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Journal Of The International AIDS Society[JOURNAL]

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Combining HIV prevention Options with Mental health service delivery for Adolescent girls and young women (CHOMA): results of a pilot hybrid effectiveness-implementation randomized trial in South Africa.

Velloza J, Ndimande-Khoza N, Mills L … +10 more , Poovan N, Adler A, Sherwin EB, Mathew C, Sokhela Z, Verhey R, Chibanda D, Gandhi M, Celum C, Delany-Moretlwe S

J Int AIDS Soc · 2025 Sep · PMID 40903994 · Full text

INTRODUCTION: Adolescent girls and young women (AGYW) at risk of HIV frequently have symptoms of common mental disorders (CMDs), which are associated with lower pre-exposure prophylaxis (PrEP) adherence. We conducted a p... INTRODUCTION: Adolescent girls and young women (AGYW) at risk of HIV frequently have symptoms of common mental disorders (CMDs), which are associated with lower pre-exposure prophylaxis (PrEP) adherence. We conducted a pilot hybrid effectiveness-implementation trial (CHOMA) to evaluate whether an evidence-based mental health intervention adapted for PrEP delivery ("Youth Friendship Bench SA") could address CMD and PrEP adherence among South African AGYW. METHODS: CHOMA was conducted in Johannesburg from April 2023 to February 2024. We enrolled AGYW (18-25 years) who were already on or willing to initiate PrEP and had CMD symptoms (Self-Reporting Questionnaire 20-item [SRQ-20]≥7). Participants were randomized to our Youth Friendship Bench SA intervention (five problem-solving sessions with a lay counsellor, one group session) or standard-of-care CMD services (brief CMD assessment, referral). Counselling sessions occurred at enrolment and Weeks 2, 4, 8 and 12. Co-primary outcomes were PrEP adherence (positive result on a urine tenofovir assay) and reduced CMD symptoms (SRQ-20<7) at Week 12 and, secondarily, Week 4. We used Poisson regression to assess intervention effects and summarized responses to three validated scales assessing intervention acceptability, appropriateness and feasibility (ranges: 1-4). RESULTS: Of 116 AGYW enrolled, the median SRQ-20 score was 9. We retained 69% through Week 12. Of 57 intervention participants, 64.9% (N = 37) received four or more sessions. At Week 4, 29/36 (80.6%) participants in the intervention and 25/41 (61.0%) in the standard-of-care had recent PrEP use (RR = 1.40; 95% CI = 1.03-1.89; p = 0.03), but this was not sustained through Week 12 (RR = 0.88; 95% CI = 0.64-1.22; p = 0.44). Enrolment SRQ-20 score was not associated with Week 12 PrEP adherence or retention. CMD symptoms did not differ by arm at Week 4 or 12, although the proportion with SRQ-20 scores >7 decreased overall between Weeks 4 (54.5%, 42/77) and 12 (35.0%, 28/80; p = 0.02). Median acceptability, appropriateness and feasibility scores were 3.50, 3.75 and 3.25, respectively. CONCLUSIONS: The intervention improved PrEP adherence at Week 4, although the effect was not durable to Week 12, possibly due to retention challenges. Reductions in CMD symptoms were seen in both arms. Findings suggest different mental health and PrEP support interventions may be needed to improve integrated service delivery among AGYW.

Aligning HIV treatment and hypertension clinic visits and dispensing as a first step towards service delivery integration in South Africa.

Mokgethi O, Huber A, Mokhele I … +4 more , Shumba K, Ntjikelane V, Rosen S, Pascoe S

J Int AIDS Soc · 2025 Jul · PMID 40879611 · Full text

INTRODUCTION: Global and national guidelines recommend the integration of care for HIV and other chronic conditions to improve individual and public health outcomes. South Africa's differentiated service delivery (DSD) m... INTRODUCTION: Global and national guidelines recommend the integration of care for HIV and other chronic conditions to improve individual and public health outcomes. South Africa's differentiated service delivery (DSD) models extend beyond HIV care, relying on pickup points that also distribute hypertension (HTN) medications. We assessed the alignment between antiretroviral treatment (ART) and HTN medication collection visits and dispensing intervals as an indicator of integration progress. METHODS: The AMBIT project conducted a SENTINEL survey across 18 public clinics in three South African districts between September 2022 and April 2023, enrolling adult clients ≥ 6 months on ART. We recruited up to 180 clients across each model of care: conventional care-not DSD eligible (conventional-not-eligible); conventional care-DSD eligible but not enrolled (conventional-eligible); facility- (FAC-PuP) and external (EX-PuP) pickup points. Healthcare interaction data were extracted from paper and electronic sources for clients with a 12-month observation period. We analysed both self-reported alignment and actual visit data. We estimated the number and proportion of HTN visits aligned with ART dispensing. Log-binomial regression estimated adjusted risk ratios (ARR) to assess the association with a higher visit burden (> 5 interactions). RESULTS: Of 724 enrolled, 644 (90%) client records were successfully linked (76% female; median age 42; 15% Conventional-not-eligible; 17% Conventional-eligible; 18% FAC-PuP; 28% EX-PuP). Among these, 85 (13%) with HTN (81 self-reported, 4 from medical records), self-reported 94% and 95% aligned facility visits and medication pickups, respectively. Visit data was retrieved for self-reported HTN diagnoses. Of 477 visits for HIV/HTN comorbid clients, 83% (395) dispensed both ART and HTN medication, and 97% had aligned dispensing durations (Conventional-not-eligible 97%, Conventional-eligible 95%, FAC-PuP 98%, EX-PuP 100%). Comorbid clients had a similar visit burden to ART-only clients (ARR 1.05, 95% CI: 0.80-1.39). FAC-PuP (ARR 0.55, 95% CI: 0.40-0.78) and EX-PuP (ARR 0.75, 95% CI: 0.57-0.98) clients were less likely than Conventional-E clients to have high annual visit burden. CONCLUSIONS: Aligning medication visits and dispensing for HIV and other chronic diseases marks an initial step towards integrated service delivery. Our results demonstrate achievable medication visit alignment without increased visit burden for comorbid clients and those in DSD models, suggesting that HIV-HTN integration is feasible within DSD models, matching client preferences for comprehensive care.

