NCT03995953Completed
Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia
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
Source: ClinicalTrials.gov · Last updated 15 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 2150 (actual)
- First submitted
- 21 Jun 2019
- Start date
- 10 May 2021
- Primary completion date
- 11 Mar 2024
- Lead sponsor
- RTI International
- Diseases
- HIV
- NCT number
- NCT03995953
What you commit to
- Study type: Interventional
- Participants enrolled: 2150
- From 10 May 2021 to the primary completion date, 11 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- pregnant
Who the study is looking for
- HIV negative or unknown cohort
- Female
- 10 to 20 years of age
- self-report HIV status as negative or unknown (no HIV testing within the past 6 months
- not pregnant, does not suspect pregnancy, and does not express a desire to become pregnant over the next 18 months
- is willing to sign a release for medical records (to obtain clinic data on service use)
- plans to reside in the current location for the next 18 months
- has not been part of the other planned formative research activities
- HIV positive cohort
- Female
- 16 to 24 years of age
- diagnosed with HIV within the past 3 years or newly diagnosed at the time of the study
- not pregnant, does not suspect pregnancy, and does not express a desire to become pregnant over the next 18 months
- is willing to sign a release for medical records (to obtain clinic data on service use)
- plans to reside in the current location for the next 18 months
- has not been part of the other planned formative research activities
Age in the registry: 10 years to 24 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Population Council Coordinator of this site? Confirm its status | Lusaka | Zambia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.