Ricky K. Hsu, Michael G. Sension, Jennifer S. Fusco, Laurence Brunet, Quateka Cochran, Brooke Levis, Gayathri Sridhar, Vani Vannappagari, Jean Van Wyk, Michael B. Wohlfeiler, Gregory P. Fusco
Introduction
Cabotegravir + rilpivirine long-acting (CAB+RPV LA) injectable was approved in the United States in 2021 for HIV-1 treatment in virologically suppressed (viral load [VL] <50 copies/mI individuals. In clinical trials, CAB+RPV LA was non-inferior to oral antiretroviral therapy (ART) regimens in virologically suppressed individuals. We compared real-world effectiveness between CAB+RPV LA and oral ART regimens and assessed predictors of confirmed virologic failure (CVF) on CAB+RPV LA.
Methods
From the OPERA® cohort, ART-experienced, virologically suppressed adults with HIV switching to CAB+RPV LA or a new oral ART regimen between 21 January 2021 and 31 December 2022 were followed through 30 June 2023. CVF was defined as 2 VL ≥200 copies/ml or 1 VL ≥200 copies/ml + discontinuation. Logistic regression was used to assess CVF risk by regimen and CVF predictors among CAB+RPV LA users.
Results
During the study period, 1362 virologically suppressed adults switched to CAB+RPV LA, and 2783 switched to a new oral ART regimen (92% second-generation integrase inhibitor [INSTI]-based). Compared to oral ART users, CAB+RPV LA users were younger, on their prior regimen less time and more likely to switch from an INSTI; median CD4 counts at initiation were similar. At study end, 81% of CAB+RPV LA users and 80% of oral ART users were on their respective regimens. CVF risk with CAB+RPV LA did not statistically differ compared to oral ART (adjusted odds ratio: 0.64; 95% confidence interval [CI]: 0.34, 1.14). Among CAB+RPV LA users, only baseline CD4 predicted CVF; every 100 CD4 cells/µl increase was associated with 20% lower CVF risk (OR [95% CI]: 0.80 [0.64, 0.97]).
Conclusions
In the United States, routine clinical care, CVF risk did not differ between a switch to CAB+RPV LA or new oral ART, with most individuals remaining on their regimens at study end. Lower CD4 count at initiation was the only predictor of CVF on CAB+RPV LA.
{"title":"Comparable real-world effectiveness between switches to cabotegravir + rilpivirine long-acting or modern daily oral regimens in the United States: an OPERA cohort study","authors":"Ricky K. Hsu, Michael G. Sension, Jennifer S. Fusco, Laurence Brunet, Quateka Cochran, Brooke Levis, Gayathri Sridhar, Vani Vannappagari, Jean Van Wyk, Michael B. Wohlfeiler, Gregory P. Fusco","doi":"10.1002/jia2.70068","DOIUrl":"10.1002/jia2.70068","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Cabotegravir + rilpivirine long-acting (CAB+RPV LA) injectable was approved in the United States in 2021 for HIV-1 treatment in virologically suppressed (viral load [VL] <50 copies/mI individuals. In clinical trials, CAB+RPV LA was non-inferior to oral antiretroviral therapy (ART) regimens in virologically suppressed individuals. We compared real-world effectiveness between CAB+RPV LA and oral ART regimens and assessed predictors of confirmed virologic failure (CVF) on CAB+RPV LA.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>From the OPERA<sup>®</sup> cohort, ART-experienced, virologically suppressed adults with HIV switching to CAB+RPV LA or a new oral ART regimen between 21 January 2021 and 31 December 2022 were followed through 30 June 2023. CVF was defined as 2 VL ≥200 copies/ml or 1 VL ≥200 copies/ml + discontinuation. Logistic regression was used to assess CVF risk by regimen and CVF predictors among CAB+RPV LA users.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>During the study period, 1362 virologically suppressed adults switched to CAB+RPV LA, and 2783 switched to a new oral ART regimen (92% second-generation integrase inhibitor [INSTI]-based). Compared to oral ART users, CAB+RPV LA users were younger, on their prior regimen less time and more likely to switch from an INSTI; median CD4 counts at initiation were similar. At study end, 81% of CAB+RPV LA users and 80% of oral ART users were on their respective regimens. CVF risk with CAB+RPV LA did not statistically differ compared to oral ART (adjusted odds ratio: 0.64; 95% confidence interval [CI]: 0.34, 1.14). Among CAB+RPV LA users, only baseline CD4 predicted CVF; every 100 CD4 cells/µl increase was associated with 20% lower CVF risk (OR [95% CI]: 0.80 [0.64, 0.97]).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>In the United States, routine clinical care, CVF risk did not differ between a switch to CAB+RPV LA or new oral ART, with most individuals remaining on their regimens at study end. Lower CD4 count at initiation was the only predictor of CVF on CAB+RPV LA.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 12","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12710068/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145766681","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}
Blanca Lopez-Villalba, Monica Alonso-Gonzalez, Bernardo Nuche-Berenguer, J. Javier Castrodeza-Sanz, Omar Sued
<p>The collection and analysis of HIV-related mortality trends and their causes in Latin America (LA) are limited, which impedes planning and prioritization of interventions. National HIV surveillance databases within the region typically do not track deaths among people living with HIV directly. Instead, countries report information received from the vital registration (VR) system or rely on modelled statistical estimates. VR system uses the International Classification of Diseases (ICD) to standardize, record and categorize causes of death. While this coding system is essential for monitoring mortality trends, its implementation is often delayed and affected by multiple factors that compromise the quality of death certification [<span>1</span>].</p><p>In the case of HIV, the ICD codes B20−24 are used to classify deaths related to conditions listed as WHO Stage 4 or CDC Stage C. However, misclassifications leading to underreporting are common. These often result from the use of ill-defined codes (i.e. symptoms, signs, and abnormal clinical and laboratory findings such as codes R00−R99) or garbage codes (e.g. listing only the immediate or intermediate causes of death without identifying the underlying cause, often due to lack of knowledge, stigma or confidentiality concerns). Misclassification can also lead to overreporting by incorrectly attributing HIV deaths to diseases that mimic HIV infection or by assigning HIV as the underlying cause in deaths primarily due to other conditions. While globally the misclassification has declined, researchers estimated that between 8.5% and 39.7% of total HIV deaths remain misclassified [<span>2</span>].</p><p>In LA, only two studies—over a decade old—have examined how HIV-related deaths are captured in VR systems. These studies, conducted in Brazil [<span>3</span>] and Mexico [<span>4</span>], highlight the limited availability of data on this topic. Notably, they also identified inaccuracies in death attribution with estimated misclassification rates of around 27% and 11%, respectively. These findings suggest persistent weaknesses in how HIV deaths are coded in LA information systems.</p><p>Frameworks to improve the accuracy and comparability of cause-of-death data have been developed to estimate trends in HIV mortality. These frameworks account for variability in the completeness of VR data, redistribute deaths attributed to garbage codes and correct for misclassifications [<span>2</span>]. However, their effectiveness is limited by countries’ analytic capacity to conduct such analyses.</p><p>One such approach is the Coding Causes of Death in HIV (CoDe) Project, developed by the EuroCoord/EACS collaboration [<span>5</span>]. CoDe uses data collection from multiple sources, such as medical records, autopsy reports and death certificates, and uses a centralized adjudication process with independent reviewers to accurately attribute the cause of death (e.g. AIDS-related, non-AIDS-related, unknown). This metho
{"title":"What is not measured cannot be improved: the urgency to understand causes of HIV-related deaths in Latin America","authors":"Blanca Lopez-Villalba, Monica Alonso-Gonzalez, Bernardo Nuche-Berenguer, J. Javier Castrodeza-Sanz, Omar Sued","doi":"10.1002/jia2.70065","DOIUrl":"https://doi.org/10.1002/jia2.70065","url":null,"abstract":"<p>The collection and analysis of HIV-related mortality trends and their causes in Latin America (LA) are limited, which impedes planning and prioritization of interventions. National HIV surveillance databases within the region typically do not track deaths among people living with HIV directly. Instead, countries report information received from the vital registration (VR) system or rely on modelled statistical estimates. VR system uses the International Classification of Diseases (ICD) to standardize, record and categorize causes of death. While this coding system is essential for monitoring mortality trends, its implementation is often delayed and affected by multiple factors that compromise the quality of death certification [<span>1</span>].</p><p>In the case of HIV, the ICD codes B20−24 are used to classify deaths related to conditions listed as WHO Stage 4 or CDC Stage C. However, misclassifications leading to underreporting are common. These often result from the use of ill-defined codes (i.e. symptoms, signs, and abnormal clinical and laboratory findings such as codes R00−R99) or garbage codes (e.g. listing only the immediate or intermediate causes of death without identifying the underlying cause, often due to lack of knowledge, stigma or confidentiality concerns). Misclassification can also lead to overreporting by incorrectly attributing HIV deaths to diseases that mimic HIV infection or by assigning HIV as the underlying cause in deaths primarily due to other conditions. While globally the misclassification has declined, researchers estimated that between 8.5% and 39.7% of total HIV deaths remain misclassified [<span>2</span>].</p><p>In LA, only two studies—over a decade old—have examined how HIV-related deaths are captured in VR systems. These studies, conducted in Brazil [<span>3</span>] and Mexico [<span>4</span>], highlight the limited availability of data on this topic. Notably, they also identified inaccuracies in death attribution with estimated misclassification rates of around 27% and 11%, respectively. These findings suggest persistent weaknesses in how HIV deaths are coded in LA information systems.</p><p>Frameworks to improve the accuracy and comparability of cause-of-death data have been developed to estimate trends in HIV mortality. These frameworks account for variability in the completeness of VR data, redistribute deaths attributed to garbage codes and correct for misclassifications [<span>2</span>]. However, their effectiveness is limited by countries’ analytic capacity to conduct such analyses.</p><p>One such approach is the Coding Causes of Death in HIV (CoDe) Project, developed by the EuroCoord/EACS collaboration [<span>5</span>]. CoDe uses data collection from multiple sources, such as medical records, autopsy reports and death certificates, and uses a centralized adjudication process with independent reviewers to accurately attribute the cause of death (e.g. AIDS-related, non-AIDS-related, unknown). This metho","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 12","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70065","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145619236","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, Richard M. Ochanda, Sara M. Allinder, Rena Janamnuaysook, Andrew Grulich, Kenneth Ngure
<p>From the earliest days of the HIV epidemic, communities of people living with, and affected by, HIV have mobilized to advocate, driving political action, transforming research and service delivery, and fighting for equitable access to lifesaving care. This leadership has enabled millions to survive and thrive. Over the past year, the global HIV response has entered a period of heightened uncertainty, marked by significant funding cuts, widening inequities in prevention and treatment access, and growing pressure on health systems to sustain progress with fewer resources. As funding declines, human rights have been eroded, and science and global health assistance have become politicized, placing progress at risk. Meeting this moment requires renewed commitment to the values that have defined the HIV response: science, solidarity and social justice.</p><p>At IAS 2025 in Rwanda, over 700 scientists, advocates and public health leaders adopted the Kigali Declaration, a call to protect and build on more than four decades of progress against a disease that has killed over 44 million people [<span>1, 2</span>]. The declaration outlined five principles: embracing meaningful partnerships; supporting global HIV research; prioritizing HIV prevention; protecting human rights; and rejecting the politicization of science.</p><p>Building on this momentum, IAS—the International AIDS Society, through its <i>Road to Rio</i> initiative, launched a global consultation to accelerate implementation of these principles ahead of AIDS 2026—the 26th International AIDS Conference that will take place in Rio de Janeiro, Brazil. Participants identified three key advocacy priorities rooted in science and community leadership: sustaining investment in HIV science; ensuring that health systems are person-centred and grounded in human rights; and securing equitable access to prevention to achieve epidemic control.</p><p>These messages form a framework for coordinated action to advance priorities through a unified, evidence-based approach.</p><p><b>Investment in science saves lives</b></p><p>Continued investment in HIV research will drive the next generation of breakthroughs, benefiting public health far beyond the HIV field. The same research that revolutionized HIV care has already transformed multiple medical disciplines, including chimeric antigen receptor T-cell therapy for cancer, curative hepatitis C treatments [<span>3</span>], and insights into cardiovascular, autoimmune and blood conditions [<span>4</span>]. The development of HIV research infrastructure and implementation capacity have enabled faster, more coordinated responses to other health challenges, including COVID-19 and Mpox. Yet, the systems that enabled these advances are fragile. As research funding decreases, the discovery pipeline risks slowing just as new long-acting medications have demonstrated efficacy and transformative technologies like gene editing and immune-based cures are within reach. Sustaine
{"title":"From Kigali to Rio: advancing an evidence-based and equitable HIV response","authors":"Beatriz Grinsztejn, Richard M. Ochanda, Sara M. Allinder, Rena Janamnuaysook, Andrew Grulich, Kenneth Ngure","doi":"10.1002/jia2.70064","DOIUrl":"https://doi.org/10.1002/jia2.70064","url":null,"abstract":"<p>From the earliest days of the HIV epidemic, communities of people living with, and affected by, HIV have mobilized to advocate, driving political action, transforming research and service delivery, and fighting for equitable access to lifesaving care. This leadership has enabled millions to survive and thrive. Over the past year, the global HIV response has entered a period of heightened uncertainty, marked by significant funding cuts, widening inequities in prevention and treatment access, and growing pressure on health systems to sustain progress with fewer resources. As funding declines, human rights have been eroded, and science and global health assistance have become politicized, placing progress at risk. Meeting this moment requires renewed commitment to the values that have defined the HIV response: science, solidarity and social justice.</p><p>At IAS 2025 in Rwanda, over 700 scientists, advocates and public health leaders adopted the Kigali Declaration, a call to protect and build on more than four decades of progress against a disease that has killed over 44 million people [<span>1, 2</span>]. The declaration outlined five principles: embracing meaningful partnerships; supporting global HIV research; prioritizing HIV prevention; protecting human rights; and rejecting the politicization of science.</p><p>Building on this momentum, IAS—the International AIDS Society, through its <i>Road to Rio</i> initiative, launched a global consultation to accelerate implementation of these principles ahead of AIDS 2026—the 26th International AIDS Conference that will take place in Rio de Janeiro, Brazil. Participants identified three key advocacy priorities rooted in science and community leadership: sustaining investment in HIV science; ensuring that health systems are person-centred and grounded in human rights; and securing equitable access to prevention to achieve epidemic control.</p><p>These messages form a framework for coordinated action to advance priorities through a unified, evidence-based approach.</p><p><b>Investment in science saves lives</b></p><p>Continued investment in HIV research will drive the next generation of breakthroughs, benefiting public health far beyond the HIV field. The same research that revolutionized HIV care has already transformed multiple medical disciplines, including chimeric antigen receptor T-cell therapy for cancer, curative hepatitis C treatments [<span>3</span>], and insights into cardiovascular, autoimmune and blood conditions [<span>4</span>]. The development of HIV research infrastructure and implementation capacity have enabled faster, more coordinated responses to other health challenges, including COVID-19 and Mpox. Yet, the systems that enabled these advances are fragile. As research funding decreases, the discovery pipeline risks slowing just as new long-acting medications have demonstrated efficacy and transformative technologies like gene editing and immune-based cures are within reach. Sustaine","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 12","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70064","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145619235","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}
