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.

Factors that influence the satisfaction of people living with HIV with differentiated antiretroviral therapy delivery models in east Central Uganda: a cross-sectional study.

BACKGROUND: The World Health Organization (WHO) and the Uganda Ministry of Health recommend differentiated service delivery models (DSDMs) as patient-centered antiretroviral therapy (ART) mechanisms for people living with HIV/AIDS (PLHIV) with undetectable viral loads. We studied patient satisfaction with ART services, and its associated factors amongst PLHIV enrolled in DSDMs in Uganda. METHODS: This cross-sectional study involved a random sample of PLHIV accessing DSDM-related ART at nine facilities in East Central Uganda. Eligible patients were adult PLHIV (≥18 years), on ART, and enrolled for at least 12 months in one of three DSDMs: Community Client-Led ART Delivery (CCLAD), Community Drug Distribution Points (CDDP), or Fast-Track Drug Refill (FTDR). We collected data from June to July 2019. A validated tool measured satisfaction. General Estimating Equations with modified Poisson regression and exchangeable correlation structures accounted for clustering at health facilities and identified DSDM-related satisfaction factors. RESULTS: Of 842 participants enrolled, 530 (63.5%) accessed HIV care through CDDP, 166 (20.1%) through CCLAD, and 146 (16.3%) through FTDR; 541 (64.2%) were satisfied with DSDM services: 78.7% in CDDP, 42.8% in CCLAD, and 36.3% in FTDR. The delivery and treatment factors positively associated with satisfaction included: being enrolled on CDDP [adjusted prevalence ratio (aPR) = 1.51, 95% CI:1.47-1.56] or FTDR [aPR = 1.47, 95% CI:1.26-1.71] relative to CCLAD and being enrolled in a DSDM for more than 3 years [aPR = 1.28, 95% CI:1.11-1.48]. Poor ART adherence [aPR = 0.33, 95% CI:0.19-0.56] and having a baseline WHO HIV stage of 3 or 4 [aPR = 0.36, 95% CI:0.20-0.64] relative to stages 1 and 2 were negatively associated. Among socioeconomic factors, having lower transport costs (< $1.35) per clinic visit [aPR = 1.34, 95% CI:1.17-1.53], being employed [aPR = 1.61, 95% CI:1.38-1.87], and being single [aPR = 1.10, 95% CI:1.08-1.13] were positively associated with satisfaction; drinking alcohol at least once a week [aPR = 0.77, 95% CI:0.63-0.93] was negatively associated with patient satisfaction. CONCLUSIONS: Results showed that 64.2% of patients were satisfied with DSDM services. HIV service delivery and treatment factors (DSDM type, time in DSDM, WHO stage, ART adherence), plus social factors (employment and marital status, transport costs, alcohol consumption), were associated with patient satisfaction. DSDM implementers should tailor services to address these factors to improve patient satisfaction.

Acceptability and Preferences of Two Different Community Models of ART Delivery in a High Prevalence Urban Setting in Zambia: Cluster-Randomized Trial, Nested in the HPTN 071 (PopART) Study.

Community delivery of Antiretroviral therapy (ART) is a novel innovation to increase sustainable ART coverage for People living with HIV (PLHIV) in resource limited settings. Within a nested cluster-randomised sub-study in two urban communities that participated in the HPTN 071 (PopART) trial in Zambia we investigated individual acceptability and preferences for ART delivery models. Stable PLHIV were enrolled in a cluster-randomized trial of three different models of ART: Facility-based delivery (SoC), Home-based delivery (HBD) and Adherence clubs (AC). Consenting individuals were asked to express their stated preference for ART delivery options. Those assigned to the community models of ART delivery arms could choose ("revealed preference") between the assigned arm and facility-based delivery. In total 2489 (99.6%) eligible individuals consented to the study and 95.6% chose community models of ART delivery rather than facility-based delivery when offered a choice. When asked to state their preference of model of ART delivery, 67.6% did not state a preference of one model over another, 22.8% stated a preference for HBD, 5.0% and 4.6% stated a preference for AC and SoC, respectively. Offering PLHIV choices of community models of ART delivery is feasible and acceptable with majority expressing HBD as their stated preferred option.

