Adherence clubs and decentralized medication delivery to support patient retention and sustained viral suppression in care: Results from a cluster-randomized evaluation of differentiated ART delivery models in South Africa

Abstract

Background Differentiated 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 findings We 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. Conclusions In this study, we found comparable DMD outcomes versus standard ...

Retention in care and viral suppression in differentiated service delivery models for HIV treatment delivery in sub‐Saharan Africa: a rapid systematic review

“…For example client‐led groups have model IDs CLG1 through CLG5, indicating that there were five distinct CLG models identified. In one instance (HCWLG11), the same model is referred to in more than one source document [23,24].…”

“…Most of the remaining studies (n = 6) were randomized controlled trials, for which we assessed quality using the Cochrane Collaboration’s tool for assessing risk of bias cluster randomized trials (Table )[21]. All three full‐length articles (four models) were at low risk for bias [24,26,36] but a concern about bias applied to the two abstracts, driven mainly by the fact that the conference abstracts did not contain full information on study methodology [40,49].…”

Community-based antiretroviral therapy versus standard clinic-based services for HIV in South Africa and Uganda (DO ART): a randomised trial

“…24 If clients are transferred to ART refills outside the clinic (eg, decentralised dispensing, adherence groups, community, and home) compared with clinic ART, they remained virally supressed. [25][26][27] Offering convenient locations and times after hours and on weekends, being flexible to meet travel or mobility needs, offering quarterly refills, and streamlining monitoring and resupply had better viral suppression outcomes, especially for men.…”

Leaving No Man Behind: How Differentiated Service Delivery Models Increase Men’s Engagement in HIV Care

“…The adherence club model was designed to decongest the healthcare facilities of PLHIV on ART and to encourage peer support among patients. The adherence club model groups stable patients (15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) who meet and get antiretroviral supply every 2 months. 31 The groups are facilitated by a lay health worker who provides counselling and education sessions where patients discuss various issues for social-support, weighs the patients and give them pre-packed medication.…”