Journal of the International AIDS Society

IntroductionMaximizing the impact of new and forthcoming long-acting injectable HIV pre-exposure prophylaxis (PrEP) products will require novel delivery approaches that widen accessibility and prioritize clients needs and preferences. To understand the potential barriers and facilitators to delivering injectable PrEP via private pharmacies in Kenya, we conducted qualitative formative research. MethodsFrom July to September 2023, we interviewed pharmacy providers, pharmacy clients, and other key stakeholders of HIV service delivery in Central and Western Kenya. Our purposive sample included some providers and clients with prior experience delivering or obtaining oral PrEP at a pharmacy as part of a pilot study and some without such experience. We analyzed verbatim transcripts thematically using a combination of inductive and deductive approaches, the latter informed by the Consolidated Framework for Implementation Research (CFIR). ResultsWe interviewed 25 pharmacy clients, 16 pharmacy providers, and 9 key stakeholders. Each group was [~]50% female, and median age among clients was 25 (IQR 23-29). Overall, participants supported the idea of pharmacy-based injectable PrEP delivery. Anticipated facilitators included perceived benefits of injectable over oral PrEP; characteristics of pharmacies (e.g., long operating hours) that could fulfill clients need for accessible, fast, and private injectable PrEP services; and existing skillsets of pharmacy providers, especially those already trained on injectable contraception. Anticipated barriers included gaps in enabling policy; pharmacies lack of integration with the public health sector, such as its health information system; low client knowledge of and/or ability to pay for injectable PrEP; and pharmacy staffing and compensation structures that could disincentivize providers. ConclusionsParticipants in this study expressed cautious optimism that private pharmacies could be an effective delivery channel for injectable PrEP in Kenya. If private pharmacies facilitate access to and use of injectable PrEP, they could play a pivotal role in ending HIV as a public health threat.

Because of its recent regulatory approval in southern and eastern Africa, CAB PrEP represents a scientific advancement with unknown implementation costs in most African countries. To our knowledge, this paper is the first study comparing PrEP costs in health facilities where clients had a choice between three PrEP methods. We collected and analyzed the direct service delivery costs for each method using the same costing approach and assumptions at three facilities in Lesotho and six facilities in Zimbabwe. On average, in Lesotho, the direct costs of providing CAB PrEP were $57.22 for an initiation visit and $54.20 for a refill visit (same PrEP product dose dispensed in both visit types), while the direct costs of oral PrEP were $22.47 (initiation visit with one month of PrEP dispensed) and $31.98 (refill visit dispensing a three-month dose of medication), and the direct costs of the dapivirine ring were $34.27 (initiation visit with one month of PrEP dispensed) and $50.70 (refill visit dispensing a three-month supply). In Zimbabwe, the average per-visit direct costs to provide CAB PrEP were $48.26 (initiation visit) and $47.40 (refill visit), to provide oral PrEP were $13.47 (initiation visit with one month of PrEP dispensed) and $21.78 (refill visit dispensing a three-month dose), and to provide the dapivirine ring were $42.56 (refill visit dispensing a three-month supply). Initiation visits for the dapivirine ring were not observed in Zimbabwe. At a time when national governments are creating budgets for the HIV response with decreased financial support from bilateral and multilateral partners, this paper will inform HIV prevention planning by providing critical client-level data from the healthcare provider perspective.

IntroductionReplacing conventional, facility-based HIV treatment with less intensive differentiated service delivery (DSD) models could benefit DSD clients and the health system, but its value depends on maintaining or improving clinical outcomes. We compared retention and viral suppression between antiretroviral therapy (ART) clients enrolled in DSD models to those eligible for but not enrolled in DSD models in South Africa. MethodsWe applied a target trial emulation (TTE) methodology to data from South Africas electronic medical record system (TIER.Net) for 18 clinics across 3 provinces and estimated retention in care (attended clinic visit within 12 months) and viral suppression (<400 copies/ml3) at 12, 24, and 36 months after follow-up start date, defined as DSD enrollment date for the intervention arm and the first trial enrollment period clinic visit for the comparison arm. Clients were eligible for DSD models if they were [&ge;]18 years old, on ART [&ge;]12 months, and had two suppressed viral load (VL) measurements, per prevailing national guidelines. For the TTE, we designated eight 6-month target trial enrolment periods between 1 July 2017 and 1 July 2021. For each period, we estimated the risk differences for retention in care and viral suppression by comparing those enrolled in DSD models to those not enrolled, using a Poisson distribution with an identity link function. We report adjusted and unadjusted risk differences for clients enrolled in DSD models and for DSD-eligible clients not enrolled in a DSD model. Results and discussion49,595 unique individuals were eligible for DSD enrolment over eight target trials, contributing to a total of 148,943 trial-clients, of whom 17% (25,775) were enrolled in DSD models. The pooled adjusted risk difference for retention in care between clients enrolled in DSD and those not enrolled in DSD was 3.2% (95% confidence interval (CI) 1.6%; 4.7%) at 12 months, 4.2% (2.4%; 6.0%) at 24 months, and 4.4% (2.0%; 6.8%) at 36 months. For viral suppression, the adjusted risk difference comparing DSD to non-DSD was estimated to be 1.4% (-0.5%; 3.2%) at 12 months, 1.7% (-0.5%; 4.0%) at 24 months, and 1.4% (- 0.6%; 4.4%) at 36 months. Results remained consistent across target trials. Clients who were younger, lived in urban settings, or had less ART experience at trial enrolment had lower retention. ConclusionsClients enrolled in DSD models in South Africa had slightly better retention in care and similar viral suppression to those who were eligible for but not enrolled in DSD. With better or equivalent outcomes, DSD models can be assessed on the basis of non-clinic costs and benefits, such as changes in quality of care and resource utilization. RegistrationClinicaltrials.gov NCT04149782.

