditional services and expand overall biomedical HIV prevention coverage. We discuss challenges with the assessment of PEP effectiveness in human trials and potential study designs that could generate evidence needed to inform the use of new, single-administered, long-acting ARVs for PEP. DISCUSSION: Challenges with determining the effectiveness of new long-acting PEP agents in human trials include the low likelihood of observing an HIV acquisition and the short period for outcome assessment (likely 1 month) following PEP administration. Additional challenges include recruiting individuals in the brief window in which they could benefit (<72 hours of a potential HIV exposure) and ethics of conducting informed consent during a period of high stress/vulnerability. Consequently, design approaches where the efficacy goal is to establish that the HIV incidence rate following PEP administration (of the standard or a novel agent) approaches zero should be considered. HIV RNA testing conducted within 5 days of a potential exposure could define prevention per exposure. Novel recruitment venues-such as community-based retail or online pharmacies-could be used to reach individuals after a potential exposure. Potential study designs include one- or two-arm individual-level product assignment aimed at demonstration of short-course efficacy or longer-term effectiveness compared to a background rate; cluster-randomized controlled trials of recruitment venues; and novel individual-level approaches that either do not or do utilize randomization in combination with choice, enabling assessment of preferences and effectiveness. CONCLUSIONS: Over the past decade, multiple new HIV PrEP products-but no new PEP products-have been developed to meet the diverse needs of individuals seeking HIV prevention services. Challenges exist with generating PEP effectiveness evidence, but they are not insurmountable. Effectiveness research on new PEP products could advance the number of HIV prevention options available.
Healthcare provider recommendations to improve post-violence care HIV post-exposure prophylaxis access and adherence in Mozambique.
Duffy M, Xavier EMF, de Almeida A … +9 more , Correia D, Nhavane Dos Prazeres M, Adriano J, Parruque B, Bule MO, Denhard L, Almeida M, Baptista A, Cossa de Pinho R
J Int AIDS Soc · 2025 Jun · PMID 40569899 · Full text
INTRODUCTION: In Mozambique, post-exposure prophylaxis (PEP) to prevent HIV is offered as part of the essential package of post-violence care services at 1450 health facilities. However, HIV PEP access and adherence cont...
INTRODUCTION: In Mozambique, post-exposure prophylaxis (PEP) to prevent HIV is offered as part of the essential package of post-violence care services at 1450 health facilities. However, HIV PEP access and adherence continue to be a challenge. Healthcare providers were interviewed to identify and synthesize their recommendations for improving PEP access and adherence. METHODS: We conducted semi-structured, in-depth interviews with 20 adolescent and adult healthcare providers (3 men and 17 women) who had a range of 2-15 years of experience from 20 health facilities across seven provinces during March-August 2023. Data were analysed using inductive and theoretical thematic analysis. We analysed how frequently health providers mentioned specific recommendations. RESULTS: Regarding PEP access, healthcare providers recommended community education as the most effective strategy (10 mentions). In particular, providers cited the importance of palestras [community health talks]. Providers also commonly highlighted the need to have PEP kits prepared (7 mentions) and PEP readily available at health facilities (6 mentions). Regarding PEP adherence, providers recommended client counselling/education (13 mentions) to ensure clients understand the importance of taking PEP, how to properly take PEP and the potential side effects, which can often deter clients from adhering. Additionally, providers highlighted chamadas preventivas [follow-up telephone calls] within 2 weeks or so after the initial visit (9 mentions) as the best means to ensure clients complete the full, 28-day regimen and return for retesting after 3 months. Healthcare providers explained that follow-up telephone calls, despite the client living far from the health facility, can create a bond that supports clients. Providers recommended the institutionalization of follow-up telephone calls for consistent implementation in all healthcare facilities that offer PEP. CONCLUSIONS: Interviewed healthcare providers offered valuable insights and recommendations to improve PEP access and adherence, which could be considered for implementation in Mozambique and other sub-Saharan African countries.
Poor post-exposure prophylaxis completion despite improvements in post-violence service delivery in 14 PEPFAR-supported sub-Saharan African countries, 2018-2023.
Kanagasabai U, Davis SM, Thorsen V … +21 more , Rowlinson E, Laterra A, Hegle J, Angumua C, Ekra A, Mpingulu M, Getahun M, Sida F, Mndzebele P, Kambona C, Ramphalla P, Mtingwi E, Msungama W, Duffy M, Adewumi B, Olotu E, Sebeza J, Kitalile J, Apondi R, Muleya C, Cain M
J Int AIDS Soc · 2025 Jun · PMID 40569898 · Full text
INTRODUCTION: Sexual violence (SV) affects millions globally and has a well-documented bidirectional association with HIV. Post-exposure prophylaxis (PEP) is a critical, yet often underutilized, HIV prevention tool in po...
INTRODUCTION: Sexual violence (SV) affects millions globally and has a well-documented bidirectional association with HIV. Post-exposure prophylaxis (PEP) is a critical, yet often underutilized, HIV prevention tool in post-SV care. Despite its potential impact to reduce HIV transmission, SV care remains an overlooked service delivery point for HIV prevention. The U.S. Centers for Disease Control and Prevention (CDC), as part of the President's Emergency Plan for AIDS Relief (PEPFAR), supports PEP provision within broader post-violence care (PVC) services. Understanding PEP utilization is crucial for optimizing service delivery and HIV prevention efforts. METHODS: Using Monitoring Evaluation and Reporting data from fiscal years 2018-2023, we conducted a descriptive analysis of clients who received PVC and SV services through CDC-supported programming in 14 sub-Saharan African countries. RESULTS: From 2018 to 2023, the annual number of clients receiving any PVC, and specifically SV, services increased by 233% (in 2018, n = 206,764; in 2023, n = 689,349) and 163% (in 2018, n = 42,848; in 2023, n = 112,838), respectively. Fewer than half of SV clients completed PEP (38% in 2018, n = 16,103; 31% in 2023, n = 35,118). Across all years combined, most SV clients (female: 185,414; male: 59,618) were aged 15-19 years. The age band and sex with the lowest proportion of clients completing PEP were males aged 15-19 (4%, n = 2296). CONCLUSIONS: The findings underscore a critical gap between the scaling of SV services and the completion of PEP within violence response programmes. Innovative implementation science approaches may help to identify and address barriers inhibiting effective PEP delivery and uptake within PVC service delivery programmes. Enhancing PEP uptake and completion can support mitigating the bidirectional relationship between violence and HIV acquisition, particularly among vulnerable populations like adolescents and young adults. Low PEP coverage also reflects missed opportunities, particularly among adolescent girls and young women, who experience disproportionate rates of HIV acquisition.
Limited awareness and use of HIV post-exposure prophylaxis among people vulnerable to HIV acquisition in Western Kenya: a cross-sectional analysis.
Schluck G, Romo ML, Kosgei J … +13 more , Thigpen MC, Burns N, Bor R, Langat D, Akoth C, Yates A, Charles C, Qian H, Gayle B, Yacovone M, Sawe F, Crowell TA, Multinational Observational Cohort of HIV and other Infections (MOCHI) Study Group
J Int AIDS Soc · 2025 Jun · PMID 40569897 · Full text
INTRODUCTION: HIV post-exposure prophylaxis (PEP) can prevent HIV acquisition and facilitates linkage to pre-exposure prophylaxis (PrEP) for people with ongoing vulnerability. We assessed PEP awareness and use in Western...
INTRODUCTION: HIV post-exposure prophylaxis (PEP) can prevent HIV acquisition and facilitates linkage to pre-exposure prophylaxis (PrEP) for people with ongoing vulnerability. We assessed PEP awareness and use in Western Kenya. METHODS: We used cross-sectional screening/enrolment data from the Multinational Observational Cohort of HIV and other Infections (MOCHI) study. Eligible participants had behavioural vulnerability to HIV and were ages 14-55 years. Participants completed questionnaires on demographics, sexual/behavioural history, and PEP/PrEP awareness and use. Depression was assessed using the Patient Health Questionnaire (PHQ-9) with none/minimal, mild and moderate/severe depression defined as PHQ-9 scores of 0-4, 5-9 and ≥10, respectively. We used multivariable robust Poisson regression with purposeful variable selection to estimate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs) for factors associated with PEP awareness. RESULTS: From December 2021 to May 2023, 398 participants indicated whether they heard of PEP. The median age was 22 years (IQR 19-24), 316/399 (79.2%) were female and 315/389 (81.0%) reported sex work or transactional sex. One hundred fourteen (28.6%) participants had never heard of PEP, of whom 79 (69.3%) had also not heard of PrEP. Among 284 participants who had heard of PEP, 74 (26.1%) did not know where to access it. Seventy-one participants (17.8%) had taken PEP, of whom 17 (23.9%) encountered problems accessing PEP such as unavailability (n = 5) or prohibitive expense (n = 4). In the final model, only <12 years of education (aPR 1.65 [95% CI 1.16-2.34]) and not cohabitating (aPR 2.81 [95% CI = 1.11-7.08]) were associated with never having heard of PEP. Among participants who had heard of PEP, factors associated with not knowing where to access PEP were <12 years of education (aPR 2.20 [95% CI 1.37-3.54]) and depression (mild aPR 1.86 [95% CI 1.17-2.96]; moderate/severe aPR 1.84 [95% CI 1.09-3.09], compared to none/minimal). CONCLUSIONS: Despite enrolling a behaviourally vulnerable group potentially eligible for PEP, we identified substantial gaps in PEP awareness, access and use. Demand generation and improved access to PEP are needed to maximize the impact on reducing HIV incidence. Interventions to improve PEP awareness and access may be most impactful for people with lower education or when coupled with mental health services.
Developing and evaluating a community-driven intervention to promote uptake of HIV and contraception services among students enrolled in colleges and universities in Zimbabwe.
Kuguyo O, Mancitshana L, Mangenah C … +7 more , Tumushime MK, Ruhode N, Matsikire E, Kalweo J, Terris-Prestholt F, Cowan FM, Sibanda EL
J Int AIDS Soc · 2025 Jun · PMID 40569896 · Full text
INTRODUCTION: There is a growing appreciation that community-led interventions are key to sustaining the HIV response and achieving HIV prevention and treatment targets. Together with young people in colleges/universitie...
INTRODUCTION: There is a growing appreciation that community-led interventions are key to sustaining the HIV response and achieving HIV prevention and treatment targets. Together with young people in colleges/universities and Ministry of Health (MOH), we developed and evaluated a student-led intervention for promoting the uptake of HIV self-testing (HIVST), post-exposure prophylaxis (PEP) and emergency contraception (EC) among college/university students. METHODS: Over 3 months, in biweekly study team meetings, two workshops with students, two meetings with MOH, and a joint workshop with students, MOH and relevant stakeholders, we co-developed an intervention for peer-led promotion/distribution of HIVST, PEP, EC and condoms. The agreed intervention was piloted in three Zimbabwean colleges/universities from December 2023 to February 2024. Student peers distributed HIVST and condoms directly, and vouchers for PEP and EC that were redeemed at college/nearby clinics. During co-development, students strongly preferred peer distribution of all commodities but this was restricted by regulatory requirements for PEP and EC. Peer distributors (n = 14) kept daily audio diaries of their experiences. In-depth interviews were held with students (n = 18), peer distributors (n = 11) and key informants (n = 12) to explore views/preferences, with participant observations and four focus group discussions to provide additional insights. We determined the intervention development and implementation costs. RESULTS: Peer-led distribution of HIVST, PEP and EC to college/university students was acceptable, feasible, appropriate and generally implemented as intended. PEP and EC acceptability was driven by high HIV and pregnancy risk among students, who had no easy access to services. Of 100 PEP and 257 EC vouchers distributed, 30% and 40% were redeemed, respectively. The main barrier to PEP and EC uptake was moral judgement against premarital sex, which affected female students more. Judgemental health worker attitudes also limited uptake of PEP and EC. EC voucher redemption among female students was lower versus males, aOR = 0.4 (95% CI = 0.2-0.8), p = 0.019. Redemption was also higher at the college where the nearby clinic could be accessed discreetly. Total cost of the intervention per student was $14.57 (cross-institution range: $7.26-$35.52). CONCLUSIONS: Student-led distribution of HIVST, PEP and EC was feasible, acceptable and affordable. Making the intervention more community-driven according to the 2024 WHO PEP guidelines will likely achieve great impact.
Modelling the impact of initiation delay, duration and prior PrEP on the efficacy of post-exposure prophylaxis containing a tenofovir/emtricitabine backbone.
Zhang L, Collins S, Fox J … +1 more , von Kleist M
J Int AIDS Soc · 2025 Jun · PMID 40569890 · Full text
INTRODUCTION: Pre- and post-exposure prophylaxis (PrEP and PEP) are important pillars of the HIV prevention portfolio to reduce the risk of acquisition just before or after HIV exposure. While PrEP efficacy has been eluc...
INTRODUCTION: Pre- and post-exposure prophylaxis (PrEP and PEP) are important pillars of the HIV prevention portfolio to reduce the risk of acquisition just before or after HIV exposure. While PrEP efficacy has been elucidated in many randomized clinical trials, corresponding data for PEP is extremely difficult to obtain in a controlled setting. Consequently, it is almost impossible to study the impact of PEP initiation delay and duration on HIV risk reduction clinically, which would inform recommendations on PEP use. METHODS: We employ pharmacokinetics, pharmacodynamics and viral dynamics models, along with individual factors, such as drug adherence to investigate the impact of initiation delay and PEP duration on HIV risk reduction. We evaluated PEP using two- and three-drug regimens with a TDF/FTC backbone. Moreover, we study PEP efficacy in the context of PrEP-to-PEP transitions. RESULTS: In our simulations, early initiation of PEP emerged as a pivotal factor for HIV risk reduction. We found that 2-drug (TDF/FTC) PEP may insufficiently protect when initiated > 1 hour post-exposure. When adding a third drug, early initiation was still a critical factor; however, over 90% efficacy could be achieved when PEP was initiated 48 hours post-exposure and taken for at least 14-28 days, depending on the efficacy of the third-drug component. When investigating PrEP-PEP transitions, we observed that preceding PrEP can (1) contribute directly to prophylactic efficacy, and (2) boost subsequent PEP efficacy by delaying initial viral dynamics and building-up drug concentrations, overall facilitating self-managed transitioning between PrEP and PEP. CONCLUSIONS: Our study confirms the critical role of early (< 48 hours) PEP initiation, preferably with three drugs taken for 28 days. Self-start with TDF/FTC and later addition of a third drug is better than not self-starting. Furthermore, our study highlights the synergy between recent PrEP intake and PEP and may help to inform recommendations on PEP use.
Characteristics of individuals who received post-exposure prophylaxis and HIV seroconversion in Malawi: an analysis of national routine HIV testing data.
Tweya H, Chimpandule T, Wu W … +11 more , Goeke L, Zheng Z, Mbiriyawanda S, Masina T, Ozitiosauka W, Muyaso M, Drabko A, Bilicki D, Chen J, Nyirenda R, Jahn A
J Int AIDS Soc · 2025 Jun · PMID 40569889 · Full text
INTRODUCTION: In Malawi, where HIV prevalence remains high at 6.7%, post-exposure prophylaxis (PEP) has been implemented as one of the HIV prevention strategies. However, there is limited data on the characteristics of P...
INTRODUCTION: In Malawi, where HIV prevalence remains high at 6.7%, post-exposure prophylaxis (PEP) has been implemented as one of the HIV prevention strategies. However, there is limited data on the characteristics of PEP users and HIV seroconversion. Using national routine HIV testing services (HTS) programme data, we described the demographic characteristics and risk of exposure to HIV for HTS clients reporting PEP use and determined HIV seroconversion rates among those with baseline HIV-negative results. METHODS: We conducted a descriptive cross-sectional study of individuals aged 2 years and older accessing HTS who reported PEP use. A subset was included in a retrospective cohort to determine HIV seroconversion rates. The risk of exposure to HIV was classified as high, ongoing, low and not assessed. HTS encounters data were extracted from a national HTS data repository. Some HTS clients had multiple HTS encounters. Descriptive statistics were reported for the study populations and Poisson regression model with an offset was used to estimate HIV seroconversion rates. RESULTS: Between November 2022 and July 2023, there were 21,298 HTS encounters where PEP use was reported any time prior. Of the 21,298 encounters, 1847 (8.7%) HTS clients with a baseline HIV-negative status were included in the cohort study component. The median follow-up time was 30 days (interquartile range 30-61). Of the 1847 HTS clients, 1055 (57.1%) were males and 928 (50.2%) were aged 20 and 29 years. A total of 329 (17.8%) HTS clients reported a high-risk HIV exposure event in the past 3 months, 581 (31.5%) had an ongoing risk of exposure to HIV, 892 (48.3%) had low risk of exposure to HIV and 45 (2.4%) assessment was not done. Overall, five individuals seroconverted, yielding a seroconversion rate of 2.08 (0.87-4.99) per 100 person-years. CONCLUSIONS: The majority of PEP users were young adults and males. A sizeable proportion had an ongoing risk of exposure to HIV. The HIV seroconversion rate was high. Targeted efforts should focus on promoting condom use, encouraging partner testing and expanding access to PEP for those with ongoing HIV exposure.