High peak viraemia followed by spontaneous HIV-1 control in women living with HIV-1 subtype A1 in East Africa.

Li Y, Dearlove BL, Lewitus E … +19 more , Bai H, Shangguan S, Pham P, Bose M, Sanders-Buell E, Miller SH, Rosario Y, Ehrenberg PK, Tovanabutra S, Thomas R, Ake JA, Vasan S, Eller LA, Nitayaphan S, Maganga L, Kibuuka H, Sawe FK, Robb ML, Rolland M

J Int AIDS Soc · 2025 Aug · PMID 40879355 · Full text

INTRODUCTION: Cases of spontaneous control of HIV-1 can help define strategies to induce remission. Since the identification of viral control in the absence of treatment typically occurs after a prolonged period post-HIV... INTRODUCTION: Cases of spontaneous control of HIV-1 can help define strategies to induce remission. Since the identification of viral control in the absence of treatment typically occurs after a prolonged period post-HIV-1 diagnosis, our knowledge of the early events after HIV-1 acquisition that led to viral control is limited. METHODS: The RV217 prospective cohort enrolled 2276 participants in East Africa (Kenya, Uganda, Tanzania) and Thailand between 2009 and 2015. We analysed HIV-1 sequences and clinical data from 102 individuals who were diagnosed with acute HIV-1 infection and had a negative HIV-1 RNA test in the week before. We focused on 69 participants with longitudinal follow-up and identified viraemic controllers who maintained viral loads <2000 copies/ml for over a year without treatment. We evaluated viral genetic and clinical features that are associated with viral control. RESULTS: Eleven women from East Africa showed control of viral replication for an average duration of 891 (range: 405-1425) days within an average of 130 days from diagnosis. The majority were living with subtype A1 (n = 6), or A1 recombinant strains (n = 4), with one living with subtype D; 10 were from Kenya, one from Uganda. Controllers had significantly slower CD4+ T cell decline (p = 0.028) and higher Natural Killer (NK) cell counts (p = 0.047) than non-controllers, but none carried human leukocyte antigen (HLA) alleles previously reported to be associated with viral control. Peak viraemia was recorded at an average of 541 million copies/ml with no difference between controllers and non-controllers (p = 0.97). Viral loads became lower in controllers (3459 copies/ml) than in non-controllers (23,157 copies/ml) as early as nadir viraemia (p = 0.009), with a more significant difference observed at set point (1069 vs. 24,084 copies/ml, respectively; p<0.0001). CONCLUSIONS: Our findings confirm the role of HIV-1 subtype A1 in mediating viral control. The fact that controllers showed high viral loads in acute infection indicates that these viruses were not intrinsically impaired for replication, underlining the intersection between host immunity and favourable genotypes in the subsequent control of HIV-1. These data suggest that conducting HIV-1 remission studies in East Africa could provide favourable conditions to achieve durable post-treatment control of viraemia.

High syphilis incidence among PrEP-adherent men who have sex with men and transgender women in Peru.

Vargas SK, Konda KA, Moreira RI … +9 more , Leite IC, Cunha M, Hoagland B, Guanira JV, Benedetti M, Pimenta C, Grinztejn B, Veloso VG, Caceres CF

J Int AIDS Soc · 2025 Sep · PMID 40866798 · Full text

INTRODUCTION: Syphilis remains a public health concern in Peru. Pre-exposure prophylaxis (PrEP) implementation programmes in Latin America need to assess their impact on sexually transmitted infections (STIs), along with... INTRODUCTION: Syphilis remains a public health concern in Peru. Pre-exposure prophylaxis (PrEP) implementation programmes in Latin America need to assess their impact on sexually transmitted infections (STIs), along with their feasibility. We assessed the relationship between PrEP adherence and syphilis incidence among men who have sex with men (MSM) and transgender women (TW) enrolled in ImPrEP, a multi-country PrEP demonstration project; however, this analysis focuses on Peru. METHODS: Between April 2018 and June 2021, 2292 HIV-negative MSM/TW attending Peruvian STI clinics were enrolled and followed in ImPrEP. Participants had to be aged ≥18 years and report recent condomless anal sex (CAS), sex with a partner living with HIV, STI history (diagnosis/symptoms) and/or transactional sex. Quarterly follow-up visits included PrEP dispensing, behavioural assessment, HIV and syphilis screening (treponemal test and Rapid Plasma Reagin [RPR] if syphilis negative at enrolment; RPR only if reactive-treponemal test at baseline). PrEP adherence was assessed using the medication possession ratio (MPR: #pills prescribed / #days between visits). Generalized estimating equation (GEE) Poisson regression models were used to evaluate factors related to syphilis incidence and also assessed syphilis incidence during two periods: pre-COVID-19 lockdown (up to 16 March 2020) and during COVID-19-lockdown (17 March 2020-June 2021). RESULTS: We enrolled 2039 cisgender-MSM and 253 TW, with a median follow-up time of 514 days; 205 incident syphilis cases were identified among 185 individuals. Overall syphilis incidence was 9.1 cases/100 person-years (p.y.) (95% CI: 7.9-10.4), 14.7/100 p.y. (95% CI: 10.5-20.1) among TW and 8.3/100 p.y (95% CI: 7.1-10.0) among cisgender-MSM. During the COVID-19 pre-lockdown period, syphilis incidence was 10.0/100 p.y. (95% CI: 8.3-12.1) and 8.1/100 p.y. (95% CI: 6.6-10.0) during-lockdown. Multivariate GEE analysis showed higher syphilis incidence among PrEP-adherent participants (MPR≥0.6) (adjusted incidence rate ratio [aIRR]: 1.46 [95% CI: 1.08-1.99]), those reporting receptive CAS (aIRR: 1.53 [95% CI: 1.11-2.11]) and TW (aIRR: 1.64 [95% CI: 1.08-2.51]). Syphilis incidence pre-lockdown was higher for participants reporting receptive CAS (aIRR: 2.35 [95% CI: 1.43-3.86]); during-lockdown, syphilis incidence was higher among those diagnosed with syphilis at enrolment (aIRR: 2.70 [95% CI: 1.67-4.36]). CONCLUSIONS: Syphilis incidence is high among PrEP-adherent MSM/TW, those reporting receptive-CAS and among TW. Health systems implementing PrEP should strengthen existing STI prevention strategies and incorporate new ones, like Doxy-PEP for PrEP-adherent MSM, TW and individuals engaging in receptive-CAS. MPR may be a tool to identify PrEP users at risk for syphilis.