BackgroundPrEP uptake among Black and Latino gay, bisexual, and other men who have sex with men (GBM) remains low in the United States. The design and implementation of PrEP delivery programs that incorporate the preferences of Black and Latino GBM may overcome barriers to uptake. We aimed to identify preferences for PrEP care among high-priority GBM in the U.S. with a large discrete choice experiment. MethodsWe conducted two discreet choice experiments (DCE) to elicit care preferences for (1) Starting PrEP and (2) Continuing PrEP care among GBM clinically indicated for PrEP. The DCE web-based survey was nested in a longitudinal cohort study of GBM in the U.S., implemented with video and audio directions among 16-49 year-old participants, not using PrEP, and verified to be HIV-negative. All participants were presented with 16 choice sets, with choices determined by BLGBM and PrEP implementation stakeholders. We calculated overall utility scores and relative importance and used latent class analyses (LCA) to identify classes within the Starting and Continuing PrEP DCE. Multivariable analysis was performed to identify factors associated with class membership. FindingsAmong 1514 participants, mean age was 32 years; 46{middle dot}5% identified as Latino, 21{middle dot}4% Black, and 25{middle dot}2 White; 37{middle dot}5% had an income less than USD $20,000. Two latent classes were identified for Starting PrEP: Class 1 (n=431 [28{middle dot}5%]) was driven by preference for more traditional in-person care, and Class 2 (n=1083 [71{middle dot}5%]) preferred flexible care options and on-demand PrEP. In a multivariable model, having a sexual health doctor (adjusted OR 0{middle dot}7, CI 0{middle dot}5, 0{middle dot}9), having a primary care provider (OR 0{middle dot}7,CI 0{middle dot}5, 0{middle dot}9, p= 0{middle dot}023), and concerns over PrEP side effects (OR 1{middle dot}1, CI 1{middle dot}0,1{middle dot}2, p= 0{middle dot}003) were all associated with class membership. InterpretationThe different preferences identified for PrEP care indicate the need for diverse care and formulation choices to improve PrEP uptake and persistence. Addressing these preferences and understanding the factors that shape them can inform the implementation of programs that increase PrEP uptake.

Structured AbstractO_ST_ABSBackgroundC_ST_ABSNovel formulations for PrEP such as injectables, implants, and intravaginal rings are emerging as long-acting alternatives to daily pills for the prevention of HIV. Sub-Saharan Africa has the highest HIV burden as well as the highest PrEP coverage globally. As long-acting formulations continue to become available, it is crucial to understand the product preferences of potential users. ObjectiveTo conduct a scoping review focused on the region of Sub-Saharan Africa to understand which PrEP products, especially long-acting formulations, different patients and demographic groups prefer as well as the factors that influence their preferences. DesignWe identified 34 publications published between 2014 and 2024 that assessed preferences regarding at least one long-acting PrEP product in the region of Sub-Saharan Africa. ResultsParticipants preferred longer-acting products over oral pills when given the choice in almost all studies. On-demand PrEP was commonly preferred over daily dosing, and long-acting products were preferred over on-demand dosing. A majority of studies found injectables to be most commonly preferred compared to daily oral PrEP, implants, and rings. This preference was observed across a range of demographics including men and women, youth, men who have sex with men, and female sex workers. Duration, efficacy, and discretion were the three most important factors influencing participants choices. ConclusionsLong-acting products, especially injectables, are acceptable for a wide range of individuals at risk of HIV in Sub-Saharan Africa and tend to be preferred over daily oral pills. Participants expressed a diversity of values and opinions regarding preferences, emphasizing the benefit of providing multiple formulations to maximize coverage over heterogeneous populations. Strength and Limitations of this StudySome key populations, such as transgender women, were underrepresented in the literature. With most studies published before long-acting products became widely available, the hypothetical preferences of non-experienced users may differ from preferences in practice.