<p>I have learned that successful public health programmes rely on the strength of three pillars: science, community and political will [<span>1</span>]. Each public health challenge requires a different degree of support from these pillars, but if any one of them is undermined, public health struggles to uphold its mission—to protect people's health. HIV serves as a compelling case study of this principle, both in the United States and globally.</p><p>The story begins with the pillar of community. AIDS in America was first identified in the early 1980s among gay men—a community that had only recently mobilized for its liberation. Faced with a deadly outbreak, the infrastructure of the gay rights movement shifted from fighting for civil rights to fighting for survival. This community demanded that science be prioritized and that political will be shown at a time when both were lacking in response to the emerging epidemic. The community stormed the US Food and Drug Administration and the US National Institute of Health, staged powerful symbolic protests, burned effigies in public and forged strong alliances with government and scientists in private. This surge of community activism not only facilitated scientific efforts, but also helped shape and accelerate them, resulting in steady progress and major breakthroughs driven by, and for, the community.</p><p>Because of this, progress against HIV has often outpaced changes in society over the past three decades. Antiretroviral medications transformed HIV into a chronic, manageable disease for those who could access treatment. Later, it was discovered that the same treatment preventing disease progression also stopped sexual transmission of the virus—giving rise to the concept “Undetectable = Untransmittable” [<span>2</span>]. Pre-exposure prophylaxis moved quickly from clinical trial results to real-world implementation, albeit unevenly. Long-acting injectable treatments and preventatives have further strengthened the idea that, even without a vaccine, controlling the HIV epidemic is possible.</p><p>This period was, in many ways, a golden age for public health and science. But, as with all golden ages, challenges soon emerged. When political will wanes, the foundation is at risk of crumbling. When science is undermined by cultural battles and deprioritized by funders, the breakthroughs of previous decades can fade into memory. And when vital programmes are threatened with elimination by the very politicians who created them, both progress and people's health are put in jeopardy.</p><p>This is where we stand today. Both domestic and global HIV funding now face serious threats, caught in a storm of politics that intentionally disregards health equity. Current rhetoric labels gender identity as an ideology rather than a personal expression, prioritizes efforts to “end wokeness” over the goal of ending the HIV epidemic, misrepresents global HIV initiatives as wasteful “foreign aid,” and seeks to dismantl
{"title":"This is not normal: a call for HIV activism","authors":"Demetre C. Daskalakis","doi":"10.1002/jia2.70063","DOIUrl":"https://doi.org/10.1002/jia2.70063","url":null,"abstract":"<p>I have learned that successful public health programmes rely on the strength of three pillars: science, community and political will [<span>1</span>]. Each public health challenge requires a different degree of support from these pillars, but if any one of them is undermined, public health struggles to uphold its mission—to protect people's health. HIV serves as a compelling case study of this principle, both in the United States and globally.</p><p>The story begins with the pillar of community. AIDS in America was first identified in the early 1980s among gay men—a community that had only recently mobilized for its liberation. Faced with a deadly outbreak, the infrastructure of the gay rights movement shifted from fighting for civil rights to fighting for survival. This community demanded that science be prioritized and that political will be shown at a time when both were lacking in response to the emerging epidemic. The community stormed the US Food and Drug Administration and the US National Institute of Health, staged powerful symbolic protests, burned effigies in public and forged strong alliances with government and scientists in private. This surge of community activism not only facilitated scientific efforts, but also helped shape and accelerate them, resulting in steady progress and major breakthroughs driven by, and for, the community.</p><p>Because of this, progress against HIV has often outpaced changes in society over the past three decades. Antiretroviral medications transformed HIV into a chronic, manageable disease for those who could access treatment. Later, it was discovered that the same treatment preventing disease progression also stopped sexual transmission of the virus—giving rise to the concept “Undetectable = Untransmittable” [<span>2</span>]. Pre-exposure prophylaxis moved quickly from clinical trial results to real-world implementation, albeit unevenly. Long-acting injectable treatments and preventatives have further strengthened the idea that, even without a vaccine, controlling the HIV epidemic is possible.</p><p>This period was, in many ways, a golden age for public health and science. But, as with all golden ages, challenges soon emerged. When political will wanes, the foundation is at risk of crumbling. When science is undermined by cultural battles and deprioritized by funders, the breakthroughs of previous decades can fade into memory. And when vital programmes are threatened with elimination by the very politicians who created them, both progress and people's health are put in jeopardy.</p><p>This is where we stand today. Both domestic and global HIV funding now face serious threats, caught in a storm of politics that intentionally disregards health equity. Current rhetoric labels gender identity as an ideology rather than a personal expression, prioritizes efforts to “end wokeness” over the goal of ending the HIV epidemic, misrepresents global HIV initiatives as wasteful “foreign aid,” and seeks to dismantl","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 12","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70063","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145619234","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}
Bonnie E. Shook-Sa, Paul N. Zivich, Stephen R. Cole, Nora E. Rosenberg, Michael G. Hudgens, Deborah J. Donnell, Sizulu Moyo, Khangelani Zuma, Helen Ayles, Peter Bock, Joseph J. Eron, Richard J. Hayes, Jessie K. Edwards
Introduction
HIV Prevention Trials Network (HPTN) 071 (PopART) was a cluster-randomized trial to evaluate universal testing and treatment (UTT) strategies for HIV prevention. HPTN071 compared three arms: (A) combination prevention with UTT; (B) combination prevention with universal testing and antiretroviral therapy initiation according to local guidelines; and (C) standard of care (SOC). Interventions were implemented in entire randomized communities, with impacts on HIV incidence measured in “population cohorts,” that is the HPTN071 sample. Unexpectedly, a significantly lower incidence was not observed in arm A relative to SOC. Importantly, rates of participation in the HPTN071 sample differed among population subgroups, for example men were underrepresented.
Methods
To correct for underrepresented subgroups, PopART intervention effects are estimated in a population of interest, adults aged 18−44 in trial provinces, characterized with two nationally representative HIV-focused surveys. The HPTN071 sample is weighted to match the population of interest by demographics and HIV risk factors. Risk of HIV acquisition is compared across arms, both in the trial population (unweighted) and the population of interest (weighted). Both (1) the risk of HIV acquisition between 1 and 3 years and (2) the risk of HIV acquisition by 3 years are compared.
Results
In the trial population, estimated risk in arm A is, counterintuitively, slightly higher than SOC (Year 1−3 Risk Difference [RD]: 0.10%; 95% CI: −1.15%, 1.25%). After weighting, risk in arm A is lower than SOC in the population of interest (RD: −0.34%; 95% CI: −2.04%, 0.96%). Weighting also strengthened the estimated effect in arm B relative to SOC (unweighted RD: −0.66%, 95% CI: −1.88%, 0.46%; weighted RD: −1.18%, 95% CI: −2.85%, 0.15%). Weighted year 3 risk difference estimates indicated even stronger possible intervention effects: A versus SOC −0.83% (95% CI: −2.94%, 0.99%), B versus SOC −1.86% (95% CI: −3.80%, −0.09%).
Conclusions
PopART interventions are estimated to be more protective in the population of interest than observed in the HPTN071 sample. These results partially explain the unexpected finding in arm A, providing further support for UTT strategies for HIV prevention. This analysis also highlights the importance of considering heterogeneous treatment effects among population subgroups when measuring the overall efficacy of HIV interventions.
{"title":"Examining the effect of universal testing and treatment strategies for HIV prevention in Zambia and South Africa: generalizing the results of the HPTN 071 (PopART) trial","authors":"Bonnie E. Shook-Sa, Paul N. Zivich, Stephen R. Cole, Nora E. Rosenberg, Michael G. Hudgens, Deborah J. Donnell, Sizulu Moyo, Khangelani Zuma, Helen Ayles, Peter Bock, Joseph J. Eron, Richard J. Hayes, Jessie K. Edwards","doi":"10.1002/jia2.70062","DOIUrl":"https://doi.org/10.1002/jia2.70062","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>HIV Prevention Trials Network (HPTN) 071 (PopART) was a cluster-randomized trial to evaluate universal testing and treatment (UTT) strategies for HIV prevention. HPTN071 compared three arms: (A) combination prevention with UTT; (B) combination prevention with universal testing and antiretroviral therapy initiation according to local guidelines; and (C) standard of care (SOC). Interventions were implemented in entire randomized communities, with impacts on HIV incidence measured in “population cohorts,” that is the HPTN071 sample. Unexpectedly, a significantly lower incidence was not observed in arm A relative to SOC. Importantly, rates of participation in the HPTN071 sample differed among population subgroups, for example men were underrepresented.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>To correct for underrepresented subgroups, PopART intervention effects are estimated in a population of interest, adults aged 18−44 in trial provinces, characterized with two nationally representative HIV-focused surveys. The HPTN071 sample is weighted to match the population of interest by demographics and HIV risk factors. Risk of HIV acquisition is compared across arms, both in the trial population (unweighted) and the population of interest (weighted). Both (1) the risk of HIV acquisition between 1 and 3 years and (2) the risk of HIV acquisition by 3 years are compared.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In the trial population, estimated risk in arm A is, counterintuitively, slightly higher than SOC (Year 1−3 Risk Difference [RD]: 0.10%; 95% CI: −1.15%, 1.25%). After weighting, risk in arm A is lower than SOC in the population of interest (RD: −0.34%; 95% CI: −2.04%, 0.96%). Weighting also strengthened the estimated effect in arm B relative to SOC (unweighted RD: −0.66%, 95% CI: −1.88%, 0.46%; weighted RD: −1.18%, 95% CI: −2.85%, 0.15%). Weighted year 3 risk difference estimates indicated even stronger possible intervention effects: A versus SOC −0.83% (95% CI: −2.94%, 0.99%), B versus SOC −1.86% (95% CI: −3.80%, −0.09%).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>PopART interventions are estimated to be more protective in the population of interest than observed in the HPTN071 sample. These results partially explain the unexpected finding in arm A, providing further support for UTT strategies for HIV prevention. This analysis also highlights the importance of considering heterogeneous treatment effects among population subgroups when measuring the overall efficacy of HIV interventions.</p>\u0000 ","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 12","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70062","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145601145","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}
Carol S. Camlin, Anjeline Onyango, Jason Johnson-Peretz, Cecilia Akatukwasa, Titus O. Arunga, Lawrence Owino, Frederick Atwine, Ambrose Byamukama, Andrew Mutabazi, Laura B. Balzer, Maggie Czarnogorski, Elijah Kakande, Helen Sunday, Gabriel Chamie, James Ayieko, Maya Petersen, Nicole Sutter, Moses R. Kamya, Diane V. Havlir, Jane Kabami
<div> <section> <h3> Introduction</h3> <p>Despite oral HIV pre-exposure prophylaxis (PrEP) effectiveness, uptake and adherence remains a challenge. Newer HIV prevention technologies, including long-acting injectable cabotegravir (CAB-LA), are promising for addressing known barriers to oral PrEP uptake and adherence, yet research remains limited on experiences with CAB-LA among at-risk adults in community settings. This descriptive qualitative study explored experiences with CAB-LA among adults participating in the SEARCH Dynamic Choice HIV Prevention (DCP) trial in rural Kenya and Uganda, which evaluated HIV prevention uptake through a structured, person-centred DCP model.</p> </section> <section> <h3> Methods</h3> <p>We conducted in-depth semi-structured interviews in July−October 2023 with a purposively selected sample of 47 DCP trial participants who initiated CAB-LA and had at least two injections. Interviews explored participants’ reasons for choosing CAB-LA and their experiences with the method. We also included 10 participants who subsequently discontinued CAB-LA or switched to another method. Data were analysed using inductive coding, memoing and framework analysis.