NCT04710784

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2020

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 12, 2024

Status Verified

July 1, 2024

Enrollment Period

2.3 years

First QC Date

December 19, 2020

Last Update Submit

November 7, 2024

Conditions

HIV/AIDSSexually Transmitted Infections

Keywords

HIV PreventionHIV Self-testingYoung peopleNigeria4 Youth by Youth

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Uptake of Facility-Based HIV testing

    Up to 24 months

  • Sexually Transmitted Infection (STI) Testing

    Up to 24 months

  • Sexually Transmitted Infection (STI) Treatment

    Up to 24 months

  • PrEP Referral

    Up to 24 months

  • 100% Condom Use

    Up to 24 months

  • +2 more secondary outcomes

Other Outcomes (1)

  • Key Implementation Factors

    Up to 24 months

Study Arms (1)

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.

Behavioral: Sexual health informationBehavioral: I-TEST branded HIVST packageOther: Follow-up testing and clinic assessments

Interventions

Sexual health informationBEHAVIORAL

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)
I-TEST Intervention Package
I-TEST branded HIVST packageBEHAVIORAL

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
I-TEST Intervention Package
Follow-up testing and clinic assessmentsOTHER

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
I-TEST Intervention Package

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigerian Institute of Medical Research

Yaba, Lagos, 00000, Nigeria

Location

Related Publications (7)

  • 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/

    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.

    PMID: 32469971BACKGROUND

  • Saunders AN. Incubator noise: a method to decrease decibels. Pediatr Nurs. 1995 May-Jun;21(3):265-8.

    PMID: 7792110BACKGROUND

  • Cincotta FA. Dental anesthesia: the private office versus the hospital. Dent Surv. 1980 Aug;56(8):20-1. No abstract available.

    PMID: 6935128BACKGROUND

  • 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.

    PMID: 40262659DERIVED

  • 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.

    PMID: 38687582DERIVED

  • 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.

    PMID: 34800699DERIVED

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: Stepped-wedge cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 19, 2020

First Posted

January 15, 2021

Study Start

May 10, 2021

Primary Completion

August 31, 2023

Study Completion

December 1, 2023

Last Updated

November 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP

Locations

NG(1)