IntroductionDespite improvements in treatment for people living with HIV (PWH), adherence remains a challenge for many. In this study we aimed to identify preferences for daily pill or long-acting injectable (LAI) antiretroviral therapy (ART) and for possible treatment package features, among PWH enrolled in Ryan White HIV/AIDS Program Part A (RWPA) Medical Case Management (MCM) programs. MethodsParticipants were recruited from six MCM programs from across the New York RWPA eligible metropolitan area (the five boroughs of New York City and Rockland, Putman, and Westchester counties). We developed a discrete choice experiment (DCE) with four attributes: (1) Type of ART Medication (daily pills or LAI), (2) Service Location and Mode, (3) Support, and (4) Rewards. We used an alternative-specific design in which the levels for the last three attributes were dependent on levels within the first (Type of ART). Latent class multinomial logit analysis (LCA) was used for preference estimation and hypothesis-free investigation of preference heterogeneity. ResultsFrom June 2022 through January 2023, 200 New York RWPA MCM clients completed the DCE. We selected a two-group LCA solution. A majority of participants had a higher preference for LAI regimens compared to daily pills (n=114 [57%] versus n=86 [43%]). Those who preferred LAI ART were younger (median age 49 versus 58.5 years, p<0.001), less likely to identify as straight/heterosexual (69% versus 82%, p=0.03), and more likely to identify as Latino/a (54% versus 30%; p<0.001). Preferences for service locations/mode, supports, and rewards were similar across LCA groups. Participants who preferred LAI ART were more likely to have heard of LAI ART before the survey (59% versus 41%, p=0.012). Overall, only 4% of participants self-reported having tried LAI ART. ConclusionsAssessing preferences among groups under-represented in clinical trials is essential to effective and equitable real-world implementation of innovative treatment options. Our study found that there were distinct groups that differed in their preferred ART regimen type and that New York RWPA MCM clients had limited familiarity with LAI ART. To inform regimen selection, we began pilot-testing educational materials and a patient-provider decision-making tool in 2023.

IntroductionAttrition from HIV treatment is high during patients first 6 months after antiretroviral therapy (ART) initiation and patients with less than 6 months on ART are systematically excluded from most differentiated service delivery (DSD) models, which are intended to reduce attrition. Despite eligibility criteria requiring greater than 6 months on ART, some patients enroll earlier. Using routinely-collected medical record data in Zambia, we compared loss to follow-up (LTFU) among patients enrolling in DSD models early (<6 months on ART) to LTFU among those who enrolled according to guidelines ([&ge;]6 months on ART) in order to assess whether the ART experience eligibility criterion is necessary. MethodsWe extracted data from electronic medical records for adults ([&ge;]15 years) who initiated ART between 01/01/2019 and 31/12/2019 and evaluated LTFU, defined as >90 days late for last scheduled medication pickup, at 18 months for "early enrollers" (DSD enrolment after <6 months on ART) and "established enrollers" (DSD enrolment after [&ge;]6 months on ART). We used a log-binomial model to compare LTFU risk between groups, adjusting for age, sex, urban/rural status, ART refill interval and DSD model. ResultsFor 6,340 early enrollers and 25,857 established enrollers there were no important differences between the groups in sex (61% female), age (median 37 years), or setting (65% urban). ART refill intervals were longer for established vs early enrollers (72% vs 55% were given 4-6-month refills). LTFU at 18 months was 3% (192/6,340) for early enrollers and 5% (24,646/25,857) for established enrollers. Early enrollers were 41% less likely to be LTFU than established patients (adjusted risk ratio [95% confidence interval] 0.59 [0.50-0.68]). ConclusionsPatients enrolled in DSD models in Zambia with < 6 months on ART were more likely to be retained in care than patients referred after they were established on ART. A limitation of the analysis is that early enrollers may have been selected for DSD participation due to providers and patients expectations about future retention. Offering DSD model entry to at least some ART patients <6 months after ART initiation may help address high attrition during the early treatment period.

IntroductionFor clients on HIV treatment in sub-Saharan Africa, disengagement from HIV care in the early treatment period is a critical obstacle to achieving UNAIDSs second 95 target. While South Africas Differentiated Service Delivery Guideline on Fast Track Initiation and Counseling (FTIC) define normative procedures, the effect of guideline implementation and the underlying drivers of disengagement remain unclear. MethodsThe PREFER mixed-methods study enrolled a prospective cohort of adult clients initiating ART, returning to care after a period of disengagement or already on ART for [&le;]6 months at 18 public sector healthcare facilities in South Africa. A survey collected data on demographic and clinical characteristics and preferences of participants who were followed up through routinely-collected medical visit records for up to 7 months after treatment initiation to estimate continuity of HIV care (attended all scheduled visits within 28 days). Focus group discussions (FGDs) were conducted approximately 12 months after enrollment among a subset of participants who had expressed concerns about treatment retention. ResultsDuring the study period 7/9/2022-30/6/2023, PREFER-SA enrolled 1,049 participants (72% female, median age=33 years, 24% with CD4 count<200cells/mm3); 122 of whom also participated in focus group discussions. By 6 months on ART, 23% were not continuously in HIV care. Those newly initiating ART at study enrollment were more likely to have disengaged or interrupted treatment by 6 months as those who had remained in care for [&ge;]1 visit. Disengagement was also more likely among men and younger (18-24 years) participants, those reporting food scarcity, and those initiated on regimens other than Dolutegravir. Disengagement did not differ by gender, relationship status, or CD4 count. Qualitative FGD results suggest participants experience barriers to adherence within and between all levels of the socio-ecologic model. Challenges related to the facility experience were most prominent. ConclusionsAmong adults initiating or re-initiating ART in South Africa, the highest risk of disengagement is immediately after initiation. We identified several potentially modifiable individual and social characteristics associated with early disengagement. Improving the patient facility experience and strengthening implementation of SAs Service Delivery Guidelines may increase retention during the early treatment period.

