Dataset Information

Twenty-four-month outcomes from a cluster-randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs.

ABSTRACT:

Introduction

The antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients' retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non-inferiority cluster randomized trial comparing standard of care (SoC) ACs and six-month refill intervention ACs in a primary care facility in Khayelitsha, South Africa.

Methods

Existing community-based and facility-based ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually, receiving two-month refills with a four-month refill over year-end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving six-month refills, with an individual blood collection visit before the annual clinical assessment AC visit. The first study visits were in October and November 2017 and participants followed for 27 months. We report retention in care, viral load completion and viral suppression (<400 copies/mL) 24 months after enrolment and calculated intention-to-treat risk differences for the primary outcomes using generalized estimating equations specifying for clustering by AC.

Results

Of 2150 participants included in the trial, 977 were assigned to the intervention arm (40 ACs) and 1173 to the SoC (48 ACs). Patient characteristics at enrolment were similar across groups. Retention in care at 24 months was similarly high in both arms: 93.6% (1098/1173) in SoC and 92.6% (905/977) in the intervention arm, with a risk difference of -1.0% (95% CI: -3.2 to 1.3). The intervention arm had higher viral load completion (90.8% (999/1173) versus 85.1% (887/977)) and suppression (87.3% (969 /1173) versus 82.6% (853/977)) at 24 months, with a risk difference for completion of 5.5% (95% CI: 1.5 to 9.5) and suppression of 4.6% (95% CI: 0.2 to 9.0).

Conclusions

Intervention AC patients receiving six-month ART refills showed non-inferior retention in care, viral load completion and viral load suppression to those in SoC ACs, adding to a growing literature showing good outcomes with extended ART dispensing intervals.

SUBMITTER: Cassidy T

PROVIDER: S-EPMC7749539 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Publications

Twenty-four-month outcomes from a cluster-randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs.

Cassidy Tali T Grimsrud Anna A Keene Claire C Lebelo Keitumetse K Hayes Helen H Orrell Catherine C Zokufa Nompumelelo N Mutseyekwa Tabitha T Voget Jacqueline J Gerstenhaber Rodd R Wilkinson Lynne L

Journal of the International AIDS Society 20201201 12

<h4>Introduction</h4>The antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients' retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non-inferiority cluster randomized trial comparing standard of care (SoC) ACs and six-month refill intervention ACs in a primary care facility in Khayelitsha, South ...[more]

PMID: 33340284

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Project description:BackgroundWith an increasing number of countries implementing Option B+ guidelines of lifelong antiretroviral therapy (ART) for all pregnant and breastfeeding women, there is urgent need to identify effective approaches for retaining this growing and highly vulnerable population in ART care.MethodsNewly postpartum, breastfeeding women who initiated ART in pregnancy and met eligibility criteria were enrolled, and offered the choice of two options for postpartum ART care: (i) referral to existing network of community-based adherence clubs or (ii) referral to local primary health care clinic (PHC). Women were followed at study measurement visits conducted separately from either service. Primary outcome was a composite endpoint of retention in ART services and viral suppression [VS < 50 copies/mL based on viral load (VL) testing at measurement visits] at 12 months postpartum. Outcomes were compared across postpartum services using chi-square, Fisher's exact tests and Poisson regression models. The primary outcome was compared across services where women were receiving care at 12 months postpartum in exploratory analyses.ResultsBetween February and September 2015, 129 women (median age: 28.9 years; median time postpartum: 10 days) were enrolled with 65% opting to receive postpartum HIV care through an adherence club. Among 110 women retained at study measurement visits, 91 (83%) achieved the composite endpoint, with no difference between those who originally chose clubs versus those who chose PHC services. Movement from an adherence club to PHC services was common: 31% of women who originally chose clubs and were engaged in care at 12 months postpartum were attending a PHC service. Further, levels of VS differed significantly by where women were accessing ART care at 12 months postpartum, regardless of initial choice: 98% of women receiving care in an adherence club and 76% receiving care at PHC had VS < 50 copies/mL at 12 months postpartum (p = 0.001).ConclusionThis study found comparable outcomes related to retention and VS at 12 months postpartum between women choosing adherence clubs and those choosing PHC. However, movement between postpartum services among those who originally chose adherence clubs was common, with poorer VS outcomes among women leaving clubs and returning to PHC services.Trial registrationClinicalTrials.gov NCT02417675 , April 16, 2015 (retrospectively registered).

