Clinical trial NCT07000513: HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs) in Nigeria
Official title: Innovative Tools to Expand HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: HIV
Keywords: HIV
PrEP
Long-acting Injectables
Nigeria
Minibus drivers
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: The George Washington University Milken Institute School of Public Health (GWU)
First posted: 2025-06-03
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. Our team has 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). We 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. Our multi-disciplinary research team proposes a hybrid type I effectiveness-implementation study to assess clinical and implementation determinants outcomes simultaneously.

Eligibility criteria: 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

Primary outcomes:
measure: ART or PrEP Initiation
timeFrame: Baseline and follow-up surveys at 6-,12-, 18-, and 24 months
Secondary outcomes:
measure: HIV Testing
timeFrame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
measure: ART Adherence
timeFrame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
measure: PrEP Adherence
timeFrame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
measure: Viral Load Supression
timeFrame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
measure: HIV Acquisition
timeFrame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
Other outcomes:
Locations:
city: Lagos
country: Nigeria
facility: National Institute of Medical Research
Study officials:
References:
citation: Majam M, Conserve DF, Zishiri V, Haile ZT, Tembo A, Phiri J, Hatzold K, Johnson CC, Venter F. Implementation of different HIV self-testing models with implications for HIV testing services during the COVID-19 pandemic: study protocol for secondary data analysis of the STAR Initiative in South Africa. BMJ Open. 2021 May 18;11(5):e048585. doi: 10.1136/bmjopen-2020-048585.
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.