HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs) in Nigeria

Phase 4

Not yet recruiting

• Conditions: HIV

• Registration Number: NCT07000513
• Lead Sponsor: George Washington University

Brief Summary

Long-acting injectable antiretroviral therapy (LAI ART) and Pre-Exposure Prophylaxis (LAI PrEP) have the potential to transform HIV treatment and prevention, especially in reaching individuals such as commercial minibus drivers who have minimal or no contact with traditional health facilities. The project proposes to use a culturally appropriate and community-engaged approach to promote the uptake of HIV self-testing, LAI-ART, and LAI-PrEP among commercial minibus drivers in Nigeria by engaging commercial minibus drivers as peer educators/research facilitators.

Detailed Description

Commercial minibus drivers constitute a large social network of highly mobile men who work long and demanding hours, are at increased risk for HIV, and have limited time to seek health services for HIV. In our preliminary work, our team found a high HIV seropositivity rate of 12.5% among 407 commercial minibus drivers in Nigeria, a prevalence that is nine times higher than the national HIV average. Despite the high willingness to test for HIV among the drivers, the mobile nature of their work poses substantial barriers for those living with HIV to initiate and adhere to antiretroviral therapy (ART) and for those who are HIV-negative and are at risk for HIV to obtain pre-exposure prophylaxis (PrEP). Therefore, innovative strategies such as HIV self-testing (HIVST), which allows individuals to test at home or in private, and long-actinginjectable ART (LAI ART) or LAI PrEP may work better to address the barriers that impede commercial drivers from accessing HIV testing, prevention, and treatment services. The investigators have recently evaluated a youth-friendly HIVST intervention combined with linkage to PrEP in Nigeria as part of an NIH-funded project called ITEST: Innovative Tools to Expand Youthfriendly HIV Self-Testing (UH3HD096929). The investigators propose to leverage our established research program in Nigeria in collaboration with the National Institute of Medical Research to implement a tailored ITEST intervention for commercial minibus drivers (ITEST LAIs), which will include male peer-led distribution of HIV self-testing kits combined with demand creation for both oral and LAI modalities of ART and PrEP. The multi-disciplinary research team proposes a hybrid type I effectiveness-implementation study to assess clinical and implementation determinants outcomes simultaneously.

Study Timeline

• Study First Submitted: 2025-05-24
• Study First Submitted QC: 2025-05-24
• Status Verified: 2025-06
• Study First Posted: 2025-06-03
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01
• Study Start: 2026-02-01
• Primary Completion: 2029-02-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 400

Inclusion Criteria

1. Male commercial minibus drivers who have worked as a driver for at least 6 months
2. 18 years old or older
3. Currently and planning on residing in one of the LGAs during the next 12 months
4. Owning a mobile phone

Exclusion Criteria

1. Known HIV positivity
2. Not ability to provide informed consent3
3. No access to a cell phone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ART or PrEP Initiation	Baseline and follow-up surveys at 6-,12-, 18-, and 24 months	Use of patient records and self-report to determine initiation of HIV treatment or preventive medications.

Secondary Outcome Measures

Name	Time	Method
HIV Testing	Baseline and follow-up surveys at 6-,12-, 18-, and 24-months	Use of patient records and self-report to determine HIV testing behavior (including use of HIVST and confirmatory testing in clinics).
ART Adherence	Baseline and follow-up surveys at 6-,12-, 18-, and 24-months	Use of self-report and hair sample to measure medication adherence.
PrEP Adherence	Baseline and follow-up surveys at 6-,12-, 18-, and 24-months	Use of hair samples and self-report to measure medication adherence.
Viral Load Supression	Baseline and follow-up surveys at 6-,12-, 18-, and 24-months	Use of blood samples to measure viral load suppression among those who received an HIV diagnosis.
HIV Acquisition	Baseline and follow-up surveys at 6-,12-, 18-, and 24-months	Use of blood samples, self-report, and patient records to measure seroconversion among study participants.

Trial Locations

Locations (1)

National Institute of Medical Research; 🇳🇬 Lagos, Nigeria