A Pragmatic Trial to Expand Youth-friendly HIV Self-testing (I-TEST)

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: HIV/AIDS; Sexually Transmitted Infections
• Intervention / Treatment: Behavioral: Sexual health information; Behavioral: I-TEST branded HIVST package; Other: Follow-up testing and clinic assessments

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.

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Lagos
    • Yaba, Lagos, Nigeria, 00000
      • Nigerian Institute of Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: I-TEST Intervention Package; 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; 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); Behavioral: I-TEST branded HIVST package; 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; Other: Follow-up testing and clinic assessments; 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); University of North Carolina, Chapel Hill; Nigerian Institute of Medical Research
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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/
• 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.
• 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.
• 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.
• 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.

Helpful Links

• 4 Youth by Youth Website
• SESH Crowdsourcing Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HIV Prevention; Nigeria; Young people; HIV Self-testing; 4 Youth by Youth
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: 31457; 4UH3HD096929 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes