Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia
NCT03995953 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2150
Last updated 2025-09-15
Summary
The study team will test a multilevel package of interventions to connect adolescent girls and young women (AGYW) with a source of regular care to provide a sustainable platform for successful implementation of regular human immunodeficiency virus (HIV) testing and support for linkage to care, retention in care, and adherence to antiviral treatment. Interventions will include integrated wellness care (IWC) clinics and the SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) to educate and empower AGYW and their families, and to create community-based youth clubs to foster peer support. A cluster randomized controlled trial will be implemented where AGYW participants, stratified by age group and HIV status, will be randomized based on their residence within the six study clinic catchment areas, into the following intervention arms: no intervention, the SHIELD intervention, and the SHIELD intervention and IWC clinics.
Conditions
Interventions
- BEHAVIORAL
-
SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization)
The SHIELD intervention includes a three-session, six-module program for AGYW that increases knowledge, skills, and self-efficacy to engage along the HIV prevention and care continuum, and a two-session, four-module program for caregivers to increase social support. In addition, the SHIELD intervention includes youth clubs to foster peer support.
- OTHER
-
Integrated wellness care (IWC) clinics
IWC clinics will be created within health facilities where AGYWs can receive sexual and reproductive health services, including HIV testing and treatment, family planning, sexually transmitted disease screening and treatment, and HPV vaccination in a youth-friendly environment.
Sponsors & Collaborators
-
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
Population Council
collaborator OTHER -
University of North Carolina, Chapel Hill
collaborator OTHER -
RTI International
lead OTHER
Principal Investigators
-
Sujha Subramanian, PhD · Implenomics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 10 Years
- Max Age
- 24 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-10
- Primary Completion
- 2024-03-11
- Completion
- 2024-03-11
Countries
- Zambia
Study Locations
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