A cross-sectional study evaluating the frequency of HIV drug resistance mutations among individuals diagnosed with HIV-1 in tenofovir disoproxil fumarate-based pre-exposure prophylaxis rollout programmes in Kenya, Zimbabwe, Eswatini and South Africa.

Parikh UM, Kudrick LD, Levy L … +25 more , Bosek E, Chohan BH, Mukui I, Masyuko S, Ndlovu N, Mahaka I, Mugurungi O, Ncube G, Hettema A, Matse SN, Mullick S, Wallis CL, Heaps AL, Penrose KJ, McCormick KD, Wiesner L, Anderson PL, Peterson JM, Celum C, Richardson BA, Castor D, Allen S, Torjesen K, Mellors JW, Global Evaluation of Microbicide Sensitivity (GEMS) Project

J Int AIDS Soc · 2025 Aug · PMID 40836601 · Full text

INTRODUCTION: The ongoing rollout of oral tenofovir-based pre-exposure prophylaxis (PrEP) has the potential to reduce HIV-1 incidence, but HIV drug resistance (HIVDR) in individuals who acquire HIV-1 on PrEP could threat... INTRODUCTION: The ongoing rollout of oral tenofovir-based pre-exposure prophylaxis (PrEP) has the potential to reduce HIV-1 incidence, but HIV drug resistance (HIVDR) in individuals who acquire HIV-1 on PrEP could threaten the treatment effectiveness of overlapping antiretrovirals (tenofovir/emtricitabine), contribute to development of resistance, and undermine HIV control efforts. Accordingly, the Global Evaluation of Microbicide Sensitivity (GEMS) project was established to monitor HIVDR in PrEP rollout programmes in Southern and Eastern Africa. METHODS: GEMS monitored resistance in >100,000 estimated persons who accessed PrEP through national programmes or implementation projects in Southern/Eastern Africa. Participants self-reported demographics and PrEP adherence. HIV-1 RNA and tenofovir-diphosphate levels were measured in blood samples collected at the time of study enrolment from consenting participants diagnosed with HIV who had received PrEP. HIVDR mutations were detected by population genotyping. RESULTS: Of 283 reported seroconversions on PrEP from December 2017 through September 2023, 255 (90%) individuals enrolled in GEMS, of which 81 (32%) were from Kenya, 77 (30%) from South Africa, 69 (27%) from Zimbabwe and 28 (11%) from Eswatini. Half (130; 51%) were 15-24 years of age at seroconversion, and three-quarters (193; 76%) were female. Thirty-four seroconversions occurred within 30 days of PrEP initiation. Tenofovir-diphosphate levels were consistent with moderate to high levels (≥350 femtomoles per punch) in 53% (120 of 226) individuals with drug-level data. Of 154 samples successfully genotyped, 34 (22%; 95% CI [16%, 30%]) had PrEP-associated mutations; these included 27 samples with M184I/V, one sample with K65KR, and six samples with both K65R and M184I/V. CONCLUSIONS: The frequency of HIVDR mutations associated with tenofovir or emtricitabine among individuals diagnosed with HIV who had received PrEP (22%) exceeded background levels of transmitted nucleoside reverse transcriptase inhibitor resistance in Southern and Eastern Africa (≤5%) but people with PrEP-associated mutations are likely to achieve virologic suppression with current first-line antiretroviral therapy (ART). Improved screening for acute infection before initiating PrEP, surveillance of HIVDR with the introduction of new PrEP programmes and the monitoring of longer-term ART outcomes in individuals who acquire HIV-1 on PrEP will be essential to preserve antiretroviral options for both treatment and prevention.

Preferences for HIV pre-exposure prophylaxis among men who have sex with men and trans women in 15 countries and territories in Asia and Australia: a discrete choice experiment.

Tieosapjaroen W, Bavinton BR, Schmidt HA … +11 more , Chan C, Green KE, Phanuphak N, Poonkasetwattana M, Suwandi NS, Fraser D, Boonyapisomparn H, Cassell M, Zhang L, Tang W, Ong JJ

