A Pragmatic Trial to Expand Youth-friendly HIV Self-testing

Summary

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).

Conditions

• HIV/AIDS
• Sexually Transmitted Infections

Interventions

BEHAVIORAL

Sexual health information

We will provide participants with sexual health information, that is basic, accurate, and directly contributes to health-promoting decisions and behavior, once a week at the beginning of the study.

BEHAVIORAL

I-TEST branded HIVST package

The I-TEST branded HIVST package will include HIV self-testing (HIVST) kits, referral coupons, condoms, female or male hygiene products, and instructions on how to use the I-TEST photo verification App or USSD (Unstructured Supplementary Service Data) system to verify the HIVST results. Study participants will be referred to a youth-friendly health clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment and PrEP referral.

OTHER

Follow-up testing and clinic assessments

Information to encourage routine retesting for HIV every 6 months and linkage to the youth-friendly clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment, and PrEP referral. Additionally, follow-up surveys will be administered to assess HIV testing, sexual behavior history, youth participation experience, and other related outcomes will be collected from enrolled participants.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill

  collaborator OTHER

• Nigerian Institute of Medical Research

  collaborator OTHER_GOV

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Juliet Iwelunmor, PhD · St. Louis University

• Oliver Ezechi, MD · Nigerian Institute of Medical Research

• Joseph Tucker, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

14 Years

Max Age

24 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-05-10

Primary Completion

2023-08-31

Completion

2023-12-01

Countries

• Nigeria

Study Locations