</p> </section> <section> <h3> Results</h3> <p>The 47 participants ranged from 20 to 59 years of age; 13 were men and 34 were women. Participants were enthusiastic about CAB-LA. They perceived it as novel, efficacious and advantageous relative to oral daily PrEP, which had been hindered by stigma, interruptions due to work, family visits and travel, side effects, and pill attributes (size and smell). Two major advantages of CAB-LA over PrEP were improved protection from HIV stigma and from HIV acquisition due to easier adherence. Participants felt CAB-LA was clearly distinguishable from antiretroviral therapy and would not mark them (mistakenly) as living with HIV; among women, clandestine use to guard against stigma from family members was more achievable compared to oral PrEP. Appointments for injections were rare enough (monthly, then bimonthly) that they could be kept, especially with reminders from providers, although for some, unpredictable work and travel schedules hindered their uptake of CAB-LA. Participants cited injection-site pain as the main drawback.</p> </section> <section> <h3> Conclusions</h3> <p>CAB-LA overcame several known barriers to HIV prevention uptake and adherence for women and men. In contexts of continued HIV-related stigma, CAB-LA met some participants’ preferences for a product that permitted prevention to be visibly distinguishable from treatment, e
{"title":"Early experiences with usage of long-acting injectable cabotegravir among adults in rural Ugandan and Kenyan communities: qualitative research from the SEARCH “Dynamic Choice HIV Prevention” intervention trials","authors":"Carol S. Camlin, Anjeline Onyango, Jason Johnson-Peretz, Cecilia Akatukwasa, Titus O. Arunga, Lawrence Owino, Frederick Atwine, Ambrose Byamukama, Andrew Mutabazi, Laura B. Balzer, Maggie Czarnogorski, Elijah Kakande, Helen Sunday, Gabriel Chamie, James Ayieko, Maya Petersen, Nicole Sutter, Moses R. Kamya, Diane V. Havlir, Jane Kabami","doi":"10.1002/jia2.70059","DOIUrl":"10.1002/jia2.70059","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Despite oral HIV pre-exposure prophylaxis (PrEP) effectiveness, uptake and adherence remains a challenge. Newer HIV prevention technologies, including long-acting injectable cabotegravir (CAB-LA), are promising for addressing known barriers to oral PrEP uptake and adherence, yet research remains limited on experiences with CAB-LA among at-risk adults in community settings. This descriptive qualitative study explored experiences with CAB-LA among adults participating in the SEARCH Dynamic Choice HIV Prevention (DCP) trial in rural Kenya and Uganda, which evaluated HIV prevention uptake through a structured, person-centred DCP model.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We conducted in-depth semi-structured interviews in July−October 2023 with a purposively selected sample of 47 DCP trial participants who initiated CAB-LA and had at least two injections. Interviews explored participants’ reasons for choosing CAB-LA and their experiences with the method. We also included 10 participants who subsequently discontinued CAB-LA or switched to another method. Data were analysed using inductive coding, memoing and framework analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The 47 participants ranged from 20 to 59 years of age; 13 were men and 34 were women. Participants were enthusiastic about CAB-LA. They perceived it as novel, efficacious and advantageous relative to oral daily PrEP, which had been hindered by stigma, interruptions due to work, family visits and travel, side effects, and pill attributes (size and smell). Two major advantages of CAB-LA over PrEP were improved protection from HIV stigma and from HIV acquisition due to easier adherence. Participants felt CAB-LA was clearly distinguishable from antiretroviral therapy and would not mark them (mistakenly) as living with HIV; among women, clandestine use to guard against stigma from family members was more achievable compared to oral PrEP. Appointments for injections were rare enough (monthly, then bimonthly) that they could be kept, especially with reminders from providers, although for some, unpredictable work and travel schedules hindered their uptake of CAB-LA. Participants cited injection-site pain as the main drawback.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>CAB-LA overcame several known barriers to HIV prevention uptake and adherence for women and men. In contexts of continued HIV-related stigma, CAB-LA met some participants’ preferences for a product that permitted prevention to be visibly distinguishable from treatment, e","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 11","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70059","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145595699","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}
Min Xi, Darrell H. S. Tan, Stefan D. Baral, Howsikan Kugathasan, Lisa Masucci, Becky Skidmore, Derek R. MacFadden, Kednapa Thavorn, Sharmistha Mishra
<div> <section> <h3> Introduction</h3> <p>Economic evaluations of HIV pre-exposure prophylaxis (PrEP) and associated implementation strategies guide evidence-based policies, programmes and resource allocation. Since 2015, there has been an evolution in PrEP modalities, implementation strategies and prioritization of key populations with unmet HIV prevention needs, alongside the scale-up of other HIV prevention interventions. Our systematic review describes the evolving landscape of economic evaluations of PrEP to help identify evidence gaps relevant to the current HIV epidemic and response (PROSPERO: CRD42016038440).</p> </section> <section> <h3> Methods</h3> <p>We searched five databases, without language restrictions, for peer-reviewed economic evaluations from inception to 21 August 2025. We describe the evolution of study characteristics over time, including the perspective of analysis, region, population, PrEP modality/implementation strategy and comparators.</p> </section> <section> <h3> Results</h3> <p>Of 5400 studies identified, 128 met inclusion criteria, of which 94 examined HIV epidemics in 2015 or later and 17 adopted a societal perspective. HIV epidemics studied primarily spanned countries in sub-Saharan Africa (<i>N</i> = 51) and in North America (<i>N</i> = 34). Modelled populations for receipt of PrEP primarily comprised: gay, bisexual and other men who have sex with men (<i>N</i> = 73), female sex workers (<i>N</i> = 26), serodifferent partnerships (<i>N</i> = 17) and persons who inject drugs (<i>N</i> = 12). Most evaluated oral, daily PrEP (<i>N</i> = 76), followed by long-acting injectable PrEP (<i>N</i> = 17), on-demand PrEP (<i>N</i> = 16) and others (e.g. vaginal ring, topical gel; <i>N</i> = 7). Twelve studies compared different PrEP modalities with each other. Five studies evaluated different implementation strategies to increase PrEP uptake, adherence and persistence. Of the 123 studies that compared PrEP to a combination of other HIV prevention interventions, only 31 scaled up at least part of the comparator over time.</p> </section> <section> <h3> Discussion</h3> <p>To support decision-making, future economic evaluations should consider costs and benefits beyond the health system (society) and consider comparators that better reflect the current HIV response across regions and populations. The increasing availability of novel PrEP modalities allows future studies to evaluate a mix of PrEP modalities and person-centred implementation strategies.</p> </section> <section>
{"title":"Evolving landscape of economic evaluations of HIV pre-exposure prophylaxis and pre-exposure prophylaxis implementation strategies: a systematic review","authors":"Min Xi, Darrell H. S. Tan, Stefan D. Baral, Howsikan Kugathasan, Lisa Masucci, Becky Skidmore, Derek R. MacFadden, Kednapa Thavorn, Sharmistha Mishra","doi":"10.1002/jia2.70058","DOIUrl":"10.1002/jia2.70058","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Economic evaluations of HIV pre-exposure prophylaxis (PrEP) and associated implementation strategies guide evidence-based policies, programmes and resource allocation. Since 2015, there has been an evolution in PrEP modalities, implementation strategies and prioritization of key populations with unmet HIV prevention needs, alongside the scale-up of other HIV prevention interventions. Our systematic review describes the evolving landscape of economic evaluations of PrEP to help identify evidence gaps relevant to the current HIV epidemic and response (PROSPERO: CRD42016038440).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We searched five databases, without language restrictions, for peer-reviewed economic evaluations from inception to 21 August 2025. We describe the evolution of study characteristics over time, including the perspective of analysis, region, population, PrEP modality/implementation strategy and comparators.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Of 5400 studies identified, 128 met inclusion criteria, of which 94 examined HIV epidemics in 2015 or later and 17 adopted a societal perspective. HIV epidemics studied primarily spanned countries in sub-Saharan Africa (<i>N</i> = 51) and in North America (<i>N</i> = 34). Modelled populations for receipt of PrEP primarily comprised: gay, bisexual and other men who have sex with men (<i>N</i> = 73), female sex workers (<i>N</i> = 26), serodifferent partnerships (<i>N</i> = 17) and persons who inject drugs (<i>N</i> = 12). Most evaluated oral, daily PrEP (<i>N</i> = 76), followed by long-acting injectable PrEP (<i>N</i> = 17), on-demand PrEP (<i>N</i> = 16) and others (e.g. vaginal ring, topical gel; <i>N</i> = 7). Twelve studies compared different PrEP modalities with each other. Five studies evaluated different implementation strategies to increase PrEP uptake, adherence and persistence. Of the 123 studies that compared PrEP to a combination of other HIV prevention interventions, only 31 scaled up at least part of the comparator over time.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>To support decision-making, future economic evaluations should consider costs and benefits beyond the health system (society) and consider comparators that better reflect the current HIV response across regions and populations. The increasing availability of novel PrEP modalities allows future studies to evaluate a mix of PrEP modalities and person-centred implementation strategies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 ","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 11","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12640620/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145585558","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}
Lara Vojnov, Roger L. Shapiro, Lloyd B. Mulenga, Adeodata R. Kikitiinwa, Alexandra C. Vrazo, Patricia Fassinou Ekouévi, Nelly Pato Dindi, Appolinaire Tiam, Deborah Persaud, Lynne Mofenson
Introduction
Progress in reducing and eliminating vertical transmission of HIV in children has stagnated over recent years. Unfortunately, recent decisions in the global donor space are likely to lead to considerably lower funding available for HIV and other disease programmes in high-burden low- and middle-income settings. Understanding and implementing the most effective strategies to prevent, diagnose, treat and monitor HIV acquisition in children are critical to maximize available resources and provide the best care for children.
Discussion
A set of tools to support the elimination of vertical transmission and end AIDS in children exists across the cascade of care for pregnant mothers and their children, including those for prevention, diagnosis, treatment, monitoring and service delivery. Each tool comes with its own challenges in implementation and scale-up; however, the effectiveness of many has been well-studied and documented. Ensuring all women living with HIV have consistent and secure access to optimized antiretroviral therapy will prevent the largest number of leaks in the cascade that can lead to vertical transmission events. Implementing effective infant diagnosis strategies, including same-day point-of-care testing and birth testing where feasible, will lead to earlier and faster identification of children living with HIV. Subsequently, rapid linkage to optimized treatment will save and improve the lives of children living with HIV. Finally, implementing accompanying monitoring modalities and country-specific service delivery approaches will improve implementation and the effectiveness of these tools as well as retention and commitment in care programmes by children as they become adolescents and adults.
Conclusions
Ending AIDS in children is possible. We have the tools to do so. However, now is the time for national, regional and global stakeholders to come together to prioritize children and ensure appropriate funding, implementation and equitable access are in place. Testing infants quickly and accurately for HIV is the first step to ensuring their lifelong health and wellbeing. As national and global public health structures shift, programmes need to act quickly—gains in paediatric HIV cannot be lost but must be accelerated. Doing so will require political will, financing, infrastructure, community-led initiatives, and commitment by and access to all to achieve those goals.