Exploring drivers and barriers to the utilization of community client-led ART delivery model in South-Western Uganda: patients' and health workers' experiences.

BACKGROUND: In an effort to accommodate the growing number of HIV clients, improve retention in care and reduce health care burden, the differentiated service delivery (DSD) models were introduced in 2014. One such model, Community Client-Led ART Delivery (CCLAD) was rolled out in Uganda in 2017. The extent of utilization of this model has not been fully studied. The aim of the study was to explore the patients' and health workers' experiences on the utilization of CCLAD model at Bwizibwera Health Centre IV, south western Uganda. METHODS: This was a descriptive study employing qualitative methods. The study had 68 purposively selected participants who participated in 10 focus group discussions with HIV clients enrolled in CCLAD; 10 in-depth interviews with HIV clients not enrolled in CCLAD and 6 in-depth interviews with the health workers. Key informant interviews were held with the 2 focal persons for DSD. The discussions and interviews were audio recorded, transcribed verbatim and then translated. Both deductive and inductive approaches were employed to analyse the data using in NVivo software. RESULTS: Patients' and health workers' experiences in this study were categorized as drivers and barriers to the utilization of the CCLAD model. The main drivers for utilization of this model at different levels were: individual (reduced costs, living positively with HIV, improved patient self-management), community (peer support and contextual factors) and health system (reduced patient congestion at the health centre, caring health workers as well as CCLAD sensitization by health workers). However, significant barriers to the utilization of this community-based model were: individual (personal values and preferences, lack of commitment of CCLAD group members), community (stigma, gender bias) and health system (frequent drug stockouts, certain implementation challenges, fluctuating implementing partner priorities, shortage of trained health workers and insufficient health education by health workers). CONCLUSION: Based on our findings the CCLAD model is meeting the objectives set out by Differentiated Service Delivery for HIV care and treatment. Notwithstanding the benefits, challenges remain which call on the Ministry of Health and other implementing partners to address these hindrances to facilitate the scalability, sustainability and the realisation of the full-range of benefits that the model presents.

The Standardized Pediatric Expedited Encounters for ART Drugs Initiative (SPEEDI): description and evaluation of an innovative pediatric, adolescent, and young adult antiretroviral service delivery model in Tanzania.

BACKGROUND: As countries scale up antiretroviral therapy (ART) for children, innovative strategies to deliver quality services to children are needed. Differentiated ART delivery models have been successful in adults, but no such program has been described in children. We describe the Standardized Pediatric Expedited Encounters for ART Drugs Initiative (SPEEDI). METHODS: Descriptive analysis of patients eligible for SPEEDI was done via retrospective review of children, adolescents, and young adults on ART at the Baylor Centre of Excellence (COE) in Mbeya, Tanzania between January 2013 and December 2015. Eligibility for SPEEDI visits included the following: stable children, adolescents, and young adults on ART for approximately 3 months or longer, no medical or social complications, good adherence to ART, and presence of reliable caregiver. During a SPEEDI visit, patients were fast tracked in triage to collect medications directly without physically seeing a clinician. SPEEDI patients came to clinic every two months, and alternated SPEEDI visits with standard visits. Baseline characteristics, mortality, and lost-to-follow up rates of SPEEDI patients were analyzed. RESULTS: One thousand one hundred sixty-four patients utilized SPEEDI, totaling 3493 SPEEDI visits. SPEEDI reached 51.3% (1164/2269) of pediatric ART patients, accounting for 7.7% (3493/44489) of total patient encounters. SPEEDI patients were 52% (605/1164) female, median age of 11.7 years (range 1.2-25.5 yr), median time on ART of 21 months (range 4-130 months) and 83.5% (964/1155) categorized as no or mild HIV-associated immunodeficiency. SPEEDI patients had good outcomes (98.8%), low LTFU (0.1%) and low mortality rates (0.61 deaths per 100 patient-years). CONCLUSION: SPEEDI was an effective model for delivering ART to children, adolescents, and young adults in our setting, leading to good clinical outcomes, low mortality, and low LTFU. The SPEEDI program safely and effectively expedited and spaced out ART visits for children, adolescents, and young adults, and can serve as an adaptable ART delivery model for other resource limited settings.

