Integrated Care Delivery for HIV Prevention and Treatment in Adolescent Girls and Young Women in Zambia: Protocol for a Cluster-Randomized Controlled Trial

Sujha Subramanian, Patrick Edwards, Sarah T Roberts, Maurice Musheke, Michael Mbizvo, Sujha Subramanian, Patrick Edwards, Sarah T Roberts, Maurice Musheke, Michael Mbizvo

Abstract

Background: Among countries in sub-Saharan Africa, Zambia has one of the highest incidences of HIV. Adolescent girls and young women (AGYW) are a particularly affected group because of their social and economic vulnerability.

Objective: The goal of this study is to test a multilevel package of interventions at the community and health system levels in Zambia in order to connect AGYW with a source of regular care, which will in turn allow for sustainable, successful implementation of regular HIV testing and adherence to antiretroviral treatment.

Methods: We will adapt prior tools to create the SHIELD (Support for HIV Integrated Education, Linkages to Care, and Destigmatization) intervention to educate and empower Zambian AGYW of 10-24 years of age and their families and to create community-based youth clubs to foster peer support. We will also develop integrated wellness care clinics to offer a youth-friendly environment that provides tailored clinical services. We will perform formative research, including focus groups and in-depth interviews, 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 six clinic catchment areas randomized into three groups: zones with integrated wellness care clinics and SHIELD intervention, zones with only SHIELD intervention, and control zones with no intervention. We will assess HIV testing 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. We will use in-depth interviews and surveys to collect staff and stakeholder feedback after the trial. Cost-effectiveness of the interventions and return-on-investment impacts will be quantified using a microsimulation model.

Results: Interim results are expected in 2021, and the final results are expected in 2022. 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.

Conclusions: This integrated service delivery model can also be a platform to implement additional preventive services, so HIV-/u and HIV+ AGYW can receive comprehensive, integrated services.

Trial registration: ClinicalTrials.gov NCT03995953; https://ichgcp.net/clinical-trials-registry/NCT03995953.

International registered report identifier (irrid): PRR1-10.2196/15314.

Keywords: HIV; Zambia; adolescent girls and young women; prevention; treatment.

Conflict of interest statement

Conflicts of Interest: None declared.

©Sujha Subramanian, Patrick Edwards, Sarah T Roberts, Maurice Musheke, Michael Mbizvo. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 03.10.2019.

Figures

Figure 1
Figure 1
Conceptual framework for creating a comprehensive care continuum for HIV-affected adolescent girls and young women. HIV-/u: HIV-negative or unknown; SHIELD: Support for HIV Integrated Education, Linkages to Care, and Destigmatization; IWC: integrated wellness care; ART: antiretroviral therapy.
Figure 2
Figure 2
Experimental design and sample sizes. AGYW: adolescent girls and young women; SHIELD: Support for HIV Integrated Education, Linkages to Care, and Destigmatization; IWC: integrated wellness care.
Figure 3
Figure 3
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) flow diagram of the cluster-randomized controlled trial. IWC: integrated wellness care; SHIELD: Support for HIV Integrated Education, Linkages to Care, and Destigmatization.

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