Actively Recruiting

Phase Not Applicable
Age: 14Years - 24Years
All Genders
Healthy Volunteers
ID07072481

Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing in Nigerian Adolescents and Young Adults with Enhanced Sustainability Strategies

Led by Washington University School of Medicine · Updated on 2025-10-29

1216

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

Sponsors

W

Washington University School of Medicine

Lead Sponsor

N

Nigerian Institute of Medical Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating strategies to sustain and expand HIV self-testing and youth-friendly prevention services among adolescents and young adults (ages 14-24) at risk for HIV in Nigeria. This study builds on previous efforts and uses participatory methods like crowdsourcing and designathons to develop sustainability plans for community-based organizations (CBOs). The goal is to improve uptake and continuation of HIV prevention services including HIV testing, STI screening, and pre-exposure prophylaxis (PrEP) over 24 months. The study compares two approaches: standard 4YBY implementation delivered by CBOs, which includes providing HIV self-testing kits, STI screening navigation, trained community health workers, and peer support; and an enhanced sustainability strategy that adds formal sustainability plans, sustainability teams, bi-weekly learning collaboratives, monitoring adaptations, and access to coaches for support. Forty community sites and CBOs are randomized to receive either the standard or enhanced approach, with both groups receiving core 4YBY activities. Participants aged 14-24 are recruited through social media, events, and community referrals and complete baseline and follow-up surveys every six months for 24 months. Data collection includes tracking intervention implementation, participant engagement, and sustainment of the program’s core elements. Researchers measure the percentage of sustained activities, benefits, and capacity related to 4YBY over time, alongside qualitative interviews and assessments of youth and community health worker characteristics.

CONDITIONS

Brief Title

Sustaining Innovative Tools to Expand Youth-Friendly HIV Self-Testing

Who Can Participate

Age: 14Years - 24Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 to 24 years
  • Condomless anal or vaginal sex in the past six months
  • Meet PrEP eligibility according to Nigerian guidelines (e.g., sex worker, MSM, drug user, partner with HIV, sexually exposed youth, transactional sex)
  • No prior use of PrEP
  • HIV negative based on a fourth-generation test
  • Resident of the recruitment city with plans to stay for 12 to 24 months
  • Able to complete a written survey in English or Pidgin English
  • Provide informed consent and a mobile phone number for follow-up
Not Eligible

You will not qualify if you...

  • Younger than 14 or older than 24 years
  • Unable to comply with the study protocol
  • Illness, cognitive impairment, or behavior posing acute risk to self or others
  • No informed consent provided
  • No contact phone number available
  • Not residing in any of the specified local government areas (LGAs)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or online) to assess eligibility and collect baseline information

Enrollment and Baseline Data Collection

Duration - Up to 1 month

Participants are enrolled in the study and baseline data are collected through surveys and assessments.

1 visit (in-person or online) for enrollment and baseline survey completion

Outpatient Treatment

Duration - Up to 24 months

Participants receive the 4YBY HIV self-testing intervention through community-based organizations including provision of HIV self-testing bundles, navigation to youth-friendly clinical sites, community health worker support, and peer-to-peer engagement. Some participants receive an enhanced sustainability strategy involving additional support and training to sustain intervention activities.

Ongoing engagement through community activities and periodic training sessions; follow-up surveys every 6 months

Follow-up

Duration - 24 months

Participants complete follow-up surveys every six months to assess sustainment of HIV prevention activities, benefits, and capacity. Surveys are accessed via mobile phone in person or online with reminders sent by text message.

Follow-up surveys every 6 months (5 total) completed remotely or in person

Trial Site Locations

Total: 1 location

1

Nigerian Institute of Medical Research

Yaba, Lagos, Nigeria

Actively Recruiting

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Research Team

J

Juliet Iwelunmor, PhD

O

Oliver C Ezechi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Factors associated with HIV self-testing and PrEP use among Nigerian youth: Baseline outcomes of a pragmatic, stepped-wedge, cluster-randomized controlled trial.

Juliet Iwelunmor, Ebenezer Adeoti, Titilola Gbaja-Biamila...

https://pubmed.ncbi.nlm.nih.gov/39547480

Accelerating adolescent HIV research in low-income and middle-income countries: evidence from a research consortium.

Joseph D Tucker, Juliet Iwelunmor, Elaine Abrams...

https://pubmed.ncbi.nlm.nih.gov/34870930

Sustaining HIV Research in Resource-Limited Settings Using PLAN (People, Learning, Adapting, Nurturing): Evidence from the 4 Youth by Youth Project in Nigeria.

Juliet Iwelunmor, Joseph D Tucker, Oliver Ezechi...

https://pubmed.ncbi.nlm.nih.gov/36988831