N/A
N=1,198
High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya
HIV · Adolescent Behavior
Bottom Line
View on ClinicalTrials.gov: NCT02735642 ↗Enrolled (actual)
1,198
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV — 23; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SMART Randomization 1 - Referral (Behavioral); SMART Randomization 1 - Referral and SMS (Behavioral); SMART Randomization 2 - SMS (Behavioral); SMART Randomization 2 - Incentive (Behavioral); High Risk Negative Cohort (N=185) (Behavioral); All participants. Approximately (N=1200) (Other)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV |
23; 9 | — |
| SECONDARY SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services. |
10; 10; 0; 1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02735642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.