Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial


Autoři: Monika Roy aff001;  Carolyn Bolton-Moore aff002;  Izukanji Sikazwe aff002;  Mpande Mukumbwa-Mwenechanya aff002;  Emilie Efronson aff002;  Chanda Mwamba aff002;  Paul Somwe aff002;  Estella Kalunkumya aff002;  Mwansa Lumpa aff002;  Anjali Sharma aff002;  Jake Pry aff002;  Wilbroad Mutale aff002;  Peter Ehrenkranz aff005;  David V. Glidden aff001;  Nancy Padian aff006;  Stephanie Topp aff007;  Elvin Geng aff001;  Charles B. Holmes aff008
Působiště autorů: University of California, San Francisco, San Fancisco, California, United States of America aff001;  Centre for Infectious Disease Research in Zambia, Lusaka, Zambia aff002;  University of Alabama, Tuscaloosa, Alabama, United States of America aff003;  University of California, Davis, Davis, California, United States of America aff004;  Bill and Melinda Gates Foundation, Seattle, Washington, United States of America aff005;  University of California, Berkeley, Berkeley, California, United States of America aff006;  James Cook University, Townsville, Queensland, Australia aff007;  Johns Hopkins University, Baltimore, Maryland, United States of America aff008;  Center for Global Health Practice and Impact, Georgetown University School of Medicine, Washington, District of Columbia, United States of America aff009
Vyšlo v časopise: Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial. PLoS Med 17(7): e32767. doi:10.1371/journal.pmed.1003116
Kategorie: Research Article
doi: 10.1371/journal.pmed.1003116

Souhrn

Background

Current models of HIV service delivery, with frequent facility visits, have led to facility congestion, patient and healthcare provider dissatisfaction, and suboptimal quality of services and retention in care. The Zambian urban adherence club (AC) is a health service innovation designed to improve on-time drug pickup and retention in HIV care through off-hours facility access and pharmacist-led group drug distribution. Similar models of differentiated service delivery (DSD) have shown promise in South Africa, but observational analyses of these models are prone to bias and confounding. We sought to evaluate the effectiveness and implementation of ACs in Zambia using a more rigorous study design.

Methods and findings

Using a matched-pair cluster randomized study design (ClinicalTrials.gov: NCT02776254), 10 clinics were randomized to intervention (5 clinics) or control (5 clinics). At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC. Clinical and antiretroviral drug pickup data were obtained through the existing electronic medical record. AC meeting attendance data were collected at intervention facilities prospectively through October 28, 2017. The primary outcome was time to first late drug pickup (>7 days late). Intervention effect was estimated using unadjusted Kaplan–Meier survival curves and a Cox proportional hazards model to derive an adjusted hazard ratio (aHR). Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity) were additionally evaluated as secondary outcomes. Baseline characteristics were similar between 571 intervention and 489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female), median time since ART initiation (4.8 versus 5.0 years), median CD4 count at study enrollment (506 versus 533 cells/mm3), and baseline retention (53% versus 55% with at least 1 late drug pickup in previous 12 months). The rate of late drug pickup was lower in intervention participants compared to control participants (aHR 0.26, 95% CI 0.15–0.45, p < 0.001). Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001). Although 18% (683/3,734) of AC group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% (350/683) of these missed visits through alternate means (use of buddy pickup or early return to the facility). Qualitative evaluation suggests that the intervention was acceptable to both patients and providers. While patients embraced the convenience and patient-centeredness of the model, preference for traditional adherence counseling and need for greater human resources influenced intervention appropriateness and feasibility from the provider perspective. The main limitations of this study were the small number of clusters, lack of viral load data, and relatively short follow-up period.

Conclusions

ACs were found to be an effective model of service delivery for reducing late ART drug pickup among HIV-infected adults in Zambia. Drug pickup outside of group meetings was relatively common and underscores the need for DSD models to be flexible and patient-centered if they are to be effective.

Trial registration

ClinicalTrials.gov NCT02776254.

Klíčová slova:

Antiretroviral therapy – Drug adherence – Drug delivery – Employment – HIV – Patients – South Africa – Zambia


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