Bello G, Kabaghe AN, Pals S
… +23 more, Kalata NL, Bighignoli B, van Oosterhout JJ, Mkungudza J, Agyemang E, Zheng DP, Panja L, Matola WB, Chitenje M, Kampira E, Zeh C, Mvula B, Alvarez B, Kagoli M, Mzumara W, Simon KR, Namakhoma I, O'Malley G, Chipeta S, Nyirenda R, da Silva J, Wadonda N, For Malawi HIV Drug Resistance Surveillance Team
J Int AIDS Soc
· 2026 May · PMID 42175669
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INTRODUCTION: Malawi began transitioning children living with HIV (CLHIV) to dolutegravir-based regimens (DBRs) in 2020, and 99.9% were on a DBR by September 2023. With nearly universal use of DBR, surveillance of HIV dr...INTRODUCTION: Malawi began transitioning children living with HIV (CLHIV) to dolutegravir-based regimens (DBRs) in 2020, and 99.9% were on a DBR by September 2023. With nearly universal use of DBR, surveillance of HIV drug resistance (HIVDR) to dolutegravir is essential. We describe the prevalence and patterns of HIVDR among CLHIV on DBR with confirmed virological failure (viral load [VL] twice ≥1000 copies/mL). METHODS: We randomly selected 19 of the 25 highest-volume ART health facilities in Malawi for participant enrolment between July 2022 and February 2023. Enrolment criteria included CLHIV aged 2-14 years, on a DBR for ≥9 months and VL ≥1000 copies/mL. Sanger HIVDR genotyping was performed if a repeat VL result post-intensive adherence counselling was ≥1000 copies/mL. The Stanford University HIVDR Database was used for drug resistance interpretation. We present weighted HIVDR prevalence estimates with 95% confidence limits accounting for correlation within clinics. RESULTS: Of 302 CLHIV enrolled, 133 (44%) had confirmed virological failure. The weighted prevalence of dolutegravir resistance among CLHIV with confirmed virological failure was 15.6% (95% CI: 7.1-24.0%), with the presence of major dolutegravir drug resistance mutations (DRMs) in 14.2% (95% CI: 4.8-23.6). The most common dolutegravir DRMs were R263K (n = 11) and G118R (n = 4). Weighted prevalence rates of resistance to nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors were 42.2%, 65.5% and 5.0%, respectively. Three children had HIVDR to all four drug classes. CONCLUSIONS: Dolutegravir resistance was found in nearly one in six Malawian CLHIV with confirmed virological failure on DBRs. This raises concerns for treatment options in this vulnerable population, given the coexistence of high prevalence of resistance to NRTIs and NNRTIs. These results point to the need for regular HIVDR surveillance and further research to guide genotyping prioritization and next-line treatment strategies.
J Int AIDS Soc
· 2026 May · PMID 42163504
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INTRODUCTION: Children and adolescents living with HIV in sub-Saharan Africa (SSA) continue to face significant barriers to diagnosis, treatment adherence, retention in care and psychosocial support, despite progress in...INTRODUCTION: Children and adolescents living with HIV in sub-Saharan Africa (SSA) continue to face significant barriers to diagnosis, treatment adherence, retention in care and psychosocial support, despite progress in prevention and treatment coverage. Family-centred care (FCC) has emerged as a promising model that positions families-not just individual children-as the central unit of care, with potential to improve clinical and psychosocial outcomes while addressing persistent gaps in health system responsiveness. METHODS: Our scoping review synthesized evidence on FCC implementation strategies and outcomes for children and adolescents living with HIV in SSA, to inform the development of a contextually relevant FCC intervention. We followed Arksey and O'Malley's five-stage framework and the PRISMA-ScR guidelines. A comprehensive search of peer-reviewed and grey literature published between 2000 and 2025 was conducted across multiple databases and organizational websites between May and July 2025. Fourteen studies met the inclusion criteria and were selected for analysis. RESULTS: FCC was conceptualized as a multidimensional framework integrating clinical care, psychosocial support, caregiver engagement, treatment literacy and community-based delivery. Implementation models ranged from facility-based integrated services to community-driven and hybrid approaches. Interventions commonly included antiretroviral therapy provision, family-based testing, counselling and enhanced psychosocial wellbeing. Community-based and decentralized models showed particular promise in improving retention and reducing structural barriers. However, gaps persist, including limited longitudinal data, underrepresentation of fathers and adolescent caregivers, narrow assumptions of nuclear family structures and a lack of standardized FCC frameworks. DISCUSSION: Most FCC interventions were small-scale and donor-funded, raising concerns regarding sustainability and health-system integration. Additionally, many studies assumed nuclear family structures, overlooking the role of extended and non-biological caregivers common in African contexts. The limited engagement of diverse caregiving networks and inconsistent conceptualization of FCC constrain its broader applicability and scalability. CONCLUSIONS: FCC offers a compelling and contextually appropriate model for strengthening HIV care for children and adolescents in SSA. Advancing the FCC requires standardized frameworks, inclusive and context-sensitive programme design, and integration into national health systems to ensure equitable and sustainable delivery of holistic HIV care.
