HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs) in Nigeria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ITEST-LAI.
- Who it may be relevant to
- Registry conditions: HIV. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Nigeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
Interventions
- Behavioral ITEST-LAI
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).
Primary outcome measures
- ART or PrEP Initiation [Time frame: Baseline and follow-up surveys at 6-,12-, 18-, and 24 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Known HIV positivity
- Not ability to provide informed consent3
- No access to a cell phone
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Nigeria · 1 center
- National Institute of Medical Research — Lagos
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. PMID 34006558
- 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 PMID 34800699
Identifiers
NCT: NCT07000513 · NCR245734 · 1R01AI186786-01