{"title":"The time is now to use the tools we have to end AIDS in children","authors":"Lara Vojnov, Roger L. Shapiro, Lloyd B. Mulenga, Adeodata R. Kikitiinwa, Alexandra C. Vrazo, Patricia Fassinou Ekouévi, Nelly Pato Dindi, Appolinaire Tiam, Deborah Persaud, Lynne Mofenson","doi":"10.1002/jia2.70055","DOIUrl":"10.1002/jia2.70055","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Progress in reducing and eliminating vertical transmission of HIV in children has stagnated over recent years. Unfortunately, recent decisions in the global donor space are likely to lead to considerably lower funding available for HIV and other disease programmes in high-burden low- and middle-income settings. Understanding and implementing the most effective strategies to prevent, diagnose, treat and monitor HIV acquisition in children are critical to maximize available resources and provide the best care for children.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Discussion</h3>\u0000 \u0000 <p>A set of tools to support the elimination of vertical transmission and end AIDS in children exists across the cascade of care for pregnant mothers and their children, including those for prevention, diagnosis, treatment, monitoring and service delivery. Each tool comes with its own challenges in implementation and scale-up; however, the effectiveness of many has been well-studied and documented. Ensuring all women living with HIV have consistent and secure access to optimized antiretroviral therapy will prevent the largest number of leaks in the cascade that can lead to vertical transmission events. Implementing effective infant diagnosis strategies, including same-day point-of-care testing and birth testing where feasible, will lead to earlier and faster identification of children living with HIV. Subsequently, rapid linkage to optimized treatment will save and improve the lives of children living with HIV. Finally, implementing accompanying monitoring modalities and country-specific service delivery approaches will improve implementation and the effectiveness of these tools as well as retention and commitment in care programmes by children as they become adolescents and adults.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Ending AIDS in children is possible. We have the tools to do so. However, now is the time for national, regional and global stakeholders to come together to prioritize children and ensure appropriate funding, implementation and equitable access are in place. Testing infants quickly and accurately for HIV is the first step to ensuring their lifelong health and wellbeing. As national and global public health structures shift, programmes need to act quickly—gains in paediatric HIV cannot be lost but must be accelerated. Doing so will require political will, financing, infrastructure, community-led initiatives, and commitment by and access to all to achieve those goals.</p>\u0000 </section>\u0000 </div>","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 11","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70055","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145511342","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}
Susan S. Witte, Fred M. Ssewamala, Joshua Kiyingi, Scarlett L. Bellamy, Lyla Sunyoung Yang, Proscovia Nabunya, Ozge Sensoy Bahar, Larissa Jennings Mayo-Wilson, Yesim Tozan, Abel Mwebembezi, Joseph Kagaayi
<div> <section> <h3> Introduction</h3> <p>Women engaged in sex work (WESW) in Uganda face a high risk of HIV and other sexually transmitted infections (STIs), driven by the intersection of gender inequality, poverty and structural barriers. This paper reports on the Kyaterekera Project, a cluster-randomized controlled trial (c-RCT) testing the efficacy of a combined HIV risk reduction (HIVRR) and economic empowerment intervention to reduce biologically confirmed STIs and HIV risk behaviours.</p> </section> <section> <h3> Methods</h3> <p>The study recruited 542 WESW from 19 HIV hotspots across four districts in Uganda between June 2019 and March 2020. Participants were randomized into three groups: (1) HIVRR intervention alone; (2) HIVRR combined with financial literacy training and an unconditional matched savings account; or (3) HIVRR combined with financial literacy training and an unconditional matched savings account and vocational training. Although initially implemented as a three-arm c-RCT, the COVID-19 lockdown prevented the implementation of the vocational training component. Therefore, the two treatment groups were combined, and the trial was re-approved as a two-arm c-RCT. Biological assessments were conducted at baseline, 18 and 24 months. Behavioural assessments were conducted at baseline, 6, 12, 18 and 24 months from April 2019 to December 2023. Primary outcomes included incident HIV acquisitions (seroconversions among baseline HIV-negative participants), point prevalence of STIs at each visit, and the number/proportion of unprotected sexual acts with paying and regular partners. This study utilized community-based participatory research methods, engaging a community advisory board to ensure the study's alignment with local needs.</p> </section> <section> <h3> Results</h3> <p>Across follow-up, condomless sex with paying partners decreased and income shifted towards non-sex work in both arms; no between-group differences were detected. Eighteen incident HIV acquisitions occurred (14 by 18 months; 4 additional by 24 months) with no between-group differences. STI prevalence was lower at 18 months compared to baseline, but not sustained at 24 months.</p> </section> <section> <h3> Conclusions</h3> <p>In an environment of high baseline HIV prevalence, substantial pre-exposure prophylaxis uptake and COVID-19 disruptions, the added financial literacy/savings components did not yield measurable incremental benefits over HIVRR alone. Integrating an unconditional matched-savings model within an HIVRR platform was feasible.</p> </s
{"title":"A cluster-randomized controlled trial of a combination HIV risk reduction and economic empowerment intervention for women engaged in sex work in Uganda","authors":"Susan S. Witte, Fred M. Ssewamala, Joshua Kiyingi, Scarlett L. Bellamy, Lyla Sunyoung Yang, Proscovia Nabunya, Ozge Sensoy Bahar, Larissa Jennings Mayo-Wilson, Yesim Tozan, Abel Mwebembezi, Joseph Kagaayi","doi":"10.1002/jia2.70057","DOIUrl":"10.1002/jia2.70057","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Women engaged in sex work (WESW) in Uganda face a high risk of HIV and other sexually transmitted infections (STIs), driven by the intersection of gender inequality, poverty and structural barriers. This paper reports on the Kyaterekera Project, a cluster-randomized controlled trial (c-RCT) testing the efficacy of a combined HIV risk reduction (HIVRR) and economic empowerment intervention to reduce biologically confirmed STIs and HIV risk behaviours.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The study recruited 542 WESW from 19 HIV hotspots across four districts in Uganda between June 2019 and March 2020. Participants were randomized into three groups: (1) HIVRR intervention alone; (2) HIVRR combined with financial literacy training and an unconditional matched savings account; or (3) HIVRR combined with financial literacy training and an unconditional matched savings account and vocational training. Although initially implemented as a three-arm c-RCT, the COVID-19 lockdown prevented the implementation of the vocational training component. Therefore, the two treatment groups were combined, and the trial was re-approved as a two-arm c-RCT. Biological assessments were conducted at baseline, 18 and 24 months. Behavioural assessments were conducted at baseline, 6, 12, 18 and 24 months from April 2019 to December 2023. Primary outcomes included incident HIV acquisitions (seroconversions among baseline HIV-negative participants), point prevalence of STIs at each visit, and the number/proportion of unprotected sexual acts with paying and regular partners. This study utilized community-based participatory research methods, engaging a community advisory board to ensure the study's alignment with local needs.