Six-monthly appointment spacing for clinical visits as a model for retention in HIV Care in Conakry-Guinea: a cohort study.

BACKGROUND: The outbreak of the Ebola virus disease (EVD) in 2014 led to massive dropouts in HIV care in Guinea. Meanwhile, Médecins Sans Frontières (MSF) was implementing a six-monthly appointment spacing approach adapted locally as Rendez-vous de Six Mois (R6M) with an objective to improve retention in care. We sought to evaluate this innovative model of ART delivery in circumstances where access to healthcare is restricted. METHODS: A retrospective cohort study in 2014 of the outcome of a group of stable patients (viral load ≤1000 copies/µl) enrolled voluntarily in R6M compared with a group of stable patients continuing standard one to three monthly visits in Conakry. Log-rank test and Cox proportional hazards model were used to compare rates of attrition (deaths and defaulters) from care between the two groups. A linear regression analysis was used to describe the trend or pattern in the number of clinical visits over time. RESULTS: Included were 1957 adults of 15 years old and above of whom 1166 (59.6%) were enrolled in the R6M group and 791 (40.4%) in the standard care group. The proportion remaining in care at 18 months and beyond was 90% in the R6M group; significantly higher than the 75% observed in the control group (p < 0.0001). After adjusting for duration on ART and tuberculosis co-infection as covariates, the R6M strategy was associated with a 60% reduction in the rate of attrition from care compared with standard care (adjusted Hazard Ratio = 0.40, 95%CI: 0.27-0.59, p < 0.001). There was a negative secular trend in the number of monthly clinical visits for 24 months as the predicted caseload reduced on average by just below 50 visits per month (ß = -48.6, R2 = 0.82, p < 0.0001). CONCLUSION: R6M was likely to reduce staff workload and to mitigate attrition from ART care for stable patients in Conakry despite restricted access to healthcare caused by the devastating EVD on the health system in Guinea. R6M could be rolled out as the model of care for stable patients where and when feasible as a strategy likely to improve retention in HIV care.

Factors Influencing ART Adherence Among Persons Living with HIV Enrolled in Community Client-Led Art Delivery Groups in Lira District, Uganda: A Qualitative Study.

Background: Community client-led ART delivery groups (CCLADs) were introduced as one of the strategies to better serve individual needs and reduce unnecessary burdens on the health system. However, limited data adequately explained the factors influencing ART adherence among HIV/AIDS patients in CCLAD's model of care. The study aimed to assess the factors influencing ART adherence among HIV-positive patients attending CCLADs in Lira District, Uganda. Materials and Methods: We employed a qualitative method of data collection recruiting 25 study participants (expert clients) between July and August 2020. The study purposefully chose 25 participants to participate in with HIV/AIDS patients enrolled in community-based HIV care models. The interviews were recorded on audiotape, transcribed, and translated verbatim. We used a thematic approach to analyze the data. Results: Our study shows that social support among group members, patient self-motivation, counselling, and guidance were the major facilitators of adherence. From the analysis of results, our study found the following themes: Lack of food, stigma, forgetfulness, stress, unfair staff at the hospital, and socio-cultural beliefs were among the major barriers identified in this study. Conclusion: The study emphasizes that CCLADs improve ART adherence for HIV-positive clients by providing a supportive environment and medication access. Peer influence on alternative medicine usage hinders adherence. We recommend that continued support, funding, and education are necessary to address misconceptions and sustain CCLADs' effectiveness.

Availability and experiences of differentiated antiretroviral therapy delivery at HIV care facilities in rural Zimbabwe: a mixed-method study.

