Sarah E. Stansfield, Mia Moore, Lise Jamieson, Gesine Meyer-Rath, Leigh F. Johnson, David Kaftan, Anna Bershteyn, Jennifer Smith, Valentina Cambiano, Loveleen Bansi-Matharu, Andrew Phillips, Jesse Heitner, Ruanne V. Barnabas, Brett Hanscom, Deborah J. Donnell, Marie-Claude Boily, Dobromir Dimitrov
Introduction
Long-acting injectable cabotegravir (CAB-LA) demonstrated superiority to daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) in two clinical trials. This analysis projects the impact of expanding PrEP coverage with CAB-LA in South Africa between 2022 and 2042.
Methods
Three independently calibrated models of HIV transmission in South Africa (Synthesis, EMOD-HIV, Thembisa) projected HIV acquisitions and effective coverage (average PrEP coverage across exposure groups, weighted by HIV incidence in the absence of PrEP in each group) over 20 years under multiple scenarios of PrEP expansion compared to no PrEP expansion. PrEP expansion scenarios differed in targeted overall coverage, speed of expansion, coverage of high-exposure groups, and relative coverage of women and men.
Results
Achieving 5% PrEP coverage with CAB-LA by 2032 prioritizing high-exposure groups resulted in 49% (Synthesis), 18% (EMOD-HIV), and 8% (Thembisa) effective coverage and averted a median of 43%, 29% and 10% of new HIV acquisitions, respectively. Similar expansion with TDF/FTC resulted in lower impact by 19 percentage points (pp), 18pp and 3pp, respectively. Increasing CAB-LA coverage to 15% led to an additional 7pp, 12pp and 16pp, respectively, of HIV acquisitions averted. Achieving 5% CAB-LA coverage expanding to women only resulted in a lower impact by 16pp (Synthesis) and 13pp (EMOD-HIV), and a higher impact by 2pp (Thembisa). Scenarios with similar effective coverage resulted in comparable impact estimates across models.
Conclusions
Offering CAB-LA in South Africa may substantially impact the HIV epidemic based on these projections. Effective coverage proved to be a good predictor of intervention effectiveness.
{"title":"Estimated impact of long-acting injectable PrEP in South Africa: a model comparison analysis","authors":"Sarah E. Stansfield, Mia Moore, Lise Jamieson, Gesine Meyer-Rath, Leigh F. Johnson, David Kaftan, Anna Bershteyn, Jennifer Smith, Valentina Cambiano, Loveleen Bansi-Matharu, Andrew Phillips, Jesse Heitner, Ruanne V. Barnabas, Brett Hanscom, Deborah J. Donnell, Marie-Claude Boily, Dobromir Dimitrov","doi":"10.1002/jia2.26453","DOIUrl":"https://doi.org/10.1002/jia2.26453","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Long-acting injectable cabotegravir (CAB-LA) demonstrated superiority to daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) in two clinical trials. This analysis projects the impact of expanding PrEP coverage with CAB-LA in South Africa between 2022 and 2042.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Three independently calibrated models of HIV transmission in South Africa (Synthesis, EMOD-HIV, Thembisa) projected HIV acquisitions and effective coverage (average PrEP coverage across exposure groups, weighted by HIV incidence in the absence of PrEP in each group) over 20 years under multiple scenarios of PrEP expansion compared to no PrEP expansion. PrEP expansion scenarios differed in targeted overall coverage, speed of expansion, coverage of high-exposure groups, and relative coverage of women and men.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Achieving 5% PrEP coverage with CAB-LA by 2032 prioritizing high-exposure groups resulted in 49% (Synthesis), 18% (EMOD-HIV), and 8% (Thembisa) effective coverage and averted a median of 43%, 29% and 10% of new HIV acquisitions, respectively. Similar expansion with TDF/FTC resulted in lower impact by 19 percentage points (pp), 18pp and 3pp, respectively. Increasing CAB-LA coverage to 15% led to an additional 7pp, 12pp and 16pp, respectively, of HIV acquisitions averted. Achieving 5% CAB-LA coverage expanding to women only resulted in a lower impact by 16pp (Synthesis) and 13pp (EMOD-HIV), and a higher impact by 2pp (Thembisa). Scenarios with similar effective coverage resulted in comparable impact estimates across models.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Offering CAB-LA in South Africa may substantially impact the HIV epidemic based on these projections. Effective coverage proved to be a good predictor of intervention effectiveness.</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/jia2.26453","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144524833","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}
Cristina Pimenta, Claudio G. Mann, Brenda Hoagland, Eduardo Carvalheira, Cristina Jalil, Marcos Benedetti, Nilo Fernandes, Carolina Coutinho, Emilia M. Jalil, Mayara Secco Torres Silva, Roberta Trefiglio, Alessandro Farias, Maria Paula G. Mourão, José Valdez Madruga, Josué N. de Lima, Ronaldo Zonta, Gabrielle O'Malley, Valdilea G. Veloso, Beatriz Grinsztejn, Thiago S. Torres, for the ImPrEP CAB-Brasil Study
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 prevent
{"title":"Exploring perceptions and preferences for PrEP choice and of an mHealth intervention: insights from the ImPrEP CAB-Brasil study","authors":"Cristina Pimenta, Claudio G. Mann, Brenda Hoagland, Eduardo Carvalheira, Cristina Jalil, Marcos Benedetti, Nilo Fernandes, Carolina Coutinho, Emilia M. Jalil, Mayara Secco Torres Silva, Roberta Trefiglio, Alessandro Farias, Maria Paula G. Mourão, José Valdez Madruga, Josué N. de Lima, Ronaldo Zonta, Gabrielle O'Malley, Valdilea G. Veloso, Beatriz Grinsztejn, Thiago S. Torres, for the ImPrEP CAB-Brasil Study","doi":"10.1002/jia2.26493","DOIUrl":"https://doi.org/10.1002/jia2.26493","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>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.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>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 prevent","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/jia2.26493","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144524764","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}
