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

Yale University

Status: Completed

Conditions: HIV; Adolescent Behavior

Treatments: Behavioral: High Risk Negative Cohort (N=185); Behavioral: SMART Randomization 1 - Referral and SMS; Behavioral: SMART Randomization 1 - Referral; Behavioral: SMART Randomization 2 - Incentive; Other: All participants. Approximately (N=1200); Behavioral: SMART Randomization 2 - SMS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02735642

1512016985

1R01AI122797 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,198 patients

Sex: Female

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Able to understand spoken English or Kiswahili or Dholuo
• Resides in Homa Bay County
• Not previously diagnosed as HIV positive
• Willing to give informed consent or if younger than 18 years of age has a parent or guardian willing to provide consent in addition to the minor's assent

Exclusion criteria

• Male
• Unable to understand spoken English, or Kiswahili or Dholuo
• Females who do not meet age inclusion criteria
• Resides outside of Homa Bay County
• HIV positive
• If under 18 and not an emancipated minor, unable to get parental consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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1,198 participants in 6 patient groups

SMART Randomization 1 - Referral

Experimental group

Description:

Participants who are HIV positive will be enrolled in the SMART trial adaptive linkage to care intervention pilot. (HIV Positive Cohort approximately N=108).

Treatment:

Behavioral: SMART Randomization 1 - Referral

SMART Randomization 1 - Referral and SMS

Experimental group

Description:

Participants who are HIV positive will be enrolled in the SMART trial adaptive linkage to care intervention pilot. (HIV Positive Cohort approximately N=108).

Treatment:

Behavioral: SMART Randomization 1 - Referral and SMS

SMART Randomization 2 - SMS

Experimental group

Description:

HIV positives that have not successfully linked to care after the first randomization will be re-randomized to receive either an SMS message or economic incentive to link to care. (HIV Positive Cohort approximately N=108).

Treatment:

Behavioral: SMART Randomization 2 - SMS

SMART Randomization 2 - Incentive

Experimental group

Description:

HIV positives that have not successfully linked to care after the first randomization will be re-randomized to receive either an SMS message or economic incentive to link to care. (HIV Positive Cohort approximately N=108).

Treatment:

Behavioral: SMART Randomization 2 - Incentive

High Risk Negative Cohort (N=185)

Other group

Description:

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).

Treatment:

Behavioral: High Risk Negative Cohort (N=185)

All participants. Approximately (N=1200)

Other group

Description:

HIV testing options that female youth 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).

Treatment:

Other: All participants. Approximately (N=1200)