INTRODUCTION: Zimbabwe adopted differentiated HIV care policies in 2015 to promote client-centred care and relieve strain on health facilities. We examined the availability, experiences and perceptions of differentiated antiretroviral therapy (ART) delivery in rural Zimbabwe following the policy adoption. METHODS: We undertook a cross-sectional mixed methods study in all the 26 facilities providing HIV care in a rural district in Zimbabwe. We collected quantitative data about ART delivery and visit durations from 31 healthcare providers and a purposive stratified sample of 378 clients obtaining ART either through routine care or differentiated ART delivery models. We performed 26 semi-structured interviews among healthcare providers and seven focus group discussions (FGDs) among clients to elicit their perceptions and experiences of ART delivery. Data were collected in 2019, with one follow-up FGD in 2021. We analysed the transcripts thematically, with inductive coding, to identify emerging themes. RESULTS: Twenty facilities (77%) offered at least one differentiated ART delivery models, including community ART refill groups (CARGs; 13 facilities, 50%), fast-track refill (8, 31%), family refill (6, 23%) or club refill (1, 4%). Thirteen facilities (50%) offered only one model. The median visit duration was 28 minutes (interquartile range [IQR]: 16-62). Participants in fast-track had the shortest visit durations (18 minutes, IQR: 11-24). Confidentiality and disclosure of HIV status, travelling long distances, travel costs and waiting times were the main issues influencing clients' views on differentiated ART delivery. Fast-track refill was perceived as the preferred model of clients for its limited involuntary disclosure and efficiency. In contrast, group- and community-based refill models reduced travel costs but were felt to be associated with involuntary disclosure of HIV status, which could discourage clients. Healthcare providers also experienced an additional workload when offering facility-based group models, such as CARGs. CONCLUSIONS: Differentiated ART delivery models were widely available in this rural setting, but most facilities did not offer a choice of models to address clients' diverse preferences. A minority offered fast-track refills, although this model was often mentioned as desirable. Confidentiality, travel expenses and client waiting times are key elements to consider when planning and rolling out differentiated HIV care.

Experiences and Perceptions on Community Client-Led ART Delivery (CCLADS) Model of Antiretroviral (ART) Delivery: Patients' and Providers' Perspectives in South Western Uganda.

Purpose: Community Client-Led ART Delivery groups (CCLADS) were introduced as part of the differentiated service delivery models in 2017 to better serve growing number of HIV patients and reduce unnecessary burden on the HIV care delivery system. However, there is limited evidence on the exact patients' and care providers' experiences and perceptions regarding the CCLADS model of ART delivery. We therefore aimed to explore the experiences and perceptions on CCLADS model from the patient and provider perspectives. Participants and Methods: A descriptive qualitative study was conducted at two ART clinics in Southwestern Uganda. We conducted in-depth interviews (IDI) to get a deeper understanding of the patient and providers' perspective regarding the model. Responses from participants were recorded using audio recorders and were translated and transcribed. We used thematic approach to analyze the data. Results: A total of 20 in depth interviews were conducted, with providers, CCLAD leaders and Adults Living with HIV (ALHIV) to assess the experiences and perceptions to participation among People Living with HIV (PLHIV) enrolled in CCLADS and the care providers. Key themes included benefits, limitations, experiences and perceptions of CCLADS. Benefits to ALHIV included: Longer refills, reduced transport costs, receive drugs in time, peer advice; to providers: time saving, less tiresome and reduced congestion at facility. Barriers included: stigma, limited outreaches, failure to comply. Patients perceived the model positively (cost effective, improved quality care, no missed appointment where as others were negative (blood samples not taken like before). Experiences also included enough time, learnt some activities and good adherence. Conclusion: Participation in the CCLADS groups provides several benefits to the patient including reduced transport, longer refills and good adherence. Stigma remains a challenge to CCLADS participation, which requires innovative and collaborative strategies from Ministry of Health (MOH) and implementation partners to address in order to sustain CCLADS participation.

The effectiveness, feasibility and acceptability of HIV service delivery at private pharmacies in sub-Saharan Africa: a scoping review.

