Date Published: May 21, 2019
Publisher: Public Library of Science
Author(s): Colleen F. Hanrahan, Sheree R. Schwartz, Mutsa Mudavanhu, Nora S. West, Lillian Mutunga, Valerie Keyser, Jean Bassett, Annelies Van Rie, Marie-Louise Newell
Abstract: BackgroundAdherence clubs, where groups of 25–30 patients who are virally suppressed on antiretroviral therapy (ART) meet for counseling and medication pickup, represent an innovative model to retain patients in care and facilitate task-shifting. This intervention replaces traditional clinical care encounters with a 1-hour group session every 2–3 months, and can be organized at a clinic or a community venue. We performed a pragmatic randomized controlled trial to compare loss from club-based care between community- and clinic-based adherence clubs.Methods and findingsPatients on ART with undetectable viral load at Witkoppen Health and Welfare Centre in Johannesburg, South Africa, were randomized 1:1 to a clinic- or community-based adherence club. Clubs were held every other month. All participants received annual viral load monitoring and medical exam at the clinic. Participants were referred back to clinic-based standard care if they missed a club visit and did not pick up ART medications within 5 days, had 2 consecutive late ART medication pickups, developed a disqualifying (excluding) comorbidity, or had viral rebound. From February 12, 2014, to May 31, 2015, we randomized 775 eligible adults into 12 pairs of clubs—376 (49%) into clinic-based clubs and 399 (51%) into community-based clubs. Characteristics were similar by arm: 65% female, median age 38 years, and median CD4 count 506 cells/mm3. Overall, 47% (95% CI 44%–51%) experienced the primary outcome of loss from club-based care. Among community-based club participants, the cumulative proportion lost from club-based care was 52% (95% CI 47%–57%), compared to 43% (95% CI 38%–48%, p = 0.002) among clinic-based club participants. The risk of loss to club-based care was higher among participants assigned to community-based clubs than among those assigned to clinic-based clubs (adjusted hazard ratio 1.38, 95% CI 1.02–1.87, p = 0.032), after accounting for sex, age, nationality, time on ART, baseline CD4 count, and employment status. Among those who were lost from club-based care (n = 367), the most common reason was missing a club visit and the associated ART medication pickup entirely (54%, 95% CI 49%–59%), and was similar by arm (p = 0.086). Development of an excluding comorbidity occurred in 3% overall of those lost from club-based care, and was not different by arm (p = 0.816); no deaths occurred in either arm during club-based care. Viral rebound occurred in 13% of those lost from community club-based care and 21% of those lost from clinic-based care (p = 0.051). In post hoc secondary analysis, among those referred to standard care, 72% (95% CI 68%–77%) reengaged in clinic-based care within 90 days of their club-based care discontinuation date. The main limitations of the trial are the lack of a comparison group receiving routine clinic-based standard care and the potential limited generalizability due to the single-clinic setting.ConclusionsThese findings demonstrate that overall loss from an adherence club intervention was high in this setting and that, importantly, it was worse in community-based adherence clubs compared to those based at the clinic. We urge caution in assuming that the effectiveness of clinic-based interventions will carry over to community settings, without a better understanding of patient-level factors associated with successful retention in care.Trial registrationPan African Clinical Trials Registry (PACTR201602001460157).
Partial Text: World Health Organization (WHO) recommendations for universal antiretroviral therapy (ART) for all people living with HIV regardless of level of immunosuppression have been recently implemented across many high-HIV-burden countries [1,2]. Although intended to provide health benefits at the individual level as well as reduce population-level HIV transmission, this policy may also have the unintended consequence of overburdening already taxed or weak health systems, particularly in low-resourced, high-burden settings. Adherence clubs for clinically stable ART patients have been implemented in some settings to promote task-shifting to lower skilled healthcare workers in order to allow clinicians to handle more complex patients such as those newly initiating ART and those with more complex needs (e.g., comorbidities) . Adherence clubs are groups of 20–30 patients who meet for counseling and ART medication pickup; club visits last approximately 1 hour and occur every 2 to 3 months, with patients also annually having an individual clinician consultation. In addition to decongesting busy clinics, adherence clubs represent a streamlined care experience for people living with HIV that reduces the time spent accessing care [4–6]. Three large observational cohort studies have demonstrated that adherence clubs promote retention in care and viral suppression compared to the clinic-based standard of care [7–9].
Findings from this pragmatic randomized controlled trial demonstrate that loss from an adherence club intervention for stable patients on ART in South Africa was high overall, with only 53% of all participants virally suppressed and retained in club care at 24 months following the first club visit. Importantly, loss from club-based care was significantly higher among those in community-based clubs (52%) compared to those in clubs based within the clinic (43%). Although the majority (72%) of adherence club participants who were referred back to clinic-based standard care reengaged in care within 90 days, the disparity between participants in community- versus clinic-based clubs persisted when considering the outcome of 24-month loss from any kind of ART care. Such poor adherence club retention, where nearly half of those receiving the intervention were referred back into routine clinic-based care, cannot be considered a success, particularly given that decongesting busy clinics and streamlining patient care are the primary goals of adherence clubs.