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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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HIV/AIDS, Sexually Transmitted Infections

Intervention / Treatment
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* Behavioral: Sexual health information
* Behavioral: I-TEST branded HIVST package
* Other: Follow-up testing and clinic assessments


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped-wedge cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-TEST Intervention Package<br>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. | Behavioral: Sexual health information<br>* 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.<br>* Other names: Pre-Implementation (Control Phase);Behavioral: I-TEST branded HIVST package<br>* 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.<br>* Other names: Intervention Implementation;Other: Follow-up testing and clinic assessments<br>* 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.<br>* Other names: Post-Implementation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of HIV Self-testing | 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 to verify the HIVST results. The number of persons who tested with an HIV self-test | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of Facility-Based HIV testing | The number of persons who received an HIV test at a youth-friendly clinic among the total number of participants in the study. | Up to 24 months | 
| Sexually Transmitted Infection (STI) Testing | 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). | Up to 24 months | 
| Sexually Transmitted Infection (STI) Treatment | The number of persons initiating STI treatment among the total number of persons with active infection linked to care. | Up to 24 months | 
| PrEP Referral | 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. | Up to 24 months | 
| 100% Condom Use | 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. | Up to 24 months | 
| Youth Engagement | 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. | Up to 24 months | 
| Cost effectiveness of the intervention | The incremental cost-effectiveness ratio of participants involved in the I-TEST intervention phase compared to the control phase. | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Prevention, HIV Self-testing, Young people, Nigeria, 4 Youth by Youth