Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 1, 2019
Open Peer Review Period: Jul 2, 2019 - Jul 9, 2019
Date Accepted: Aug 17, 2019
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Integrated care delivery of HIV prevention and treatment in adolescent girls and young women in Zambia: a cluster randomized controlled trial
ABSTRACT
Background:
Zambia is among countries in sub-Sahara African countries with one of the highest incidences of HIV, and adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability. The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia to connect AGYW with a source of regular care to provide a sustainable platform for successful implementation of regular HIV testing and adherence to antiretroviral treatment. Methods/Design: We will adapt prior tools to create the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower Zambian AGYW of ages 10-24 years and their families, and to create community-based youth clubs to foster peer support. We will also develop the integrated wellness care (IWC) clinics to offer a youth-friendly environment to provide tailored clinical services. Formative research, including focus groups and in-depth interviews, will be performed among AGYW, caregivers, and stakeholders to help inform the development and tailoring of the interventions. A cluster randomized controlled trial will be implemented in Lusaka with 6 clinic catchment areas randomized into 3 groups: zones with IWC clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. HIV testing will be assessed among the HIV negative or unknown (HIV-/u) cohort and retention in care along with viral load suppression will be evaluated in the HIV positive (HIV+) cohort. In-depth interviews and surveys will be used to gather staff and stakeholder feedback following the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model. Discussion: If this multilevel intervention is successful in establishing a comprehensive care continuum for HIV-affected AGYW, the Zambian Ministry of Health may advocate for expansion to additional settings to support national scale-up. This integrated service delivery model can also serve as a platform to implement additional preventive services to provide comprehensive and integrated services to HIV-/u and HIV+ AGYW.
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