J Int AIDS Soc · 2025 Aug · PMID 40836488 · Full text

INTRODUCTION: Scaling up pre-exposure prophylaxis (PrEP) for HIV among men who have sex with men (MSM) and transgender women (TGW) in the Asia-Pacific region has been slow. We identified the drivers of PrEP use and forec... INTRODUCTION: Scaling up pre-exposure prophylaxis (PrEP) for HIV among men who have sex with men (MSM) and transgender women (TGW) in the Asia-Pacific region has been slow. We identified the drivers of PrEP use and forecasted PrEP uptake given different PrEP programmes for MSM and TGW living in 15 countries and territories in Asia and Australia. METHODS: Separate online discrete choice experiment surveys for MSM and TGW were distributed in 15 Asian countries and territories and Australia between May and November 2022. We used random parameters logit models to estimate the relative importance of service attributes and predicted PrEP uptake for different programme configurations. RESULTS: Among 21,943 participants included in the MSM survey and 1522 in the TGW survey, the mean age was 31.7 (±9.5) years and 28.1 (±7.0) years, respectively. Cost emerged as the primary driver of PrEP use for MSM and TGW across countries, followed by the type of PrEP. When switching from the least preferred PrEP programme (i.e. very high service fee, PrEP implant, rare kidney problems as side effects of PrEP and a 2-monthly clinic visit) to an optimal programme (i.e. free access to PrEP via peer-led community clinics which offered sexually transmitted infection [STI] testing, and a 6-12 monthly visit), the predicted PrEP uptake could improve by over 50% for MSM in Australia, China, Hong Kong SAR China, Japan, the Philippines, Taiwan (China) and Thailand, and 37% for TGW. Compared to those at lower risk of HIV, free access was more preferred by MSM at a higher risk of HIV, while telehealth was more preferred by TGW at a substantial risk of HIV. CONCLUSIONS: Tailoring services to local contexts, including ensuring affordability, preferred type of PrEP and providing differentiated services, could accelerate the uptake of PrEP among MSM and TGW in Asia and Australia. Novel innovations, such as STI and HIV self-testing, should be explored as alternatives to conventional testing, given that most MSM and TGW prefer less frequent clinic visits and long-acting PrEP options.

Life-years lost associated with mental disorders in people with HIV: a cohort study in South Africa, Canada and the United States.

Ruffieux Y, Joska JA, Lang R … +18 more , Zheng C, Folb N, Kirk GD, Parcesepe AM, Silverberg MJ, Napravnik S, Gebo K, Jr JJE, Hogan BC, Althoff KN, Tlali M, Grelotti DJ, Loutfy M, Rebeiro PF, Davies MA, Egger M, Maartens G, Haas AD

J Int AIDS Soc · 2025 Aug · PMID 40826829 · Full text

INTRODUCTION: People with HIV (PWH) have a high burden of mental health disorders, which contribute to increased mortality due to elevated rates of physical illness, suicide or fatal accidents. Additionally, mental healt... INTRODUCTION: People with HIV (PWH) have a high burden of mental health disorders, which contribute to increased mortality due to elevated rates of physical illness, suicide or fatal accidents. Additionally, mental health disorders can adversely affect antiretroviral therapy (ART) adherence, leading to increased HIV-related mortality. This study aims to quantify the difference in mortality between PWH who have a mental health disorder and PWH without mental health disorders in South Africa (SA) and North America (NA). METHODS: This cohort study includes PWH aged 18 years or older who initiated ART between 2000 and 2021 at a national private-sector HIV programme in SA and 13 programmes in the United States and Canada. Mental health disorders were diagnosed according to ICD-10 codes F10-F99, which include psychotic disorders, bipolar disorders, depression, anxiety and substance use disorders. We estimated life-years lost (LYL) associated with mental health disorders, quantifying the average difference in remaining life expectancy between individuals diagnosed with a mental health disorder and those without such diagnoses. RESULTS: The study included 119,785 participants from SA (57.4% female, median age 39 years) and 142,044 from NA (85.0% male, median age 43 years). In SA, 57,999 (48.4%) were diagnosed with a mental health disorder, compared with 93,518 (65.8%) in NA. In SA, the LYL associated with any mental health disorder were 3.42 years (95% CI 2.42-4.28) in males and 2.95 years (0.67-5.95) in females. Corresponding figures for NA were 4.16 years (3.71-4.59) in males and 4.64 years (2.93-6.05) in females. In both regions, LYL were higher for psychotic and substance use disorders than for depression and anxiety. Losses were primarily due to natural deaths at CD4 counts ≥200 cells/µl, with considerable contributions at CD4 counts <200 cells/µl. Unnatural causes also contributed to the loss of life-years in males from SA and males and females from NA. CONCLUSIONS: PWH affected by mental health disorders experience higher mortality, primarily from natural causes. LYL were associated with both immunosuppression and higher CD4 levels. Improved management of HIV and physical comorbidities among PWH affected by mental health disorders may enhance their prognosis.

Socio-demographic and geographic disparities in HIV prevalence, HIV testing and treatment coverage: An analysis of 108 national household surveys in 33 African countries.

Allorant A, Kuchukhidze S, Stannah J … +5 more , Xia Y, Masuku SS, Ekanmian GK, Imai-Eaton JW, Maheu-Giroux M

J Int AIDS Soc · 2025 Aug · PMID 40804796 · Full text

INTRODUCTION: Socio-demographic and geographic disparities in HIV prevalence, uptake of HIV testing and access to antiretroviral therapy (ART) persist in high HIV burden countries. Understanding demographic, spatial and... INTRODUCTION: Socio-demographic and geographic disparities in HIV prevalence, uptake of HIV testing and access to antiretroviral therapy (ART) persist in high HIV burden countries. Understanding demographic, spatial and temporal factors can guide interventions. METHODS: We analysed 108 geo-referenced population-based surveys conducted over 2000-2023 across 33 African countries, involving 2.3 million respondents. Multilevel Bayesian logistic regression models assessed associations between HIV outcomes (HIV prevalence, recent HIV testing and ART coverage) and socio-demographic characteristics (age, education, place of residence, relative wealth), geographic location (country, district) and time trends. Separate models were estimated for men and women in central, eastern, southern and western Africa. RESULTS: Inequalities in HIV risk and access to testing and treatment services were driven by differences in educational attainment and within-country variations. In southern Africa, women with tertiary education had a 12%-point lower HIV prevalence (95% Credible Interval [CrI]: -27% to -2%) than those with less than primary education. In eastern Africa, they had a 13%-points (95% CrI: 2-22%) higher probability of recent HIV testing. Associations with relative wealth were weaker and more heterogeneous: in southern Africa, HIV prevalence shifted over time from higher to lower wealth quintiles, and adolescent girls and young women became the most frequently tested age group. In central Africa, wealthier men maintained higher recent testing and ART coverage levels. District-level variations accounted for disparities in HIV outcomes. In western Africa, the expected difference in ART coverage between individuals with similar socio-demographic characteristics living in different districts was 14%-points (95% CrI: 3-32%) for men and 10%-points (95% CrI: 3-27%) for women. CONCLUSIONS: Disparities in HIV outcomes are strongly associated with differences in education, and across districts of the same country. Higher education levels are associated with lower HIV prevalence, greater testing and higher ART coverage, while districts with limited services sustain higher population viraemia. Despite the scale-up of HIV prevention and treatment programmes, important disparities remain, and renewed education-centred and geographically targeted efforts are needed to close gaps.