BackgroundSix multi-month dispensing (6MMD) of antiretroviral therapy (ART) for HIV treatment clients has expanded rapidly in the past decade, but its effect on individual outcomes in routine (non-trial) care is still poorly documented and based on observational programmatic data. Malawi launched 6MMD in April 2019 and scaled-up implementation in 2020. We compared retention in care for clients who received 6MMD to those who did not using a target trial emulation (TTE) approach to minimize bias. MethodsWe used routine clinical data from Malawis Electronic Medical Record (EMR) system to identify ART clients eligible for 6MMD in 27 districts from 01/2020-12/2021. Eligible participants were non-pregnant adults ([&ge;]18 years), on ART for [&ge;]6 months, clinically stable as evidenced by a dispensing duration of 3 months (3MMD), and with no prior 6MMD exposure. We created four six-month trials, defined eligibility at the start of each trial period, and classified participants as either receiving 6MMD or non-6MMD (dispensing duration of 1-3 months) within the six-month interval. Follow-up started at 6MMD enrollment for the 6MMD arm or the first visit in the trial enrollment period for the non-6MMD arm. Retention at 12 and 24 months was defined as having a clinic visit within 12-24 (trial 1-4) and 24-36 (trial 1-2) months from trial enrollment. Using an intention-to-treat approach, we estimated adjusted risk differences (aRD) with 95% confidence intervals (CI) using a Poisson regression model with an identity link function and robust standard errors adjusting for age, sex, duration on ART, facility type, regional location, WHO clinical stage at ART initiation. Pooled RDs were estimated by accounting for within-subject variation in a Poisson regression model using data from all trials. ResultsOf the 159,801 unique patients eligible for this study (65% female, median age 37 years), 74% (118,910) were ever enrolled in 6MMD. Retention rates at 12 months (trials 1-4) and 24 months (trials 1-2) were consistently higher in the 6MMD group than the non-6MMD group. The pooled risk for retention was 3% higher in the 6MMD vs non-6MMD groups (aRD 3.0%; 95% CI: 2.8%-3.3%) at 12 months and 2.0% higher (aRD: 2.0%; 95% CI: 1.7%-2.4%) at 24 months. ConclusionsWe observed slightly higher retention in care rates in Malawi at 12 and 24 months among patients on 6MMD compared to those receiving shorter medication dispensing intervals. Future work to assess the impact of 6MMD on visit burden and resource use would offer a comprehensive view of the benefits to both ART clients and the health system.

BackgroundSix-monthly injectable lenacapavir is a promising product for HIV pre-exposure prophylaxis (PrEP). However, health and budget impacts and threshold price at which lenacapavir could be cost-effective in Eastern and Southern Africa is unknown. MethodsWe adapted an agent-based model, EMOD-HIV, to simulate lenacapavir scale-up in Zimbabwe, South Africa, and western Kenya from 2026-2036; uptake assumptions were informed by a literature review of PrEP product preferences. In the main analysis, we varied lenacapavir coverage by subgroup: female sex workers (32%), male clients of FSWs (30%), adolescent girls/young women >1 partner (32%), older females with >1 partner (36%), and males >1 partner (32%). We also assessed a higher coverage scenario (64-76% across subgroups) and scenarios of expanding lenacapavir use, varying from concentrated among those with highest HIV risk to broader coverage. We estimated maximum per-dose lenacapavir price that achieved cost-effectiveness (<US$500/disability-adjusted life-year averted) and 5-year budget impact, compared to daily oral PrEP only. FindingsIn the main analysis, lenacapavir was projected to achieve 1.4-3.5% population coverage across settings and avert 12.3-18.0% of infections over 10 years. Maximum per-dose price was highest in South Africa ($106.30), followed by Zimbabwe ($21.10), and lowest in western Kenya ($16.60). The 5-year budget impact (in millions) was US$507.25 in South Africa, US$16.80 in Zimbabwe, and US$4.09 in western Kenya. Lenacapavir provision costs made up >90% of the budget impact. In the higher coverage scenario, lenacapavir distribution reached 2.7-6.9% population coverage and averted 21-33% of HIV infections across setting; price thresholds were 10-18% lower: $88.34 in South Africa, $17.71 in Zimbabwe, and $14.78 in western Kenya. Expanding lenacapavir coverage resulted in higher HIV incidence reductions but lower price thresholds. InterpretationLenacapavir can avert substantial HIV incidence; price thresholds and budget impacts vary by setting and coverage. Results can inform policy deliberations regarding lenacapavir pricing and resource planning. RESEARCH IN CONTEXTO_ST_ABSEvidence before this studyC_ST_ABSWe searched PubMed for modelling studies published through July 31, 2024 that assessed the health or economic impact of long-acting PrEP scale-up in Africa using the terms: "HIV" AND "lenacapavir" OR "pre-exposure prophylaxis" OR "PrEP" AND (a list of terms indicating health impact), "cost*", "budget impact", "economic evaluation" and (a list of countries in sub-Saharan Africa), "sub-Saharan" AND "model*", OR "mathematical model*". We did not find modeling studies evaluating the maximum cost or budget impact of lenacapavir for PrEP. However, several modelling studies evaluated the cost-effectiveness of other long-acting injectable PrEP products in South Africa. Two studies found that CAB-LA was cost-effective when used by populations at substantial HIV risk, while another found it was not cost-effective when delivered to heterosexual men. Five more recent modelling studies evaluating CAB-LA (four parameterized to South Africa and one to sub-Saharan Africa), found that CAB-LA is not cost-effective when targeted to those at highest risk unless the price is reduced. One compartment model evaluated the price threshold at which CAB-LA would be similarly cost-effective to oral PrEP in South Africa and found a per-dose cost ranging from $9.05-$14.47. We found a lack of studies evaluating LA-PrEP in other African settings aside from South Africa, which has a considerably higher gross domestic product than other countries in the region. Added value of this studyWe evaluate the health impact and budget impact and maximum price threshold of lenacapavir in three African settings (South Africa, Zimbabwe, and Kenya) using an individual-based network transmission model. We find that lenacapavir scale up to 1.4-3.5% population coverage across settings can avert 12.3-18.0% of infections and can be cost-effectively implemented at a price per-dose of $106.30 (South Africa), $21.10 (Zimbabwe), and $16.60 (western Kenya) in our main analysis based on PrEP preference data. Price threshold, volume of doses needed, and budget impact, varied by setting and coverage. Implications of all the available evidenceLA PrEP formulations have the potential to substantially reduce HIV burden in low- and middle-income countries, but costs will likely need to be reduced to enable equitable implementation. Our findings can inform price negotiations and public health planning regarding adoption of novel PrEP products.

