Clinical trial NCT04710784: A Pragmatic Trial to Expand Youth-friendly HIV Self-testing
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Sexually Transmitted Infections
Keywords: HIV Prevention
HIV Self-testing
Young people
Nigeria
4 Youth by Youth
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Nigerian Institute of Medical Research
First posted: 2021-01-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge cluster randomized controlled trial
Primary purpose: PREVENTION

Brief 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of HIV Self-testing
timeFrame: Up to 24 months
Secondary outcomes:
measure: Uptake of Facility-Based HIV testing
timeFrame: Up to 24 months
measure: Sexually Transmitted Infection (STI) Testing
timeFrame: Up to 24 months
measure: Sexually Transmitted Infection (STI) Treatment
timeFrame: Up to 24 months
measure: PrEP Referral
timeFrame: Up to 24 months
measure: 100% Condom Use
timeFrame: Up to 24 months
measure: Youth Engagement
timeFrame: Up to 24 months
measure: Cost effectiveness of the intervention
timeFrame: Up to 24 months
Other outcomes:
measure: Key Implementation Factors
timeFrame: Up to 24 months
Locations:
city: Yaba
country: Nigeria
facility: Nigerian Institute of Medical Research
state: Lagos
Study officials:
affiliation: St. Louis University
name: Juliet Iwelunmor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nigerian Institute of Medical Research
name: Oliver Ezechi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Joseph Tucker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
citation: 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.
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citation: 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.