INTRODUCTION: Private pharmacies are an understudied setting for differentiated delivery of HIV services that may address barriers to clinic-delivered services, such as stigma and long wait times. To understand the potential for pharmacy-delivered HIV services in sub-Saharan Africa, we conducted a scoping review of the published and grey literature. METHODS: Using a modified Cochrane approach, we searched electronic databases through March 2022 and HIV conference abstracts in the past 5 years for studies that: (1) focused on the delivery of HIV testing, antiretroviral therapy (ART) and/or pre-exposure prophylaxis (PrEP) at private pharmacies in sub-Saharan Africa; (2) reported on effectiveness outcomes (e.g. HIV incidence) or implementation outcomes, specifically feasibility and/or acceptability; and (3) were published in English. Two authors identified studies and extracted data on study setting, population, design, outcomes and findings by HIV service type. RESULTS AND DISCUSSION: Our search identified 1646 studies. After screening and review, we included 28 studies: seven on HIV testing, nine on ART delivery and 12 on PrEP delivery. Most studies (n = 16) were conducted in East Africa, primarily in Kenya. Only two studies evaluated effectiveness outcomes; the majority (n = 26) reported on feasibility and/or acceptability outcomes. The limited effectiveness data (n = 2 randomized trials) suggest that pharmacy-delivered HIV services can increase demand and result in comparable clinical outcomes (e.g. viral load suppression) to standard-of-care clinic-based models. Studies assessing implementation outcomes found actual and hypothetical models of pharmacy-delivered HIV services to be largely feasible (e.g. high initiation and continuation) and acceptable (e.g. preferable to facility-based models and high willingness to pay/provide) among stakeholders, providers and clients. Potential barriers to implementation included a lack of pharmacy provider training on HIV service delivery, costs to clients and providers, and perceived low quality of care. CONCLUSIONS: The current evidence suggests that pharmacy-delivered HIV services may be feasible to implement and acceptable to clients and providers in parts of sub-Saharan Africa. However, limited evidence outside East Africa exists, as does limited evidence on the effectiveness of and costs associated with pharmacy-delivered HIV services. More research of this nature is needed to inform the scale-up of this new differentiated service delivery model throughout the region.

A comparison of different community models of antiretroviral therapy delivery with the standard of care among stable HIV+ patients: rationale and design of a non-inferiority cluster randomized trial, nested in the HPTN 071 (PopART) study.

BACKGROUND: Following the World Health Organization's (WHO) 2015 guidelines recommending initiation of antiretroviral therapy (ART) irrespective of CD4 count for all people living with HIV (PLHIV), many countries in sub-Saharan Africa have adopted this strategy to reach epidemic control. As the number of PLHIV on ART rises, maintenance of viral suppression on ART for over 90% of PLHIV remains a challenge to government health systems in resource-limited high HIV burden settings. Non facility-based antiretroviral therapy (ART) delivery for stable HIV+ patients may increase sustainable ART coverage in resource-limited settings. Within the HPTN 071 (PopART) trial, two models, home-based delivery (HBD) or adherence clubs (AC), were offered to assess whether they achieved similar viral load suppression (VLS) to standard of care (SoC). In this paper, we describe the trial design and discuss the methodological issues and challenges. METHODS: A three-arm cluster randomized non-inferiority trial, nested in two urban HPTN 071 trial communities in Zambia, randomly allocated 104 zones to SoC (35), HBD (35), or AC (34). ART and adherence support were delivered 3-monthly at home (HBD), adherence clubs (AC), or clinic (SoC). Adult HIV+ patients defined as "stable" on ART were eligible for inclusion. The primary endpoint was the proportion of PLHIV with virological suppression (≤ 1000 copies HIV RNA/ml) at 12 months (± 3months) after study entry across all three arms. Viral load measurement was done at the routine government laboratories in accordance with national guidelines, annually. The study was powered to determine if either of the community-based interventions would yield a viral suppression rate drop compared to SoC of no more than 5% in its absolute value. Both community-based interventions were delivered by community HIV providers (CHiPs). An additional qualitative study using observations, interviews with PLHIV, and FGDs with community HIV providers was nested in this study to complement the quantitative data. DISCUSSION: This trial was designed to provide rigorous randomized evidence of safety and efficacy of non-facility-based delivery of ART for stable PLHIV in high-burden resource-limited settings. This trial will inform policy regarding best practices and what is needed to strengthen scale-up of differentiated models of ART delivery in resource-limited settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03025165 . Registered on 19 January 2017.

Investigating the implementation of differentiated HIV services and implications for pregnant and postpartum women: A mixed methods multi-country study.

