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Introduction: Antiretroviral therapy (ART) and tuberculosis preventive treatment (TPT) both prevent tuberculosis (TB) disease and deaths among people living with HIV. Differentiated care models, including community‐based care, can increase the uptake of ART and TPT to prevent TB in settings with a high burden of HIV‐associated TB, particularly among men. Methods: We developed a gender‐stratified dynamic model of TB and HIV transmission and disease progression among 100,000 adults ages 15−59 in KwaZulu‐Natal, South Africa. We drew model parameters from a community‐based ART initiation and resupply trial in sub‐Saharan Africa (Delivery Optimization for Antiretroviral Therapy, DO ART) and other scientific literature. We simulated the impacts of community‐based ART and TPT care programmes during 2018−2027, assuming that community‐based ART and TPT care were scaled up to similar levels as in the DO ART trial (i.e. ART coverage increasing from 49% to 82% among men and from 69% to 83% among women) and sustained for 10 years. We projected the number of TB cases, deaths and disability‐adjusted life years (DALYs) averted relative to standard, clinic‐based care. We calculated programme costs and incremental cost‐effectiveness ratios from the provider perspective. Results: If community‐based ART care could be implemented with similar effectiveness to the DO ART trial, increased ART coverage could reduce TB incidence by 27.0% (range 21.3%−34.1%) and TB mortality by 34.6% (range 24.8%–42.2%) after 10 years. Increasing both ART and TPT uptake through community‐based ART with TPT care could reduce TB incidence by 29.7% (range 23.9%−36.0%) and TB mortality by 36.0% (range 26.9%−43.8%). Community‐based ART with TPT care reduced gender disparities in TB mortality rates, with a projected 54 more deaths annually among men than women (range 11–103) after 10 years of community‐based care versus 109 (range 41–182) in standard care. Over 10 years, the mean cost per DALY averted by community‐based ART with TPT care was $846 USD (range $709–$1012). Conclusions: By substantially increasing coverage of ART and TPT, community‐based care for people living with HIV could reduce TB incidence and mortality in settings with high burdens of HIV‐associated TB and reduce TB gender disparities. [ABSTRACT FROM AUTHOR]

Background: Couple-based interventions (CBIs), despite strong efficacy in improving numerous HIV risk behaviors, are not widely available and have not been tested to improve women's antiretroviral therapy (ART) adherence. We examined barriers and facilitators to participation in a CBI based on cognitive behavioral couple therapy for women's ART adherence in KwaZulu-Natal, South Africa. Methods: Semi-structured interviews were conducted with women with HIV (n = 15) and men of mixed HIV status (n = 15). Thematic analyses were guided by the Consolidated Framework for Implementation Research. Results: Facilitators mostly related to the couple's relationship, including having an existing healthy relationship, men's desire to support their partners, and a potential opportunity for men's HIV disclosure. Barriers included a lack of understanding of how a CBI approach would be useful for women's ART adherence, sole focus on women if male partners were also living with HIV, and men's lack of prior HIV status disclosure to female partners. Conclusion: Findings indicate that relationship context and the male partner's HIV status need to be addressed during recruitment, enrolment, and during the intervention to promote uptake. [ABSTRACT FROM AUTHOR]

Introduction: Significant progress has been made in the HIV response in South Africa; however, gaps remain in ensuring engagement in care to support life-long medication adherence and viral suppression. The National Department of Health (NDoH) has introduced community-based and clinic-based HIV differentiated service delivery (DSD) models to tackle suboptimal adherence and retention in care. Nevertheless, differentiated care models require adaptation to better serve clients who struggle with adherence. There is limited research on the acceptability of fee for home delivery of ART in resource-constrained settings. The current study investigates the acceptability of fee for home delivery of ART among people living with HIV in South Africa. Methods: Two mixed-gender focus group discussions (FGDs) took place between June and November 2019, consisting of 10 participants in each group. A purposive sampling strategy was employed to identify and select 10 people living with HIV who were ART-eligible but not in care, and 10 people living with HIV who were currently taking ART and in care. Participants were grouped according to their treatment status. A coding framework, informed by a priori categories and derived from topics in the interview guide, was developed and utilized to facilitate analysis. Results: Participants expressed enthusiasm for having ART home-delivered, as it would save the time spent waiting in long queues at the clinic. However, some participants raised concerns about potential payment difficulties due to high unemployment rates in the community. Some participants believed this would be acceptable, as patients already incur costs for travel and food when visiting the clinic. Participants in both FGDs expressed strong concerns about home delivery of their ART based on fear of accidental disclosure, especially for those who have not disclosed to their immediate families and partners. Conclusion: Our study suggests that charging a fee for home delivery is an acceptable and innovative approach to supporting PLHIV in maintaining adherence to their medication and remaining in care. [ABSTRACT FROM AUTHOR]

