A Pragmatic Trial to Expand Youth-friendly HIV Self-testing (I-TEST)

The Washington University

Status: Completed

Conditions: Sexually Transmitted Infections; HIV/AIDS

Treatments: Behavioral: Sexual health information; Behavioral: I-TEST branded HIVST package; Other: Follow-up testing and clinic assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT04710784

31457

4UH3HD096929 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The current study extends the study team's earlier efforts described in ClinicalTrail ID#: NCT04070287 and NCT03874663. The I-TEST (Innovative Tools to Expand Youth-friendly HIV Self-Testing) study known locally as the 4 Youth by Youth project, sought to develop and evaluate novel youth-friendly HIVST services in Nigeria using open challenges and apprenticeship training informed by a participatory learning collaborative model. The study thus aims to reach young Nigerians that remain undiagnosed for HIV and to facilitate linkage and retention in preventive services (includes STI testing/treatment, PrEP referral, condom use).

Full 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 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 32 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 32 local government areas through in-person events, social media platforms, and online advertisements, clinics, and community centers that cater to young people. We included two additional LGAs in November 2021 to account for civil unrest activities that are taking place across two other study sites. Due to the civil unrest, the implementation of the intervention has been affected hence the addition of the two new sites. 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.

Enrollment: 1,500 patients

Sex: All

Ages: 14 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 14-24
• Self-reported HIV negative or unknown HIV status
• Currently and planning on residing in one of the 30 areas during the next 12 months
• Able to complete the survey in English (the national language of Nigeria)
• All participants must agree to informed consent and provide their cell mobile number for follow-up and retention

Exclusion criteria

• Younger than 14 and older than 24
• Inability to comply with the study protocol
• Illness, cognitive impairment, or threatening behavior with acute risk to self or others
• No informed consent
• No contact phone number

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,500 participants in 1 patient group

I-TEST Intervention Package

Experimental group

Description:

Each study site will begin in the baseline, pre-implementation phase, and then be randomized to implement the I-TEST intervention package for a duration of three months, followed by the post-implementation phase.

Treatment:

Other: Follow-up testing and clinic assessments

Behavioral: I-TEST branded HIVST package

Behavioral: Sexual health information