High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya
Condition: HIV; Adolescent Behavior
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): SMART Randomization 1 - Referral; SMART Randomization 1 - Referral and SMS; SMART Randomization 2 - SMS; SMART Randomization 2 - Incentive; High Risk Negative Cohort (N=185); All participants. Approximately (N=1200)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Other
Intervention description(s): Participants will be randomized to receive standard referral to link to HIV care. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.; Participants will be randomized to receive referral plus SMS to link to HIV care. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.; Those that have not linked to care after the first randomization, will be re-randomized to receive an SMS message. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.; Those that have not linked to care after the first randomization, will be re-randomized to receive a one-time economic incentive. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.; A subset of negatives identified as 'high risk' from the CAPI baseline survey will be invited to participate in the primary prevention intervention (N=185). They will receive an SMS health promotion message with survey at 6 and 12 months. At 12 months, they will be re-tested for HIV and an exit interview completed.; HIV testing approaches that females can choose from include: (1) oral fluid HIV self-testing (OHIVST) at their convenience; (2) immediate staff-aided testing at home/mobile site; and (3) a referral to a health care facility where HIV testing will be done by a health care provider (standard facility-based HTS).
All participants will receive a behavioral CAPI survey at baseline visit, an SMS HIV test experience satisfaction survey, and for those who choose the self-testing option, a staff-administered questionnaire.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Adaptive linkage to care interventions for newly diagnosed HIV-positive participants. Total N recruited will depend on HIV prevalence found in the study.
Masking: Single (Participant)
Primary purpose: Supportive Care