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Completed

NCT Number: NCT04710784

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sexual health information

Behavioral

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.

Other names: Pre-Implementation (Control Phase)

I-TEST branded HIVST package

Behavioral

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 names: Intervention Implementation

Follow-up testing and clinic assessments

Other

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.

Other names: Post-Implementation

Primary outcomes

  1. Uptake of HIV Self-testing

    Time frame: Up to 24 months

    The number of persons who tested with an HIV self-test. We will assess the number of persons who tested with an HIV self-test among the total number of participants in the study. The primary outcome will be ascertained using a photographic verification approach via a mobile application or a USSD (Unstructured Supplementary Service Data) system. We will also use self-reported data on HIVST results for those unable to use both systems accurately.

Secondary outcomes

  1. Uptake of Facility-Based HIV testing

    Time frame: Up to 24 months

    The number of persons who received an HIV test at a youth-friendly clinic among the total number of participants in the study.

  2. Sexually Transmitted Infection (STI) Testing

    Time frame: Up to 24 months

    The number of persons who completed a consultation at the youth-friendly clinic for STI testing. In addition, the baseline and follow-up surveys include items on knowledge and testing of sexually transmitted infections (gonorrhea, chlamydia, syphilis, and hepatitis B virus).

  3. Sexually Transmitted Infection (STI) Treatment

    Time frame: Up to 24 months

    The number of persons initiating STI treatment among the total number of persons with active infection linked to care.

  4. PrEP Referral

    Time frame: Up to 24 months

    PrEP referral will be assessed based on the proportion of participants who are "optimal" (assessed based on the sexual behavioral history and willingness to use PrEP) candidates for PrEP referral and the total number of participants referred for PrEP initiation at the health care facilities.

  5. 100% Condom Use

    Time frame: Up to 24 months

    The baseline and follow-up survey includes items on condom usage in the last sexual intercourse and a 4-item Condom Use Self Efficacy Scale.

  6. Youth Engagement

    Time frame: Up to 24 months

    A 12-item scale on youth engagement will be used to assess the HIV prevention services proposed by the youth teams. The scale was adapted from the 20-item Tiffany-Eckenrode Program Participation Scale (TEPPS). Responses to the participation items were measured on a 5-point Likert-type scale, ranging from "strongly disagree (0)" to "Strongly agree (4)". Higher TEPPS scores indicate higher levels of program participation. The item is only included in the follow-up survey.

  7. Cost effectiveness of the intervention

    Time frame: Up to 24 months

    The incremental cost-effectiveness ratio of participants involved in the I-TEST intervention phase compared to the control phase.

Other outcomes

  1. Key Implementation Factors

    Time frame: Up to 24 months

    Guided by the RE-AIM framework for implementation science, semi-structured, in-depth interviews will be conducted at the individual and setting level to explore the factors associated with the implementation of the intervention (e.g., reach, adoption, implementation, and maintenance).

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Nigerian Institute of Medical Research
  • University of North Carolina, Chapel Hill

Registry information

Official study title

The 4 Youth by Youth Project: a Pragmatic Stepped-wedge Cluster Randomized Controlled Trial to Expand Youth-friendly HIV Self-testing Services in Nigeria

Acronym: I-TEST

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 15, 2021
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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