Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
108

Summary

Conditions
  • Adolescent Behavior
  • HIV
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention 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)Masking Description: We utilized an approach called permuted blocks randomization for participant assignment to the SMART trial linkage to care intervention.Primary Purpose: Supportive Care

Participation Requirements

Age
Between 15 years and 24 years
Gender
Only males

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 preferre...

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.

Tracking Information

NCT #
NCT02735642
Collaborators
  • Kenyatta National Hospital
  • Impact Research & Development Organization
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Ann E. Kurth, PhD, CNM Yale University School of Nursing Principal Investigator: Irene Inwani, MD, MPH Kenyatta National Hospital Principal Investigator: Kawango Agot, PhD, MPH Impact Research & Development Organization