Costs of home-delivered antiretroviral therapy refills for persons living with HIV: evidence from a pilot randomized controlled trial in KwaZulu-Natal, South Africa.

Antiretroviral therapy (ART) is needed across the lifetime to maintain viral suppression for people living with HIV. In South Africa, obstacles to reliable access to ART persist and are magnified in rural areas, where HIV services are also typically costlier to deliver. A recent pilot randomized study (the Deliver Health Study) found that home-delivered ART refills, provided at a low user fee, effectively overcame logistical barriers to access and improved clinical outcomes in rural South Africa. In the present costing study using the payer perspective, we conducted retrospective activity-based micro-costing of home-delivered ART within the Deliver Health Study and when provided at-scale (in a rural setting), and compared to facility-based costs using provincial expenditure data (covering both rural and urban settings). Within the context of the pilot Deliver Health Study which had an average of three deliveries per day for three days a week, home-delivered ART cost (in 2022 USD) $794 in the first year and $714 for subsequent years per client after subtracting client fees, compared with $167 per client in provincial clinic-based care. We estimated that home-delivered ART can reasonably be scaled up to 12 home deliveries per day for five days per week in the rural setting. When delivered at scale, home-delivered ART cost $267 in the first year and $183 for subsequent years per client. Average costs of home delivery further decreased when increasing the duration of refills from three-months to six- and 12-month scripts (from $183 to $177 and $135 per client, respectively). Personnel costs were the largest cost for home-delivered refills while ART drug costs were the largest cost of clinic-based refills. When provided at scale, home-delivered ART in a rural setting not only offers clinical benefits for a hard-to-reach population but is also comparable in cost to the provincial standard of care.

Estimating the Effect of COVID-19 Pandemic Restrictions on Self-reported Antiretroviral Therapy Use and Late Refill Visits Among People Living With HIV in Rural South Africa.

BACKGROUND: People living with HIV require reliable access to and adequate supply of antiretroviral therapy (ART) for viral suppression. The Deliver Health Study, a randomized trial conducted during the COVID-19 pandemic, found that home-delivered ART significantly increased viral suppression compared with clinic-based care. The effect of changing COVID-19 alert levels on self-reported ART use has not been quantified. SETTING: KwaZulu-Natal, South Africa. METHODS: Adults living with HIV were followed in the Deliver Health Study during October 2019-December 2020. We used difference-in-differences (DiD) to estimate the effect of changing COVID-19 alert levels during 3 distinct periods on self-reported missed ART doses (missed 0 vs. ≥1 doses in past week) for participants receiving home-delivered vs. clinic-based refills. We additionally estimated the effect of changing COVID-19 alert levels on late clinic ART refill visits (late vs. on-time). We used relative risk regression for both binary outcomes. RESULTS: Of 155 participants, 46% were women and the median age was 36 years. The mean number of missed weekly doses was 0.11, 0, and 0.12 in the home-delivery group and 0.09, 0.08, and 0.18 in the clinic group during periods 1, 2, and 3, respectively. There were no differences in relative risk of self-reported daily ART use between refill groups when comparing across periods [DiDperiod 2 vs. 1 = 1.05; 95% confidence interval: 0.97, 1.13 and DiDperiod 3 vs. 2 = 0.99; 95% confidence interval (CI): 0.91, 1.08]. In the clinic group, the risk of late refill visits was significantly higher during COVID-19 restrictions (vs. before alert level 5 implementation) and even after the COVID-19 alert level was downgraded to level 1 (RRperiod 2 vs. 1 = 1.83, 95% CI: 1.34, 2.51 and RRperiod 3 vs. 2 = 1.71; 95% CI: 1.43, 2.04). CONCLUSION: The COVID-19 pandemic did not differentially impact self-reported ART adherence by the method of ART refills, but the risk of late clinic refill visits was significantly higher during COVID-19 restrictions and sustained after restrictions were loosened.

Are mHealth Interventions Effective in Improving the Uptake of Sexual and Reproductive Health Services among Adolescents? A Scoping Review.

Adolescents continue to face challenges to their sexual and reproductive health (SRH) both locally and internationally. Digital technologies such as the Internet, text messaging, and social media are often viewed as valuable tools for disseminating information on SRH. Mobile health, also known as mHealth, is a medical and public health practise that uses these digital technologies to communicate information. The literature has revealed that mHealth interventions have a positive outcome in delivering SRH information to adolescents. This review aimed to synthesise empirical studies that evaluate mHealth interventions and assess the extent to which these mHealth interventions promote sexual and reproductive health outcomes among young people. This scoping review reviewed the literature across four databases, including EBSCOhost, Scopus, Proquest, and Cochrane, and included 12 articles. The findings have shown that mHealth interventions are effective in enhancing sexual and reproductive health (SRH) knowledge and attitudes among young people in both low-middle and high-income countries. However, comprehensive longitudinal studies are necessary to measure the sustainability and long-term influence of mHealth interventions on behaviour. It is recommended that with artificial intelligence (AI) improvements, there is a possible path to bolstering mHealth interventions.