Euvrard J, Keene CM, Heyden EV
… +6 more, Osler M, Pienaar D, Mahomed H, Meintjes G, Davies MA, Boulle A
J Int AIDS Soc
· 2026 May · PMID 42145055
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INTRODUCTION: South Africa has the largest antiretroviral therapy (ART) programme in the world, with universal access available through the public health system. Yet, gaps in coverage persist. In the Western Cape (WC), a...INTRODUCTION: South Africa has the largest antiretroviral therapy (ART) programme in the world, with universal access available through the public health system. Yet, gaps in coverage persist. In the Western Cape (WC), an estimated 200,000 people living with HIV are not currently on ART-many of whom are known to the health services. Exploring how people who are not on ART differ from those who are on ART may help guide more effective strategies for re-engagement and retention in care. METHODS: We conducted a cross-sectional analysis of routine person-level data from the WC Provincial Health Data Centre, including adults (≥15 years) known to be living with HIV who accessed public services between October 2022 and September 2024. ART status was inferred from visit and dispensing records. Relative risks (RRs) of current disengagement were estimated using multivariable log-binomial regression on 25 imputed data sets, adjusting for sex, age, years since diagnosis, diagnosis setting and baseline CD4 count. RESULTS: Of 494,071 adults included, 131,368 (27%) were currently disengaged from ART. Those at elevated risk included men (aRR 1.20, 95% CI 1.19-1.21), younger people aged 15-24 years (aRR 1.54, 95% CI 1.51-1.57), those with CD4 >500 cells/mm at diagnosis (aRR 1.26, 95% CI 1.24-1.28) and individuals diagnosed in hospital (aRR 1.41, 95% CI 1.39-1.43) or during pregnancy (aRR 1.20, 95% CI 1.18-1.22). However, the majority of those disengaged were not from these groups, proportionally representing the underlying population living with HIV. Model discrimination was poor (AUC 0.614), indicating that these characteristics do not reliably identify those disengaged. CONCLUSIONS: Most disengaged individuals are from larger, lower-risk demographic groups and would be missed by interventions targeting higher-risk demographics. Whole-population strategies that address common barriers to retention through more inclusive, person-centred care offer the greatest potential to improve ART coverage.
Chen W, Luz PM, Srinivasan A
… +6 more, Grinsztejn B, Scott JA, Neilan AM, Veloso VG, Dugdale CM, Freedberg KA
J Int AIDS Soc
· 2026 May · PMID 42136105
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INTRODUCTION: In Brazil, men who have sex with men (MSM) and transgender women (TGW) remain heavily affected by HIV. Long-acting pre-exposure prophylaxis (LA PrEP) with injectable cabotegravir (CAB-LA) or lenacapavir (LE...INTRODUCTION: In Brazil, men who have sex with men (MSM) and transgender women (TGW) remain heavily affected by HIV. Long-acting pre-exposure prophylaxis (LA PrEP) with injectable cabotegravir (CAB-LA) or lenacapavir (LEN-LA) is more effective at preventing HIV acquisition than oral PrEP. Our objective was to assess the potential clinical and economic impact of offering CAB-LA or LEN-LA to MSM and TGW with high vulnerability to HIV acquisition in Brazil and determine the maximum cost at which they would be cost-effective. METHODS: We used the CEPAC microsimulation model of HIV prevention and treatment to evaluate two strategies for MSM and TGW aged 18-49: (1) SOC: standard-of-care oral PrEP at current coverage, and (2) SOC+LA: offering oral and LA PrEP (either CAB-LA or LEN-LA). Input parameters are derived from Brazil-based data from 2010 to 2024 and published studies: HIV incidence (%/year, MSM: 3.4 [age 18-29 years], 1.1 [30-49 years]; TGW: 5.0 [18-29 years], 1.7 [30-49 years]), relative risk reduction, LA versus oral PrEP (66% [CAB-LA]; 89% [LEN-LA]), PrEP coverage (20% [oral PrEP]; 20% [LA PrEP]) and oral PrEP cost (programmatic+drug = $207/year). Outcomes include lifetime HIV risk, life expectancy (LE) and incremental cost-effectiveness ratio (ICER) of SOC+LA versus SOC in 2024 USD/year of life saved (YLS). We identified the maximum LA PrEP cost with ICER below the established Brazilian willingness-to-pay threshold of $8740/YLS. RESULTS: Compared to SOC, SOC+CAB-LA would decrease MSM lifetime HIV risk from 21.4% to 16.8%, increase undiscounted LE from 39.0 to 39.4 years. For TGW, SOC+CAB-LA would decrease lifetime HIV risk from 29.5% to 23.4%, increase LE from 36.0 to 36.9 years. Results for SOC+LEN-LA would be similar to SOC+CAB-LA. SOC+LA would remain cost-effective for MSM at cost below $710/year for CAB-LA and $740/year for LEN-LA. Findings are most sensitive to LA PrEP cost, HIV incidence, and whether and by how much LA PrEP increases coverage. CONCLUSIONS: Offering LA PrEP with cabotegravir or lenacapavir in addition to oral PrEP for MSM and TGW in Brazil could markedly improve clinical outcomes and be cost-effective at ∼$700/year. Cost agreements are critical to ensure these prevention options are accessible in high-incidence settings.