BackgroundTracing HIV treatment clients who have interrupted or disengaged from care is a common, guideline-recommended practice globally. Most guidelines prioritize tracing based on clinical condition or HIV transmission risk, not likelihood of client traits that may affect return to care after tracing. Targeting tracing to those most likely to return could increase efficiency substantially. We conducted a systematic review to identify characteristics of clients most likely to return after tracing. MethodsWe searched PubMed, EMBASE, and Web of Science for studies published between 1/2004 and 7/2025 that reported outcomes of tracing interventions in sub-Saharan Africa. Eligible studies reported characteristics of clients who interrupted care, were eligible for a tracing intervention with the intent to return them to care (i.e. not solely research to determine client outcomes after interruption) and were subsequently traced or had tracing attempted. Our primary outcome was client characteristics associated with return to care after tracing, compared to those who did not return after tracing or attempted tracing. ResultsWe identified 13,208 articles; 9 met the inclusion criteria. Older age and female sex were the most consistent predictors of return after tracing. Earlier tracing (relative to last missed visit) was associated with return in 3 studies; 1 found the opposite. Frequent contact attempts, rural location, and psychosocial factors (stigma, disclosure) were also associated with return. Clinical characteristics (CD4 counts and WHO stage) showed mixed or null associations with tracing effectiveness. ConclusionCharacteristics of clients who return to care after tracing, compared to those who are traced or for whom tracing is attempted and do not return, are rarely reported, making it difficult to evaluate this intervention. Using a "high-benefit" approach to targeting tracing--i.e. prioritizing based on likely benefit generated by a successful response, rather than clinical need--may potentially improve the efficiency of HIV programming.

BackgroundThe era of universal treatment for HIV has seen high rates of disengagement from antiretroviral therapy (ART) programs and re-engagement after interruptions, with modeled estimates of non-naive initiators >50% in many places. Most re-engagers are reluctant to admit prior antiretroviral exposure, and non-self-reported data on proportions of re-initiators are scarce. We synthesized data from multiple sources to explore the proportion of people who present for initiation with evidence of prior ART use in South Africa. MethodsWe enrolled a sequential sample of adults presenting to initiate ART or to re-initiate ART after an interruption >3 months and collected 1) self-reported previous treatment experience; 2) electronic medical record (EMR) evidence of prior ART clinic visits; 3) baseline blood tests for metabolites of tenofovir diphosphate; and 4) laboratory records indicating prior ART-related tests. Interviews were conducted with a sub-sample of clients who self-reported no prior ART use but had evidence of metabolites. ResultsAmong 89 enrolled participants (median age 32.5, 62% female), 16 (18%) self-reported previously taking ART >3 months prior to enrolment. An additional 33 (45%) who did not self-report prior exposure had EMR or laboratory evidence of prior ART use, for a total of 49 (55%) clients with known prior treatment exposure at initiation. Sensitivity of self-report was 40%, EMR 43%, metabolite testing 45%, and laboratory records 73%. Interviewees (n=11) reported opting to present as naive because they perceived that disclosure of prior disengagement would cause delays accessing treatment, require additional documentation, and elicit negative responses from healthcare workers. Study limitations included short duration of metabolite detectability (90 days), inability to link individuals within the EMR to discern ART experience at other facilities, and lack of baseline viral load testing. ConclusionsAt least 55% of clients initiating ART in South Africa have prior treatment experience, but only a third of re-initiators voluntarily reveal this. Laboratory records, which reflect long-term experience, yielded the most accurate results for ascertaining prior treatment exposure. As numbers re-engaging in HIV care after a treatment interruption increase, understanding reluctance to self-report ART experience and exploring opportunities to overcome barriers are critical for preventing repeated interruptions.

