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: Introduction: Differentiated service delivery (DSD) models aim to increase the responsiveness of HIV treatment programmes to the individual needs of antiretroviral therapy (ART) clients to improve treatment outcomes and quality of life. Little is known about how DSD client experiences differ from conventional care. Methods: From May to November 2021, we interviewed adult (≥18) ART clients at 21 primary clinics in four districts of South Africa. Participants were enrolled consecutively at routine visits and stratified into four groups: conventional care‐not eligible for DSD (conventional‐not‐eligible); conventional care eligible for but not enrolled in DSD (conventional‐not‐enrolled); facility pickup point DSD model; and external pickup point DSD model. Satisfaction was assessed using questions with 5‐point Likert‐scale responses. Mean scores were categorized as not satisfied (score ≤3) or satisfied (>3). We used logistic regression to assess differences and report crude and adjusted odds ratios (aORs). Qualitative themes were identified through content analysis. Results: Eight hundred and sixty‐seven participants (70% female, median age 39) were surveyed: 24% facility pick‐up points; 27% external pick‐up points; 25% conventional‐not‐eligible; and 24% conventional‐not‐enrolled. Seventy‐four percent of all study participants expressed satisfaction with their HIV care. Those enrolled in DSD models were more likely to be satisfied, with an aOR of 6.24 (95% CI [3.18–12.24]) for external pick‐up point versus conventional‐not‐eligible and an aOR of 3.30 (1.95–5.58) for facility pick‐up point versus conventional‐not‐eligible. Conventional‐not‐enrolled clients were slightly but not significantly more satisfied than conventional‐not‐eligible clients (1.29, 0.85–1.96). Those seeking outside healthcare (crude OR 0.57, 0.41–0.81) or reporting more annual clinic visits (0.52, 0.29–0.93) were less likely to be satisfied. Conventional care participants reporting satisfaction with their current model of care perceived providers as helpful, respectful, and friendly and were satisfied with care despite long queues. DSD model participants emphasized ease and convenience, particularly not having to queue. Conclusions: Most adult ART clients in South Africa were satisfied with their care, but those enrolled in DSD models expressed slightly greater satisfaction than those remaining in conventional care. Efforts should focus on enrolling more eligible patients into DSD models, expanding eligibility criteria to cover a wider client base, and further improving the models’ desirable characteristics., INTRODUCTION Like many countries in sub‐Saharan Africa and globally [1–4], South Africa has scaled up differentiated service delivery models (DSD) to improve HIV treatment coverage and outcomes, make treatment programmes [...]

: Introduction: Lack of viral suppression (VS) among pregnant and breastfeeding women living with HIV poses challenges for maternal and infant health, and viral load (VL) monitoring via centralized laboratory systems faces many barriers. We aimed to determine the impact of point‐of‐care (POC) VL and targeted drug resistance mutation (DRM) testing in improving VS among pregnant and postpartum women on antiretroviral therapy. Methods: We conducted a pre/post‐intervention prospective cohort study among 820 pregnant women accessing HIV care at five public‐sector facilities in western Kenya from 2019 to 2022. The pre‐intervention or “control” group consisted of standard‐of‐care (SOC) centralized VL testing every 6 months and the post‐intervention or “intervention” group consisted of a combined strategy of POC VL every 3 months, targeted DRM testing, and clinical management support. The primary outcome was VS (VL ≤1000 copies/ml) at 6 months postpartum; secondary outcomes included uptake and turnaround times for VL testing and sustained VS. Results: At 6 months postpartum, 321/328 (98%) of participants in the intervention group and 339/347 (98%) in the control group achieved VS (aRR 1.00, 95% confidence interval [CI] 0.98, 1.02). When assessing VS using a threshold of 1000 copies/ml) who underwent successful DRM testing in the intervention group, all (46/46, 100%) had some DRMs and 20 (43%) had major DRMs (of which 80% were nucleos(t)ide reverse transcriptase inhibitor mutations). POC VL testing uptake was high (>89%) throughout pregnancy, delivery, and postpartum periods, with a median turnaround time of 1 day (IQR 1, 4) for POC VL in the intervention group and 7 days (IQR 5, 9) for SOC VL in the control group. Sustained VS throughout follow‐up was similar between groups with either POC or SOC VL testing (90−91% for Conclusions: Our combined strategy markedly decreased turnaround time but did not increase VS rates, which were already very high, or sustained VS among pregnant and postpartum women living with HIV. Further research on how best to utilize POC VL and DRM testing is needed to optimize sustained VS among this population., INTRODUCTION Globally, an estimated 1.3 million pregnant women were living with HIV in 2021 [1]. Given the widespread scale‐up of universal antiretroviral therapy (ART) initiation for all individuals, an estimated [...]