Rutstein SE, Mulholland GE, Limarzi-Klyn L
… +3 more, Gallinek A, Brown N, Miller WC
J Int AIDS Soc
· 2026 May · PMID 42083316
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INTRODUCTION: When assessing the effectiveness of pre-exposure prophylaxis (PrEP) programmes, interventions, or modalities, it is important to understand patterns of PrEP use. Continued use of PrEP is frequently referred...INTRODUCTION: When assessing the effectiveness of pre-exposure prophylaxis (PrEP) programmes, interventions, or modalities, it is important to understand patterns of PrEP use. Continued use of PrEP is frequently referred to as PrEP "persistence." But persistence is not defined consistently, and differences impact the interpretation of study outcomes and public health policy. We conducted a scoping review to describe and compare definitions of PrEP persistence. METHODS: We searched PubMed, Embase, Scopus and Global Health records (01/01/2012-01/26/2026) for results that discussed longitudinal anti-HIV agents for HIV prevention. We included HIV, prevention and text variations of "persist-." We screened abstracts for relevance, reviewed relevant full-text articles, and then extracted key outcomes. Screening and extraction were performed independently by two investigators; conflicts were reviewed and resolved by a third. RESULTS: Our search returned 1549 de-duplicated results. We reviewed 362 full-text articles, yielding 147 studies for extraction. Approximately one-third (42/147, 29%) provided only qualitative persistence definitions. Among studies with operational definitions (105/147; 71%), three-quarters (80/105; 76%) considered a prescription refill and/or clinic visit date, and more than half (60/105; 57%) relied exclusively on these dates. Adherence (e.g. reported or measured drug taking) was commonly considered; 28% (29/105) of studies with an operational persistence definition included adherence assessment, and 11% (12/105) used only adherence to assess persistence. Thresholds used to classify persistent versus non-persistent PrEP use varied considerably. DISCUSSION: Definitions of PrEP persistence are heterogeneous. Most considered engagement in PrEP services (e.g. a clinic visit or medication refill), but nearly one-third included or relied exclusively on adherence measures. The differences in definitions have important implications for cross-study comparisons. CONCLUSIONS: The heterogeneity observed among persistence definitions complicates comparisons of PrEP interventions and related public health decision-making. A single consensus definition of persistence is unlikely to suit all study settings, objectives, and designs; however, interpretability and comparability of results could be improved by increasing transparency and consistency in reporting. Our findings emphasize the importance of capturing clinically relevant, prevention-effective use when possible and of rigorously considering the implications of a chosen persistence definition on estimates and associated conclusions.
McFall AM, Loeb TA, Baishya JJ
… +6 more, Kedar A, Sinha A, Srikrishnan AK, Solomon SS, Lucas GM, Mehta SH
J Int AIDS Soc
· 2026 May · PMID 42051162
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INTRODUCTION: Long-acting injectable (LAI) antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) have significant potential to impact the HIV epidemic, but there is little data on the acceptability of these ne...INTRODUCTION: Long-acting injectable (LAI) antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) have significant potential to impact the HIV epidemic, but there is little data on the acceptability of these newer technologies among people who inject drugs (PWID) and men who have sex with men (MSM) in low-resource settings. We examined acceptability and preferences of LAI ART and PrEP among community-based samples of PWID and MSM in India. METHODS: We conducted a cross-sectional survey of PWID and MSM in eight Indian cities (November 2022-May 2024) using respondent-driven sampling. Participants completed a survey including socio-demographics, substance use, risk behaviours, HIV testing/care history, acceptability of LAI ART and knowledge, acceptability, and preferences of different PrEP modalities (i.e. daily oral, monthly oral, LAI and implant). We assessed correlates of acceptability using Poisson regression models. To understand PrEP preferences, we used a modified Borda count method-a rank voting procedure. RESULTS: Overall, 2249 MSM and 4499 PWID (98% male) were recruited. Among those previously diagnosed with HIV, 89% (MSM) and 75% (PWID) reported a very good chance they would use LAI ART. MSM experiencing unstable housing and PWID virally suppressed were more willing to use LAI ART. Twenty percent and five percent of MSM and PWID, respectively, had ever heard of PrEP. Among those without an HIV diagnosis, 77% (MSM) and 62% (PWID) reported a very good chance they would use LAI PrEP. MSM with more sexual partners and sexually transmitted infection symptoms and PWID who had heard of PrEP were more willing to use LAI PrEP. Among MSM interested in PrEP, monthly oral pills were most preferred, followed by LAI, daily oral pills and then implant. Among PWID, monthly oral pills were most preferred, followed by daily oral pills, LAI and then implant. CONCLUSIONS: MSM and PWID in India were open and interested in LAI ART and PrEP. Once these become available, programmes with thoughtful community outreach and education, alongside flexible delivery models, will be critical to success. For PrEP, continued investment in the development of extended-duration oral formulations is warranted and valuable in order to provide a variety of HIV prevention choices.
