Resilient HIV Implementation Science With SGM Youths Using Evidence

Обзор

The Resilient HIV Implementation Science with SGM Youths using Evidence (RISE) Clinical Research Center will use a Type 2 hybrid-effectiveness-implementation study to evaluate the effectiveness and implementation of HMP, a youth-tailored digital health platform. It is hypothesized that SGM youths in the HMP intervention group will demonstrate improved PrEP initiation and viral load suppression over 12 months compared to the delayed HMP group.

Подробное описание

RISE is a randomized control trial where participants are randomized (1:1) to either healthMPower (HMP) exposure for a 12 month period or delayed access to the HMP within 8 strata based on the serostatus group. HIV seropositive and HIV seronegative at risk, age group 15 to 17 or 18 to 24 years of age and country either Nigeria, Kenya, Malawi, or Zambia. Within the strata of serostatus, age, and country, participants will be randomly assigned to the next treatment allocation from a randomly permuted block sequencing using block size of four.

750 Participants will be randomly assigned to the HMP exposure while the other 750 participants will have delayed access to HMP. The HMP is a culturally adapted status neutral mobile app that works to address HIV prevention to care continuum (PHCC) for SGM youth at each of the CBSPs.

Participants who are delayed access for 12 months will be granted "Open access" for 12 months thereafter, when compared to participants who were provided access for 12 months then provided 12 months of access called "continued access" without other external support. Therefore, participants will either be provided access for 12 or 24 months depending on the randomization.

Primary outcome, clinical effectiveness endpoint for HIV seronegative at risk young will be the uptake of PrEP and for HIV seropositive viral load suppression. Secondary outcome, PHCC pathway characterized for HIV seronegative at risk youth such as PrEP education and continuation and for HIV seropositive HIV testing, linkage, and ART initiation.

Вмешательства

• Поведенческое HealthMPowerment (HMP)
  Participants will be provided access to the status neutral platform (HMP)mobile app for 12 months exposure period or a delayed access period. The HMP is developed specific to RISE and will be adapted based off feedback from each local site via stakeholders/YABs. The HMP will encompass a range of features including a robust content management system and back end administrative dashboard, multi media resources and information center, social support features such as connections to peers and provide

Первичные конечные точки

• PrEP initiation for HIV seronegative seropositive [Срок оценки: 24 months]
• Viral load suppression for HIV [Срок оценки: 24 months]
• RE-AIM [Срок оценки: 24 months]

Вторичные конечные точки (4)

• HIV testing cascade [Срок оценки: 12-24 months]
• PrEP continuum [Срок оценки: 12-24 months]
• HIV care and treatment continuum [Срок оценки: 12-24 months]
• Implementation effectiveness [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Male sex at birth
• Age 15-24 years
• Own an Android or iOS smartphone
• Had receptive or insertive sex with another man in the past 12 months
• Receiving care or prevention services at the CBSP-associated with the CRPS at the time of study.

Критерии исключения

• Less than 15 years old
• Greater than 24 years old
• Inability or cognitively impaired to provide consent
• Does not own an Android or iOS smartphone.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Nigeria · 2 центра

• Icarh/Ihvn — Abuja
• Centre for Population Health Initiative — Lagos

Zambia · 1 центр

• CIHEB Zambia Limited — Lusaka

Публикации

• Brasileiro J, Muessig KE, Lascko T, Sam-Agudu NA, Rochelle A, Mansfield ME, Ehoche A, Adebajo S, Hightow-Weidman LB, Charurat ME, Shoyemi E, Claassen CW, Trapence G, Kimani J, Aghedo OG, Ayorinde O, Sambambi K, Ndalumbira G, Gichuki R, Lavoie MC. Adapting the HealthMpowerment (HMP) mobile application for youth living with or at risk of HIV in Africa using the ADAPT-ITT model. Implement Sci Commun. PMID 41968361
• Adebajo S, Lascko T, Lavoie MC, Ehoche A, Mutumba C, Aernan NS, Nganga N, Njoroge B, Chinseu PD, Gichuki R, Ayorinde O, Aghedo OG, Sambambi K, Ndalumbira G, Ngulube MC, Chama J, Shoyemi E, Trapence G, Kimani J, Claassen CW, Sam-Agudu NA, Hightow-Weidman L, Charurat M; RISE Study. Implementing youth advisory boards with sexual minority adolescents and young men: sharing experiences, challenges and PMID 41808215

Идентификаторы

NCT: NCT06350682 · HP-00107323

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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