One and a half million children (0–14 years) were estimated to be living with HIV globally in 2022 by the Joint United Nations Programme on HIV/AIDS (UNAIDS), with 89% of [...]

: Introduction: The number of children exposed to HIV and possibly to antiretroviral therapy (ART) in utero and during breastfeeding and are uninfected (HEU) globally will continue to increase from the estimated 15.9 million in 2021. Discussion: There are still significant gaps in our understanding of the impact of HIV and/or ART exposure in children who are HEU, in terms of prevalence/incidence and severity on health and wellbeing, and long after exposure has ended. While there have been substantial programmatic efforts to support the elimination of vertical transmission of HIV, additional rigorous research is needed to better understand the biological, (psycho)social and structural factors contributing to optimal health for populations who are HEU. Furthermore, the best approaches to address and study the gaps in understanding also need to be explored. Given the scope of the problem including the large numbers of affected people as well as the often limited and competing in‐country resources for populations affected by HIV, novel methodologies, including multi‐level approaches and advanced analytics, need to be considered. Conclusions: A growing population of children who are HEU are maturing into adolescence and young adulthood. Research to advance understanding of the possible negative long‐term effects of HIV and/or ART exposure in these youth is supported by the US National Institutes of Health. Both large epidemiological studies and smaller more comprehensive cohort studies may be required to address the complexity of the issue. Integrating both types of studies could allow the establishment of more reliable and validated predictions of which youth who are HEU are at the highest risk for specific negative health outcomes, such as mental health and neurocognitive disorders, and which interventional approaches may be most successful to address specific deficits both in terms of prevention and treatment. Finally, these goals can be more rapidly achieved with data science efforts, data harmonisation between studies and with sustainable data‐sharing practices. It is important to expand the commitment to research to identify biological, social and structural drivers, to develop screening tools, and impactful and contextually appropriate interventions to address the health and wellbeing of children who are HEU from birth through adulthood., INTRODUCTION The number of children exposed to HIV and possibly to antiretroviral therapy (ART) in utero and during breastfeeding who are uninfected (HEU) will continue to increase from the estimated [...]

: Introduction: The PROMISE study, launched in 2018, evaluates the implementation of revisions to the HIV Care Coordination Program (CCP) designed to minimize persistent disparities in HIV outcomes among high‐need persons living with HIV in New York City. We conducted a discrete choice experiment (DCE) assessing the preferences of CCP clients to inform improvements to the program's design. Methods: Clients chose between two hypothetical CCP options that varied across four program attributes: help with antiretroviral therapy (ART) adherence (directly observed therapy [DOT] vs. remind via phone/text vs. adherence assessment), help with primary care appointments (remind and accompany vs. remind and transport vs. remind only), help with issues other than primary care (coverage and benefits vs. housing and food vs. mental health vs. specialty medical care) and visit location (meet at home vs. via phone/video vs. program visit 30 or 60 minutes away). The latent class analysis identified different preference patterns. A choice simulation was performed to model client preferences for hypothetical CCPs as a whole. Results: One hundred and eighty‐one CCP clients from six sites implementing the revised CCP completed the DCE January 2020–March 2021. Most clients had stable housing (68.5%), reported no problem substance use in the last 3 months (72.4%) and achieved viral suppression (78.5) with only 26.5% receiving DOT within a CCP. 77.3% of responses were obtained before the COVID‐19 pandemic. Preferences clustered into three groups. Visit location and ART adherence support were the most important attributes. Group 1 (40%) endorsed telehealth for visit location; telehealth for ART adherence support; and help with securing housing/food; Group 2 (37%) endorsed telehealth for visit location; telehealth for ART adherence support; and staff reminding/arranging appointment transportation; Group 3 (23%) endorsed staff meeting clients at program location and staff working with clients for medication adherence. In the choice simulation, Basic and Medium hypothetical CCPs were endorsed more than Intensive CCPs. Conclusions: This DCE revealed a strong preference for telehealth and a relatively low preference for intensive services, such as DOT and home visits; preferences were heterogeneous. The findings support differentiated care and remote service delivery options in the NYC CCP, and can inform improvements to CCP design., INTRODUCTION Persistent inequities across the HIV care continuum threaten the United States’ progress towards ending the HIV epidemic [1]. In New York City, rates of viral load suppression (VS) are [...]