Allorant A, Bekelynck A, Monroe-Wise A
… +14 more, da Silva CB, Chidarikire T, Edun O, Joaquim L, Kisia C, Larmarange J, Lyimo JJ, James JM, Musanhu C, Ncube G, Sathane I, Simo-Fotso A, Taasi G, Johnson CC
J Int AIDS Soc
· 2026 May · PMID 42051152
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INTRODUCTION: Evidence from routine, national programme data on HIV self-testing (HIVST) scale-up is limited. This study examines HIVST scale-up in eight African countries, describing how HIVST has been integrated into t...INTRODUCTION: Evidence from routine, national programme data on HIV self-testing (HIVST) scale-up is limited. This study examines HIVST scale-up in eight African countries, describing how HIVST has been integrated into testing strategies and how testing coverage, test positivity, and linkage to antiretroviral therapy (ART) have evolved. METHODS: We conducted a retrospective descriptive analysis of national programme data from January 2019 to December 2023 across Kenya, Lesotho, Malawi, Mozambique, South Africa, Tanzania, Uganda and Zimbabwe. Data were disaggregated by quarter and subnational district. Indicators included HIVST kits distributed, conventional testing volumes, new HIV diagnoses and new ART initiations. We derived testing rates, testing positivity, ART linkage, and stability of HIVST distribution by district and over time. RESULTS: HIVST scale-up varied across countries. By the most recent quarter, HIVST accounted for 63% of total testing in Lesotho, 19%-25% in Malawi and Zimbabwe, but <15% in Kenya, Tanzania, Uganda and South Africa. In Malawi, Lesotho and Zimbabwe, large volumes of HIVST partially offset declines in conventional testing during the COVID-19 pandemic. HIVST remained modest (<15% of total tests) in Kenya and Tanzania. In Mozambique, both conventional testing and HIVST expanded. In South Africa, conventional testing remained high after COVID-19, while HIVST expanded slowly. Despite divergent trajectories, new HIV diagnoses and ART initiations remained stable in most settings, indicating programmes adapted to maintain case-finding even as testing volumes shifted. CONCLUSIONS: This descriptive analysis shows HIVST has been scaled to different degrees, with its contribution to overall testing shaped by national contexts, and distribution models. Interpretation is constrained by incomplete reporting, the inability to identify kits used out of kits distributed and distinguishing first-time from repeat testers. These findings can guide optimizing HIV testing services, an essential step towards meeting global HIV targets and ending AIDS by 2030.
J Int AIDS Soc
· 2026 May · PMID 42051133
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INTRODUCTION: Pre-exposure prophylaxis (PrEP) represents a major advance in HIV prevention, but its rollout in France remains limited, particularly among women, migrants and socially vulnerable populations. Despite full...INTRODUCTION: Pre-exposure prophylaxis (PrEP) represents a major advance in HIV prevention, but its rollout in France remains limited, particularly among women, migrants and socially vulnerable populations. Despite full reimbursement by the national health system, oral PrEP is still rarely prescribed outside hospital settings, hindered by organizational constraints, inaccurate medical perceptions and persistent access inequalities. In this paper, we discuss the current limits of PrEP implementation in France, identify structural and individual barriers to its uptake and highlight possible strategies to make HIV prevention more accessible for all vulnerable populations across the country. DISCUSSION: The goal of eliminating HIV transmission by 2030 in France continues to be jeopardized by insufficient PrEP coverage. The current prevention model remains overly hospital-centred and primarily focused on a group of men who have sex with men (MSM), which limits its broader impact. In addition to structural barriers, the insufficient diversity of prescribers and the lack of inclusive communication continue to reinforce inequalities in access. The arrival of long-acting injectable PrEP offers an important opportunity to ensure greater discretion and better adherence. However, its success will depend on expanding the range of authorized prescribers to include gynaecologists, general practitioners and family planning clinics, supported by specific training and outreach consultations. Equally critical is strengthening public awareness campaigns and extending them beyond MSM and urban centres such as Paris, to reach diverse populations across the country. Durable improvements in PrEP uptake and retention also depend on close collaboration with community-based organizations, building trust with marginalized populations and participatory approaches that actively listen to individuals' concerns and lived experiences. CONCLUSIONS: France, which is lagging behind its objective of ending the HIV epidemic, has the opportunity to rethink its prevention strategy to address unmet needs and move beyond a hospital- and MSM-centred model. A structural, coordinated and inclusive response is essential to expand PrEP uptake and ensure equitable protection for all populations at risk.
Murray A, Louwman N, Luk A
… +8 more, Parker A, Madyiwa N, Parker H, Woodward K, Gallegos CF, Dorward J, Stevens RJ, Fanshawe TR
J Int AIDS Soc
· 2026 Apr · PMID 42041228
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INTRODUCTION: Chronic inflammation is a unique contributor to cardiovascular disease (CVD) risk among people living with HIV, yet there is a lack of consensus on the predictive utility of inflammatory biomarkers in this...INTRODUCTION: Chronic inflammation is a unique contributor to cardiovascular disease (CVD) risk among people living with HIV, yet there is a lack of consensus on the predictive utility of inflammatory biomarkers in this population. We conducted a systematic review assessing the predictive value of inflammatory biomarkers for major adverse cardiovascular events in people living with HIV to inform their potential integration into CVD risk assessment. METHODS: MEDLINE, Embase and Google Scholar were searched for articles published up to 01 May 2024. We included prospective cohort and nested case-control studies of adults living with HIV with inflammatory biomarker measurements in blood and at least one year of follow-up to major adverse cardiovascular events. Risk of bias was assessed using the Quality in Prognostic Studies (QUIPS) tool. Where at least two studies reported the same type of effect measure for a biomarker, results were pooled using an inverse variance heterogeneity model. RESULTS: Among 5156 screened citations, 21 studies reporting 31 inflammatory biomarkers met inclusion criteria. Meta-analysis showed high-sensitivity C-reactive protein (hsCRP) positively associated with future cardiovascular events (hazard ratio = 1.86 per log unit; 95% CI 1.39-2.50, n = 5,254). Three biomarkers, interleukin 6 (IL-6), D-dimer, and N-terminal pro-brain natriuretic peptide (NT-proBNP), demonstrated positive, statistically significant associations with adverse cardiovascular outcomes in at least two non-overlapping studies, though heterogeneous effect measures precluded meta-analysis. Most research (14/21 studies) was conducted exclusively in high-income settings, and female representation was low (median proportion = 15.5%; IQR 8.4-20.9%). All but three studies had a moderate or high risk of bias in at least one domain. DISCUSSION: We identified several inflammatory biomarkers with potential prognostic value, but most associations were derived from single or heterogeneous studies. The certainty of evidence is reduced by methodological heterogeneity, few high-quality studies and the underrepresentation of low- and middle-income countries (LMICs). CONCLUSIONS: Consistent positive associations between inflammatory biomarkers and future CVD in people living with HIV support a central role of inflammation in HIV-related CVD. Representative, large-scale studies that include women and LMICs are needed to guide the integration of candidate biomarkers into CVD risk prediction models. PROSPERO NUMBER: CRD42024542944.
Llenas-García J, Arcos Rueda MDM, Calderón Hernaiz R
… +60 more, Pedrero Tomé R, Bisbal Pardo O, Matarranz M, Torralba M, Galindo Puerto MJ, Rodríguez A, Peñaranda Vera M, Sanjoaquín Conde I, de la Fuente Moral S, Cabello-Úbeda A, Navarro San Francisco C, Antelo Cuéllar K, Pedrosa Aragón M, Aguilera García M, Tiraboschi J, Martínez Álvarez RM, Vivancos MJ, Montero Hernández C, Bernal Morell E, Cabello-Clotet N, Morano Amado LE, Gisbert Pérez L, Sepúlveda MA, Alemán Valls MR, Sánchez Guirao AJ, Fanciulli C, Escrig C, Ferreira Pasos EM, Lucas-Dato A, García Torras S, Hidalgo Tenorio C, Estébanez M, Muelas-Fernandez M, Losa García JE, Cerezales Calviño A, Pino Díaz ME, Martínez Montes C, Arenas García V, Arnaiz de Las Revillas F, Pernas Pardavila H, Padilla S, Garcinuño Jiménez MÁ, Alonso Alonso L, Ramos Vicente N, Barragán Gallo PN, Cabo Magadan R, Del Álamo M, Egido Murciano MV, Juárez Toquero A, Romero Palacios A, Clavero Olmos M, García Navarro MDM, Sanz J, Gainzarain JC, Milian Sanz M, de la Calle B, Ferrero Benéitez OL, Troya J, Buzón-Martín L, RELATIVITY Group
J Int AIDS Soc
· 2026 Apr · PMID 42011965
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INTRODUCTION: Migrants living with HIV often face high mobility, vulnerability and limited baseline information on HIV-1 genotype or treatment history. We aimed to assess the effectiveness and persistence of long-acting...INTRODUCTION: Migrants living with HIV often face high mobility, vulnerability and limited baseline information on HIV-1 genotype or treatment history. We aimed to assess the effectiveness and persistence of long-acting injectable cabotegravir and rilpivirine (LAI CAB+RPV) among migrants in Spain. METHODS: This multicentre cohort study across 58 Spanish hospitals included virologically suppressed adults switching to CAB+RPV LAI before January 2025. Data collection started in June 2023. Baseline characteristics and outcomes were compared by migrant status, and multivariate Cox proportional hazards regression models were fitted to assess factors associated with virological failure (VF) and discontinuation. Propensity score matching (PSM) by gender, age, known genotype and prior VF was employed to control for confounding. RESULTS: Of 3135 participants, 951 (30.3%) were migrants, predominantly from Latin America. Median follow-up was 13.8 months (interquartile range 8.91-19.1). VF occurred in 0.9% of migrants versus 0.5% of Spanish-born individuals (odds ratio 1.89, 95% confidence interval [CI] 0.69-5.03; p = 0.22). In adjusted models, migrant status showed a non-significant trend towards higher VF (adjusted hazard ratio [aHR] 2.16, 95% CI 0.89-5.22; p = 0.079). At 12 months, 95.8% of migrants (461/481) persisted on LAI CAB+RPV treatment versus 98.3% of Spanish-born individuals (1348/1372) (p = 0.005). Discontinuation due to any adverse event was more frequent in migrants (3.3% vs. 1.8%). Migrant status was significantly associated with discontinuation due to both local (aHR 2.63, 95% CI 1.33-5.26; p = 0.005) and systemic adverse events (aHR 3.33, 95% CI 1.45-7.69, p = 0.005). In the PSM cohort (n = 932 per group), migrant status was independently associated with increased risk of VF (aHR 3.51, 95% CI 0.95-12.98, p = 0.045) and discontinuation due to systemic adverse events (aHR 2.88, 95% CI 1.01-8.17, p = 0.047). CONCLUSIONS: Nearly one-third of participants switching to LAI CAB+RPV were migrants. While VF was rare overall, migrants had a significantly higher risk of treatment discontinuation, partly driven by adverse events. These findings highlight the need for closer monitoring and tailored strategies to optimize persistence with LAI regimens in migrant populations.
