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BMC Health Services Research
Published in: BMC Health Services Research 1/2017

Open Access 01-12-2017 | Study protocol

The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania

Authors: Pascal Geldsetzer, Joel M. Francis, Nzovu Ulenga, David Sando, Irene A. Lema, Eric Mboggo, Maria Vaikath, Happiness Koda, Sharon Lwezaula, Janice Hu, Ramadhani A. Noor, Ibironke Olofin, Elysia Larson, Wafaie Fawzi, Till Bärnighausen

Published in: BMC Health Services Research | Issue 1/2017

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Abstract

Background

Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) may improve ART retention by reducing the time burden and out-of-pocket expenditures to regularly attend an ART clinic. In addition, ART home delivery may shorten waiting times and improve quality of care for those in facility-based care by decongesting ART clinics. This trial aims to determine whether ART home delivery for patients who are clinically stable on ART combined with facility-based care for those who are not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression.

Methods

This is a non-inferiority cluster-randomized trial set in Dar es Salaam, Tanzania. A cluster is one of 48 healthcare facilities with its surrounding catchment area. 24 clusters were randomized to ART home delivery and 24 to the standard of care. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART and CHW home visits without ART home delivery). In addition, half of the healthcare facilities in each study arm were randomized to standard counseling during home visits (covering family planning, prevention of HIV transmission, and ART adherence), and half to standard plus nutrition counseling (covering food production and dietary advice). The non-inferiority design applies to the endpoints of the ART home delivery trial; the primary endpoint is the proportion of ART patients at a healthcare facility who are virally suppressed at the end of the study period. The margin of non-inferiority for this primary endpoint was set at nine percentage points.

Discussion

As the number of ART patients in sub-Saharan Africa is expected to rise, this trial provides causal evidence on the effectiveness of a home-based care model that could decongest ART clinics and reduce patients’ healthcare expenditures. More broadly, this trial will inform the increasing policy interest in task-shifting of chronic disease care from facility- to community-based healthcare workers.

Trial registration

ClinicalTrials.gov: NCT02711293. Registration date: 16 March 2016.
Appendix
Available only for authorised users
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Metadata
Title
The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania
Authors
Pascal Geldsetzer
Joel M. Francis
Nzovu Ulenga
David Sando
Irene A. Lema
Eric Mboggo
Maria Vaikath
Happiness Koda
Sharon Lwezaula
Janice Hu
Ramadhani A. Noor
Ibironke Olofin
Elysia Larson
Wafaie Fawzi
Till Bärnighausen
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2017
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/s12913-017-2032-7

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