High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya — GIRLS  

HIV Clinical Trial

Official title: High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS)

Status Completed

Clinical Trial Summary

Knowledge of HIV status is a first step towards accessing HIV care, treatment, and prevention services.The GIRLS study will rigorously compare two 'seek' recruitment strategies, three 'test' strategies, and two enhancements to an adaptive (SMART trial design) 'linkage' to care intervention, among young at-risk women, 15-24 years old, in Homa Bay County, western Kenya. Additionally, we will evaluate a scalable primary prevention messaging intervention to support identified HIV-negative young women in reducing HIV risk and adhering to recommended HIV re-testing recommendations. We will also conduct an economic evaluation, using cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention interventions.

Lessons learned will inform Government of Kenya, and other key policymakers, implementing partners and agencies throughout sub-Saharan Africa that are exploring policies about appropriate scale up of these multiple seek, test, link, retain, and prevention strategies to realize the dream of an AIDS-free future for adolescent girls and young women.

Clinical Trial Description

The GIRLS study will inform best practices to increase adolescent girls and young women's uptake of HIV prevention, testing, and linkage for HIV to care services in a high-HIV burden African setting to optimize engagement in both the HIV prevention and care continua.

Aim 1: To determine the preferred recruitment venue and testing modality that targets and finds the highest number of HIV infected and at risk female youth aged 15-24 years in Homa Bay County, Nyanza region, western Kenya.

• This will be determined by examining the uptake and yield of previously undiagnosed HIV infection of the two (2) 'seek' strategies (community or home-based) and the three (3) 'test' strategies (self-testing, HIV testing services (HTS) in a home/mobile setting, or facility-based HTS) among female youth;

Aim 2: (a) To pilot and evaluate an adaptive intervention to link newly diagnosed HIV-positive female youth to treatment and care services; and (b) To identify barriers and facilitators to seeking HIV care services after receiving a positive diagnosis; (c) To identify barriers and facilitators to seeking HIV prevention services for high risk female youth after receiving a negative HIV test result; (d) To provide an HIV prevention intervention to a randomly selected subset of high risk negatives, and to re-test them; and

Aim 3: To conduct an economic evaluation, using cost effectiveness analyses to determine the relative utility of each seek, test, link, and prevention intervention. ;

Related Conditions & MeSH terms

• Adolescent Behavior
• HIV

• NCT number: NCT02735642
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Completion date: June 30, 2019