Impact of point-of-care maternal viral load testing at delivery on vertical HIV transmission risk assessment and neonatal prophylaxis: a cluster randomized trial.

Lwilla AF, Elsbernd K, Boniface S … +18 more , Edom R, Mahumane A, Meggi B, Buck WC, Lequechane J, Pereira K, Chiwerengo N, Chale F, Mudenyanga C, Mutsaka D, Mueller M, Ntinginya NE, Taveira N, Hoelscher M, Jani I, Kroidl A, Sabi I, and the LIFE Study Consortium

J Int AIDS Soc · 2025 Aug · PMID 40719344 · Full text

INTRODUCTION: Despite global reductions in vertical HIV transmission (VHT), 120,000 children newly acquired HIV in 2023. High maternal viral load (VL) is a major risk factor for VHT. We estimated the impact of point-of-c... INTRODUCTION: Despite global reductions in vertical HIV transmission (VHT), 120,000 children newly acquired HIV in 2023. High maternal viral load (VL) is a major risk factor for VHT. We estimated the impact of point-of-care (PoC) maternal VL testing at delivery in profiling the risk of VHT and its impact on appropriate postnatal prophylaxis for infants born to women living with HIV (WLWH). METHODS: The cluster-randomized LIFE (Long term Impact on inFant hEalth) study was conducted at 28 health facilities in Tanzania and Mozambique from 2019 to 2021. At delivery, the intervention arm applied PoC maternal VL plus clinical criteria for VHT risk assessment, while the control arm used clinical criteria only. In Tanzania, both arms provided ePNP based on maternal risk factors, while Mozambique provided ePNP universally. We used mixed effects logistic regression to estimate the intervention effect on the proportion of infants at high risk (Tanzania and Mozambique) and infants at high risk receiving ePNP (Tanzania only). RESULTS: A total of 6467 WLWH were enrolled: 66.3% were diagnosed before the third trimester, 99% were on antiretroviral therapy and 78% were virally suppressed at delivery. Of 6564 newborns of WLWH included, 774 (11.7%) were identified to be at a high risk: 629 (19.3%) versus 145 (4.4%) in intervention and control arms, respectively; p<0.0001. In the intervention arm, 520 (82.7%) infants at high risk were classified only based on maternal PoC VL at delivery. In the control arm, 720 (21.8%) additional infants at high risk would have been identified if their mothers had received PoC VL assessment. In Tanzania, infants at high risk in the intervention arm were significantly more likely to receive ePNP: 59.5% versus 31.4% (OR 4.42, 95% CI: 1.09, 17.89). However, 40.5% from intervention arm and 68.6% from control arm did not receive ePNP despite high-risk classification at delivery. CONCLUSIONS: PoC maternal VL testing at delivery significantly increased the proportion of infants identified to be at high risk. Infants at high risk whose mothers received PoC VL at delivery were more often initiated on ePNP. However, the linkage of infants at high risk to appropriate prophylaxis remains suboptimal, warranting consideration of universal ePNP.

Approaches used to monitor the effectiveness of community-led monitoring programmes: a scoping review to inform HIV programmes.

Malik F, Turusbekova N, Perez S

J Int AIDS Soc · 2025 Aug · PMID 40714934 · Full text

INTRODUCTION: Community-led monitoring (CLM) for HIV is a technique implemented by local community-led organizations and groups that systematically gather data about HIV services to advocate for improvement. This review... INTRODUCTION: Community-led monitoring (CLM) for HIV is a technique implemented by local community-led organizations and groups that systematically gather data about HIV services to advocate for improvement. This review was conducted to explore fields other than HIV where CLM or similar approaches have been used, and to identify methods and tools used to monitor the effectiveness of such approaches. METHODS: Using a systematic search in PubMed®, Embase® and Web of Science™, we identified publications describing community involvement in the monitoring of public services. We searched for English-language, peer-reviewed articles and abstracts published from inception until 7 March 2024 with search terms covering two broad areas: "community-led monitoring" and "impact/effectiveness." We double-screened titles and abstracts and single-extracted data on publication type, region and geographic location, field, programme goals, the methods used to monitor the programme, indicators used for monitoring and the frequency with which the programme was monitored. In addition, a web search was conducted to identify relevant grey literature. RESULTS: We identified 282 records, of which 28 publications were included. Additionally, 24 documents were included through a search of grey literature. Seven peer-reviewed publications related to HIV CLM, 10 were from other health services and 11 were from monitoring of natural resources. No peer-reviewed publications documented results from routine evaluations of CLM programmes or described a monitoring framework for CLM. Common themes identified across different fields were the role of multi-stakeholder collaboration as an enabling factor for community monitoring, challenges in sustainability due to fragmented funding and the inability of existing evaluation approaches to capture the longer-term impact of community monitoring. DISCUSSION: Having a robust monitoring and evaluation system is essential for improving CLM programme operations and demonstrating impact. However, demonstrating the impact of community-led advocacy efforts is complex and more research is needed to assess longer-term impacts. Monitoring of locally led adaptation programmes for climate resilience offers useful examples of impact assessments. CONCLUSIONS: The synthesized findings and lessons from this scoping review have been used, along with consultations with CLM implementers, to develop a guide to monitor outcomes and impact of HIV CLM programmes.

Opportunities and challenges for hepatitis B cure in people living with HIV and hepatitis B virus.