Gengiah TN, Lewis L, Harkoo I
… +4 more, Myeni N, Mansoor LE, Karim SSA, Karim QA
J Int AIDS Soc
· 2026 Apr · PMID 41987600
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INTRODUCTION: The CAPRISA 018 Phase I trial evaluated the safety, tolerability and pharmacokinetics of a 110 mg tenofovir alafenamide (TAF) implant for HIV prevention in South African women. This follow-up cohort study,...INTRODUCTION: The CAPRISA 018 Phase I trial evaluated the safety, tolerability and pharmacokinetics of a 110 mg tenofovir alafenamide (TAF) implant for HIV prevention in South African women. This follow-up cohort study, CAPRISA 097, assessed the long-term resolution of implant site reactions (ISRs) after implant removal and explored user acceptability and implant attribute preferences to inform the development of next-generation pre-exposure prophylaxis (PrEP) implants. METHODS: Women previously enrolled in CAPRISA 018 were recruited and followed quarterly for 12 months between 13 October 2022 and 27 October 2023. ISR prevalence, severity and resolution were evaluated at each visit. Implant acceptability, implant attribute preferences and PrEP preferences were assessed at enrolment and at month 12. RESULTS: Of 36 eligible participants, 35 were enrolled a median of 299 days after implant removal (IQR: 243-490). At enrolment, all 35 participants (100%) had ongoing mild (Grade 1) scarring, with additional findings of hyperpigmentation (14%), induration (6%) and hypopigmentation (3%). By study exit, scarring persisted in all participants (median duration: 623 days; IQR: 579-819), while hyperpigmentation and induration remained in two and one participant, respectively. Acceptability ratings for implant visibility were similar at enrolment and month 12 (77.1% vs. 75.0%), as were ratings for pain (68.6% vs. 78.1%). Side effects due to ISRs received the highest "very unacceptable" ratings, in 37.1% of participants at enrolment and 21.9% at study exit. Scarring was considered acceptable by 65.7% of participants at enrolment, increasing to 78.1% at exit. Perceived partner interest in the various PrEP products aligned with participant interest. A palpable 12-month implant was acceptable to most participants, whereas increased length, width or stiffness reduced the likelihood of use. Preferred PrEP options were a 12-monthly implant (38.2% at enrolment vs. 50.0% at month 12), a 6-monthly injection (29.0% vs. 37.5%) and daily oral PrEP tablets (12.0% vs. 3.0%). CONCLUSIONS: Mild but persistent scarring was observed following TAF implant removal, with limited cases of hyperpigmentation and induration. Despite these local side effects, a 12-monthly implant remained the most preferred PrEP option among women previously enrolled in the TAF implant trial.
Lazarus G, Kawi NH, Luis H
… +14 more, Rahmawati DP, Sihotang EP, Oktaviani M, Januraga PP, Suwarti, Sukmaningrum E, Yunihastuti E, Dijkstra M, Sanders EJ, Wignall FS, Gedela K, Irwanto, Hamers RL, INTERACT Study Group
J Int AIDS Soc
· 2026 Apr · PMID 41987569
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INTRODUCTION: Indonesia has an escalated HIV epidemic among key populations, especially men who have sex with men (MSM). Diagnosis and immediate treatment of acute HIV infection (AHI), the earliest phase with the highest...INTRODUCTION: Indonesia has an escalated HIV epidemic among key populations, especially men who have sex with men (MSM). Diagnosis and immediate treatment of acute HIV infection (AHI), the earliest phase with the highest transmission risk, is beneficial for individual health and can reduce onward transmission. To inform whom to test for possible AHI using targeted, risk-stratified HIV-PCR testing, this study evaluated the performance of the validated, seven-item Amsterdam AHI risk score among Indonesian MSM, and developed a locally optimized score. METHODS: We used the INTERACT prospective cohort of MSM (≥16 years) attending sexual health clinics in Jakarta and Bali (May 2023-February 2025) who were tested with add-on Xpert HIV-PCR (Cepheid) if their HIV antibody rapid testing was negative or inconclusive. We used generalized estimating equation models to generate risk scores, combining symptoms, risk factors and socio-demographics. The optimized risk score was internally validated using bootstrap resampling. We calculated area under the curve (AUC), sensitivity and specificity (ISRCTN41396071). RESULTS: Among 1887 individuals, 20 were diagnosed with AHI, and 1867 tested AHI negative across 3446 test visits. The Amsterdam score yielded an AUC of 0.82 (95% CI 0.75-0.90) with a sensitivity of 85.0% (64.0%-94.8%) and a specificity of 59.2% (57.5-60.8). The optimized risk score included one symptom (fever <2 weeks), one risk factor (condomless receptive anal intercourse <6 months) and two socio-demographic characteristics (age 16-30 years, not having received higher education), and achieved an AUC of 0.91 (0.87-0.96) with a sensitivity of 100% (83.9-100) and a specificity of 65.3% (63.6%-66.8%). Internal validation yielded an AUC of 0.86 (0.67-0.97). Applying this risk score would classify 35.1% of MSM as eligible for add-on HIV-PCR testing, identifying 83.9%-100% of individuals who have AHI. CONCLUSIONS: This four-item risk score of easily collected variables can facilitate efficient AHI detection in high-yield clinic settings, enhancing opportunities for HIV prevention. In the Indonesian context, younger MSM with lower educational attainment were particularly vulnerable to AHI.
