N/A
Completed N=2,150
Integrated Care Delivery of HIV Prevention and Treatment in AGYW in Zambia
Source: ClinicalTrials.gov NCT03995953 ↗Enrolled (actual)
2,150
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: HIV Testing — 33; 52; 139 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HIV Testing |
33; 52; 139 | — |
| PRIMARY HIV-/u Proportion Tested for HIV in the Past 6 Months |
40; 95; 125 | — |
| PRIMARY Retention in Care |
— | — |
| PRIMARY HIV+ Proportion With Undetectable Viral Load at 12 Months |
99; 74; 76 | — |
| SECONDARY HIV Risk Behavior - Delay in First Intercourse |
17.22; 17.20; 17.28 | — |
| SECONDARY HIV Risk Behavior - Reduction in Sexual Partners |
1.09; 1.15; 1.14 | — |
| SECONDARY HIV Risk Behavior - Increases in Condom Use |
2; 5; 7 | — |
| SECONDARY HIV Early Detection |
2; 2; 1 | — |
| SECONDARY Linkages to HIV Care - Enrollment at HIV Clinic |
— | — |
| SECONDARY Linkages to HIV Care - ART Initiation |
— | — |
| SECONDARY Adherence to ART |
71; 71; 84 | — |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
- pregnant
Data sourced from ClinicalTrials.gov (NCT03995953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.