Singh KP, Audsley J, Zhao W … +1 more , Lewin SR

J Int AIDS Soc · 2025 Jul · PMID 40708534 · Full text

Abstract loading — click title to view on PubMed.

Rewriting the narrative: resilience of youth in the HIV response.

Chiu F, Liu K, Senyonga I

J Int AIDS Soc · 2025 Jul · PMID 40681477 · Full text

Abstract loading — click title to view on PubMed.

Cost and clinical flow of point-of-care urine tenofovir testing for treatment monitoring among people living with HIV initiating ART in South Africa.

Wang M, Moodley P, Khanyile M … +9 more , Bulo E, Zondi M, Naidoo K, Sookrajh Y, Dorward J, Gandhi M, Garrett N, Drain PK, Sharma M

J Int AIDS Soc · 2025 Jul · PMID 40660747 · Full text

INTRODUCTION: Point-of-care (POC) urine tenofovir (TFV) tests can provide timely information regarding antiretroviral therapy (ART) adherence to support management of HIV treatment in clinics. However, there are limited... INTRODUCTION: Point-of-care (POC) urine tenofovir (TFV) tests can provide timely information regarding antiretroviral therapy (ART) adherence to support management of HIV treatment in clinics. However, there are limited data on the costs and feasibility of integrating POC testing into HIV clinics in sub-Saharan Africa. We characterized clinic flow and implementation costs of POC adherence testing for persons initiating ART in HIV care clinics in South Africa. METHODS: We conducted a microcosting within a randomized controlled implementation trial of POC TFV test in government clinics in Durban, South Africa (STREAM HIV). Time-and-motion observation was conducted between 1st March and 31st December 2022, to assess staff and client time needed for POC TFV testing and counselling. We estimated both financial and economic costs for capital, clinic consumables and personnel using a provider (national government) perspective. RESULTS: The estimated cost of POC TFV was USD $13 per client, assuming a clinic volume of 20 individuals initiating ART per month. The largest component costs of POC TFV testing were the test strip consumables, which accounted for 53% of the test cost. The median total time of a clinic visit with a POC TFV test, starting from client registration, was 49:19 (minutes: seconds) (IQR: 29:19-89:35). TFV testing took 9:22 (IQR: 7:35-14:11), taking up 19% of the total clinic visit time, including sample collection, sample loading, TFV test processing and counselling provision based on test results. Overall, 29% of the clinic visit time included direct clinical care and assessment with a provider, with clients spending a median 14:09 (IQR: 10:35-21:22) getting vitals checked, receiving adherence monitoring via POC TFV testing, and collecting their ART refill. Waiting in line for ART took most (48%) of the clinic visit time. CONCLUSIONS: POC TFV testing can be administered at reasonable costs, requires less than 10 minutes of healthcare provider time, and, therefore, may be feasible to implement in South African clinics. Findings can inform policy and budgetary planning for ART monitoring in South Africa and future cost-effectiveness analyses of POC TFV testing. CLINICAL TRIAL NUMBER: NCT04341779.

Persistent sex disparities in access to dolutegravir-based antiretroviral therapy in Latin America and the Caribbean: results from a retrospective observational study using data from 2017 to 2022.

Fonseca FF, Ranadive P, Shepherd BE … +13 more , Ferreira FGF, Rodríguez MF, Machado DM, Rouzier V, Varela D, Maruri F, Ribeiro P, Grinsztejn B, Wagner Cardoso S, Veloso VG, Castilho JL, Jalil EM, CCASAnet

J Int AIDS Soc · 2025 Jul · PMID 40635404 · Full text

INTRODUCTION: Despite its reversal in July 2019, the World Health Organization warning issued in May 2018 of potential teratogenicity associated with dolutegravir (DTG) may have produced persistent sex disparities in acc... INTRODUCTION: Despite its reversal in July 2019, the World Health Organization warning issued in May 2018 of potential teratogenicity associated with dolutegravir (DTG) may have produced persistent sex disparities in access to DTG. We compared DTG uptake of people with HIV (PWH) by sex in Latin America and the Caribbean (LAC) and its potential impact on virologic outcomes. METHODS: We evaluated DTG initiation among antiretroviral therapy (ART)-naïve and -experienced cisgender PWH ≥16 years of age after DTG availability in Brazil (February/2017), Chile (August/2019), Haiti (November/2018) and Honduras (December/2018). Time was divided into pre- (before May/2018), during- (May/2018-July/2019) and post- (after July/2019) warning periods. We examined interactions of sex, age and calendar era with multivariable modified Poisson regression models and Cox proportional hazard models for the outcomes of DTG initiation among ART-naïve and ART-experienced PWH, respectively, and HIV RNA <50 copies/ml in the first year of therapy among ART-naïve PWH, adjusting for site and tuberculosis. RESULTS: Among 4622 ART-naïve PWH, 3853 (83%) initiated DTG. ART-naïve females aged 16-49 years were less likely to initiate DTG compared to males of the same age both in the pre/during-warning (adjusted prevalence ratio [aPR]: 0.75 [95% confidence interval (95% CI): 0.71-0.80]) and in the post-warning periods (aPR: 0.97 [95% CI: 0.95-1.00]). Among 16,154 ART-experienced PWH, 9236 (57%) initiated DTG. ART-experienced females 16-49 years were less likely to initiate DTG compared to males of the same age in the pre/during-warning (adjusted hazard ratio [aHR]: 0.69 [95% CI: 0.66-0.73]) and post-warning periods (aHR: 0.79 [95% CI: 0.70-0.90]). This sex difference was not observed among older ART-experienced females and males pre/during-warning (aHR: 1.06 [95% CI: 0.99-1.14]). Compared to starting ART without DTG, DTG-based ART use was associated with a higher likelihood of HIV RNA suppression in the first year (aPR = 1.10 [95% CI: 1.04-1.16]). In the post-warning period, females aged 16-49 years had a likelihood of viral suppression similar to males of the same age (aPR: 1.03 [95% CI: 0.96-1.10]), which did not change after adjusting for DTG use (aPR: 1.03 [95% CI: 0.97-1.11]). CONCLUSIONS: Despite the updated guidelines recommending DTG for all PWH, there are persistent sex disparities in the access to DTG in LAC, especially among females within the reproductive age.