: Introduction: Non‐communicable diseases (NCDs) are highly prevalent in people living with HIV above 50 years of age and account for increasing mortality. There is little published evidence supporting person‐centred, integrated models of HIV care, hypertension and diabetes treatment in southern Africa, and no data demonstrating mortality reduction. Where clinical visits for NCDs and HIV cannot be combined, integrated medication delivery presents an opportunity to streamline care and reduce patient costs. We present experiences of integrated HIV and NCD medication delivery in Eswatini and South Africa, focusing on programme successes and implementation challenges. Programmatic data from Eswatini's Community Health Commodities Distribution (CHCD) from April 2020 to December 2021 and South Africa's Central Chronic Medicines Dispensing and Distribution (CCMDD) from January 2016 to December 2021 were provided by programme managers and are summarized here. Discussion: Launched in 2020, Eswatini's CHCD provides over 28,000 people with and without HIV with integrated services, including HIV testing, CD4 cell count testing, antiretroviral therapy refills, viral load monitoring and pre‐exposure prophylaxis alongside NCD services, including blood pressure and glucose monitoring and hypertension and diabetes medication refills. Communities designate neighbourhood care points and central gathering places for person‐centred medication dispensing. This programme reported fewer missed medication refill appointments among clients in community settings compared to facility‐based settings. South Africa's CCMDD utilizes decentralized drug distribution to provide medications for over 2.9 million people, including those living with HIV, hypertension and diabetes. CCMDD incorporates community‐based pickup points, facility “fast lanes” and adherence clubs with public sector health facilities and private sector medication collection units. There are no out‐of‐pocket payments for medications or testing commodities. Wait‐times for medication refills are lower at CCMDD sites than facility‐based sites. Innovations to reduce stigma include uniformly labelled medication packages for NCD and HIV medications. Conclusions: Eswatini and South Africa demonstrate person‐centred models for HIV and NCD integration through decentralized drug distribution. This approach adapts medication delivery to serve individual needs and decongest centralized health facilities while efficiently delivering NCD care. To bolster programme uptake, additional reporting of integrated decentralized drug distribution models should include HIV and NCD outcomes and mortality trends., INTRODUCTION In low‐ and middle‐income countries, 15% of people living with HIV are aged 50 years and older [1]. Non‐communicable diseases (NCDs) have increased in prevalence among older people living [...]