Project description:BackgroundDifferentiated antiretroviral therapy (ART) delivery models, in which patients are provided with care relevant to their current status (e.g., newly initiating, stable on treatment, or unstable on treatment) has become an essential part of patient-centered health systems. In 2015, the South African government implemented Chronic Disease Adherence Guidelines (AGLs), which involved five interventions: Fast Track Initiation Counseling for newly initiating patients, Enhanced Adherence Counseling for patients with an unsuppressed viral load, Early Tracing of patients who miss visits, and Adherence Clubs (ACs) and Decentralized Medication Delivery (DMD) for stable patients. We evaluated two of these interventions in 24 South African facilities: ACs, in which patients meet in groups outside usual clinic procedures and receive medication; and DMD, in which patients pick up their medication outside usual pharmacy queues.Methods and findingsWe compared those participating in ACs or receiving DMD at intervention sites to those eligible for ACs or DMD at control sites. Outcomes were retention and sustained viral suppression (<400 copies/mL) 12 months after AC or DMD enrollment (or comparable time for controls). 12 facilities were randomly allocated to intervention and 12 to control arms in four provinces (Gauteng, North West, Limpopo, and KwaZulu Natal). We calculated adjusted risk differences (aRDs) with cluster adjustment using generalized estimating equations (GEEs) using difference in differences (DiD) with patients eligible for ACs/DMD prior to implementation (Jan 1, 2015) for comparison. For DMD, randomization was not preserved, and the analysis was treated as observational. For ACs, 275 intervention and 294 control patients were enrolled; 72% of patients were female, 61% were aged 30-49 years, and median CD4 count at ART initiation was 268 cells/μL. AC patients had higher 1-year retention (89.5% versus 81.6%, aRD: 8.3%; 95% CI: 1.1% to 15.6%) and comparable sustained 1-year viral suppression (<400 copies/mL any time ≤ 18 months) (80.0% versus 79.6%, aRD: 3.8%; 95% CI: -6.9% to 14.4%). Retention associations were apparently stronger for men than women (men RD: 13.1%, 95% CI: 0.3% to 23.5%; women RD: 6.0%, 95% CI: -0.9% to 12.9%). For DMD, 232 intervention and 346 control patients were enrolled; 71% of patients were female, 65% were aged 30-49 years, and median CD4 count at ART initiation was 270 cells/μL. DMD patients had apparently lower retention (81.5% versus 87.2%, aRD: -5.9%; 95% CI: -12.5% to 0.8%) and comparable viral suppression versus standard of care (77.2% versus 74.3%, aRD: -1.0%; 95% CI: -12.2% to 10.1%), though in both cases, our findings were imprecise. We also noted apparently increased viral suppression among men (RD: 11.1%; 95% CI: -3.4% to 25.5%). The main study limitations were missing data and lack of randomization in the DMD analysis.ConclusionsIn this study, we found comparable DMD outcomes versus standard of care at facilities, a benefit for retention of patients in care with ACs, and apparent benefits in terms of retention (for AC patients) and sustained viral suppression (for DMD patients) among men. This suggests the importance of alternative service delivery models for men and of community-based strategies to decongest primary healthcare facilities. Because these strategies also reduce patient inconvenience and decongest clinics, comparable outcomes are a potential success. The cost of all five AGL interventions and possible effects on reducing clinic congestion should be investigated.Clinical trial registrationNCT02536768.

Project description:INTRODUCTION:Differentiated models of care that include referral of antiretroviral treatment (ART) clients to adherence clubs are an important strategy to help clinics manage increased number of clients living with HIV in resource-constrained settings. This study reported on (i) clinical outcomes among ART clients attending community-based adherence clubs and (ii) experiences of adherence clubs and perceptions of factors key to successful adherence club implementation among clients and healthcare workers. METHODS:A retrospective cohort analysis of routine data and a descriptive analysis of data collected through self-administered surveys completed by clients and healthcare workers were completed. Clients starting ART at the study clinic, between January 2014 and December 2015, were included in the cohort analysis and followed up until December 2016. The survey data were collected from August to September 2017. The primary outcome for the cohort analysis was a comparison of loss to follow-up (LTFU) between clients staying in clinic care and those referred to adherence clubs. Survey data reported on client experiences of and healthcare worker perceptions of adherence club care. RESULTS:Cohort analysis reported on 465 participants, median baseline CD4 count 374 (IQR: 234 to 532) cells/μl and median follow-up time 20.7 (IQR 14.1 to 27.7) months. Overall, 202 (43.4%) participants were referred to an adherence club. LTFU was lower in those attending an adherence club (aHR =0.25, 95% CI: 0.11 to 0.56). This finding was confirmed on analysis restricted to those eligible for adherence club referral (aHR =0.28, 95% CI: 0.12 to 0.65). Factors highlighted as associated with successful adherence club implementation included: (i) referral of stable clients to the club, (ii) an ideal club size of ≥20 members, (iii) club services led by a counsellor (iv) using churches or community halls as venues (v) effective communication between all parties, and (vi) timely delivery of prepacked medication. CONCLUSIONS:This study showed good clinical outcomes, positive patient experiences and healthcare worker perceptions of the adherence club model. Factors associated with successful adherence club implementation, highlighted in this study, can be used to guide implementers in the scale-up of adherence club services across varied high-burden settings.

Project description:IntroductionIn 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.MethodsA 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 discussionThe 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.ConclusionsThe 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.

Dataset Information

Twenty-four-month outcomes from a cluster-randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs.

Introduction

Methods

Results

Conclusions

Publications

Twenty-four-month outcomes from a cluster-randomized controlled trial of extending antiretroviral therapy refills in ART adherence clubs.

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