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Across follow-up, condomless sex with paying partners decreased and income shifted towards non-sex work in both arms; no between-group differences were detected. Eighteen incident HIV acquisitions occurred (14 by 18 months; 4 additional by 24 months) with no between-group differences. STI prevalence was lower at 18 months compared to baseline, but not sustained at 24 months.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>In an environment of high baseline HIV prevalence, substantial pre-exposure prophylaxis uptake and COVID-19 disruptions, the added financial literacy/savings components did not yield measurable incremental benefits over HIVRR alone. Integrating an unconditional matched-savings model within an HIVRR platform was feasible.</p>\u0000 </s","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 11","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12598496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145480324","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}
Mark A. Marzinke, Brett Hanscom, Daniel Haines, Kimberly K. Scarsi, Yaw Agyei, Estelle Piwowar-Manning, Craig W. Hendrix, Ryann Gollings, Scott Rose, Carrie Mathew, Ravindre Panchia, Elizabeth Spooner, Nishanta Singh, Peter Bock, Alex R. Rinehart, Susan L. Ford, James F. Rooney, Lydia Soto-Torres, Myron S. Cohen, Mina C. Hosseinipour, Sinead Delany-Moretlwe, HPTN 084 Study Team
<div> <section> <h3> Introduction</h3> <p>HPTN 084 found that long-acting cabotegravir (CAB-LA) was well-tolerated and significantly reduced the risk of HIV acquisition in women compared to tenofovir disoproxil fumarate/emtricitabine (F/TDF). During the blinded phase of the trial, participants were required to use an effective method of contraception, including an injectable or implantable hormonal contraceptive (HC) agent. A contraceptive sub-study assessed the pharmacokinetic interactions between pre-exposure prophylaxis agents (CAB-LA or F/TDF) and etonogestrel (ENG), medroxyprogesterone acetate (MPA) or norethindrone enanthate (NET-EN).</p> </section> <section> <h3> Methods</h3> <p>Participants were enrolled in a nested sub-study between 24 February 2020 and 26 October 2020. Via a convenience sampling strategy, plasma concentrations of ENG, MPA and NET-EN were evaluated at enrolment and weeks 25, 49 and 73; plasma tenofovir (TFV) and CAB concentrations were determined at contemporaneous visits. Participants were allowed to switch contraceptives, and HC assessments were adjusted accordingly. Geometric mean concentrations were calculated and compared using <i>t</i>-tests or Fisher's exact tests.</p> </section> <section> <h3> Results</h3> <p>One hundred and seventy participants were included in this analysis. Hormone concentrations at all study visits were comparable between the CAB-LA and F/TDF study arms. Among participants randomized to the CAB-LA arm, geometric mean concentrations declined from enrolment to the follow-up period for ENG (335 to 202 pg/ml), MPA (1520 to 1138 pg/ml) and NET-EN (3715 to 1888 pg/ml); similar findings were observed among participants randomized to the F/TDF arm. Observed HC declines are likely attributed to the timing of contraceptive administration relative to sampling; the percentage of participants with hormone concentrations above thresholds associated with ovulation suppression was high (73−100%) and did not differ between arms. CAB concentrations were comparable across contraceptive types, with 97.8−98.1% of participants yielding trough CAB concentrations above the protocol-specified target threshold. TFV concentrations were unquantifiable for most participants, irrespective of contraceptive agent, rendering comparisons largely uninformative.</p> </section> <section> <h3> Conclusions</h3> <p>Given the comparable hormone concentrations between arms and the likely influence of the timing of sample collection on observed measurements, clinically significant interactions between CAB-LA and HC are not expected. Ass
{"title":"Evaluation of pharmacokinetic interactions between long-acting cabotegravir or emtricitabine/tenofovir disoproxil fumarate and hormonal contraceptive agents: a tertiary analysis of South African participants in HPTN 084","authors":"Mark A. Marzinke, Brett Hanscom, Daniel Haines, Kimberly K. Scarsi, Yaw Agyei, Estelle Piwowar-Manning, Craig W. Hendrix, Ryann Gollings, Scott Rose, Carrie Mathew, Ravindre Panchia, Elizabeth Spooner, Nishanta Singh, Peter Bock, Alex R. Rinehart, Susan L. Ford, James F. Rooney, Lydia Soto-Torres, Myron S. Cohen, Mina C. Hosseinipour, Sinead Delany-Moretlwe, HPTN 084 Study Team","doi":"10.1002/jia2.70056","DOIUrl":"https://doi.org/10.1002/jia2.70056","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>HPTN 084 found that long-acting cabotegravir (CAB-LA) was well-tolerated and significantly reduced the risk of HIV acquisition in women compared to tenofovir disoproxil fumarate/emtricitabine (F/TDF). During the blinded phase of the trial, participants were required to use an effective method of contraception, including an injectable or implantable hormonal contraceptive (HC) agent. A contraceptive sub-study assessed the pharmacokinetic interactions between pre-exposure prophylaxis agents (CAB-LA or F/TDF) and etonogestrel (ENG), medroxyprogesterone acetate (MPA) or norethindrone enanthate (NET-EN).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Participants were enrolled in a nested sub-study between 24 February 2020 and 26 October 2020. Via a convenience sampling strategy, plasma concentrations of ENG, MPA and NET-EN were evaluated at enrolment and weeks 25, 49 and 73; plasma tenofovir (TFV) and CAB concentrations were determined at contemporaneous visits. Participants were allowed to switch contraceptives, and HC assessments were adjusted accordingly. Geometric mean concentrations were calculated and compared using <i>t</i>-tests or Fisher's exact tests.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>One hundred and seventy participants were included in this analysis. Hormone concentrations at all study visits were comparable between the CAB-LA and F/TDF study arms. Among participants randomized to the CAB-LA arm, geometric mean concentrations declined from enrolment to the follow-up period for ENG (335 to 202 pg/ml), MPA (1520 to 1138 pg/ml) and NET-EN (3715 to 1888 pg/ml); similar findings were observed among participants randomized to the F/TDF arm. Observed HC declines are likely attributed to the timing of contraceptive administration relative to sampling; the percentage of participants with hormone concentrations above thresholds associated with ovulation suppression was high (73−100%) and did not differ between arms. CAB concentrations were comparable across contraceptive types, with 97.8−98.1% of participants yielding trough CAB concentrations above the protocol-specified target threshold. TFV concentrations were unquantifiable for most participants, irrespective of contraceptive agent, rendering comparisons largely uninformative.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Given the comparable hormone concentrations between arms and the likely influence of the timing of sample collection on observed measurements, clinically significant interactions between CAB-LA and HC are not expected. Ass","PeriodicalId":201,"journal":{"name":"Journal of the International AIDS Society","volume":"28 11","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jia2.70056","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145407006","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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