: Introduction: Emerging long‐acting (LA) prevention and treatment medicines, technologies and regimens could be game‐changing for the HIV response, helping reach the ambitious goal of halting the epidemic by 2030. To attain this goal, the rapid expansion of at‐scale, sustainable, quality‐assured, and affordable supplies of LA HIV prevention and treatment products through accelerated and stronger competition, involving both originator and generic companies, will be essential. To do this, global health stakeholders should take advantage of voluntary licensing of intellectual property (IP) rights, such as through the United Nations‐backed, not‐for‐profit Medicines Patent Pool, as a proven mechanism to support broad access to existing HIV medicines across low‐ and middle‐income countries (LMICs). Discussion: While voluntary licensing may unlock the possibility for generic competition to take place ahead of patent expiry, there are additional elements—of amplified importance for more complex LA HIV medicines—that need to be taken into consideration. This paper discusses 10 enablers of voluntary licensing of IP rights as a model to rapidly expand at‐scale, sustainable, quality‐assured, and affordable supplies of LA HIV prevention and treatment regimens in LMICs: 1. Identifying promising LA technology platforms and drug formulations at an early developmental stage and engaging with patent holders 2. Consolidating a multidisciplinary network and strengthening early‐stage coordination and collaboration to foster innovation 3. Embedding public health considerations in product design and delivery 4. Building innovative partnerships for product development and commercialization 5. Raising awareness of and creating demand for emerging LA products 6. Estimating the market size, ensuring sufficient competition and protecting sustainability 7. Using technology transfer and hands‐on technical support to reduce product development timelines and costs 8. Exploring de‐risking mechanisms and financial incentives to support generic manufacturers 9. Optimizing strategies for generic product development and regulatory filings 10. Aligning and coordinating efforts of stakeholders across the value chain. Conclusions: Rapid access to emerging LA prevention and treatment regimens and technologies can be facilitated by voluntary licensing—catalyzed and supplemented by enabling collaborative and non‐duplicative efforts of various other stakeholders. This can effectively lead to improved—accelerated and cheaper—access to quality‐assured medicines for populations in LMICs., INTRODUCTION Emerging long‐acting (LA) prevention and treatment medicines, technologies and regimens could be game‐changing for the HIV response [1–6]. The rapid expansion of at‐scale, sustainable, quality‐assured, and affordable supplies of [...]

: Introduction: Recent advances in long‐acting antiretroviral therapy (LA‐ART) could provide new options for HIV treatment and reduce adherence barriers, if regimens are acceptable to patients. We elicited preferences for key attributes of potential LA‐ART regimens among people with HIV (PWH) in the United States, focusing on four treatment modes (oral tablets, subcutaneous injections, intramuscular injections, and implants), product characteristics and location of administration. Methods: A discrete choice experiment was conducted among PWH aged ≥18 years recruited from HIV clinics in Washington State and Atlanta, Georgia from March 2021 to June 2022. Participants responded to 17 choice scenarios, each with three options: two systematically generated hypothetical LA‐ART regimens and a constant opt‐out (their current daily oral treatment). LA‐ART regimen descriptions included treatment mode, pain, dosing frequency, location, pre‐treatment time with undetectable viral load, pre‐treatment negative reaction testing and “late‐dose leeway” (i.e. flexibility or forgiveness in timing the next dose). We used conditional logistic regression, with an interaction between treatment mode and pain, to estimate preference weights for all attribute levels. Results: Seven hundred participants (350 at each site) enrolled, with median age 51 years (range 18–73); 70% identified as cisgender male, 24% as cisgender female and 6% as non‐binary or transgender. LA oral tablets were the only mode preferred over current daily oral treatment, with annual implants and injections the next most preferred LA‐ART option. Longer time between doses was preferred, and administration at home was preferred to clinics, which were preferred to pharmacies. Attributes with less impact on preferences included oral lead‐in treatment to achieve viral suppression or test for negative reactions and late‐dose leeway around the prescribed dosing interval. Participants in Atlanta were more likely to prefer their current daily oral ART than participants from Seattle. Conclusions: PWH in the United States may soon have several options for LA‐ART. Our results suggest that LA oral tablets will be preferred by many patients over their current daily oral treatment, while implants and injections with longer duration may be acceptable to some. Future research should investigate sources of preference heterogeneity and actual uptake of and adherence to LA‐ART products, when available., INTRODUCTION In 2020, the Centers for Disease Control and Prevention estimated that for every 100 people who were diagnosed with HIV, only 74 had received HIV care and 65 were [...]

Person‐centred care is a critical attribute of high‐quality healthcare, promoting quality of life, improving an individual's interaction with the health system and valuing people's social networks [1]. Lifesaving antiretroviral therapy [...]