The potential of pre-exposure prophylaxis (PrEP), as a highly effective and empowering HIV prevention intervention, has not yet been realized. Despite the recent acceleration in the scale-up of oral PrEP, there is a substantial unmet PrEP need, and the world is not on track to meet the 2025 prevention targets. New PrEP products, and service delivery approaches, could support greater access, uptake, persistence and effective use. This commentary discusses how offering choice in PrEP products and service delivery innovations could transform global HIV prevention efforts.
Discussion
Although oral PrEP accounts for almost all PrEP use to date, slow rollout and challenges in effective use and persistence have limited the global impact. Innovative products like long-acting injectable cabotegravir and injectable lenacapavir can overcome some of the challenges associated with oral PrEP. Expanding PrEP choices is also essential for addressing diverse individual preferences and maximizing prevention outcomes. Real-world evidence suggests that offering increased options can drive demand and increase coverage of prevention.
Equally critical is tailoring service delivery through differentiated service delivery (DSD) models that prioritize accessibility and user needs and preferences, including integration of PrEP within other valued services. DSD models, including peer-led, pharmacy-based and telehealth approaches, have demonstrated success and acceptability for oral PrEP, but innovation is needed to adapt to long-acting injectable options. For example, regulatory and policy support are essential to support task-sharing with community health worker involvement may enable broader reach.
Programmatic challenges, including PrEP product and service delivery costs, updating monitoring and evaluation and ensuring stakeholder support, must also be addressed. Scaling up new PrEP products using a precision prevention lens could help to optimize approaches for achieving impact.
Conclusions
The new era of PrEP choice, with new long-acting PrEP products and DSD options, presents countries with an extraordinary opportunity to amplify prevention access, achieve higher prevention coverage and drive the meaningful reductions in new HIV acquisitions needed to end the HIV epidemic. Without coordinated and concerted efforts within countries and supported at the global level to leverage choice and embed it within the HIV prevention response, we risk prolonging the HIV epidemic.
{"title":"Seizing the moment: the potential of PrEP choice and innovation to transform HIV prevention","authors":"Heather-Marie A. Schmidt, Mateo Prochazka, Heather Ingold, Sushena Reza-Paul, Thato Chidarikire, Irvin Romyco, Michelle Rodolph","doi":"10.1002/jia2.26498","DOIUrl":"https://doi.org/10.1002/jia2.26498","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>The potential of pre-exposure prophylaxis (PrEP), as a highly effective and empowering HIV prevention intervention, has not yet been realized. Despite the recent acceleration in the scale-up of oral PrEP, there is a substantial unmet PrEP need, and the world is not on track to meet the 2025 prevention targets. New PrEP products, and service delivery approaches, could support greater access, uptake, persistence and effective use. This commentary discusses how offering choice in PrEP products and service delivery innovations could transform global HIV prevention efforts.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>Although oral PrEP accounts for almost all PrEP use to date, slow rollout and challenges in effective use and persistence have limited the global impact. Innovative products like long-acting injectable cabotegravir and injectable lenacapavir can overcome some of the challenges associated with oral PrEP. Expanding PrEP choices is also essential for addressing diverse individual preferences and maximizing prevention outcomes. Real-world evidence suggests that offering increased options can drive demand and increase coverage of prevention.</p>\u0000 \u0000 <p>Equally critical is tailoring service delivery through differentiated service delivery (DSD) models that prioritize accessibility and user needs and preferences, including integration of PrEP within other valued services. DSD models, including peer-led, pharmacy-based and telehealth approaches, have demonstrated success and acceptability for oral PrEP, but innovation is needed to adapt to long-acting injectable options. For example, regulatory and policy support are essential to support task-sharing with community health worker involvement may enable broader reach.</p>\u0000 \u0000 <p>Programmatic challenges, including PrEP product and service delivery costs, updating monitoring and evaluation and ensuring stakeholder support, must also be addressed. Scaling up new PrEP products using a precision prevention lens could help to optimize approaches for achieving impact.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The new era of PrEP choice, with new long-acting PrEP products and DSD options, presents countries with an extraordinary opportunity to amplify prevention access, achieve higher prevention coverage and drive the meaningful reductions in new HIV acquisitions needed to end the HIV epidemic. Without coordinated and concerted efforts within countries and supported at the global level to leverage choice and embed it within the HIV prevention response, we risk prolonging the HIV epidemic.</p>\u0000 ","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/jia2.26498","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144525023","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}
Naira Setrakian, Hao Thi Minh Bui, Paul C. Adamson, Thai N. Hoang, Pamina M. Gorbach, Le Minh Giang
Introduction
We examined the association of pre-exposure prophylaxis (PrEP) programme retention with the use of daily, event-driven (ED) or regimen switching reported during follow-up at any point prior to discontinuation among men who have sex with men (MSM) in Hanoi, Vietnam.
