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

<h4>Background</h4>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...

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Main Authors: Monika Roy, Carolyn Bolton-Moore, Izukanji Sikazwe, Mpande Mukumbwa-Mwenechanya, Emilie Efronson, Chanda Mwamba, Paul Somwe, Estella Kalunkumya, Mwansa Lumpa, Anjali Sharma, Jake Pry, Wilbroad Mutale, Peter Ehrenkranz, David V Glidden, Nancy Padian, Stephanie Topp, Elvin Geng, Charles B Holmes
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2020-07-01
Series:PLoS Medicine
Online Access:https://doi.org/10.1371/journal.pmed.1003116
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author Monika Roy
Carolyn Bolton-Moore
Izukanji Sikazwe
Mpande Mukumbwa-Mwenechanya
Emilie Efronson
Chanda Mwamba
Paul Somwe
Estella Kalunkumya
Mwansa Lumpa
Anjali Sharma
Jake Pry
Wilbroad Mutale
Peter Ehrenkranz
David V Glidden
Nancy Padian
Stephanie Topp
Elvin Geng
Charles B Holmes
author_facet Monika Roy
Carolyn Bolton-Moore
Izukanji Sikazwe
Mpande Mukumbwa-Mwenechanya
Emilie Efronson
Chanda Mwamba
Paul Somwe
Estella Kalunkumya
Mwansa Lumpa
Anjali Sharma
Jake Pry
Wilbroad Mutale
Peter Ehrenkranz
David V Glidden
Nancy Padian
Stephanie Topp
Elvin Geng
Charles B Holmes
author_sort Monika Roy
collection DOAJ
description <h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT02776254.
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spelling doaj.art-7527a5b309f1466c99980f1029aa78202022-12-22T04:36:27ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762020-07-01177e100311610.1371/journal.pmed.1003116Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.Monika RoyCarolyn Bolton-MooreIzukanji SikazweMpande Mukumbwa-MwenechanyaEmilie EfronsonChanda MwambaPaul SomweEstella KalunkumyaMwansa LumpaAnjali SharmaJake PryWilbroad MutalePeter EhrenkranzDavid V GliddenNancy PadianStephanie ToppElvin GengCharles B Holmes<h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov NCT02776254.https://doi.org/10.1371/journal.pmed.1003116
spellingShingle Monika Roy
Carolyn Bolton-Moore
Izukanji Sikazwe
Mpande Mukumbwa-Mwenechanya
Emilie Efronson
Chanda Mwamba
Paul Somwe
Estella Kalunkumya
Mwansa Lumpa
Anjali Sharma
Jake Pry
Wilbroad Mutale
Peter Ehrenkranz
David V Glidden
Nancy Padian
Stephanie Topp
Elvin Geng
Charles B Holmes
Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.
PLoS Medicine
title Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.
title_full Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.
title_fullStr Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.
title_full_unstemmed Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.
title_short Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.
title_sort participation in adherence clubs and on time drug pickup among hiv infected adults in zambia a matched pair cluster randomized trial
url https://doi.org/10.1371/journal.pmed.1003116
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