: Introduction: Long‐acting and extended delivery (LAED) regimens for HIV treatment and prevention offer unique benefits to expand uptake, effective use and adherence. To date, research has focused on basic and clinical science around the safety and efficacy of these products. This commentary outlines opportunities in HIV prevention and treatment programmes, both for the health system and clients, that could be addressed through the inclusion of LAED regimens and the vital role of differentiated service delivery (DSD) in ensuring efficient and equitable access. Discussion: The realities and challenges within HIV treatment and prevention programmes are different. Globally, more than 28 million people are accessing HIV treatment—the vast majority on a daily fixed‐dose combination oral pill that is largely available, affordable and well‐tolerated. Many people collect extended refills outside of health facilities with clinical consultations once or twice a year. Conversely, uptake of daily oral pre‐exposure prophylaxis (PrEP) has consistently missed global targets due to limited access with high individual cost and lack of choice contributing to substantial unmet PrEP need. Recent trends in demedicalization, simplification, additional method options and DSD for PrEP have led to accelerated uptake as its availability has become more aligned with user preferences. How people currently receive HIV treatment and prevention services and their barriers to adherence must be considered for the introduction of LAED regimens to achieve the expected improvements in access and outcomes. Important considerations include the building blocks of DSD: who (provider), where (location), when (frequency) and what (package of services). Ideally, all LAED regimens will leverage DSD models that emphasize access at the community level and self‐management. For treatment, LAED regimens may address challenges with adherence but their delivery should provide clear advantages over existing oral products to be scaled. For prevention, LAED regimens expand a potential PrEP user's choice of methods, but like other methods, need to be delivered in a manner that can facilitate frequent re‐initiation. Conclusions: To ensure that innovative LAED HIV treatment and prevention products reach those who most stand to benefit, service delivery and client considerations during development, trial and early implementation are critical., INTRODUCTION Successes in the HIV response can be attributed to parallel innovations both in the development of antiretroviral drugs for treatment and prevention, the “what,” as well as in the [...]

: Introduction: Engaging communities in the design, implementation and monitoring of health services is critical for delivering high‐quality, person‐centred services that keep people living with HIV engaged in care. The USAID‐funded Integrated HIV/AIDS Project in Haut‐Katanga (IHAP‐HK) integrated an electronic client feedback tool into continuous quality improvement (CQI) processes. We aimed to demonstrate this system's impact on identifying and improving critical quality‐of‐care gaps. Methods: Through stakeholder and empathy mapping, IHAP‐HK co‐designed a service quality monitoring system—comprising anonymous exit interviews and ongoing monitoring through CQI cycles—with people living with HIV, facility‐based providers and other community stakeholders. IHAP‐HK trained 30 peer educators to administer oral, 10‐ to 15‐minute exit interviews with people living with HIV following clinic appointments, and record responses via the KoboToolbox application. IHAP‐HK shared client feedback with facility CQI teams and peer educators; identified quality‐of‐care gaps; discussed remediation steps for inclusion in facility‐level improvement plans; and monitored implementation of identified actions. IHAP‐HK tested this system at eight high‐volume facilities in Haut‐Katanga province from May 2021 through September 2022. Results: Findings from 4917 interviews highlighted wait time, stigma, service confidentiality and viral load (VL) turnaround time as key issues. Solutions implemented included: (1) using peer educators to conduct preparatory tasks (pre‐packaging and distributing refills; pulling client files) or escort clients to consultation rooms; (2) limiting personnel in consultation rooms during client appointments; (3) improving facility access cards; and (4) informing clients of VL results via telephone or home visits. Due to these actions, between initial (May 2021) and final interviews (September 2022), client satisfaction with wait times improved (76% to 100% reporting excellent or acceptable wait times); reported cases of stigma decreased (5% to 0%); service confidentiality improved (71% to 99%); and VL turnaround time decreased (45% to 2% informed of VL results 3 months after sample collection). Conclusions: Our results showed the feasibility and effectiveness of using an electronic client feedback tool embedded in CQI processes to collect client perspectives to improve service quality and advance client‐responsive care in the Democratic Republic of Congo. IHAP‐HK recommends further testing and expansion of this system to advance person‐centred health services., INTRODUCTION Comprehensive community engagement is critical for delivering high‐quality, person‐centred care (PCC) that supports the continued engagement of people living with HIV in care and facilitates better health outcomes. PCC [...]