Masucci L, Jalal H, Rourke SB
… +8 more, McBain K, Xi M, Zhang W, Nguyen HV, Wong WWL, Gill MJ, Zwerling A, Thavorn K
J Int AIDS Soc
· 2026 Apr · PMID 41944034
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INTRODUCTION: While HIV self-testing (HIVST) presents a promising solution for early HIV detection, access to such testing remains limited in Canada. Achieving the United Nations 95% target for HIV status awareness requi...INTRODUCTION: While HIV self-testing (HIVST) presents a promising solution for early HIV detection, access to such testing remains limited in Canada. Achieving the United Nations 95% target for HIV status awareness requires scalable and cost-effective implementation approaches. The I'm Ready programme is a national, mail-based HIVST initiative targeting key high-risk populations supplemented by peer navigation supports to enhance engagement. This study aimed to explore the cost-effectiveness of the I'm Ready programme from the perspective of Canada's publicly funded healthcare system. METHODS: We developed a Markov model to predict the lifetime costs and quality-adjusted life-years (QALYs) for high-risk individuals receiving HIVST through the I'm Ready programme compared to point-of-care testing in a physician's office (standard care). Probability and health utility values were obtained from published literature, while costs were obtained from the pilot I'm Ready programme or secondary Canadian data sources. Costs and outcomes were discounted 1.5% annually, with costs reported in 2024 Canadian dollars. RESULTS: At a 53% uptake, 100% HIVST sensitivity and 99.5% specificity, the I'm Ready programme was associated with an incremental cost of C$270 and a QALY gain of 0.01 per person, with an incremental cost-effectiveness ratio of $23,331/QALY compared to standard care. Key drivers of cost-effectiveness included cost and utility associated with antiretroviral therapy initiation, utility of the AIDS health state and testing uptake under standard care. CONCLUSIONS: At the current test uptake and diagnostic accuracy levels, the I'm Ready programme is cost-effective at the willingness-to-pay threshold of $50,000 per QALY. While findings reflect the Canadian health system context, this study offers broader insight into the value of HIVST as a public health tool to accelerate progress towards global HIV awareness targets.
Apornpong T, Han WM, Hiransuthikul A
… +7 more, Lwin HMS, Hiranburana N, Ubolyam S, Kerr SJ, Woratanarat T, Avihingsanon A, HIV‐NAT 006 and 207 study team
J Int AIDS Soc
· 2026 Apr · PMID 41918468
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INTRODUCTION: Frailty is highly prevalent among older people with HIV (PWH), driven by multimorbidity and HIV-associated accelerated ageing. We investigated frailty transitions and associated factors over a 5-year follow...INTRODUCTION: Frailty is highly prevalent among older people with HIV (PWH), driven by multimorbidity and HIV-associated accelerated ageing. We investigated frailty transitions and associated factors over a 5-year follow-up period in an ageing cohort of PWH in Thailand. METHODS: We conducted a prospective cohort study among PWH aged ≥50 years in Bangkok, Thailand, between May 2015 and June 2024. Frailty phenotypes were assessed at baseline and at 5 years of follow-up using the Fried frailty phenotype, including unintentional weight loss, low physical activity, exhaustion, weak grip strength and slow walking speed. Multinomial logistic regression was performed to identify factors associated with frailty progression and reversibility over follow-up. RESULTS: Among 324 participants enrolled (63% male; median age of 54 [IQR, 52-59] years), 158 (49%) were robust, 153 (47%) were pre-frailty and 13 (4%) were frailty at baseline. Over 5 years, 111 participants (34%) experienced frailty worsening, 158 (49%) remained stable and 55 (17%) demonstrated frailty reversal. Among 158 PWH who were robust at baseline, 75 (47%) remained robust, 57 (36%) transitioned to pre-frailty and 26 (16%) progressed to frailty. Notably, among those frail at baseline (N = 13), 65% improved to pre-frailty or robustness. Low physical activity was the most common frailty component at baseline, while weak grip strength was the most predominant frailty phenotype at year 5. In multivariable analysis, multimorbidity (adjusted odds ratio [aOR] 3.09, 95% confidence interval [CI]: 1.42-6.72, p = 0.004), antiretroviral therapy (ART) duration>20 years (aOR 1.82, 95% CI: 1.08-3.06, p = 0.025) and baseline vitamin D deficiency (aOR 1.85, 95% CI: 1.10-3.10, p = 0.019) were independently associated with increased frailty over the 5-year follow-up. Conversely, multimorbidity (aOR 0.44, 95% CI: 0.44 [0.23-0.84], p = 0.013) and CD4 counts< 500 cells/mm (aOR 0.25, 95% CI: 0.10-0.62, p = 0.003) were associated with a lower likelihood of frailty reversal. CONCLUSIONS: Frailty among PWH aged ≥50 years in Thailand was common and highly dynamic, with over half of frail participants improving over 5 years. Multimorbidity, prolonged ART exposure and vitamin D deficiency were key predictors of frailty progression, whereas CD4< 500 cells/mm and multimorbidity reduced the likelihood of frailty reversal. These findings highlight frailty as modifiable and support integrating routine frailty screening and geriatric-informed care into long-term HIV services. CLINICAL TRIAL REGISTRATION: NCT00411983.