Cost-effectiveness analysis of a community-based model for delivery of antiretroviral therapy to people with clinically stable HIV in Cambodia.

Yam LYE, Chhoun P, Tian Z … +8 more , Nagashima-Hayashi M, Zahari M, Tuot S, Samreth S, Ngauv B, Ouk V, Prem K, Yi S

J Int AIDS Soc · 2025 Jul · PMID 40623943 · Full text

INTRODUCTION: In Cambodia, of all people living with HIV, 89% knew their status, 89% were receiving antiretroviral therapy (ART) and 87% had their viral load suppressed in 2023. In 2017, the national HIV programme introd... INTRODUCTION: In Cambodia, of all people living with HIV, 89% knew their status, 89% were receiving antiretroviral therapy (ART) and 87% had their viral load suppressed in 2023. In 2017, the national HIV programme introduced the multi-month dispensing (MMD) model to reduce visits to ART clinics, thereby reducing the burden on people living with HIV and health facilities. A quasi-experimental study introduced the community ART delivery (CAD) model, where community action workers (CAWs) delivered pre-packaged antiretrovirals to their peers in the community. This study examined the cost-effectiveness of the CAD compared to the MMD model. METHODS: This study was conducted between 2021 and 2023 and involved 2040 stable people living with HIV in the CAD arm and 2049 in the MMD arm. Baseline and endline surveys included self-reported ART adherence, quality of life, and medical and non-medical expenses. Intention-to-treat analyses (ITTs) were conducted based on participants' original treatment assignment, with multiple imputations performed for participants lost to follow-up at the endline. Incremental cost-effectiveness ratios (ICERs) on ART adherence and quality of life were generated using health system and societal perspectives. Cost-effectiveness thresholds (CETs) were one-time gross domestic product (GDP) per capita and opportunity cost. RESULTS: Both arms observed a decline in ART adherence and good physical health, with a decline in CAD less than in the MMD (p-value < 0.001). Similarly, a reduced proportion of participants reported good mental health across both arms; however, the difference was statistically insignificant. The ICERs for good physical health at the health system and societal levels were below the one-time GDP per capita (Incremental Net Benefit = 77.49-83.03) but exceeded the opportunity cost CET. The ICERs for ART adherence at the health system and societal levels were above both CETs. CONCLUSIONS: The results showed that the CAD model was cost-effective in reducing the decline in the physical health of people living with HIV during the COVID-19 pandemic in Cambodia when a less stringent threshold was used. Further investigations are required to ascertain the cost-effectiveness of the CAD model by factoring in the productivity gains within the health system. CLINICAL TRIAL NUMBER: NCT04766710.

Non-communicable disease (NCD) risk among people living with HIV in KwaZulu-Natal, South Africa: evidence from a randomised trial of community-based differentiated service delivery.

Sahu M, Szpiro AA, van Rooyen H … +11 more , Asiimwe S, Shahmanesh M, Roberts DA, Krows ML, Sausi K, Sithole N, Schaafsma T, Baeten JM, Shapiro AE, van Heerden A, Barnabas RV

J Int AIDS Soc · 2025 Jul · PMID 40623916 · Full text

INTRODUCTION: As differentiated HIV services provided outside of clinics are scaled up, clients may have fewer interactions with ancillary services for non-communicable disease (NCD) prevention and management traditional... INTRODUCTION: As differentiated HIV services provided outside of clinics are scaled up, clients may have fewer interactions with ancillary services for non-communicable disease (NCD) prevention and management traditionally offered within facilities. This study was embedded in the DO ART randomised trial (2016-2019), which demonstrated that community-based differentiated service delivery (DSD) improved HIV viral suppression compared with facility-based care. We assessed NCD risk among men and women living with HIV accessing community-based DSD versus facility-based care in KwaZulu-Natal, South Africa. METHODS: First, we described lifestyle and clinical NCD risk among DO ART participants in rural and semi-rural KwaZulu-Natal. Next, we compared clinical NCD risk at 12 months by randomisation arm (community-based DSD vs. facility-based care). Finally, we explored the relationship between 12-month viral suppression and clinical NCD risk, overall and stratified by randomisation arm (i.e. service delivery type). RESULTS: Among 1010 participants, the median age was 32 years, 245 (24%) smoked, 229 (23%) had hypertension and 502 (50%) were overweight or obese (body mass index [BMI] ≥ 25). Smoking was more common among men than women (43% vs. 6%, p ≤ 0.001), while overweight/obesity was more common among women than men (65% vs. 34%, p ≤ 0.001). We found no statistically significant association between service delivery type and clinical NCD risk factors at 1 year. We also found no significant associations between viral suppression at 12 months and blood pressure, haemoglobin A1c or smoking. However, virally suppressed clients had higher mean BMI (+0.93 kg/m, p = 0.004) and higher mean cholesterol (+5.79 mg/dl, p = 0.001). These associations were greater in effect size and statistically significant among clients receiving community-based DSD (BMI: p = 0.003; cholesterol: p = 0.001), but smaller and not significant for facility-based care (BMI: p = 0.299; cholesterol: p = 0.448). CONCLUSIONS: Relatively younger adults accessing HIV treatment in South Africa had substantial NCD risk, which differed by gender and may increase with age. Among clients receiving community-based DSD, viral suppression was associated with modestly higher BMI and cholesterol levels. Community-based DSD programmes should consider integrating NCD risk screening and management that addresses gender-specific needs to prevent premature mortality among people living with HIV. CLINICAL TRIAL NUMBER: NCT0292999.

Early findings from the integration of hypertension care into differentiated service delivery models for HIV in Uganda: a mixed-method study.