Introduction: : Tuberculosis (TB) remains the most common cause of death among people living with HIV Integrating HIV and TB services reduces mortality but is sub-optimally implemented. Quality improvement (QI) methods offer a low-cost and easily implementable approach to strengthening healthcare delivery systems. This trial assessed a QI intervention on key process indicators for delivering integrated HIV-TB care in rural South African primary healthcare (PHC) clinics. Methods: Sixteen nurse supervisors, (each with a cluster of clinics) overseeing 40 PHC clinics, were randomized 1:1 to the intervention or the standard of care (SOC) groups. The QI intervention comprised three key components: clinical and QI skills training, on-site mentorship of nurse supervisors and clinic staff, and data quality improvement activities to enhance accuracy and completeness of routine clinic data. The SOC comprised monthly supervision and data feedback meetings. From 01 December 2016 to 31 December 2018, data were collected monthly by a team of study-appointed data capturers from all study clinics. This study's outcomes were HIV testing services (HTS), TB screening, antiretroviral therapy (ART) initiation, isoniazid preventive therapy (IPT) initiation and viral load (VL) testing. Results: The QI group (eight clusters) comprised 244 clinic staff who attended to 13,347 patients during the trial compared to the SOC group (eight clusters) with 217 clinic staff who attended to 8141 patients. QI mentors completed 85% (510/600) of expected QI mentorship visits to QI clinics. HTS was 19% higher [94.5% vs. 79.6%; relative risk (RR)=1.19; 95% CI: 1.02-1.38; p=0.029] and IPT initiation was 66% higher (61.2 vs. 36.8; RR=1.66; 95% CI: 1.02-2.72; p=0.044), in the QI group compared to SOC group. The percentage of patients screened for TB (83.4% vs. 79.3%; RR=1.05; p=0.448), initiated on ART (91.7 vs. 95.5; RR=0.96; p=0.172) and VL testing (72.2% vs. 72.8%; RR=0.99; p=0.879) was similar in both groups. Conclusions: QI improved HIV testing and IPT initiation compared to SOC. TB screening, ART initiation and VL testing remained similar. Incorporating QI methods into routine supervision and support activities may strengthen integrated HIV-TB service delivery and increase the success of future QI scale-up activities. Keywords: cluster-randomized; collaboratives; HIV-TB services; integration; primary healthcare clinics; quality improvement, 1 | INTRODUCTION In South Africa (SA), the convergence of the HIV and tuberculosis (TB) epidemics created one of the largest HIV-TB co-epidemics in the world [1]. In 2016, an [...]

Introduction: In response to COVID-19, nationalministries of health adapted HIV service delivery guidelines to ensure uninterrupted access to antiretroviraltherapy (ART) and limit the frequency of contact with health facilities. In this commentary, we summarize four ways in which differentiated service delivery (DSD) for HIV treatment has been accelerated during COVID-19 in policy and implementation in sub-Saharan Africa (SSA)-(i) expanding eligibility for DSD for HIV treatment, (ii) extending multi-month dispensing (MMD) and reducing the frequency of clinicalconsultations, (iii) emphasizing community-based models and (iv) integrating/aligning with TB preventative therapy (TPT), non-communicable disease (NCD) treatments and family planning commodities. Discussion: Across SSA in 2020, countries both adapted and emphasized policies supporting DSD for HIV treatment in response to COVID-19. Access to DSD for HIV treatment was expanded by reducing the time required on ART before eligibility and being more inclusive of specific populations including children and adolescents, pregnant and breastfeeding women and those on second-and third-line regimens. Access to extended ART refills, or MMD, was accelerated across many countries. A renewed focus was given to out-of-facility community-based models of ART distribution. In some settings, there was acknowledgement of the need to integrate or align other chronic medications with ART. Conclusions: Adaptations to DSD for HIV treatment in response to COVID-19 have resulted in rapid policy change and in some cases, acceleration of implementation in SSA. As the COVID-19 pandemic evolves, there is a critical need to assess the impact of these adaptations and, where beneficial, ensure that policies implemented in response to COVID-19 become the new normal. Keywords: HIV; ART; differentiated service delivery; COVID-19; multi-month dispensing; community-based services, 1 INTRODUCTION On World AIDS Day 2020, UNAIDS announced that none of the global HIV targets-90% of people living with HIV know their status, 90% of those are receiving antiretroviraltherapy [...]