Methods
Between April 2020 and February 2023, we collected data from PrEP clients at Hanoi Medical University Sexual Health Promotion clinic who were prescribed either ED or daily PrEP at the initial visit; at subsequent visits, clients reported the regimen used since the prior visit. We defined three categories of PrEP use: ED-PrEP exclusively, daily PrEP exclusively and switching regimens. The primary outcome was time to discontinuation in the PrEP programme during the study period, defined as missing a scheduled visit by > 30 days. We performed survival analysis using Kaplan−Meier curves.
Results
In total, 2107 people were included: 61.1% (n = 1288) reported exclusive use of daily PrEP, 10.4% (n = 220) reported exclusive use of ED-PrEP and 28.4% (n = 599) reported switching PrEP regimens. Among switchers, 29.40% (n = 176) switched more than once. Furthermore, 82.5% switched from daily to ED-PrEP and 17.5% switched from ED to daily PrEP. The median time to discontinuation in the PrEP programme was 105 days (IQR: 52−182) among those reporting exclusive use of ED-PrEP, 104 days (IQR: 56−274) among those reporting exclusive use of daily PrEP and 163 days (IQR: 101−308) among those who switched. Among switchers, those who switched more than once had a median time to discontinuation in the PrEP programme of 231 days (IQR: 137−380) in comparison to 133 days (IQR: 90−274) for those who switched once.
Conclusions
We provide real-world data from MSM in an HIV PrEP programme in Vietnam that those who switched had longer periods of retention during the study period. Our findings suggest that offering flexible PrEP regimen options may improve engagement and long-term adherence among this population.
{"title":"Impact of changing pre-exposure prophylaxis regimens on retention among men who have sex with men in Hanoi, Vietnam (2020−2023): a cohort study","authors":"Naira Setrakian, Hao Thi Minh Bui, Paul C. Adamson, Thai N. Hoang, Pamina M. Gorbach, Le Minh Giang","doi":"10.1002/jia2.26478","DOIUrl":"https://doi.org/10.1002/jia2.26478","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>We examined the association of pre-exposure prophylaxis (PrEP) programme retention with the use of daily, event-driven (ED) or regimen switching reported during follow-up at any point prior to discontinuation among men who have sex with men (MSM) in Hanoi, Vietnam.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Between April 2020 and February 2023, we collected data from PrEP clients at Hanoi Medical University Sexual Health Promotion clinic who were prescribed either ED or daily PrEP at the initial visit; at subsequent visits, clients reported the regimen used since the prior visit. We defined three categories of PrEP use: ED-PrEP exclusively, daily PrEP exclusively and switching regimens. The primary outcome was time to discontinuation in the PrEP programme during the study period, defined as missing a scheduled visit by > 30 days. We performed survival analysis using Kaplan−Meier curves.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In total, 2107 people were included: 61.1% (<i>n</i> = 1288) reported exclusive use of daily PrEP, 10.4% (<i>n</i> = 220) reported exclusive use of ED-PrEP and 28.4% (<i>n</i> = 599) reported switching PrEP regimens. Among switchers, 29.40% (<i>n</i> = 176) switched more than once. Furthermore, 82.5% switched from daily to ED-PrEP and 17.5% switched from ED to daily PrEP. The median time to discontinuation in the PrEP programme was 105 days (IQR: 52−182) among those reporting exclusive use of ED-PrEP, 104 days (IQR: 56−274) among those reporting exclusive use of daily PrEP and 163 days (IQR: 101−308) among those who switched. Among switchers, those who switched more than once had a median time to discontinuation in the PrEP programme of 231 days (IQR: 137−380) in comparison to 133 days (IQR: 90−274) for those who switched once.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>We provide real-world data from MSM in an HIV PrEP programme in Vietnam that those who switched had longer periods of retention during the study period. Our findings suggest that offering flexible PrEP regimen options may improve engagement and long-term adherence among this population.</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/jia2.26478","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144524762","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}
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}
扫码关注我们
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号