Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia

Sponsor
RTI International
Study ID
NCT03995953
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
10 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

  • SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) — BEHAVIORAL
    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.
  • Integrated wellness care (IWC) clinics — OTHER
    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.

Study Details

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.

Key Dates

Start date
May 10, 2021
Status verified
Apr 2025
Primary completion
Mar 11, 2024
Completion
Mar 11, 2024

Study Design

Enrollment
2,150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Control
    2 control clinics, and their associated catchment areas, with no intervention at the clinic or community level
  • Experimental: SHIELD: Community-based behavioral intervention
    2 clinics, and their associated catchment areas, where participants attend modules designed to educate and empower adolescent girls and young women (AGYWs) and their caregivers, along with attendance at community-based youth clubs to foster peer support.
  • Experimental: SHIELD: Community- based behavioral intervention & IWC Clinic
    2 clinics, and their associated catchment areas, where participants and their caregivers receive the Support for HIV Integrated Education, Linkages to care, and Destigmatization (SHIELD) intervention along with the coupled benefits of having an integrated wellness care (IWC) clinic within health facilities where adolescent girls and young women (AGYWs) can receive sexual and reproductive health services, including HIV testing and treatment, family planning, sexually transmitted disease screening and treatment, and human papilloma virus (HPV) vaccination.

Primary Outcome Measure

HIV Testing [ Time Frame: 6 months ]

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