TABLE OF CONTENTS I. INTRODUCTION 460 IT. BACKGROUND 463 A. International Human Rights Develops into Bioethics of Genetic Modifications 463 B. The Severity of HIV and Sickle Cell Disease in [...], Recent genetic studies indicate that CRISPR-Cas9, a biological gene-editing mechanism derived from bacteria, may be capable of curing HIV and Sickle Cell Disease. Clinical research for HIV and SCD is prevalent in African nations because of the high incidence of those diseases in all forms. Because past research studies in Africa demonstrate how Western companies can abuse lax ethics regulations in developing African nations, ethics systems must prevent this new, potentially far-reaching CRISPR technology from being prematurely and unethically used on African research participants. In updating current international bioethics frameworks, drafters should pay particular attention to its application in African nations. International bioethics agreements cannot fully protect African research participants, however, until developing countries accord those agreements the power of law. African nations should accelerate the development of unitary systems of ethics laws and education programs unique to the cultural underpinnings of each nation. Only with both the reappraisal of international frameworks to better incorporate traditional African ideals and the development of coherent regional bioethics systems will African research participants be adequately protected.

: Introduction: Data‐to‐care programmes utilize surveillance data to identify persons who are out of HIV care, re‐engage them in care and improve HIV care outcomes. We assess the costs and cost‐effectiveness of re‐engagement in an HIV care intervention in the United States. Methods: The Cooperative Re‐engagement Control Trial (CoRECT) employed a data‐to‐care collaborative model between health departments and HIV care providers, August 2016–July 2018. The health departments in Connecticut (CT), Massachusetts (MA) and Philadelphia (PHL) collaborated with HIV clinics to identify newly out‐of‐care patients and randomize them to receive usual linkage and engagement in care services (standard‐of‐care control arm) or health department‐initiated active re‐engagement services (intervention arm). We used a microcosting approach to identify the activities and resources involved in the CoRECT intervention, separate from the standard‐of‐care, and quantified the costs. The cost data were collected at the start‐up and recurrent phases of the trial to incorporate potential variation in the intervention costs. The costs were estimated from the healthcare provider perspective. Results: The CoRECT trial in CT, MA and PHL randomly assigned on average 327, 316 and 305 participants per year either to the intervention arm (n = 166, 159 and 155) or the standard‐of‐care arm (n = 161, 157 and 150), respectively. Of those randomized, the number of participants re‐engaged in care within 90 days in the intervention and standard‐of‐care arms was 85 and 70 in CT, 84 and 70 in MA, and 98 and 67 in PHL. The additional number of participants re‐engaged in care in the intervention arm compared with those in the standard‐of‐care arm was 15 (CT), 14 (MA) and 31 (PHL). We estimated the annual total cost of the CoRECT intervention at $490,040 in CT, $473,297 in MA and $439,237 in PHL. The average cost per participant enrolled was $2952, $2977 and $2834 and the average cost per participant re‐engaged in care was $5765, $5634 and $4482. We estimated an incremental cost per participant re‐engaged in care at $32,669 (CT), $33,807 (MA) and $14,169 (PHL). Conclusions: The costs of the CoRECT intervention that identified newly out‐of‐care patients and re‐engaged them in HIV care are comparable with other similar interventions, suggesting a potential for its cost‐effectiveness in the US context., INTRODUCTION There are an estimated 1.2 million people with HIV (PWH) in the United States. The clinical practice guidelines for HIV recommend initiating antiretroviral therapy for everyone at diagnosis [1]. [...]

