Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3HD096929 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Nigerian Institute of Medical Research | OTHER_GOV |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I-TEST Intervention Package | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 24 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 24 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Juliet Iwelunmor, PhD | St. Louis University | Principal Investigator |
| Oliver Ezechi, MD | Nigerian Institute of Medical Research | Principal Investigator |
| Joseph Tucker, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nigerian Institute of Medical Research | Yaba | Lagos | 00000 | Nigeria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | WHO/TDR. (2018). Crowdsourcing in Health and Health Research: A Practical Guide (TDR/STRA/18.4). Retrieved from Geneva: https://www.who.int/tdr/publications/year/2018/crowdsourcing-practical-guide/en/ | ||
| 32469971 | Background | Iwelunmor J, Ezechi O, Obiezu-Umeh C, Gbaja-Biamila T, Nwaozuru U, Oladele D, Musa AZ, Idigbe I, Uzoaru F, Airhihenbuwa C, Muessig K, Conserve DF, Kapogiannis B, Tucker JD. The 4 youth by youth HIV self-testing crowdsourcing contest: A qualitative evaluation. PLoS One. 2020 May 29;15(5):e0233698. doi: 10.1371/journal.pone.0233698. eCollection 2020. | |
| 33413246 |
| Label | URL |
|---|---|
| 4 Youth by Youth Website | View source |
Not provided
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.
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 26, 2026 | |
| Reset | Feb 17, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 26, 2026 | Feb 17, 2026 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Stepped-wedge cluster randomized controlled trial
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
| 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. |
|
|
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 |
| Background |
| Obiezu-Umeh C, Gbajabiamila T, Ezechi O, Nwaozuru U, Ong JJ, Idigbe I, Oladele D, Musa AZ, Uzoaru F, Airhihenbuwa C, Tucker JD, Iwelunmor J. Young people's preferences for HIV self-testing services in Nigeria: a qualitative analysis. BMC Public Health. 2021 Jan 7;21(1):67. doi: 10.1186/s12889-020-10072-1. |
| 31881959 | Background | Nwaozuru U, Iwelunmor J, Ong JJ, Salah S, Obiezu-Umeh C, Ezechi O, Tucker JD. Preferences for HIV testing services among young people in Nigeria. BMC Health Serv Res. 2019 Dec 27;19(1):1003. doi: 10.1186/s12913-019-4847-x. |
| 40262659 | Derived | Iwelunmor J, Obiezu-Umeh C, Gbaja-Biamila T, Oladele D, Nwaozuru U, Musa AZ, Abodunrin OR, Akinsolu FT, Ojo T, Olusanya O, Bamidele T, Ezeama N, Okeke C, Johnny I, Ekene M, Rahman N, Musari-Martins T, Ajibaye S, Lateef A, Ojo V, Babatunde Y, Airhihenbuwa CO, Muessig K, Rosenberg N, BeLue R, Xian H, Conserve DF, Zou Z, Ong JJ, Zhang L, Curley J, Nkengasong S, Mason S, Tang W, Bayus B, Ogedegbe G, Tucker JD, Ezechi O. The 4 youth by youth (4YBY) crowdsourced HIV prevention intervention: A stepped-wedge longitudinal trial on HIV self-testing uptake among adolescents and young people in Nigeria. Contemp Clin Trials. 2025 Jul;154:107919. doi: 10.1016/j.cct.2025.107919. Epub 2025 Apr 20. |
| 38687582 | Derived | Anikamadu O, Ezechi O, Engelhart A, Nwaozuru U, Obiezu-Umeh C, Ogunjemite P, Bale BI, Nwachukwu D, Gbaja-Biamila T, Oladele D, Musa AZ, Mason S, Ojo T, Tucker J, Iwelunmor J. Expanding Youth-Friendly HIV Self-Testing Services During the COVID-19 Pandemic: Qualitative Analysis of a Crowdsourcing Open Call in Nigeria. JMIR Form Res. 2024 Apr 30;8:e46945. doi: 10.2196/46945. |
| 34800699 | Derived | Iwelunmor J, Tucker JD, Obiezu-Umeh C, Gbaja-Biamila T, Oladele D, Nwaozuru U, Musa AZ, Airhihenbuwa CO, Muessig K, Rosenberg N, BeLue R, Xian H, Conserve DF, Ong JJ, Zhang L, Curley J, Nkengasong S, Mason S, Tang W, Bayus B, Ogedegbe G, Ezechi O. The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria. Contemp Clin Trials. 2022 Mar;114:106628. doi: 10.1016/j.cct.2021.106628. Epub 2021 Nov 17. |
| SESH Crowdsourcing Clinic | View source |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |