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.
{"title":"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","authors":"Laio Magno, Beo Oliveira Leite, Alexandre Grangeiro, Lorenza Dezanet, Fabiane Soares, Inês Dourado","doi":"10.1002/jia2.26479","DOIUrl":"https://doi.org/10.1002/jia2.26479","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>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).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 S2","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26479","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144524832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Elijah R. Kakande, Laura B. Balzer, Jane Kabami, James Ayieko, Gabriel Chamie, Nicole Sutter, Helen Sunday, Marilyn Nyabuti, Janice Litunya, Carol Camlin, Jason Johnson-Peretz, Jenny Temple, Geoff Lavoy, Catherine Koss, Maggie Czarnogorski, Maya L. Petersen, Moses R. Kamya, Diane V. Havlir
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.
{"title":"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","authors":"Elijah R. Kakande, Laura B. Balzer, Jane Kabami, James Ayieko, Gabriel Chamie, Nicole Sutter, Helen Sunday, Marilyn Nyabuti, Janice Litunya, Carol Camlin, Jason Johnson-Peretz, Jenny Temple, Geoff Lavoy, Catherine Koss, Maggie Czarnogorski, Maya L. Petersen, Moses R. Kamya, Diane V. Havlir","doi":"10.1002/jia2.26465","DOIUrl":"https://doi.org/10.1002/jia2.26465","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Clinical Trial Number</h3>\u0000 \u0000 <p>05549726</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 S2","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26465","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144525024","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Virginia A. Fonner, Elizabeth Irungu, Mark Conlon, Carolyne A. Akello, Emily Gwavava, Kevin K'Orimba, Nicolette P. Naidoo, Patriciah Jeckonia, Imelda Mahaka, Saiqa Mullick, Mamatli Chabela, Roisin Drysdale, Jacqueline Kabongo, Millicent Kiruki, Ivan Segawa, Munyaradzi Dobbie, Nthuseng Marake, Peter Mudiope, Hasina Subedar, Rose Wafula, Andrew Kazibwe, Jason Reed, Katharine Kripke, Douglas Taylor, Mu-Tien Lee, Glory Chidumwa, Adatia Chivafa, Ramatsoai Soothoane, Margaret Eichleay, Ashley Mayo, Courtney McGuire, Tara McClure, Tatenda Yemeke, Kristine Torjesen, the CATALYST study team
<div> <section> <h3> Introduction</h3> <p>HIV incidence remains high among women in Africa, especially adolescent girls and young women (AGYW), despite existing oral pre-exposure prophylaxis (PrEP) programmes. With expanding biomedical prevention options, understanding PrEP use patterns when women are offered choice can inform HIV prevention programming in Africa.</p> </section> <section> <h3> Methods</h3> <p>The CATALYST study offers informed PrEP choice through an enhanced service delivery package for women in 27 public health sites across Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. Women attending sites who were HIV negative and interested in learning about HIV prevention were eligible. We describe uptake and use among those offered choice between oral PrEP and the monthly dapivirine ring from May 2023 through July 2024, explore factors associated with method choice using logistic regression, describe reasons for choice and assess time until PrEP discontinuation using survival analysis.</p> </section> <section> <h3> Results</h3> <p>Of 3967 participants, 44.9% were AGYW (15−24 years), 25.5% were sex workers, and 12.2% and 8.7% were breastfeeding and/or pregnant, respectively. At enrolment, 66.2% chose oral PrEP, 29.9% chose the dapivirine ring and 3.5% chose no method. Common reasons for choosing oral PrEP were ease of use (58.6%) and efficacy (31.7%); the ring was chosen due to ease of use (56.9%) and not needing to swallow pills (53.0%). In multivariable analysis, participants ≤ 24 years (<i>p</i> = 0.007) and participants who were pregnant (<i>p</i> = 0.002) or breastfeeding (<i>p</i> < 0.001) had lower odds of choosing the ring. Month 1 return was 32.7% for oral PrEP and 55.2% for the ring. Ring users reported higher adherence as compared to oral PrEP users (<i>p</i> < 0.001). Of participants returning for ≥ 1 PrEP refills, 12.1% switched methods at least once. Median time until PrEP discontinuation was 95 days (95% CI: 91, 110) for those choosing oral PrEP at enrolment and 169 days (95% CI: 139, 190) for those choosing the ring. Risk of discontinuation was greater for participants choosing oral PrEP at enrolment (<i>p</i> < 0.001) and those ≤ 24 years (<i>p</i> < 0.001), PrEP naïve at enrolment (<i>p</i> < 0.001) or not currently using contraception (<i>p</i> = 0.03).</p> </section> <section> <h3> Conclusions</h3> <p>We demonstrated that women took advantage of PrEP choice. PrEP use varied by product, with 1 month return and method continuation higher for the ring. AGYW had a greater risk of discontinuing either method
{"title":"PrEP choice in the real world: Results of a prospective cohort study describing uptake and use patterns of oral PrEP and the dapivirine vaginal ring among women in sub-Saharan Africa","authors":"Virginia A. Fonner, Elizabeth Irungu, Mark Conlon, Carolyne A. Akello, Emily Gwavava, Kevin K'Orimba, Nicolette P. Naidoo, Patriciah Jeckonia, Imelda Mahaka, Saiqa Mullick, Mamatli Chabela, Roisin Drysdale, Jacqueline Kabongo, Millicent Kiruki, Ivan Segawa, Munyaradzi Dobbie, Nthuseng Marake, Peter Mudiope, Hasina Subedar, Rose Wafula, Andrew Kazibwe, Jason Reed, Katharine Kripke, Douglas Taylor, Mu-Tien Lee, Glory Chidumwa, Adatia Chivafa, Ramatsoai Soothoane, Margaret Eichleay, Ashley Mayo, Courtney McGuire, Tara McClure, Tatenda Yemeke, Kristine Torjesen, the CATALYST study team","doi":"10.1002/jia2.26457","DOIUrl":"https://doi.org/10.1002/jia2.26457","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>HIV incidence remains high among women in Africa, especially adolescent girls and young women (AGYW), despite existing oral pre-exposure prophylaxis (PrEP) programmes. With expanding biomedical prevention options, understanding PrEP use patterns when women are offered choice can inform HIV prevention programming in Africa.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The CATALYST study offers informed PrEP choice through an enhanced service delivery package for women in 27 public health sites across Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. Women attending sites who were HIV negative and interested in learning about HIV prevention were eligible. We describe uptake and use among those offered choice between oral PrEP and the monthly dapivirine ring from May 2023 through July 2024, explore factors associated with method choice using logistic regression, describe reasons for choice and assess time until PrEP discontinuation using survival analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 3967 participants, 44.9% were AGYW (15−24 years), 25.5% were sex workers, and 12.2% and 8.7% were breastfeeding and/or pregnant, respectively. At enrolment, 66.2% chose oral PrEP, 29.9% chose the dapivirine ring and 3.5% chose no method. Common reasons for choosing oral PrEP were ease of use (58.6%) and efficacy (31.7%); the ring was chosen due to ease of use (56.9%) and not needing to swallow pills (53.0%). In multivariable analysis, participants ≤ 24 years (<i>p</i> = 0.007) and participants who were pregnant (<i>p</i> = 0.002) or breastfeeding (<i>p</i> < 0.001) had lower odds of choosing the ring. Month 1 return was 32.7% for oral PrEP and 55.2% for the ring. Ring users reported higher adherence as compared to oral PrEP users (<i>p</i> < 0.001). Of participants returning for ≥ 1 PrEP refills, 12.1% switched methods at least once. Median time until PrEP discontinuation was 95 days (95% CI: 91, 110) for those choosing oral PrEP at enrolment and 169 days (95% CI: 139, 190) for those choosing the ring. Risk of discontinuation was greater for participants choosing oral PrEP at enrolment (<i>p</i> < 0.001) and those ≤ 24 years (<i>p</i> < 0.001), PrEP naïve at enrolment (<i>p</i> < 0.001) or not currently using contraception (<i>p</i> = 0.03).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>We demonstrated that women took advantage of PrEP choice. PrEP use varied by product, with 1 month return and method continuation higher for the ring. AGYW had a greater risk of discontinuing either method","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 S2","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26457","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144525054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Beatriz Grinsztejn, Victor Appay, Linda-Gail Bekker, Chris Beyrer, Deborah Donnell, Jorge Sanchez, Davina Canagasabey, Carolina Coutinho, Yonatan Ganor, Vincent Muturi-Kioi, Katrina F. Ortblad, Erin Cooney, Gastón Devisich, Paula Ellenberg, Yanina Ghiglione, Kevin K'Orimba, Phionah Kibalama Ssemambo, Natasha Tatiana Ludwig-Barron, Dieter Kenneth Mielke, Ranajoy Mullick, Michelle Kathini Muthui, Pablo D. Radusky, Emmanuel Sendaula, Syed Raza Haider Tirmizi, Akemi V. Matsuno Sanchez, Julian Vega, Roger Pebody
<div> <section> <h3> Introduction</h3> <p>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.</p> </section> <section> <h3> Methods</h3> <p>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.</p> </section> <section> <h3> Results</h3> <p>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.</p> </section> <section> <h3> Discussion</h3> <p>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.</p> </section> <section> <h3> Conclusions</h3> <p>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 H
{"title":"The science at HIVR4P 2024: The era of choice in biomedical HIV prevention","authors":"Beatriz Grinsztejn, Victor Appay, Linda-Gail Bekker, Chris Beyrer, Deborah Donnell, Jorge Sanchez, Davina Canagasabey, Carolina Coutinho, Yonatan Ganor, Vincent Muturi-Kioi, Katrina F. Ortblad, Erin Cooney, Gastón Devisich, Paula Ellenberg, Yanina Ghiglione, Kevin K'Orimba, Phionah Kibalama Ssemambo, Natasha Tatiana Ludwig-Barron, Dieter Kenneth Mielke, Ranajoy Mullick, Michelle Kathini Muthui, Pablo D. Radusky, Emmanuel Sendaula, Syed Raza Haider Tirmizi, Akemi V. Matsuno Sanchez, Julian Vega, Roger Pebody","doi":"10.1002/jia2.70001","DOIUrl":"https://doi.org/10.1002/jia2.70001","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>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 H","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 7","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144524817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Iza Ciglenecki, Nombuso Ntshalintshali, Esther Mukooza, Skinner Lekelem, Mpumelelo Mavimbela, Sindisiwe Dlamini, Lenhle Dube, Nomvuyo Mabuza, Melat Haile, Tom Ellman, Antonio Flores, Olivia Keiser, Sindy Matse, Roberto de la Tour, Alexandra Calmy, Bernhard Kerschberger
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.
急性HIV感染（AHI）的诊断在常规环境中具有挑战性，因为它无法通过常规的第三代抗体快速诊断试验（RDTs）检测到。目前的第四代抗体/抗原RDT，即det™HIV早期检测，在实验室研究中显示出高灵敏度，但缺乏护理点的现场评估。我们在对斯瓦蒂尼农村地区性传播感染负担的大型研究中嵌套了一项诊断准确性研究。方法于2022年6月至2023年4月在Shiselweni地区的6个常规HIV检测点（HTS）招募成人。确定™HIV早期检测由HTS辅导员进行，同时使用手指刺血样本进行常规HIV检测。参考检测是血浆样本中的HIV病毒载量（VL），在中心实验室的Xpert平台上进行。AHI定义为按照国家串行RDT算法HIV检测结果为阴性或不一致，且HIV VL≥10,000 copies/ml，或在检测下限（40 copies/ml）至10,000 copies/ml之间连续两次检测HIV VL。确定HIV感染定义为连续RDT检测阳性，总体HIV感染定义为确定HIV感染或AHI。结果1363名受试者具有全部检测结果；49例（4.2%）被诊断为HIV（39例根据串行RDT算法确诊为HIV， 10例为AHI）。HIV阴性或常规RDT结果不一致的参与者中AHI患病率为0.9%（10/1124）。decide™HIV Early Detect检测总体HIV感染的敏感性为83.7% (95% CI 70.3 ~ 92.7)，检测AHI的敏感性为20% (95% CI 2.5 ~ 55.6%)；特异性同样高，为99.8% （95% CI 99.4-100）。结论：在我们的研究中，在护理点使用手指刺血样本进行的det™HIV早期检测检测AHI的灵敏度较低，与其他已发表的实验室环境评估形成对比，突出了对常用诊断测试进行现场评估的重要性。
{"title":"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","authors":"Iza Ciglenecki, Nombuso Ntshalintshali, Esther Mukooza, Skinner Lekelem, Mpumelelo Mavimbela, Sindisiwe Dlamini, Lenhle Dube, Nomvuyo Mabuza, Melat Haile, Tom Ellman, Antonio Flores, Olivia Keiser, Sindy Matse, Roberto de la Tour, Alexandra Calmy, Bernhard Kerschberger","doi":"10.1002/jia2.26517","DOIUrl":"https://doi.org/10.1002/jia2.26517","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>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).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 7","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26517","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144503212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nkgomeleng A. Lekodeba, Sydney Rosen, Bevis Phiri, Sithabiso D. Masuku, Caroline Govathson, Aniset Kamanga, Prudence Haimbe, Hilda Shakwelele, Muya Mwansa, Priscilla Lumano-Mulenga, Amy N. Huber, Sophie J. S. Pascoe, Lise Jamieson, Brooke E. Nichols
<div> <section> <h3> Introduction</h3> <p>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.</p> </section> <section> <h3> Methods</h3> <p>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.</p> </section> <section> <h3> Results</h3> <p>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.</p> </section> <section> <h3> Conclusions</h3> <p>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
{"title":"Cost and effectiveness of differentiated ART service delivery strategies in Zambia: a modelling analysis using routine data","authors":"Nkgomeleng A. Lekodeba, Sydney Rosen, Bevis Phiri, Sithabiso D. Masuku, Caroline Govathson, Aniset Kamanga, Prudence Haimbe, Hilda Shakwelele, Muya Mwansa, Priscilla Lumano-Mulenga, Amy N. Huber, Sophie J. S. Pascoe, Lise Jamieson, Brooke E. Nichols","doi":"10.1002/jia2.70003","DOIUrl":"https://doi.org/10.1002/jia2.70003","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>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","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 7","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144503211","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah Magni, Daniel Byamukama, Maryam Sani Haske, Jane Mukami, Idah Moyo, Judith D. Auerbach
Introduction
Post-exposure prophylaxis (PEP) is an important component of comprehensive HIV prevention, yet its uptake has been suboptimal globally. In July 2024, the World Health Organization (WHO) updated its global guidance on PEP to include two new recommendations intended to increase timely access to and delivery of PEP. These recommendations specifically aim to expand both where PEP can be delivered, to include community settings, and who can provide PEP, to include community health workers and task-sharing. The practical realities of adopting new public health guidelines to achieve the intended benefits in most contexts are complex. Articulating these realities is important for identifying what will be required to ensure the feasibility of expanded PEP access in community settings.
Discussion
We provide stakeholder perspectives from five African countries—Kenya, Nigeria, South Africa, Uganda and Zimbabwe—on both barriers to and strategies for implementing the new WHO PEP recommendations. These perspectives are informed by experiences in these countries that were shared at a recent workshop and highlight key themes related to PEP uptake and use: awareness and acceptability; administration and monitoring; policy alignment, including regulatory considerations; logistics; integration of services; stakeholder involvement and capacity building; and linking PEP and PrEP more directly. Running across these themes are the roles of socio-cultural norms and the need for increased resources to pay for implementing the recommendations, including capacity strengthening and monitoring in communities.
Conclusions
While significant challenges exist to expanding PEP access in community settings and through task-sharing, there are examples from our countries of successful efforts to mitigate them by leveraging existing community resources and capacities in innovative ways. Additional efforts will require engagement across multiple stakeholders to address remaining awareness gaps, logistical and regulatory obstacles, and political will. As countries work to update their guidelines and align with the new WHO recommendations, continued collaboration and innovation within and across countries will be essential to realize the full potential of PEP in comprehensive HIV prevention efforts.
{"title":"Implementing the new WHO guidelines on HIV post-exposure prophylaxis: perspectives from five African countries","authors":"Sarah Magni, Daniel Byamukama, Maryam Sani Haske, Jane Mukami, Idah Moyo, Judith D. Auerbach","doi":"10.1002/jia2.26447","DOIUrl":"https://doi.org/10.1002/jia2.26447","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Post-exposure prophylaxis (PEP) is an important component of comprehensive HIV prevention, yet its uptake has been suboptimal globally. In July 2024, the World Health Organization (WHO) updated its global guidance on PEP to include two new recommendations intended to increase timely access to and delivery of PEP. These recommendations specifically aim to expand both <i>where</i> PEP can be delivered, to include community settings, and <i>who</i> can provide PEP, to include community health workers and task-sharing. The practical realities of adopting new public health guidelines to achieve the intended benefits in most contexts are complex. Articulating these realities is important for identifying what will be required to ensure the feasibility of expanded PEP access in community settings.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>We provide stakeholder perspectives from five African countries—Kenya, Nigeria, South Africa, Uganda and Zimbabwe—on both barriers to and strategies for implementing the new WHO PEP recommendations. These perspectives are informed by experiences in these countries that were shared at a recent workshop and highlight key themes related to PEP uptake and use: awareness and acceptability; administration and monitoring; policy alignment, including regulatory considerations; logistics; integration of services; stakeholder involvement and capacity building; and linking PEP and PrEP more directly. Running across these themes are the roles of socio-cultural norms and the need for increased resources to pay for implementing the recommendations, including capacity strengthening and monitoring in communities.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>While significant challenges exist to expanding PEP access in community settings and through task-sharing, there are examples from our countries of successful efforts to mitigate them by leveraging existing community resources and capacities in innovative ways. Additional efforts will require engagement across multiple stakeholders to address remaining awareness gaps, logistical and regulatory obstacles, and political will. As countries work to update their guidelines and align with the new WHO recommendations, continued collaboration and innovation within and across countries will be essential to realize the full potential of PEP in comprehensive HIV prevention efforts.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 S1","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26447","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144492668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katrina F. Ortblad, Elizabeth R. Brown, Renee Heffron, Kenneth Ngure, Andrew Mujugira, Deborah Donnell
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.
{"title":"Research designs to generate evidence of HIV post-exposure prophylaxis effectiveness for new long-acting agents","authors":"Katrina F. Ortblad, Elizabeth R. Brown, Renee Heffron, Kenneth Ngure, Andrew Mujugira, Deborah Donnell","doi":"10.1002/jia2.26475","DOIUrl":"https://doi.org/10.1002/jia2.26475","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 S1","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26475","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144492943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Meghan Duffy, Etevaldo M. F. Xavier, Anabela de Almeida, Della Correia, Maria Nhavane dos Prazeres, Jacinto Adriano, Bainabo Parruque, Maria Olga Bule, Langan Denhard, Maura Almeida, Ana Baptista, Raquel Cossa de Pinho
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.
{"title":"Healthcare provider recommendations to improve post-violence care HIV post-exposure prophylaxis access and adherence in Mozambique","authors":"Meghan Duffy, Etevaldo M. F. Xavier, Anabela de Almeida, Della Correia, Maria Nhavane dos Prazeres, Jacinto Adriano, Bainabo Parruque, Maria Olga Bule, Langan Denhard, Maura Almeida, Ana Baptista, Raquel Cossa de Pinho","doi":"10.1002/jia2.26452","DOIUrl":"https://doi.org/10.1002/jia2.26452","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Regarding PEP access, healthcare providers recommended community education as the most effective strategy (10 mentions). In particular, providers cited the importance of <i>palestras</i> [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 <i>chamadas preventivas</i> [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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 S1","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26452","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144492784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HIV post-exposure prophylaxis (PEP) is an important but underutilized HIV prevention tool. The scientific rationale for PEP is based on (1) the known mechanism of action of antiretrovirals in interfering with HIV replication and establishment of infection, (2) animal and pharmacokinetic/pharmacodynamic studies, and (3) studies among healthcare workers and other populations treated with zidovudine-based PEP, resulting in initial PEP guidelines [1]. Since these early studies, no comparative PEP efficacy trials have been conducted. Despite the absence of efficacy data, PEP guidelines by the US Centers for Disease Control and Prevention (CDC), World Health Organization (WHO) and other agencies have been updated based on the availability of more potent and tolerable regimens, further supportive animal studies, extrapolation from treatment studies, and non-randomized research [1, 2]. Contemporary PEP recommendations consist of a 28-day, three-drug oral regimen. However, other than zidovudine for preventing vertical transmission, no antiretroviral product has a labelled indication for PEP. It is thus implemented “off-label” based on recommendations by normative bodies.
