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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RTI International
- Enrollment
- 2,150
- Locations
- 1
- Primary Endpoint
- HIV Testing
Study Overview
Brief 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.
Detailed Description
The SHIELD intervention aims to improve HIV prevention and care for adolescent girls and young women (AGYW) in Zambia. It is based on social cognitive theory and includes a program for AGYW to increase knowledge, skills, and self-efficacy, as well as a program for family members to increase social support. The intervention also incorporates youth clubs facilitated by peer navigators and integrated wellness clinics (IWC) for sexual and reproductive health services. It will be tailored for five distinct groups based on age and HIV status, with modules covering HIV prevention and treatment, wellness, sexual health, stigma reduction, and healthcare access.
IWC clinics will be established in existing government health facilities, following a model similar to cervical cancer screening clinics. Standard operating procedures (SOPs) will be developed for HIV, HPV vaccination, and sexual and reproductive health services.
Time and motion methodology will monitor AGYW clinic visits to identify areas for improvement. To establish a sampling frame, the study team will identify six clinics in Lusaka, map neighborhoods within the selected clinic catchment areas, and recruit AGYW through household visits by peer navigators.
The HIV-/u cohort will include females aged 10-20 years with self-reported HIV-negative or unknown status. They must not be pregnant or planning pregnancy, be willing to sign a medical records release, plan to reside in the area for 18 months, and not be part of other formative research activities. The study will recruit 1,000 HIV-/u AGYW, with equal numbers in age ranges 10-12, 13-15, and 16-20.
The HIV+ cohort will consist of females aged 16-24 years, diagnosed with HIV within the past 3 years, and meeting the same additional criteria as the HIV-/u cohort. The study will enroll 800 HIV+ AGYW, with equal representation among 16-20 and 21-24 age groups.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 24 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HIV negative or unknown cohort
- •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
- •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
- Not provided
Outcomes
Primary Outcomes
HIV Testing
Time Frame: 6 months
Proportion of cohort not living with HIV that self-reported being tested for HIV in the past 6 months.
HIV-/u Proportion Tested for HIV in the Past 6 Months
Time Frame: 12 months
Proportion of cohort not living with HIV that self reported being tested for HIV in past 6 months.
Retention in Care
Time Frame: 12 months
HIV+ cohort proportion with at least one visit during the 12-months follow-up. Data were not collected from any participant due to COVID 19 pandemic and associated restrictions, and will not be collected in the future.
HIV+ Proportion With Undetectable Viral Load at 12 Months
Time Frame: At 12 months since study initiation
Proportion of cohort living with HIV who had an undetectable (less than 40 copies/mL) viral load
Secondary Outcomes
- Adherence to ART(12 months)
- HIV Risk Behavior - Delay in First Intercourse(12 months)
- HIV Risk Behavior - Reduction in Sexual Partners(12 months)
- HIV Risk Behavior - Increases in Condom Use(12 months)
- HIV Early Detection(12 months)
- Linkages to HIV Care - Enrollment at HIV Clinic(12 months)
- Linkages to HIV Care - ART Initiation(12 months)
- Adherence to ART(12 months)