Perceptions of Pre-exposure Prophylaxis (PrEP) for HIV prevention among men living with HIV in the context of reproductive goals in South Africa: a qualitative study.

BACKGROUND: Pre-exposure Prophylaxis (PrEP) and Treatment as Prevention (TasP) are effective strategies to prevent HIV transmission within serodifferent couples. However, limited usage of PrEP, knowledge and interest has been amongst the barriers for men, alongside testing and treatment adherence. We explored the perceptions of PreP for HIV prevention with Men living with HIV (MWH) who have reproductive goals, to understand awareness and experiences related to PrEP use in the context of HIV prevention with their partners. METHODS: We undertook a qualitative study with 25 MWH aged 18 to 65 between April and September 2021 in South Africa. Potential participants were screened for eligibility and scheduled to participate in telephonic interviews. Interviews were audio recorded, transcribed, translated and thematically analysed. RESULTS: Themes were organized into opportunities and barriers that men with HIV articulate as important for using PrEP to meet individual, couple, and community reproductive goals. At the individual level, some men were willing to discuss PrEP with their partners to protect their partners and babies from acquiring HIV. Lack of knowledge about PrEP among men was a potential barrier to promoting PrEP among their female partners. At the couple level, PrEP use was seen as a way to strengthen relationships between partners, signifying care, trust, and protection and was seen as a tool to help serodifferent couples meet their reproductive goals safely. At the community level, PrEP was viewed as a tool to promote HIV testing and prevention efforts, especially among men, but participants emphasized the need for more education and awareness. CONCLUSION: Despite PrEP implementation in South Africa, awareness of PrEP among men with HIV in rural areas remains low. Engaging MWH to support their partners in accessing PrEP could be an innovative strategy to promote HIV prevention. Additionally, providing men with comprehensive reproductive health information can empower them to make more informed decisions, adopt safer sexual practices, and challenge societal norms and stigmas around HIV.

People living with HIV's perspectives of acceptability of fee for home delivery of ART: a qualitative study.

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.

Opportunities to leverage reproductive goals and ideals among South African men to promote HIV testing, treatment and prevention: A qualitative study.

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.

A Sequential Multiple Assignment Randomized Trial of scalable interventions for ART delivery in South Africa: the SMART ART study.

BACKGROUND: Of the 8 million people in South Africa living with HIV, 74% of persons living with HIV are on antiretroviral therapy (ART) and 65% are virally suppressed. Detectable viral load results in HIV-associated morbidity and mortality and HIV transmission. Patient barriers to care, such as missed wages, transport costs, and long wait times for clinic visits and ART refills, are associated with detectable viral load. HIV differentiated service delivery (DSD) has simplified ART delivery for clients who achieve viral suppression and engage in care. However, DSD needs adaptation to serve clients who are not engaged in care. METHODS: A Sequential Multiple Assignment Randomized Trial will be undertaken in KwaZulu-Natal, South Africa, to test adaptive ART delivery for persons with detectable viral load and/or who are not engaged in care. The types of differentiated service delivery (DSD) which will be examined in this study are clinic-based incentives, community-based smart lockers, and home delivery. The study plans to enroll up to 900 participants-people living with HIV, eligible for ART, and who are not engaged in care. The study aims to assess the proportion of ART-eligible persons living with HIV who achieve viral suppression at 18 months. The study will also evaluate the preferences of clients and providers for differentiated service delivery and evaluate the cost-effectiveness of adaptive HIV treatment for those who are not engaged in care. DISCUSSION: To increase population-level viral suppression, persons with detectable viral load need responsive DSD interventions. A Sequential Multiple Assignment Randomized Trial (SMART) design facilitates the evaluation of a stepped, adaptive approach to achieving viral suppression with "right-sized" interventions for patients most in need of effective and efficient HIV care delivery strategies. TRIAL REGISTRATION: ClinicalTrials.gov NCT05090150. Registered on October 22, 2021.

Pilot Testing Two Versions of a Social Network Intervention to Increase HIV Testing and Case-finding among Men in South Africa's Generalized HIV Epidemic.

Locating undiagnosed HIV infections is important for limiting transmission. However, there is limited evidence about how best to do so. In South Africa, men have been particularly challenging to reach for HIV testing due, in part, to stigma. We pilot-tested two versions of a network-based case-finding and care-linkage intervention. The first, TRIP, asked "seeds" (original participants) to recruit their sexual and/or injection partners. The second, TRIPLE, aimed to circumvent some stigma-related issues by asking seeds to recruit anyone they know who might be at risk of being HIV-positive-unaware. We recruited 11 (18% male) newly diagnosed HIV-positive (NDP) seeds from two clinics in KwaZulu-Natal, South Africa and randomly assigned them to either TRIP or TRIPLE. Network members were recruited two steps from each seed. The TRIP arm recruited 12 network members; the TRIPLE arm recruited 62. Both arms recruited NDPs at higher rates than local clinic testing, with TRIP (50.0%) outperforming (p = 0.012) TRIPLE (14.5%). However, TRIPLE (53.2%) was far superior to clinics (27.8%) and to TRIP (25.0%) at recruiting men. Given challenges around testing and treating men for HIV in this context, these findings suggest that the TRIPLE expanded network-tracing approach should be tested formally among larger samples in multiple settings.

The Feasibility and Acceptability of an mHealth Conversational Agent Designed to Support HIV Self-testing in South Africa: Cross-sectional Study.

BACKGROUND: HIV testing rates in sub-Saharan Africa remain below the targeted threshold, and primary care facilities struggle to provide adequate services. Innovative approaches that leverage digital technologies could improve HIV testing and access to treatment. OBJECTIVE: This study aimed to examine the feasibility and acceptability of Nolwazi_bot. It is an isiZulu-speaking conversational agent designed to support HIV self-testing (HIVST) in KwaZulu-Natal, South Africa. METHODS: Nolwazi_bot was designed with 4 different personalities that users could choose when selecting a counselor for their HIVST session. We recruited a convenience sample of 120 consenting adults and invited them to undertake an HIV self-test facilitated by the Nolwazi_bot. After testing, participants completed an interviewer-led posttest structured survey to assess their experience with the chatbot-supported HIVST. RESULTS: Participants (N=120) ranged in age from 18 to 47 years, with half of them being men (61/120, 50.8%). Of the 120 participants, 111 (92.5%) had tested with a human counselor more than once. Of the 120 participants, 45 (37.5%) chose to be counseled by the female Nolwazi_bot personality aged between 18 and 25 years. Approximately one-fifth (21/120, 17.5%) of the participants who underwent an HIV self-test guided by the chatbot tested positive. Most participants (95/120, 79.2%) indicated that their HIV testing experience with a chatbot was much better than that with a human counselor. Many participants (93/120, 77.5%) reported that they felt as if they were talking to a real person, stating that the response tone and word choice of Nolwazi_bot reminded them of how they speak in daily conversations. CONCLUSIONS: The study provides insights into the potential of digital technology interventions to support HIVST in low-income and middle-income countries. Although we wait to see the full benefits of mobile health, technological interventions including conversational agents or chatbots provide us with an excellent opportunity to improve HIVST by addressing the barriers associated with clinic-based HIV testing.

Fee for home delivery and monitoring of antiretroviral therapy for HIV infection compared with standard clinic-based services in South Africa: a randomised controlled trial.

BACKGROUND: Home delivery and monitoring of antiretroviral therapy (ART) is convenient, overcomes logistical barriers, and could increase individual ART adherence and viral suppression. With client payment and sufficient health benefits, this strategy could be scalable. The aim of the Deliver Health Study was to test the acceptability and efficacy of a user fee for home ART monitoring and delivery. METHODS: We conducted a randomised trial, the Deliver Health Study, of a fee for home delivery of ART compared with free clinic ART delivery in South Africa. People with HIV who were 18 years or older and clinically stable (including CD4 count >100 cells per µL and WHO HIV stage 1-3) were randomly assigned to: (1) fee for home delivery and monitoring of ART, including community ART initiation if needed; or (2) clinic-based ART (standard of care). The one-time fee for home delivery (ZAR 30, 60, and 90; equivalent to US$2, 4, 6) was tiered on the basis of participant income. The primary outcomes were recorded fee payment and acceptability assessed via questionnaire. The key virological secondary outcome was viral suppression with the difference between study groups assessed through robust Poisson regression including participants with viral load measured at exit (modified intention-to-treat analysis). This trial is registered on ClinicalTrials.gov (NCT04027153) and is complete, with analyses ongoing. FINDINGS: From Oct 7, 2019, to Jan 30, 2020, 162 participants were enrolled; 82 were randomly assigned to the fee for home delivery group and 80 to the clinic-based group, with similar characteristics at baseline. Overall, 87 (54%) participants were men, 101 (62%) were on ART, and 98 (60%) were unemployed. In the home delivery group, 40 (49%), 33 (40%), and nine (11%) participants qualified for the ZAR 30, 60, and 90 fee, respectively. Median follow-up was 47 weeks (IQR 43-50) with 96% retention. 80 (98%) participants paid the user fee, with high acceptability and willingness to pay. In the modified intention-to-treat analysis of 155 (96%) participants who completed follow-up, fee for home delivery and monitoring statistically significantly increased viral suppression from 74% to 88% overall (RR 1·21, 95% CI 1·02-1·42); and from 64% to 84% among men (1·31, 1·01-1·71). INTERPRETATION: Among South African adults with HIV, a fee for home delivery and monitoring of ART significantly increased viral suppression compared with clinic-based ART. Clients' paying a fee for home delivery and monitoring of ART was highly acceptable in the context of low income and high unemployment, and improved health outcomes as a result. Home ART delivery and monitoring, potentially with a user fee to offset costs, should be evaluated as a differentiated service delivery strategy to increase access to care. FUNDING: National Institutes of Mental Health.