During TB-case finding, we assessed the feasibility of implementing the advanced HIV disease (AHD) care package, including VISITECT CD4 Advanced Disease (VISITECT), a semiquantitative test to identify a CD4≤200cells/μl. Adult participants with tuberculosis symptoms, recruited near-facility in Lesotho and South-Africa between 2021–2022, were offered HIV testing (capillary blood), Xpert MTB/RIF and Ultra, and MGIT culture (sputum). People living with HIV (PLHIV) were offered VISITECT (venous blood) and Alere tuberculosis-lipoarabinomannan (AlereLAM, urine) testing. AHD was defined as a CD4≤200cells/μl on VISITECT or a positive tuberculosis test. A CD4≤200cells/μl on VISITECT triggered Immy cryptococcal antigen (Immy CrAg, plasma) testing. Participants were referred with test results. To evaluate feasibility, we assessed i) acceptability and ii) intervention delivery of point-of-care diagnostics among study staff using questionnaires and group discussions, iii) process compliance, and iv) early effectiveness (12-week survival and treatment status) in PLHIV. Predictors for 12-week survival were assessed with logistic regression. Thematic content analysis and triangulation were performed. Among PLHIV (N = 676, 48.6% of 1392 participants), 7.8% were newly diagnosed, 81.8% on ART, and 10.4% knew their HIV status but were not on ART. Among 676 PLHIV, 41.7% had AHD, 29.9% a CD4≤200cells/μl and 20.6% a tuberculosis diagnosis. Among 200 PLHIV tested with Immy CrAg, 4.0% were positive. The procedures were acceptable for study staff, despite intervention delivery challenges related to supply and the long procedural duration (median: 73 minutes). At 12 weeks, among 276 PLHIV with AHD and 328 without, 3.3% and 0.9% had died, 84.8% and 92.1% were alive and 12.0% and 7.0% had an unknown status, respectively. Neither AHD nor tuberculosis status were associated with survival. Implementing AHD care package diagnostics was feasible during tuberculosis-case finding. AHD was prevalent, and not associated with survival, which is likely explained by the low specificity of VISITECT. Challenges with CD4 testing and preventive treatment uptake require addressing. [ABSTRACT FROM AUTHOR]

Despite significant gains in HIV testing, treatment and prevention in sub-Saharan Africa, male engagement and retention in HIV care remains a challenge. We conducted in-depth interviews with 25 men with HIV (MWH) living in rural South Africa to explore how men's reproductive goals could inform approaches to engage men and their female partners in HIV care and prevention. Themes were organised into opportunities and barriers for HIV care, treatment and prevention that men articulated as important to their reproductive goals at the individual, couple and community levels. At the individual level, men are motivated to remain healthy so they can raise a healthy child. At the couple level, the importance of maintaining a healthy partner to raise children may promote serostatus-disclosure, testing and encourage men to support partners to access HIV prevention. At the community level, men described the need to be seen as fathers who provide for their families as important motivators to engage in care. Men also articulated barriers including low knowledge about antiretroviral-based HIV prevention, lack of trust within partnerships and community stigma. Addressing reproductive goals of MWH may be an untapped path for promoting male engagement in HIV care and prevention for their partners. [ABSTRACT FROM AUTHOR]

