Resilient HIV Implementation Science With SGM Youths Using Evidence
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- RE-AIM
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HealthMPowerment (HMP) Delayed Access
Delayed access for 12 months to the HMP app, individuals will have access but it will be restricted
HealthMPowerment (HMP) Open Access
Full access to the HMP app
干预措施: HealthMPowerment (HMP) (Behavioral)
结局指标
主要结局
RE-AIM
时间窗: 24 months
Implementation Effectiveness on reach (characteristics of participants enrolled), Adoption (HMP physician and client interaction), Implementation (barriers and facilitators), Maintenance (HMP immediate access group at 21-24 months) and cost effectiveness of the HMP (incremental costs effectiveness ration and net monetary benefit)
PrEP initiation for HIV seronegative seropositive
时间窗: 24 months
For those HIV seronegative, initiation of pre-exposure prophylaxis (PrEP) (Oral PrEP dispensed by pharmacy or Long-acting injectable defined as receiving first dose)
Viral load suppression for HIV
时间窗: 24 months
HIV seropositive viral load suppression at 12 months of taking ART (defined as HIV viral load of less than 1,000 copies/mL)
次要结局
- Implementation effectiveness(24 months)
- HIV testing cascade(12-24 months)
- PrEP continuum(12-24 months)
- HIV care and treatment continuum(12-24 months)
研究者
Man Charurat
Professor
University of Maryland, Baltimore