Universal antiretroviral therapy (ART) for pregnant and postpartum women in sub-Saharan Africa has required adaptations to service delivery. We compared national policies on differentiated HIV service delivery with facility-level implementation, and explored provider and user experiences in rural Malawi, Tanzania and South Africa. Four national policies and two World Health Organization guidelines on HIV treatment for pregnant and postpartum women published between 2013 and 2017 were reviewed and summarised. Results were compared with implementation data from surveys undertaken in 34 health facilities. Eighty-seven in-depth interviews were conducted with pregnant and post-partum women living with HIV, their partners and providers. In 2018, differentiated service policies varied across countries. None specifically accounted for pregnant or postpartum women. Malawian policies endorsed facility-based multi-month scripting for clinically-stable adult ART patients, excluding pregnant or breastfeeding women. In Tanzania and South Africa, national policies proposed community-based and facility-based approaches, for which pregnant women were not eligible. Interview data suggested some implementation of differentiated services for pregnant and postpartum women beyond stipulated policies in all settings. Although these adaptations were appreciated by pregnant and postpartum women, they could lead to frustrations among other users when criteria for fast-track services or multi-month prescriptions were not clear.

The rollout of Community ART Refill Groups in Zimbabwe: a qualitative evaluation.

INTRODUCTION: Community ART Refill Groups (CARGs) are an antiretroviral therapy (ART) delivery model where clients voluntarily form into groups, and a group member visits the clinic to collect ART for all group members. In late 2016, Zimbabwe began a nationwide rollout of the CARG model. We conducted a qualitative evaluation to assess the perceived effects of this new national service delivery model. METHODS: In March-June 2018, we visited ten clinics implementing the CARG model across five provinces of Zimbabwe and conducted a focus group discussion with healthcare workers and in-depth interviews with three ART clients per clinic. Clinics had implemented the CARG model for approximately one year. All discussions were audio recorded, transcribed, and translated into English, and thematic coding was performed by two independent analysts. RESULTS: In focus groups, healthcare workers described that CARGs made ART distribution faster and facilitated client tracking in the community. They explained that their reduced workload allowed them to provide better care to those clients who did visit the clinic, and they felt that the CARG model should be sustained in the future. CARG members reported that by decreasing the frequency of clinic visits, CARGs saved them time and money, reducing previous barriers to collecting ART and improving adherence. CARG members also valued the emotional and informational support that they received from other members of their CARG, further improving adherence. Multiple healthcare workers did express concern that CARG members with diseases that begin with minor symptoms, such as tuberculosis, may not seek treatment at the clinic until the disease has progressed. CONCLUSIONS: We found that healthcare workers and clients overwhelmingly perceive CARGs as beneficial. This evaluation demonstrates that the CARG model can be successfully implemented on a national scale. These early results suggest that CARGs may be able to simultaneously improve clinical outcomes and reduce the workload of healthcare workers distributing ART.

Outcomes of patients enrolled in an antiretroviral adherence club with recent viral suppression after experiencing elevated viral loads.

BACKGROUND: Eligibility for differentiated antiretroviral therapy (ART) delivery models has to date been limited to low-risk stable patients. OBJECTIVES: We examined the outcomes of patients who accessed their care and treatment through an ART adherence club (AC), a differentiated ART delivery model, immediately following receiving support to achieve viral suppression after experiencing elevated viral loads (VLs) at a high-burden ART clinic in Khayelitsha, South Africa. METHODS: Beginning in February 2012, patients with VLs above 400 copies/mL either on first- or second-line regimens received a structured intervention developed for patients at risk of treatment failure. Patients who successfully suppressed either on the same regimen or after regimen switch were offered immediate enrolment in an AC facilitated by a lay community health worker. We conducted a retrospective cohort analysis of patients who enrolled in an AC directly after receiving suppression support. We analysed outcomes (retention in care, retention in AC care and viral rebound) using Kaplan-Meier methods with follow-up from October 2012 to June 2015. RESULTS: A total of 165 patients were enrolled in an AC following suppression (81.8% female, median age 36.2 years). At the closure of the study, 119 patients (72.0%) were virally suppressed and 148 patients (89.0%) were retained in care. Six, 12 and 18 months after AC enrolment, retention in care was estimated at 98.0%, 95.0% and 89.0%, respectively. Viral suppression was estimated to be maintained by 90.0%, 84.0% and 75.0% of patients at 6, 12 and 18 months after AC enrolment, respectively. CONCLUSION: Our findings suggest that patients who struggled to achieve or maintain viral suppression in routine clinic care can have good retention and viral suppression outcomes in ACs, a differentiated ART delivery model, following suppression support.