A modified pharmacy provider-led delivery model of oral HIV pre- and post-exposure prophylaxis in Kenya: a pilot study extension.
Roche SD, Omollo V, Mogere P … +14 more , Asewe M, Gakuo S, Banerjee P, Harkey K, Sharma M, Pintye J, Mugambi ML, Shah P, Odoyo J, Ong'wen P, Were D, Bukusi EA, Ngure K, Ortblad KF
J Int AIDS Soc · 2025 Jun · PMID 40569884 · Full text
INTRODUCTION: Private pharmacies in Africa reach individuals with ongoing and periodic HIV risk, yet few countries currently leverage pharmacies as an HIV service delivery platform. We conducted a 6-month pilot to evalua...
INTRODUCTION: Private pharmacies in Africa reach individuals with ongoing and periodic HIV risk, yet few countries currently leverage pharmacies as an HIV service delivery platform. We conducted a 6-month pilot to evaluate a model for pharmacy provider-led delivery of HIV pre- and post-exposure prophylaxis (PrEP and PEP) in Kenya. METHODS: At 12 private pharmacies in Kisumu and Kiambu Counties, licensed pharmacy providers initiated and managed eligible clients ≥18 years on PrEP and PEP under remote clinician supervision (NCT04558554); four of these pharmacies additionally offered sextually transmitted infection (STI) testing. PrEP/PEP clients were scheduled for follow-up 1 month later and then quarterly (PrEP clients only). Primary outcomes included PrEP and PEP initiation and continuation during the pilot period. Client and providers rated the model across multiple constructs of acceptability and feasibility from established frameworks. RESULTS: From January to July 2022, 1028 clients interested in PrEP, PEP and/or STI testing were screened and 829 initiated one or more service: 661 PrEP, 162 PEP and 52 STI testing. About half of clients (48%, 398/829) were male, most were unmarried (78%, 644/829) and PrEP-naïve (89%, 737/829), and the median age was 25 years (IQR 22-31). Most PrEP clients reported inconsistent condom use (88%, 581/661) or sex with partners of unknown HIV status (70%, 460/661) in the past 6 months. Most PEP clients reported condomless sex (48%, 78/162) or a condom break (46%, 75/162) in the past 72 hours; 4% (6/162) reported sexual assault. Among PrEP clients eligible for a refill, 73% (479/658) refilled at least once and 60% (197/328) twice. Among PEP clients eligible for follow-up, 44% (65/148) completed follow-up HIV testing and 20% (30/148) transitioned to PrEP. Among STI clients, 19% (10/52) tested positive for gonorrhoea (n = 7) and/or chlamydia (n = 5). Most clients and providers (≥92%) found the delivery model and its implementation strategies acceptable. All providers (n = 12) thought it was possible to deliver PrEP and PEP at pharmacies in Kenya. CONCLUSIONS: Pharmacy PrEP/PEP delivery achieved high uptake, continuation and acceptability among eligible clients that could benefit, highlighting the potential of pharmacies to expand HIV prevention service coverage in Kenya, particularly to individuals not accessing these services at clinics.
How plausible is it that PEP would be cost-effective in sub-Saharan Africa?
Garnett GP, Godfrey-Faussett P
J Int AIDS Soc · 2025 Jun · PMID 40569877 · Full text
INTRODUCTION: Post-exposure prophylaxis (PEP) is an efficacious HIV prevention tool when used soon after a potential exposure. Understanding the drivers of cost-effectiveness of PEP in different contexts will likely play...