IntroductionFor differentiated models of care (DMOCs) that support client-centred HIV treatment (ART) in South Africa, a key next step in achieving integration is aligning clinic visits and medication dispensing for HIV treatment with other health needs like family planning. We assessed alignment between ART medication and family planning supply collection visits among DMOCs in South Africa. MethodsWe analysed self-reported data collected between September-December 2024 from women living with HIV (18-49 years, on ART [&ge;]6 months) at 24 public healthcare facilities in four provinces (Gauteng, Mpumalanga, KwaZulu-Natal, and Eastern Cape). Participants were enrolled from four service delivery models: conventional care not eligible for DMOC (CN), conventional care eligible for DMOC but not enrolled (CE), facility pickup points (FAC-PuP), and external pickup points (EXT-PuP). Surveys assessed contraceptive use, visit alignment for injectable (Depo-Provera & Nur-Isterate) and oral contraceptive users, and how misaligned visits affected family planning adherence. ResultsAmong 843 eligible women, 57% (460/843) reported current contraception use, with Depo-Provera being the most common (44%). Contraceptives users were younger (median 35 vs 38 years) and had slightly less ART experience (median 7 vs 8 years) than non-users. Contraceptive use varied by DMOC: CN (52%), CE (60%), FAC-PuP (63%), and EXT-PuP (50%). Half (131/260) of women using oral contraceptives or injectables collected their contraceptive and ART products on different days, with EXT-PuP showing the lowest level of alignment. Primary reasons for non-use were personal choice and beliefs (38%), followed by pregnancy-related factors (26%). Analysis of unmet family planning need in a subsample of 299 women found 22% had unmet need. ConclusionThe findings reveal a high proportion of misalignment between ART and family planning services across models of care. Aligning ART and family-planning guidelines and services will promote ART and contraceptive adherence and reduce the burden on clients, maintaining the benefits of differentiated models and promoting integration of multi-condition service delivery.

BackgroundLow uptake and high discontinuation rates remain major obstacles to realizing the potential of Pre-Exposure Prophylaxis (PrEP) in changing the trajectory of the HIV epidemic in sub-Saharan Africa. Evidence on how PrEP could be successfully delivered has thus far mainly focused on key target groups rather than the general adult population. Set in the HIV-hyperendemic country of Lesotho, which is currently rolling out PrEP for the general adult population, this study aimed to determine stakeholders views on which are the most important barriers and most promising interventions to achieving high PrEP uptake and continuation. Methods and findingsWe conducted a card sorting and ranking exercise with 155 local stakeholders to identify key barriers and interventions. Stakeholders were a purposive sample of PrEP policy makers and implementing partners (n=7), healthcare providers (n=51), and end-users (n=97). End-users included adults who were currently using PrEP (n=55), formerly using PrEP (n=36), and were offered PrEP by a healthcare provider but declined (n=6). Participants sorted pre-selected interventions and barriers to PrEP coverage into three piles - most, somewhat, and least important. After sorting, participants ranked interventions and barriers in the "most important" piles in ascending order of significance. Ranked preferences were analyzed as voting data to identify the smallest set of candidates for which each candidate in the set would win a two-candidate election against any candidate outside the set. Participants viewed a lack of PrEP awareness as the most important barrier to PrEP uptake for women, and a fear of HIV testing for men. Community-based HIV testing was ranked as the most promising intervention to improve PrEP uptake for both men and women. Perceived or experienced stigma was seen as an important barrier for PrEP continuation for both men and women, with an additional important barrier for men being daily activities that compete with the time or mental bandwidth needed to take a daily pill. Adherence counseling and multi-month PrEP prescriptions were seen as the most promising interventions to improve PrEP continuation. ConclusionsOur findings suggest community-based activities that generate PrEP demand (community-based HIV testing and mass media campaigns), reinforced with facility-based follow-up (counseling and multi-month prescription) could be promising interventions to improve PrEP uptake and continuation in PrEP programs that are aimed at the general adult population. The views of the wide range of stakeholders that participated in this study could provide a useful starting point for design and implementation choices of PrEP delivery programs for the general adult population.

