A Pragmatic Trial to Expand Youth-friendly HIV Self-testing
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HIV/AIDS
- Sexually Transmitted Infections
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: Stepped-wedge cluster randomized controlled trialMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 14 years and 24 years
- Gender
- Both males and females
Description
Following the completion of the open contests and apprenticeship training, four youth teams (with four distinct interventions) were selected to undergo a one-year pilot assessment in the community. Preliminary findings from the feasibility study suggest that the youth-developed interventions have th...
Following the completion of the open contests and apprenticeship training, four youth teams (with four distinct interventions) were selected to undergo a one-year pilot assessment in the community. Preliminary findings from the feasibility study suggest that the youth-developed interventions have the potential to impact HIV testing as well as uptake of sexually transmitted infections (STI) testing among young people in Nigeria. As a result, the investigators identified key components from the four interventions to form a single intervention that will be evaluated in the next phase of the research. Thus, the current protocol is focused on evaluating the effectiveness of a combined, youth-developed intervention on HIV testing and other HIV prevention outcomes (i.e. condom use, PrEP referral, STI testing). Using a stepped-wedge cluster randomized controlled trial design, the I-TEST intervention package will be implemented sequentially across 30 local government areas (LGA) whereby each LGA will be exposed to a pre-intervention (control), intervention (implementing the intervention), and post-intervention condition, according to a randomized schedule. Young people between the ages of 14-24 years will be recruited from the selected 30 local government areas through in-person events, social media platforms, and online advertisements, clinics, and community centers that cater to young people. Upon enrollment, the study team will collect baseline data on HIV testing history, sexual behavior history, youth participation experience, and other related outcomes from the study participants. Two trained youth alongside one trained supervisor will implement the I-TEST intervention at the LGAs.
Tracking Information
- NCT #
- NCT04710784
- Collaborators
- University of North Carolina, Chapel Hill
- Nigerian Institute of Medical Research
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- National Institutes of Health (NIH)
- Investigators
- Principal Investigator: Juliet Iwelunmor, PhD St. Louis University Principal Investigator: Oliver Ezechi, MD Nigerian Institute of Medical Research Principal Investigator: Joseph Tucker, MD University of North Carolina, Chapel Hill