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

NCT07000513 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: NCR2457341R01AI186786-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Keywords

HIV; PrEP; Long-acting Injectables; Nigeria; Minibus drivers

Outcome Measures

Primary Outcomes (1)

• ART or PrEP Initiation

  Use of patient records and self-report to determine initiation of HIV treatment or preventive medications.

  Baseline and follow-up surveys at 6-,12-, 18-, and 24 months

Secondary Outcomes (5)

• HIV Testing

  Baseline and follow-up surveys at 6-,12-, 18-, and 24-months

• ART Adherence

  Baseline and follow-up surveys at 6-,12-, 18-, and 24-months

• PrEP Adherence

  Baseline and follow-up surveys at 6-,12-, 18-, and 24-months

• Viral Load Supression

  Baseline and follow-up surveys at 6-,12-, 18-, and 24-months

• HIV Acquisition

  Baseline and follow-up surveys at 6-,12-, 18-, and 24-months

Study Arms (2)

I-TEST LAI Intervention:

EXPERIMENTAL

Participants enrolled in the intervention arm will receive instructions on HIVST and HIVST bundles from MPERFs at the motor parks after completing the baseline survey. Participants will receive HIVST bundles which will contain 3 HIVST kits with a mobile photo-verification application or USSD-Unstructured Supplementary Service Data for uploading their results and access to the nearest male-friendly health clinics. MPERFs will provide participants with instructions on how to use the photo verification application to report their results during each distribution period. During the HIVST bundle distribution and HIVST results reporting, MPERFs will also share information about the nearby male-friendly clinics and explain to the participants the need for visiting these clinics for confirmatory HIV testing. MPERFs will also provide information about the information about the benefits of LAI PrEP and LAI ART and offer to accompany participants to their appointments.

Behavioral: ITEST-LAI

Standard of Care

NO INTERVENTION

Participants at motor parks randomized to the control group will receive flyers distributed at the motor parks from the study team member at baseline, and during the follow-up surveys with information about HIV testing, including HIVST, and information about the two male-friendly clinics nearby where they can get tested for HIV, collect HIVST kits, and initiate oral or LAI ART or PrEP. All clinic staff in the SoC arm will receive training on LAI ART and LAI PrEP and the clinics will be equipped with LAI ART and LAI PrEP as well as oral ART and oral PrEP for study participants. Participants will be reminded during follow-up surveys about these clinics and receive additional flyers with information about these clinics and the availability of HIVST and LAIs at these services. The MPERFs will only contact SoC participants for follow-up surveys and to collect their HIVST results if they visit the clinics to collect the HIVST kits.

Interventions

ITEST-LAI BEHAVIORAL

The ITEST-LAI intervention includes male peer-led HIVST distribution and promotion, linkage to male-friendly clinics for confirmatory testing and follow-up care, peer support and technical assistance to address implementation challenges, and continuous monitoring and feedback for male peer educators and research facilitators (MPERFs).

I-TEST LAI Intervention:

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known HIV positivity
• Not ability to provide informed consent3
• No access to a cell phone

Sponsors & Collaborators

• George Washington University: lead
• The George Washington University Milken Institute School of Public Health (GWU): collaborator

Study Sites (1)

National Institute of Medical Research

Lagos, Lagos, Nigeria

Location

Related Publications (2)

• 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.

  PMID: 34006558 BACKGROUND

• 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: 34800699 BACKGROUND

Central Study Contacts

Donaldson F Conserve, PhD

CONTACT

917-443-6124; dconservejr@email.gwu.edu

Ucheoma Nwaozuru, PhD

CONTACT

unwaozur@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Multiple Principal Investigator

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 3, 2025
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)