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

Not Applicable

Completed

• Conditions: Adolescent Behavior; HIV
• Interventions: Behavioral: SMART Randomization 1 - Referral; Behavioral: SMART Randomization 1 - Referral and SMS; Behavioral: SMART Randomization 2 - SMS; Behavioral: High Risk Negative Cohort (N=185); Behavioral: SMART Randomization 2 - Incentive; Other: All participants. Approximately (N=1200)

• Registration Number: NCT02735642
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study First Submitted: 2016-03-29
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-13
• Study Start: 2017-05-15
• Primary Completion: 2018-04-10
• Study Completion: 2019-06-30
• Results First Submitted: 2020-09-01
• Results First Submitted QC: 2020-10-06
• Results First Posted: 2020-11-02
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1198

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SMART Randomization 1 - Referral	SMART Randomization 1 - Referral	Participants who are HIV positive will be enrolled in the SMART trial adaptive linkage to care intervention pilot. (HIV Positive Cohort approximately N=108).
SMART Randomization 1 - Referral and SMS	SMART Randomization 1 - Referral and SMS	Participants who are HIV positive will be enrolled in the SMART trial adaptive linkage to care intervention pilot. (HIV Positive Cohort approximately N=108).
SMART Randomization 2 - SMS	SMART Randomization 2 - SMS	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).
High Risk Negative Cohort (N=185)	High Risk Negative Cohort (N=185)	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).
SMART Randomization 2 - Incentive	SMART Randomization 2 - Incentive	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).
All participants. Approximately (N=1200)	All participants. Approximately (N=1200)	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).

Primary Outcome Measures

Name	Time	Method
Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV	Baseline	Our primary outcome for comparisons of recruitment and testing strategies was the number of newly diagnosed adolescent girls and young women living with HIV.

Secondary Outcome Measures

Name	Time	Method
SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services.	Baseline to about 6 weeks	After completing HIV testing, newly diagnosed adolescent girls and young women (AGYW) (N=32) participated in an adaptive intervention pilot to figure out the best way to support those newly diagnosed with HIV with initial linkage to care. The SMART trial pilot consisted of two randomizations. In the first randomization, AGYW were assigned to either standard referral (counseling and a referral note) or standard referral plus SMS message; those not linked to care after the first randomization (within a 2-week period) were randomized a second time to receive either a SMS message or financial incentive to link to care.

Trial Locations

Locations (1)

Impact Research & Development Organization; 🇰🇪 Kisumu, Kenya