Kiggundu JB, Semitala FC, Lipoto CF … +14 more , Giibwa L, Twine R, Mwaka S, Ayebare F, Kiwala C, Magambo EN, Mutungi G, Ssinabulya I, Spiegelman D, Kayima J, Muddu M, Schwartz JI, Katahoire AR, Longenecker CT

J Int AIDS Soc · 2025 Jul · PMID 40622382 · Full text

INTRODUCTION: Uganda's national guidelines recommend integrated HIV and hypertension care; however, integration of hypertension care into HIV differentiated service delivery (DSD) models has not been extensively describe... INTRODUCTION: Uganda's national guidelines recommend integrated HIV and hypertension care; however, integration of hypertension care into HIV differentiated service delivery (DSD) models has not been extensively described. We aimed to describe trends in DSD models for people living with HIV (PLHIV) with hypertension and to qualitatively describe the experiences of healthcare providers (HCPs) and PLHIV with hypertension after implementing integrated care. METHODS: We conducted a parallel convergent mixed methods study nested in an ongoing stepped wedge cluster randomised trial in Kampala and Wakiso districts. Quantitative data (age, sex, blood pressure, DSD model, medication prescriptions) were collected from routine medical records at eight clinics implementing the enhanced care package between March 2023 and July 2024. Additionally, structured interviews were conducted at two clinics with HCPs (n = 6, 3 per clinic) and PLHIV with hypertension (n = 8, 4 per clinic). Our quantitative outcome variable was enrolment in intensive DSD models (facility-based individual and group models) versus other DSDs. A generalised estimation equation was used to account for within clinic correlation and repeated measures within participants over time. Inductive thematic analysis was applied to the qualitative data using the Consolidated Framework for Implementation Research. RESULTS: Overall, 3164 PLHIV with hypertension accessed care at the eight clinics. Median age was 46 years (IQR 38-56); more than two-thirds were female. There was considerable heterogeneity across clinics in the use of DSD models during the study period. Overall, use of intensive models increased over time (OR 1.127 [1.059-1.199] per month). However, two clinics showed significant time interaction effects (Wald test χ (7) = 69.94, p < 0.001), with a decrease in the intensive models over time. HCPs and PLHIV observed that integrating hypertension care was easily adaptable in some models, while more challenging in others. The availability of resources and synchronisation of HIV and hypertension visits facilitated the integration of hypertension care within the HIV DSD models. CONCLUSIONS: The integration of hypertension management into HIV DSD models is both feasible and adaptable; however, it requires transitioning PLHIV between various models based on clinical needs. To facilitate this process, comprehensive client education by the HCPs is necessary. CLINICAL TRIAL NUMBER: clinicaltrials.gov # NCT05609513.

Scale of differentiated service delivery implementation in HIV care facilities in low- and middle-income countries: a global facility survey.

Fernández Villalobos NV, Helfenstein F, Khol V … +26 more , Twizere C, Secco M, Castelnuovo B, Huwa J, Tiendredbeogo T, Wester CW, Fong SM, Murenzi G, Caro-Vega Y, Lyamuya RE, Rafael I, Zannou DM, Petoumenos K, Nsonde DM, Pinto J, Wools-Kaloustian K, Moore CB, Takassi OE, Kiertiburanakul S, Awoh RA, Ali SM, Fatti G, Malateste K, Zaniewski E, Ballif M, International epidemiology Databases to Evaluate AIDS

J Int AIDS Soc · 2025 Jul · PMID 40622380 · Full text

INTRODUCTION: In 2016, the World Health Organization recommended differentiated service delivery (DSD) as a client-centred approach to simplify HIV care in frequency and intensity, thus reducing the clinic visit burden o... INTRODUCTION: In 2016, the World Health Organization recommended differentiated service delivery (DSD) as a client-centred approach to simplify HIV care in frequency and intensity, thus reducing the clinic visit burden on individuals and HIV programmes. We describe the scale of DSD implementation among HIV facilities in low- and middle-income countries (LMICs) in Latin America, Africa and the Asia-Pacific before the COVID-19 pandemic. METHODS: We analysed facility-level survey data from HIV care facilities participating in the International epidemiology Databases to Evaluate AIDS consortium in 2019. We used descriptive statistics to summarise the availability of DSD, multi-month dispensing (MMD) and DSD for HIV treatment models. We explored factors associated with DSD implementation using multivariable models. RESULTS: We included 175 facilities in the Asia-Pacific (n = 30), Latin America (n = 8), Central Africa (n = 21), East Africa (n = 74), Southern Africa (n = 28) and West Africa (n = 14). Overall, 133 facilities (76%) reported implementing DSD. Of these, 91% offered DSD for HIV treatment, 61% for HIV testing and 59% for antiretroviral therapy (ART) initiation. The most common duration of ART refills for clinically stable clients was 3MMD, (70%), followed by monthly (14%) and 6MMD (10%). Facility-based individual models were the most frequently available DSD for the HIV treatment model (82%), followed by client-managed group models (60%). Out-of-facility individual models were available at 48% of facilities. Facility-based individual models were particularly common among facilities in East (92%) and Southern Africa (96%). Facilities in medium and high HIV prevalence countries, and those with 3MMD, were more likely to implement DSD. CONCLUSIONS: In 2019, DSD was available in most HIV care facilities globally but was not evenly implemented across regions and HIV services. Most offered facility-based DSD for HIV treatment models and 3MMD for clinically stable clients. Efforts to expand DSD for HIV testing and ART initiation and to offer longer MMD can improve long-term retention in care of people living with HIV in LMICs, while further alleviating the operational burden on healthcare services. These findings from the pre-COVID-19 era underline the need for strengthening DSD in HIV care, which remains at the centre of current efforts towards client-centred care.

Build, do not dismantle: leveraging a differentiated service delivery approach for broader health impact amidst funding changes.

Grimsrud A, Holmes CB, Sande L

J Int AIDS Soc · 2025 Jul · PMID 40622378 · Full text

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