Clinical trial NCT02735642: High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya
Official title: High-yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Adolescent Behavior
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Kenyatta National Hospital
name: Impact Research & Development Organization
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-04-13
Enrollment: 1198
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Newly Diagnosed Adolescent Girls and Young Women Living With HIV
timeFrame: Baseline
Secondary outcomes:
measure: SMART Trial Pilot to Link Newly Diagnosed Adolescent Girls and Young Women to HIV Care Services.
timeFrame: Baseline to about 6 weeks
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Impact Research & Development Organization
Study officials:
affiliation: Yale University School of Nursing
name: Ann E. Kurth, PhD, CNM
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenyatta National Hospital
name: Irene Inwani, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Impact Research & Development Organization
name: Kawango Agot, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inwani I, Chhun N, Agot K, Cleland CM, Buttolph J, Thirumurthy H, Kurth AE. High-Yield HIV Testing, Facilitated Linkage to Care, and Prevention for Female Youth in Kenya (GIRLS Study): Implementation Science Protocol for a Priority Population. JMIR Res Protoc. 2017 Dec 13;6(12):e179. doi: 10.2196/resprot.8200.
citation: Inwani I, Chhun N, Agot K, Cleland CM, Rao SO, Nduati R, Kinuthia J, Kurth AE. Preferred HIV Testing Modalities Among Adolescent Girls and Young Women in Kenya. J Adolesc Health. 2021 Mar;68(3):497-507. doi: 10.1016/j.jadohealth.2020.07.007. Epub 2020 Aug 11.