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

Официальное название

Innovative Tools to Expand HIV Self-Testing and Long-Acting Injectables for HIV Treatment and Prevention Among Commercial Minibus Drivers (I-TEST LAIs)

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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).

Первичные конечные точки

• ART or PrEP Initiation [Срок оценки: Baseline and follow-up surveys at 6-,12-, 18-, and 24 months]

Вторичные конечные точки (5)

• HIV Testing [Срок оценки: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months]
• ART Adherence [Срок оценки: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months]
• PrEP Adherence [Срок оценки: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months]
• Viral Load Supression [Срок оценки: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months]
• HIV Acquisition [Срок оценки: Baseline and follow-up surveys at 6-,12-, 18-, and 24-months]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Nigeria · 1 центр

• National Institute of Medical Research — Lagos

Публикации

• 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

Идентификаторы

NCT: NCT07000513 · NCR245734 · 1R01AI186786-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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