Introduction: To sustainably provide good quality care to increasing numbers of people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in resource-limited settings, care delivery must shift from a "one-size-fits-all" approach to differentiated service delivery models. Such models should reallocate resources from PLHIV who are doing well to groups of PLHIV who may need more attention, such as those with treatment failure. The VIral load Triggered ART care Lesotho (VITAL) trial assesses a viral load (VL)-, participant's preference-informed, electronic health (eHealth)-supported, automated differentiated service delivery model (VITAL model). With VITAL, we aim to assess if the VITAL model is at least non-inferior to the standard of care in the proportion of participants engaged in care with viral suppression at 24 months follow-up and if it is cost-saving. Methods: The VITAL trial is a pragmatic, multicenter, cluster-randomized, non-blinded, non-inferiority trial with 1:1 allocation conducted at 18 nurse-led, rural health facilities in two districts of northern Lesotho, enrolling adult PLHIV taking ART. In intervention clinics, providers are trained to implement the VITAL model and are guided by a clinical decision support tool, the VITALapp. VITAL differentiates care according to VL results, clinical characteristics, sub-population and participants' and health care providers' preferences. Expected outcomes: Evidence on the effect of differentiated service delivery for PLHIV on treatment outcomes is still limited. This pragmatic cluster-randomized trial will assess if the VITAL model is at least non-inferior to the standard of care and if it is cost saving. Trial registration: The study has been registered with clinicaltrials.gov (Registration number NCT04527874; August 27, 2020). [ABSTRACT FROM AUTHOR]

Introduction: UNAIDS fast track targets for ending the AIDS epidemic by 2030 call for viral suppression in 95% of people using antiretroviral therapy (ART) to treat HIV infection. Difficulties in linking to care following a positive HIV test have impeded progress towards meeting treatment targets. Community‐based HIV services may reduce linkage barriers and have been associated with high retention and favourable clinical outcomes. We use qualitative data from The Delivery Optimization of Antiretroviral Therapy (DO ART) Study, a three‐arm randomized trial of community ART initiation, monitoring and re‐supply conducted in western Uganda and KwaZulu‐Natal South Africa, to identify mechanisms through which community ART delivery may improve treatment outcomes, defined as viral suppression in people living with HIV (PLHIV). Methods: We conducted open‐ended interviews with a purposeful sample of 150 DO ART participants across study arms and study sites, from October 2016 to November 2019. Interviews covered experiences of: (1) HIV testing; (2) initiating and refilling ART; and (3) participating in the DO ART Study. A combined inductive content analytic and thematic approach was used to characterize mechanisms through which community delivery of ART may have contributed to viral suppression in the DO ART trial. Results: The analysis yielded four potential mechanisms drawn from qualitative data representing the perspectives and priorities of DO ART participants. Empowering participants to schedule, re‐schedule and select the locations of community‐based visits via easy phone contact with clinical staff is characterized as flexibility. Integration refers to combining the components of clinic‐based visits into single interaction with a healthcare provider. Providers" willingness to talk at length with participants during visits, addressing non‐HIV as well as HIV‐related concerns, is termed "a slower pace". Finally, increased efficiency denotes the time savings and increased income‐generating opportunities for participants brought about by delivering services in the community. Conclusions: Understanding the mechanisms through which HIV service delivery innovations produce an effect is key to transferability and potential scale‐up. The perspectives and priorities of PLHIV can indicate actionable changes for HIV care programs that may increase engagement in care and improve treatment outcomes. [ABSTRACT FROM AUTHOR]

mHealth has been proposed to address inefficiencies in the current South African healthcare system, including home-based HIV testing and counseling (HTC) programs. Yet wide-scale adoption of mHealth has not occurred. Even as infrastructure barriers decrease, a need to better understand perceived adoption barriers by stakeholders remains. We conducted focus group discussions (FGD) in South Africa in 2016 with 10 home-based HTC field staff, 12 community health workers (CHWs) and 10 persons living with HIV (PLH). Key informant (KI) interviews were conducted with five health officials. Perceptions about current home-based HTC practices, future mHealth systems and the use of biometrics for patient identification were discussed, recorded and transcribed for qualitative analysis. Themes were based on a conceptual model for perceived mHealth service quality. Stakeholders brought up a lack of communication in sharing patient health information between clinics, between clinics and CHWs, and between clinics and patients as major barriers to care that mHealth can address. CHWs need better patient information from clinics in terms of physical location and health status to plan visitation routes and address patient needs. CHWs perceive that communication barriers create distrust towards them by clinic staff. PLH want automated appointment and medication reminders. KI see mHealth as a way to improve health information transfer to government officials to better allocate healthcare resources. Stakeholders are also optimistic about the ability for biometrics to improve patient identification but disagreed as to which biometrics would be acceptable, especially in older patients. All stakeholders provided useful information towards the development of mHealth systems. Hospitals are adopting patient-centered approaches that solicit feedback from patients and incorporate them into decision-making processes. A similar approach is needed in the development of mHealth systems. Further, such systems are critical to the successful extension of the health system from health facilities into people's homes. [ABSTRACT FROM AUTHOR]