Simon KR, Masiano S, Kaonga A
… +13 more, Vansia D, Wetzel E, Kavuta E, Nyirenda R, Namachapa K, Chiwandira B, Cox CM, O'Brien BE, Manyeki R, Hauya L, Kim MH, Tembo TA, Ahmed S
J Int AIDS Soc
· 2026 Apr · PMID 41889062
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INTRODUCTION: Despite global initiatives to improve access to life-saving antiretroviral treatment (ART), only 54% of over 900,000 children living with HIV (CLHIV) received treatment in 2021, compared to 85% of women (WL...INTRODUCTION: Despite global initiatives to improve access to life-saving antiretroviral treatment (ART), only 54% of over 900,000 children living with HIV (CLHIV) received treatment in 2021, compared to 85% of women (WLHIV). Without timely ART, half of these children could die before age 2. We describe the design, implementation and outcomes of a child index case testing tool (cICT) that identifies WLHIV with untested children and embeds paediatric follow-up into their HIV care to identify and test their untested children. METHODS: The cICT was a card used to gather information about WLHIV and their children, including ages and HIV status (living with HIV, uninfected, exposed or unknown). Community health workers (CHWs) screened WLHIV 15 years and older at 95 ART clinics in Malawi from September 2020 to August 2023 and referred untested children to HIV testing services. De-identified data were entered in SurveyCTO (Dobility, Inc., MA) to determine WLHIV screened, children's baseline HIV status, new HIV testing completed and newly identified CLHIV. Outcomes included reach (percentage of cohort offered screening), acceptability (percentage accepting cICT) and feasibility (percentage screened who completed child testing). Impact measured the proportion of women with untested children at baseline versus study conclusion, proportion of untested children tested; new CLHIV diagnosed and HIV testing yield. RESULTS: Of an estimated cohort of 116,000 WLHIV active in care, 101,273 were offered and screened (87% reach, 100% acceptability), 75,262 had at least one child 0-19 years old, with 24% (18,175/75,262) of women having at least one child with unknown HIV status. At study conclusion, only 5% (4606/101,273) of WLHIV had children with unknown status. A total of 193,402 children were listed among 75,262 WLHIV who identified as having children; 39,124 (20%) of the 193,402 children listed were untested. By study conclusion, 28,808/39,124 (74%) of them were tested. Of these, 27,934 children were confirmed HIV uninfected, while 486 were newly diagnosed CLHIV, a 1.7% testing yield. CONCLUSIONS: The cICT was acceptable and feasible to implement, revealing nearly a quarter of WLHIV had children with unknown HIV status. The tool's simplicity and scalability make it a high-impact approach for HIV programmes to quantify, track and confirm the status of HIV-exposed untested children and facilitate timely identification of CLHIV by embedding ICT screening within routine ART care for WLHIV.
Taylor MM, Tohme RA, McDonald R
… +1 more, Montandon M
J Int AIDS Soc
· 2026 Apr · PMID 41889061
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INTRODUCTION: Elimination of mother-to-child transmission (EMTCT) of HIV, syphilis and hepatitis B by 2030 is a global goal endorsed by countries. To achieve EMTCT, countries need to meet targets for programme and impact...INTRODUCTION: Elimination of mother-to-child transmission (EMTCT) of HIV, syphilis and hepatitis B by 2030 is a global goal endorsed by countries. To achieve EMTCT, countries need to meet targets for programme and impact indicators. METHODS: We examined progress and gaps in service delivery across the three infections among 21 countries with a high burden of HIV, syphilis and/or hepatitis B. We summarized national coverage of interventions to prevent vertical transmission of HIV, hepatitis B and syphilis. Service coverage indicators were extracted from public data sources for the most recent available years (2014-2024). RESULTS: Antenatal care (ANC) coverage (at least one visit) ranged from 62% to 99%; 14 countries (67%) had coverage ≥90%. Twelve countries (57%) had ANC HIV testing coverage above 90%; 13 countries (62%) reported antiretroviral treatment coverage ≥90%. Eight countries (38%) reported ANC syphilis testing coverage ≥90%; ten countries (48%) reported ≥90% treatment coverage among pregnant women diagnosed with syphilis. All 21 countries have introduced three infant doses of hepatitis B vaccine (HepB3), and six countries have introduced the hepatitis B birth dose vaccine (HepB-BD) in their national immunization schedule. Among the six countries that provide HepB-BD, only four reported coverage with timely HepB-BD given within 24 hours of birth (range 52-70%). Seven (33%) countries have achieved HepB3 coverage ≥ 90%. DISCUSSION: Antenatal service delivery for prevention of mother-to-child transmission of syphilis and hepatitis B lags behind that of HIV. Despite the availability of ANC platforms for the delivery of HIV, syphilis and hepatitis B services, many countries face new and ongoing implementation and funding challenges in reaching global targets for EMTCT of these infections. CONCLUSIONS: Integrating HIV, syphilis and hepatitis B prevention of vertical transmission services into ANC and maintaining support for EMTCT efforts is critical to close these gaps.