ART adherence clubs in the Western Cape of South Africa: what does the sustainability framework tell us? A scoping literature review.

INTRODUCTION: In 2007, the antiretroviral therapy (ART) adherence club (AC) model was introduced to South Africa to combat some of the health system barriers to ART delivery, such as staff constraints and increasing patient load causing clinic congestion. It aimed to absorb the growing number of stable patients on treatment, ensure quality of care and reduce the workload on healthcare workers. A pilot project of ACs showed improved outcomes for club members with increased retention in care, reduced loss to follow-up and a reduction in viral rebound. In 2011, clubs were rolled out across the Cape Metro District with promising clinical outcomes. This review investigates factors that enable or jeopardize sustainability of the adherence club model in the Western Cape of South Africa. METHODS: A scoping literature review was carried out. Electronic databases, organizations involved in ACs and reference lists of relevant articles were searched. Findings were analysed using a sustainability framework of five key components: (1) Design and implementation processes, (2) Organizational capacity, (3) Community embeddedness, (4) Enabling environment and (5) Context. RESULTS AND DISCUSSION: The literature search identified 466 articles, of which six were included in the core review. Enablers of sustainability included the collaborative implementation process with collective learning sessions, the programme's flexibility, the high acceptability, patient participation and political support (to some extent). Jeopardizing factors revolved around financial constraints as non-governmental organizations are the main supporters of ACs by providing staff and technical support. CONCLUSIONS: The results showed convincing factors that enable sustainability of ACs in the long term and identified areas for future research. Community embeddedness of clubs with empowerment and participation of patients, is a strong enabler to the sustainability of the model. Further policies are recommended to regulate the role of lay healthcare workers, ensure the reliability of the drug supply and the funding of club activities.

Retention on ART and predictors of disengagement from care in several alternative community-centred ART refill models in rural Swaziland.

INTRODUCTION: A broad range of community-centred care models for patients stable on anti-retroviral therapy (ART) have been proposed by the World Health Organization to better respond to patient needs and alleviate pressure on health systems caused by rapidly growing patient numbers. Where available, often a single alternative care model is offered in addition to routine clinical care. We operationalized several community-centred ART delivery care models in one public sector setting. Here, we compare retention in care and on ART and identify predictors of disengagement with care. METHODS: Patients on ART were enrolled into three community-centred ART delivery care models in the rural Shiselweni region (Swaziland), from 02/2015 to 09/2016: Community ART Groups (CAGs), comprehensive outreach care and treatment clubs. We used Kaplan-Meier estimates to describe crude retention in care model and retention on ART (including patients who returned to clinical care). Multivariate Cox proportional hazard models were used to determine factors associated with all-cause attrition from care model and disengagement with ART. RESULTS: A total of 918 patients were enrolled. CAGs had the most participants with 531 (57.8%). Median age was 44.7 years (IQR 36.3 to 54.4), 71.8% of patients were female, and 62.6% fulfilled eligibility criteria for community ART. The 12-month retention in ART was 93.7% overall; it was similar between model types (p = 0.52). A considerable proportion of patients returned from community ART to clinical care, resulting in lower 12 months retention in care model (82.2% overall); retention in care model was lowest in CAGs at 70.4%, compared with 86.3% in outreach and 90.4% in treatment clubs (p < 0.001). In multivariate Cox regression models, patients in CAGs had a higher risk of disengaging from care model (aHR 3.15, 95% CI 2.01 to 4.95, p < 0.001) compared with treatment clubs. We found, however, no difference in attrition in ART between alternative model types. CONCLUSIONS: Concurrent implementation of three alternative community-centred ART models in the same region was feasible. Although a considerable proportion of patients returned back to clinical care, overall ART retention was high and should encourage programme managers to offer community-centred care models adapted to their specific setting.

