An interventional study of Sexual health information and I-TEST branded HIVST package in HIV/AIDS and Sexually Transmitted Infections, sponsored by Washington University School of Medicine. Completed at 1 site in Nigeria. Open to participants aged 14 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention
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).
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.
424 studies on the registry are indexed under Sexually Transmitted Diseases; 71 are open to participants now.
This study's enrollment of 1,500 is above the median of 470 across 346 interventional studies indexed under Sexually Transmitted Diseases.
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Exclusion Criteria:
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 · Behavioral: I-TEST branded HIVST package · Other: Follow-up testing and clinic assessments
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.
Also known as: Pre-Implementation (Control Phase)
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.
Also known as: Intervention Implementation
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.
Also known as: Post-Implementation
Uptake of HIV Self-testing
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.
Time frame: Up to 24 months
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months
Key Implementation Factors
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).
Time frame: Up to 24 months
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with Saint Louis University.
Supporting information: Sap
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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