A Phase 4 interventional study of ITEST-LAI in HIV, sponsored by George Washington University. Not yet recruiting at 1 site in Nigeria. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by George Washington University · Phase 4, Interventional, and Health services research
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.
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.
George Washington University is the lead sponsor of 192 studies on the registry; 34 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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).
ART or PrEP Initiation
Use of patient records and self-report to determine initiation of HIV treatment or preventive medications.
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24 months
HIV Testing
Use of patient records and self-report to determine HIV testing behavior (including use of HIVST and confirmatory testing in clinics).
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
ART Adherence
Use of self-report and hair sample to measure medication adherence.
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
PrEP Adherence
Use of hair samples and self-report to measure medication adherence.
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
Viral Load Supression
Use of blood samples to measure viral load suppression among those who received an HIV diagnosis.
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
HIV Acquisition
Use of blood samples, self-report, and patient records to measure seroconversion among study participants.
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
Plan to share: No — The IPD will not be shared given the confidential nature of this study and terms under which participants agree to enroll.
Start is estimated for Feb 2027; primary completion for Feb 2029, 24 months later.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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