CompletedNot Applicable

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

Zambia2,150 participantsStarted 2021-05-10

Plain-language 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.

Who can participate

Age range10 Years – 24 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

HIV Testing

Timeframe: 6 months

HIV-/u Proportion Tested for HIV in the Past 6 Months

Timeframe: 12 months

Retention in Care

Timeframe: 12 months

HIV+ Proportion With Undetectable Viral Load at 12 Months

Timeframe: At 12 months since study initiation

Trial details

NCT IDNCT03995953

SponsorRTI International

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-11

Results submitted2024-11-13