INTRODUCTION: Post-exposure prophylaxis (PEP) is an efficacious HIV prevention tool when used soon after a potential exposure. Understanding the drivers of cost-effectiveness of PEP in different contexts will likely play a role in determining local policies for providing PEP. DISCUSSION: The cost-effectiveness of PEP depends upon the likelihood of exposure to HIV, the transmission probability per sexual act and the efficacy of PEP, along with associated costs. The transmission probability per sex act will be greater in the first few acts in a partnership than on average across all acts owing to heterogeneity in the transmission probability between partnerships. In settings with high HIV prevalence and low treatment coverage, appropriately focused PEP is cost-saving. As treatment coverage improves, PEP can remain cost-effective with HIV prevalences above 15% with treatment coverage achieving 90:90:90 treatment targets. At 95:95:95 treatment levels, it is unlikely to be cost-effective. PEP is only cost-effective for the first few sex acts within a partnership. The cost-effectiveness of PEP is sensitive to assumptions about the proportion of the population of partners with unsuppressed HIV, the pattern of mixing of those with unsuppressed virus, the transmission probability per sexual act, PEP efficacy, the costs of PEP and the value attached to preventing HIV acquisition. Where possible local parameters should be used in evaluating PEP cost-effectiveness in our model. CONCLUSIONS: We illustrate the use of simple calculations to define the cost-effectiveness of PEP. In populations where there is a high prevalence of unsuppressed HIV, PEP is likely to be cost-effective but only if used for one off sexual encounters and the first few sex acts within a partnership.
Untapped potential of post-exposure prophylaxis in sub-Saharan Africa: a comparative analysis of PEP implementation planning in Kenya, Mozambique, Nigeria, Uganda and Zambia.
Resar D, Mwamelo AJ, Olowu A … +21 more , Drakes J, Macul H, Gusmao E, Franks J, Otubu N, Osowale O, Abudiore O, Mwamba T, Silondwa M, Haimbe P, Shakwelele H, Otobo E, Borain R, Honu M, Igbomezie CC, Obermeyer C, Vernon T, Hatzold K, Ingold H, Rodolph M, Jenkins SY
J Int AIDS Soc · 2025 Jun · PMID 40569874 · Full text
INTRODUCTION: In 2023, over 210,000 new HIV acquisitions occurred in Kenya, Mozambique, Nigeria, Uganda and Zambia. While uptake of oral pre-exposure prophylaxis (oral PrEP) and coverage of voluntary medical male circumc...
INTRODUCTION: In 2023, over 210,000 new HIV acquisitions occurred in Kenya, Mozambique, Nigeria, Uganda and Zambia. While uptake of oral pre-exposure prophylaxis (oral PrEP) and coverage of voluntary medical male circumcision increased significantly over the past decade, post-exposure prophylaxis (PEP) has received less attention and remains an underused HIV prevention intervention. In 2024, the World Health Organization (WHO) released new guidance emphasizing the need for timely access to PEP, including through community-based channels and task-sharing to mitigate barriers such as stigma and ensure timely access. We conducted a comparative analysis of PEP implementation planning to understand how PEP is currently integrated into HIV prevention programmes, and to identify barriers and opportunities for optimizing the impact of PEP in the method mix. METHODS: We analysed Global Fund country proposals from Grant Cycle 6 (GC6) (2021-2023) and Grant Cycle 7 (GC7) (2024-2026) for five countries in Africa with high HIV burden and established PrEP programmes: Kenya, Mozambique, Nigeria, Uganda and Zambia. To understand how PEP implementation planning evolved across these two cycles, we used quantitative and qualitative analysis to identify trends. We extracted all PEP activities, coding them by focal population and activity type. RESULTS: We found over a five-fold increase in the number of PEP activities in GC7 compared to GC6, where there were only 10 PEP activities, and an expanded population focus, including people in prisons and pregnant and breastfeeding people. Proposals increasingly emphasized PEP not only as an intervention for occupational and sexual violence exposures but as a vital component of comprehensive HIV prevention strategies. Proposals described strategies for increasing access to PEP through differentiated service delivery models, including community-led and pharmacy-delivered approaches. However, PEP activities were not well defined, with PEP often included in product lists without articulating product-specific activities to address barriers or increase access. CONCLUSIONS: All five countries demonstrated an increased focus on PEP from GC6 to GC7. While this reflects an ambition to expand access to PEP, product-specific activities were not clearly articulated. Practical guidance and tools, as well as focused cross-country learning to support the operationalization of WHO's recommendations, will be critical to increasing access and achieving impact.
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