: Introduction: Transgender people in South Africa are disproportionately affected by HIV, discrimination and stigma. Access to healthcare and health outcomes are poor. Although integrating gender‐affirming healthcare with differentiated HIV prevention, care and treatment services has shown improvement in HIV service uptake and health outcomes among transgender people, evidence is lacking on the implementation of differentiated service delivery models in southern Africa. This article describes a differentiated service delivery model across four South African sites and transgender individuals who access these services. We assess whether hormone therapy (HT) is associated with continued use of pre‐exposure prophylaxis (PrEP) and viral load suppression. Methods: In 2019, differentiated healthcare centres for transgender individuals opened in four South African districts, providing gender‐affirming healthcare and HIV services at a primary healthcare level. Routine programme data were collected between October 2019 and June 2021. Descriptive statistics summarized patient characteristics and engagement with HIV prevention and treatment services. We conducted a multivariate logistic regression analysis to determine whether HT was associated with viral load suppression and PrEP continued use. Results: In the review period, we reached 5636 transgender individuals through peer outreach services; 86% (4829/5636) of them accepted an HIV test and 62% (3535/5636) were linked to clinical services. Among these, 89% (3130/3535) were transgender women, 5% (192/3535) were transgender men and 6% (213/3535) were gender non‐conforming individuals. Of those who received an HIV test, 14% (687/4829) tested positive and 91% of those initiated antiretroviral treatment. Viral load suppression was 75% in this cohort. PrEP was accepted by 28% (1165/4142) of those who tested negative. Five percent (161/3535) reported ever receiving HT through the public healthcare system. Service users who received HT were three‐fold more likely to achieve viral load suppression. We did not find any association between HT and continued use of PrEP. Conclusions: A differentiated HIV and gender‐affirming service delivery model at a primary healthcare level is feasible and can enhance service access in South Africa. HT can improve HIV clinical outcomes for transgender people. As trust is established between the providers and population, uptake of HIV testing and related services may increase further., INTRODUCTION South Africa bears 19% of the global HIV burden, with over 7.7 million people living with HIV [1]. The risk for HIV varies considerably between population groups, and globally [...]

: Introduction: The population of people living with HIV (PLWH) is ageing consequent to effective treatment and a steady stream of new diagnoses among older adults. PLWH experience a greater burden of age‐related comorbidities and poorer social determinants of health compared to their HIV‐negative peers, yet comprehensive requisites for care and support as PLWH age remain poorly understood. Preferences And Needs for Ageing Care among HIV‐positive Elderly people in Ontario, Canada (PANACHE ON), explored the health and community care and social support needs and preferences of a diverse group of older PLWH (age 60+) and described life course experiences among older PLWH that shape these needs and preferences and whether they are met. Methods: PANACHE ON was a qualitative community‐based participatory research study. In‐person focus groups using a semi‐structured interview guide were co‐facilitated by pairs of trained older PLWH from July to October 2019. Purposive sampling bolstered the inclusion of communities disproportionately affected by HIV in Ontario. Descriptive analysis was used to summarize demographic data; participatory data analysis was conducted by a subset of the research team, with transcripts double‐coded and analysed using NVIVO 12 Plus. Results: A total of 73 PLWH participated, 66% identified as men. The mean age was 64 years (range 55–77) and median time living with HIV was 23 years (range 2–37). The current and anticipated needs of older PLWH, many of which were only partially met, included necessities such as food and housing, mobility and sensory aids, in‐home support, social and emotional support, transportation and information. Three experiences—trauma, stigma and uncertainty—intersected in the lives of many of our participants, shaping their needs for care and support, and impacting the ease with which these needs were met. Conclusions: Unmet health and social needs and limited control over the availability and accessibility of ageing‐related care and support due to resource constraints or reduced capacity for self‐advocacy results in anxiety about the future among older PLWH, despite their well‐developed coping strategies and experience navigating systems of care. These study findings will inform the development of the first national needs assessment of older PLWH in Canada., INTRODUCTION The number of people living with HIV aged 50 or older (PLWH50+) worldwide was projected to reach 7.5 million in 2020 [1], and in sub‐Saharan Africa alone, will surpass [...]