HIVPhase 4ITEST-LAINCT07000513
HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs) in Nigeria
A Phase 4 study testing ITEST-LAI in people with HIV, run by George Washington University at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- ITEST-LAI
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Feb 2027to 1 Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male commercial minibus drivers who have worked as a driver for at least 6 months
- 18 years old or older
- Currently and planning on residing in one of the LGAs during the next 12 months
- Owning a mobile phone
Who cannot join
- Known HIV positivity
- Not ability to provide informed consent3
- No access to a cell phone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ucheoma Nwaozuru, PhD contact
Nigeria1 site
National Institute of Medical Research
Lagos, Lagos
Oliver Ezechi, MD, PhD, 234-803-306-5683, oezechi@yahoo.co.uk
About this study
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)
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.
Read the 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.
- Conditions
- HIV
- Being tested
- ITEST-LAI
- Keywords
- HIV, PrEP, Long-acting Injectables, Nigeria, Minibus drivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITEST-LAIBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ART or PrEP Initiation
Use of patient records and self-report to determine initiation of HIV treatment or preventive medications.
Measured: Baseline and follow-up surveys at 6-,12-, 18-, and 24 months
Secondary outcomes (5)
HIV Testing
Use of patient records and self-report to determine HIV testing behavior (including use of HIVST and confirmatory testing in clinics).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- The George Washington University Milken Institute School of Public Health (GWU)
- Responsible party
- Principal investigator, Donaldson Conserve, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000513
- Sponsor's protocol ID
- NCR245734
- Other IDs
- 1R01AI186786-01
- Acronym
- ITEST-LAI
- Status last verified
- May 2026
- First submitted
- 24 May 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared given the confidential nature of this study and terms under which participants agree to enroll.
Publications
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.
PubMed 34006558Iwelunmor 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.
PubMed 34800699
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07000513
- Acronym / sponsor ID
- ITEST-LAI / NCR245734
- Conditions
- HIV
- Keywords
- HIV, PrEP, Long-acting Injectables, Nigeria, Minibus drivers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- The George Washington University Milken Institute School of Public Health (GWU)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I-TEST LAI Intervention: | Experimental | Behavioral: ITEST-LAIParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male commercial minibus drivers who have worked as a driver for at least 6 months
- 18 years old or older
- Currently and planning on residing in one of the LGAs during the next 12 months
- Owning a mobile phone
Key exclusion criteria (3 listed)
- Known HIV positivity
- Not ability to provide informed consent3
- No access to a cell phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITEST-LAIThe 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). | Behavioural | I-TEST LAI Intervention: |
Primary outcome
ART or PrEP Initiation
Time frame: 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.
5 secondary outcomes
HIV Testing
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
ART Adherence
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
PrEP Adherence
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
Viral Load Supression
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
HIV Acquisition
Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 34006558Majam 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.
- Background: PubMed 34800699Iwelunmor 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.
- Individual participant dataSharing planned: No. The IPD will not be shared given the confidential nature of this study and terms under which participants agree to enroll.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ucheoma Nwaozuru, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ITEST-LAI in people with HIV, run by George Washington University at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donaldson F Conserve, PhD (917-443-6124, dconservejr@email.gwu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ART or PrEP Initiation (time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07000513, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.