BackgroundLong-acting injectable antiretroviral therapy offers an alternative to daily oral HIV treatment, potentially improving adherence and reducing stigma. While its adoption has been successful in some settings, evidence on its acceptability in sub-Saharan Africa, outside clinical trials, remains limited. MethodsWe conducted a mixed-methods study among people living with HIV (PLHIV) in two tertiary hospitals in Nairobi, Kenya--a public facility (Kenyatta National Hospital) and a private facility (Aga Khan University Hospital). A cross-sectional survey of 356 participants assessed awareness, willingness to switch, and predictors of acceptability. In addition, 30 participants took part in three focus group discussions (FGDs) exploring perceptions, concerns, and system-level considerations. Quantitative data were analyzed using descriptive and inferential statistics, while qualitative data were analyzed thematically. ResultsOverall, 72.2% of survey participants indicated willingness to switch to LAI-ART. Prior awareness of LAI-ART was the strongest independent predictor of acceptability (aOR 4.03, 95% CI: (1.45-11.18). Drivers of interest included reducing pill burden (77.8%), improving adherence (55.6%), and maintaining privacy (45.5%). Despite high acceptability, FGDs revealed cautious optimism, with concerns about side effects, treatment rigidity, and logistical challenges such as travel and clinic access. ConclusionThese findings suggest that while LAI-ART is seen as promising, its uptake will depend on education, trust-building, and reliable delivery systems. Successful introduction in Kenya will require patient-centered communication, system readiness, and equitable access strategies.

BackgroundSeveral clinical prediction models have been developed using electronic health records data to help inform decisions about HIV pre-exposure prophylaxis (PrEP) prescribing, but the characteristics and quality of these models have not been systematically assessed. We identified and critically appraised the characteristics and quality of studies reporting the development of electronic health records (EHR)-based models predicting HIV risk to inform decisions about PrEP prescribing. MethodsWe searched PubMed and the CINAHL databases between January 1, 2013 and June 19, 2023, with keywords related to EHR, HIV, and clinical prediction. We extracted data using the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS) checklist and assessed risk of bias using the Prediction model Risk Of Bias Assessment Tool (PROBAST) short form. We used narrative synthesis to describe characteristics and quality of eligible models. ResultsWe identified 324 studies, of which 7 studies (resulting in 7 models) were eligible for our review. Several studies inadequately reported key components of the corresponding model. Most models were developed in the United States and used machine learning methods. The area under the receiver operating characteristic curve was reported for six models, which ranged between 0.77 and 0.89. All models had high risk of bias, primarily because of low events per variable and risk of overfitting. ConclusionsWe observed inadequate reporting of key components and high risk of bias across all EHR-based models. Future studies would benefit from following standard reporting guidelines and best practices for developing prediction models, which may strengthen the validity and applicability of EHR-based prediction models for informing decisions about HIV PrEP prescribing. Trial registrationThe review protocol was registered and published in PROSPERO (CRD42023428057)

BackgroundIn many African countries the dispensing duration for antiretroviral therapy (ART) medication for HIV treatment has increased from 3 months to 6 months for stable clients. To help inform a decision about whether to move from three-month dispensing (3MMD) to six-month dispensing (6MMD) in South Africa, we surveyed healthcare providers about their perspectives on dispensing and scripting durations. MethodsWe conducted a cross-sectional survey of healthcare providers (nurses, managers, pharmacists) at 24 primary healthcare clinics in South Africa from May to September 2024, asking closed- and open-ended questions. Results are reported as frequencies. Results182 providers were enrolled from four provinces (median age 44, 88% female). Most (>70%) respondents said that the 3MMD guideline offered multiple benefits for providers and patients, compared to the previous two-month dispensing rule; most (64%) also said there were no challenges in implementing 3MMD. >80% of respondents across all cadres reported that they would be comfortable dispensing 6 months of ART at a time, believing that it would reduce facility overcrowding, lighten staff workloads, and be advantageous to clients by decreasing their visit burden and travel costs. Two thirds (63%) of participating nurses, who provide the largest share of direct ART care, were also in favour of resuming 12-month scripting for ART; the remaining 37% expressed concerns about decreases in treatment adherence and clinical monitoring of clients. ConclusionMost healthcare providers at primary healthcare clinics in South Africa are in favour of allowing six-month dispensing and 12-month prescriptions as options for established ART clients.

IntroductionHIV pre-exposure prophylaxis (PrEP) is a key component of HIV combination prevention. Effective prevention needs people to adhere to PrEP during periods of risk and remain in care. However, relevant models of care are under-researched. Using data from the first two years of Scotlands PrEP programme, we explored barriers and facilitators to PrEP adherence and retention in care and systematically developed evidence-based, theoretically-informed recommendations to enhance future adherence and retention. MethodsWe conducted semi-structured interviews and focus groups (09/2018-07/2019) with geographically and demographically diverse patients who were either using/declined/stopped or had been assessed as ineligible for PrEP (n=39), healthcare professionals involved in PrEP provision (n= 54), non-governmental organisation service users (n=9) and staff (n=15) across Scotland. We used thematic analysis to map key barriers and facilitators to priority areas that could enhance adherence and retention in care. Next, we used analytic tools from implementation science (Theoretical Domains Framework, Intervention Functions, Behaviour Change Technique Taxonomy, APEASE criteria) and expert opinion to systematically generate recommendations to enhance future PrEP adherence and retention in care. ResultsBarriers and facilitators to adherence and retention in care were diverse and multi-layered. Barriers included perceived complexity of event-based dosing, the tendency for users to stop PrEP before seeking professional support, troublesome side-effects, limited flexibility in the settings, timings, and nature of appointments for follow up, enduring PrEP-related stigma and emerging stigmas around not using PrEP. Facilitators included flexible appointment scheduling, reminders, and processes to follow up non-attenders. We generated 25 wide-ranging but specific recommendations for key stakeholders, for example, emphasising the benefits of PrEP reviews and providing appointments flexibly within individualised PrEP care; using clinic systems to remind/recall PrEP users for review; supporting PrEP conversations among sexual partners; clear guidance on event-based dosing; encouraging/commitment to good PrEP citizenship; and detailed discussion on managing side-effects and care/coping planning activities. ConclusionsPrEP adherence and retention in care is challenging for many people. Such challenges reduce the benefits of PrEP at individual and population levels. Our findings identify and provide solutions to where and how collaborative interventions across public health, clinical, and community practice could address these challenges.

