CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,150 enrolled
Drug / intervention
SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03995953
NCT03995953N/ACompleted

Developing and Testing a Multi-level Package of Interventions for an Integrated Care Delivery Model of HIV Prevention and Treatment Targeting Adolescent Girls in Zambia

RTI International·interventional·Posted Jun 24, 2019·Updated Sep 15, 2025

In Brief

A clinical study evaluating SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization) and Integrated wellness care (IWC) clinics for HIV. Completed, enrolled 2,150 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV
CountriesZambia

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 24, 2019
Enrollment StartMay 10, 2021
Primary CompletionMar 11, 2024
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.0 years ago

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) clinicsother

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.