Adherence to the recommended 28-day oral PEP regimen is often suboptimal [3, 4] and incomplete adherence may contribute to HIV seroconversion [5]. New long-acting antiretroviral drug formulation could thus improve PEP effectiveness and impact. However, demonstrating the efficacy (or effectiveness) of new products as PEP faces considerable challenges, including the low likelihood of HIV acquisition following PEP initiation and an effective standard-of-care PEP regimen (as discussed by Ortblad et al. in this supplement [6]). Given the consensus about existing PEP efficacy, placebo-controlled trials are not ethical, and active-control randomized non-inferiority trials may require unfeasibly large sample sizes. Considering these challenges, do we need a regulatory path for PEP, and if so, what would it look like?
An approved indication from a trusted regulatory authority implies rigorous science, review and benefit versus risk considerations for that indication, transparently debated in public—or with public access to the process. It builds confidence among policymakers, healthcare providers and users. An approved indication authorizes the marketing of that product for that indication, possibly resulting in improved awareness and access. A labelled indication may facilitate coverage through health insurance or public healthcare systems, further improving access. More available products with a PEP indication would increase product choice, aligning with user preferences and needs and potentially improving uptake and effective use. Finally, regulatory approvals for a PEP indication may improve global access through regulation by reliance. In this process, a regulatory authority utilizes the assessment of another trus
{"title":"Do we need a regulatory path for HIV post-exposure prophylaxis?","authors":"Veronica Miller, Robin Schaefer","doi":"10.1002/jia2.26449","DOIUrl":"https://doi.org/10.1002/jia2.26449","url":null,"abstract":"<p>HIV post-exposure prophylaxis (PEP) is an important but underutilized HIV prevention tool. The scientific rationale for PEP is based on (1) the known mechanism of action of antiretrovirals in interfering with HIV replication and establishment of infection, (2) animal and pharmacokinetic/pharmacodynamic studies, and (3) studies among healthcare workers and other populations treated with zidovudine-based PEP, resulting in initial PEP guidelines [<span>1</span>]. Since these early studies, no comparative PEP efficacy trials have been conducted. Despite the absence of efficacy data, PEP guidelines by the US Centers for Disease Control and Prevention (CDC), World Health Organization (WHO) and other agencies have been updated based on the availability of more potent and tolerable regimens, further supportive animal studies, extrapolation from treatment studies, and non-randomized research [<span>1, 2</span>]. Contemporary PEP recommendations consist of a 28-day, three-drug oral regimen. However, other than zidovudine for preventing vertical transmission, no antiretroviral product has a labelled indication for PEP. It is thus implemented “off-label” based on recommendations by normative bodies.</p><p>Adherence to the recommended 28-day oral PEP regimen is often suboptimal [<span>3, 4</span>] and incomplete adherence may contribute to HIV seroconversion [<span>5</span>]. New long-acting antiretroviral drug formulation could thus improve PEP effectiveness and impact. However, demonstrating the efficacy (or effectiveness) of new products as PEP faces considerable challenges, including the low likelihood of HIV acquisition following PEP initiation and an effective standard-of-care PEP regimen (as discussed by Ortblad et al. in this supplement [<span>6</span>]). Given the consensus about existing PEP efficacy, placebo-controlled trials are not ethical, and active-control randomized non-inferiority trials may require unfeasibly large sample sizes. Considering these challenges, do we need a regulatory path for PEP, and if so, what would it look like?</p><p>An approved indication from a trusted regulatory authority implies rigorous science, review and benefit versus risk considerations for that indication, transparently debated in public—or with public access to the process. It builds confidence among policymakers, healthcare providers and users. An approved indication authorizes the marketing of that product for that indication, possibly resulting in improved awareness and access. A labelled indication may facilitate coverage through health insurance or public healthcare systems, further improving access. More available products with a PEP indication would increase product choice, aligning with user preferences and needs and potentially improving uptake and effective use. Finally, regulatory approvals for a PEP indication may improve global access through regulation by reliance. In this process, a regulatory authority utilizes the assessment of another trus","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 S1","pages":""},"PeriodicalIF":4.6,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.26449","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144492944","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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