"We are part of a family". Benefits and limitations of community ART groups (CAGs) in Thyolo, Malawi: a qualitative study.

INTRODUCTION: In 2012 Community ART Groups (CAGs), a community-based model of antiretroviral therapy (ART) delivery were piloted in Thyolo District, Malawi as a way to overcome patient barriers to accessing treatment, and to decrease healthcare workers' workload. CAGs are self-formed groups of patients on ART taking turns to collect ART refills for all group members from the health facility. We conducted a qualitative study to assess the benefits and challenges of CAGs from patients' and healthcare workers' (HCWs) perspectives. METHODS: Data were collected by means of 15 focus group discussions, 15 individual in-depth interviews, and participant observation in 2 health centres. The 94 study participants included CAG members, ART patients eligible for CAGs who remained in conventional care, former CAG members who returned to conventional care and HCWs responsible for providing HIV care. Patient participants were purposively selected from ART registers, taking into account age and gender. Narratives were audio-recorded, transcribed, and translated from Chichewa to English. Data were analyzed through a thematic analysis. RESULTS: Patients and HCWs spoke favourably about the practical benefits of CAGs. Patient benefits included a reduced frequency of clinic visits, resulting in reduced transportation costs and time savings. HCW benefits included a reduced workload. Additionally peer support was perceived as an added value of the groups allowing not only sharing of the logistical constraints of drugs refills, but also enhanced emotional support. Identified barriers to joining a CAG included a lack of information on CAGs, unwillingness to disclose one's HIV status, change of residence and conflicts among CAG members. Participants reported that HIV-related stigma persists and CAGs were seen as an effective strategy to reduce exposure to discriminatory labelling by community members. CONCLUSION: In this setting, patients and HCWs perceived CAGs to be an acceptable model of ART delivery. Despite addressing important practical barriers to accessing ART, and providing peer support, CAGs were not well known by patients and had a limited impact on reducing HIV-related stigma. The CAG model of ART delivery should be considered in similar settings. Further measures need to be devised and implemented to address HIV-related stigma.

Implementation of community-based adherence clubs for stable antiretroviral therapy patients in Cape Town, South Africa.

INTRODUCTION: Community-based models of antiretroviral therapy (ART) delivery have been recommended to support ART expansion and retention in resource-limited settings. However, the evidence base for community-based models of care is limited. We describe the implementation of community-based adherence clubs (CACs) at a large, public-sector facility in peri-urban Cape Town, South Africa. METHODS: Starting in May 2012, stable ART patients were down-referred from the primary care community health centre (CHC) to CACs. Eligibility was based on self-reported adherence, >12 months on ART and viral suppression. CACs were facilitated by four community health workers and met every eight weeks for group counselling, a brief symptom screen and distribution of pre-packed ART. The CACs met in community venues for all visits including annual blood collection and clinical consultations. CAC patients could send a patient-nominated treatment supporter ("buddy") to collect their ART at alternate CAC visits. Patient outcomes [mortality, loss to follow-up and viral rebound (>1000 copies/ml)] during the first 18 months of the programme are described using Kaplan-Meier methods. RESULTS AND DISCUSSION: From June 2012 to December 2013, 74 CACs were established, each with 25-30 patients, providing ART to 2133 patients. CAC patients were predominantly female (71%) and lived within 3 km of the facility (70%). During the analysis period, 9 patients in a CAC died (<0.1%), 53 were up-referred for clinical complications (0.3%) and 573 CAC patients sent a buddy to at least one CAC visit (27%). After 12 months in a CAC, 6% of patients were lost to follow-up and fewer than 2% of patients retained experienced viral rebound. CONCLUSIONS: Over a period of 18 months, a community-based model of care was rapidly implemented decentralizing more than 2000 patients in a high-prevalence, resource-limited setting. The fundamental challenge for this out of facility model was ensuring that patients receiving ART within a CAC were viewed as an extension of the facility and part of the responsibility of CHC staff. Further research is needed to support down-referral sooner after ART initiation and to describe patient experiences of community-based ART delivery.