BackgroundHIV testing services (HTS) aim to increase HIV status awareness and serve as the gateway to prevention, care, and treatment. Understanding clients experiences accessing facility-based HTS is important to ensure comprehensive service provision, improve linkage to care, and ultimately contribute to better health outcomes. MethodsWe surveyed a convenience sample of adults presenting for HIV testing at 42 health facilities in Malawi, South Africa, and Zambia between September 2022 and April 2023. A structured questionnaire captured data on HTS history, reasons for testing, services obtained, and offer and uptake of pre-exposure prophylaxis (PrEP) or treatment. Open-ended questions captured participants experiences qualitatively. We report participant characteristics, experiences, and services provided using proportions stratified by country and HIV test result and summarize emergent themes from qualitative responses. ResultsWe enrolled 1,142 clients who presented for facility-based HIV testing (324 from Malawi, 389 from South Africa, 429 from Zambia). Of these, 32%, 24%, and 34% tested positive for HIV in Malawi, South Africa, and Zambia, respectively. Although most participants had tested for HIV prior to the current test, this proportion varied by country and current test result but was substantially lower for positive testers (64%, 66%, and 71% for Malawi, South Africa and Zambia) than for negative testers (82%, 88%, and 86%, respectively). Over a third of those who tested positive for HIV at this test had never previously tested for HIV. Among participants who tested positive, ill health was most frequently reported as the reason for testing; negative testers most often reported testing voluntarily (for their own information). Most participants reported being tested by lay counselors and receiving counseling before and after testing. Most participants who tested positive reported receiving ART initiation services, but fewer than a third in Malawi and South Africa and 39% in Zambia said they received adherence counselling. The proportion of those testing negative who were offered PrEP varied across the three countries, ranging from 27% of females in Malawi to 53% of females in Zambia. Participants in all three countries reported high satisfaction with the HTS services received and many qualitatively described high quality counseling, feelings of encouragement, and kind, warm treatment by providers. ConclusionWhile HIV testing clients in Malawi, South Africa, and Zambia were generally satisfied with their testing experiences, we identified opportunities for improvement in HTS services. ART adherence counseling was not universally provided, and prevention services were not offered to most negative testers. Of concern are the large proportion of positive testers who had never been tested before and self-reported testing because of ill health, which may indicate late presentation for testing. Emphasis on comprehensive linkage to services should be prioritized for all clients presenting for HIV testing. Statements and DeclarationsWe have no financial or non-financial competing interests to disclose.

Real-time, urine tenofovir testing may allow for clinic-based monitoring of adherence to antiretroviral therapy (ART). We aimed to assess (1) the acceptability of monthly point-of-care urine tenofovir testing over the first five months following ART initiation and (2) perspectives on the implementation of point-of-care urine tenofovir testing among people living with HIV (PLWH) and healthcare providers participating in a randomized controlled trial which used the urine test in South Africa. We conducted in-depth interviews with 20 PLWH six-months post-ART initiation and with eight healthcare providers. We assessed the acceptability (using constructs from the Theoretical Framework of Acceptability), appropriateness, feasibility, and willingness to use the point-of-care urine tenofovir test, as well as participants preferred form of adherence monitoring and perspectives on differentiated implementation strategies. Participants found monthly point-of-care tenofovir testing highly acceptable, preferrable to self-reported adherence measures, appropriate for this population, and potentially feasible to integrate with standard-of-care ART monitoring. Participants overall acceptability of routine urine tenofovir testing was shaped by experiences and perceptions that shaped their overall acceptability. Routine urine tenofovir testing was well-liked, perceived to be low-burden with few opportunity costs, and perceived to have several positive effects. These included encouraging consistent ART adherence, strong client-provider relationship and communications, and accurate self-reporting of adherence. Participants desire to impress and build trust with their provider motivated them to take their ART daily to achieve a positive adherence test result at each clinic visit. Overall, point-of-care urine tenofovir testing may be an acceptable and beneficial tool for motivating optimal adherence, improving ART adherence monitoring, and strengthening client-provider relations.