Antiretroviral treatment adherence club drop-out rates were significantly higher for people attending community-based clubs compared to clinic-based clubs, reveals a study from South Africa. Overall, loss from adherence clubs was high at 47%, but clinic-based clubs had less loss to follow-up, at 43% compared to 52% in the community.
In this randomised control trial, patients living with HIV at the Witkoppen Health and Welfare Centre in Johannesburg, South Africa who had been virally suppressed for at least 12 months were assigned to an adherence club based either in-clinic or in the community.
Adherence clubs were designed as a task-shifting initiative to relieve the burden on clinicians. Patients who are stable on their ART meet with lower skilled healthcare workers in groups in order to allow clinicians to handle more complex patients such as those newly starting ART.
From February 2014 to May 2015, 775 eligible adults were put into 12 pairs of clubs—376 (49%) into clinic-based clubs and 399 (51%) into community-based clubs. The median age across both groups was 38 years old, 65% were female, and the median CD4 count was 506 cells/mm.
Adherence clubs were held every other month. These included 25 to 30 people and consisted of an hour-long discussion around an adherence-related topic that was led by a lay counsellor. Attendees collected their two-monthly supply of ART, were weighed and screened for signs of TB and other conditions. At the six-month interval, a nurse would collect blood for viral load and rescript medicine where necessary. Patients could pre-select a buddy to pick-up their medication for them, and on a limited basis could pick up medication five days after the session on days they could not attend.
Clinic-based clubs were held at a meeting space separate from where clinical exam rooms were located at the Witkoppen clinic. Community-based clubs were held at community venues within the pre-selected area of residence, including community-based organisation facilities, churches, and community centres.
The primary outcome was loss from club-based care. Participants were referred back to regular clinical consultations instead of club-based care, if they met any of the following conditions: two consecutive buddy pickups in a row (where a friend picks up their medication), two consecutive late medication pickups, three late pickups in 12 months, missing a medication pickup entirely, becoming pregnant, TB diagnosis, requiring treatment for another condition, ART regimen change for any reason, and viral rebound.
After adjusting for sex, age, nationality, time on ART, baseline CD4 count, and employment status, those in the community arm were 1.38 times more likely to be loss to follow-up compared to clinic-based care. Among those lost to care, the most common reason was missing a club visit and ART pickup. This was insignificantly higher in the community arm.
Among those who were lost to care, 72% did re-engage after three months, the authors note, “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 de-congesting busy clinics and streamlining patient care are the primary goals of adherence clubs.”
Adherence clubs are designed to keep people living with HIV engaged in their HIV care and sticking to their drug-taking regime. In low-resourced contexts, they help lessen the burden on clinics and healthcare workers, as people responding well to their treatment and going to adherence clubs only need to attend an annual clinical health check.
Community-based initiatives are recommended by the World Health Organisation (WHO) as an innovative care model, but until now it was unknown whether community or clinic-based adherence clubs offer comparable effectiveness in terms of retention in care and viral suppression, or if they are acceptable to patients.
“We urge caution in assuming that the effectiveness of clinic-based interventions will carry over to the community setting, without a better understanding of patient-level factors associated with loss from care,” remarked the investigators in their conclusion, “examining the outcome of loss from club-based care rather than just loss from ART care is essential to understanding the value of these and future interventions designed to provide differentiated care to people living with HIV.”
Abstract
Background: Adherence 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 findings: Patients 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.
Conclusions: These 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.
Authors
Colleen F Hanrahan, Sheree R Schwartz, Mutsa Mudavanhu, Nora S West, Lillian Mutunga, Valerie Keyser, Jean Bassett, Annelies van Rie
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[link url="https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002808"]PLOS Medicine abstract[/link]