Understanding the factors that impact effective uptake and maintenance of HIV care programs in South African primary health care clinics.

BACKGROUND: There is an increasingly urgent gap in knowledge regarding the translation of effective HIV prevention and care programming into scaled clinical policy and practice. Challenges limiting the translation of efficacious programming into national policy include the paucity of proven efficacious programs that are reasonable for clinics to implement and the difficulty in moving a successful program from research trial to scaled programming. This study aims to bridge the divide between science and practice by exploring health care providers' views on what is needed to implement new HIV programs within existing HIV care. METHODS: We conducted 20 in-depth interviews with clinic managers and clinic program implementing staff and five key informant interviews with district health managers overseeing programming in the uMgungundlovu District of KwaZulu-Natal Province, South Africa. Qualitative data were analyzed using a template approach. A priori themes were used to construct templates of relevance, including current care context for HIV and past predictors of successful implementation. Data were coded and analyzed by these templates. RESULTS: Heath care providers identified three main factors that impact the integration of HIV programming into general clinical care: perceived benefits, resource availability, and clear communication. The perceived benefits of HIV programs hinged on the social validation of the program by early adopters. Wide program availability and improved convenience for providers and patients increased perceived benefit. Limited staffing capacity and a shortage of space were noted as resource constraints. Programs that specifically tackled these constraints through clinic decongestion were reported as being the most successful. Clear communication with all entities involved in clinic-based programs, some of which include external partners, was noted as central to maximizing program function and provider uptake. CONCLUSIONS: Amid the COVID-19 pandemic, new programs are continuously being developed for implementation at the primary health care level. A better understanding of the factors that facilitate and prevent programmatic success will improve public health outcomes. Implementation is likely to be most successful when programs capitalize on endorsements from early adopters, tackle resource constraints, and foster greater communication among partners responsible for implementation.

Understanding the Factors that Impact Effective Uptake and Integration of Health Programs in South African Primary Health Care Clinics.

Introduction : There is an increasingly urgent gap in knowledge regarding the translation of effective HIV prevention and care programming into scaled clinical policy and practice. Challenges limiting the translation of efficacious programming into national policy include both the paucity of proven efficacious programs that are reasonable for clinics to implement and the difficulty in moving a successful program from research trial to scaled programming. This study aims to bridge the divide between science and practice by exploring health care providers’ views on what is needed to integrate of HIV programming into clinic systems. Methods : We conducted 20 in-depth interviews with clinic managers and clinic program implementing staff and 5 key informant interviews with district health managers overseeing programming in the uMgungundlovu District of KwaZulu-Natal Province, South Africa. Qualitative data were analyzed using a template approach. A priori themes were used to construct templates of relevance including current care context for HIV and past predictors of successful implementation. Data were coded and analyzed in accordance with these templates. Results : Heath care providers identified three main factors that impact integration of HIV programming into general clinical care: perceived benefits, resource availability, and clear communication. The perceived benefits of HIV programs hinged on the social validation of the program by early adopters. Wide program availability and improved convenience for providers and patients increased perceived benefit. Limited staffing capacity and a shortage of space were noted as resource constraints. Programs that specifically tackled these constraints through, for example clinic decongestion, were reported as being the most successful. Clear communication with all entities involved in clinic-based programs, some of which include external partners, was noted as central to maximizing program function and provider uptake. Conclusions : Amid the COVID-19 pandemic, new programs are already being developed for implementation at the primary health care level. A better understanding of the factors which both facilitate and prevent programmatic success will improve public health outcomes. Implementation is likely to be most successful when programs capitalize on endorsements from early adopters, tackle resource constraints, and foster greater communication among partners responsible for implementation.