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

Not Applicable

Completed

Conditions: HIV

Registration Number: NCT03995953

Lead Sponsor: RTI International

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.

AGYW will be encouraged to select caregivers who will participate in some of the education sessions. The role of the caregiver is to support AGYW. Primary and secondary outcomes will be reported for AGYW only.

Data collection will use electronic tablets with pre-loaded software and instruments in multiple languages. Voice-enabled components and self-administration options will be available for sensitive questions. Instruments will be pretested with AGYW and caregivers. The study team will abstract data from clinic records with support from the Zambian Ministry of Health, conducting pilot data abstraction and staff training to ensure high-quality data for the study.

Key aspects of the intervention include tailored education modules for AGYW and caregivers, youth clubs led by peer navigators, and integrated wellness clinics offering comprehensive sexual and reproductive health services.

The SHIELD study aims to improve HIV prevention and care for AGYW in Zambia by addressing knowledge, skills, self-efficacy, social support, and healthcare access through a comprehensive, theory-based intervention. By combining education, social support, and improved healthcare services, the researchers hope to make significant strides in reducing HIV transmission and improving health outcomes for adolescent girls and young women in Zambia.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 2150

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HIV Testing	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	12 months	Proportion of cohort not living with HIV that self reported being tested for HIV in past 6 months.
Retention in Care	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	At 12 months since study initiation	Proportion of cohort living with HIV who had an undetectable (less than 40 copies/mL) viral load

Secondary Outcome Measures

Name	Time	Method
HIV Risk Behavior - Delay in First Intercourse	12 months	HIV-/u self reported age of first intercourse.
HIV Risk Behavior - Reduction in Sexual Partners	12 months	Self-reported number of casual partners in last 3 months among HIV-/u cohort.
HIV Risk Behavior - Increases in Condom Use	12 months	HIV-/u AGYW who reported always using condoms with casual partners in past 3 months.
HIV Early Detection	12 months	HIV-/u proportion with HIV identified through voluntary testing.
Linkages to HIV Care - Enrollment at HIV Clinic	12 months	Proportion enrolled at an HIV clinic in ≤ 30 days
Linkages to HIV Care - ART Initiation	12 months	Proportion with ART initiated in ≤ 90 days
Adherence to ART	12 months	AGYW living with HIV who self-reported "Excellent" medication adherence.