Quantitative and Qualitative Research for "A Video-Based Mobile Health Program to Support People Living With HIV Across the HIV Care Continuum"
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Viral Suppression
研究概览
简要总结
The goal of this randomized control trial (RCT) is to assess the effectiveness of Amp, a mobile health (mHealth) app designed to improve outcomes along the HIV care continuum for young Black men who have sex with men (YBMSM) living with HIV. HIV care continuum (linkage to care, retention, viral suppression), quality of life and self efficacy outcomes will be compared after a 4-month period between the intervention group (use Amp and standard of care) and the control group (standard of care only).
详细描述
A maximum of 400 YBMSM participants will be recruited into a randomized control trial from multiple sites across the US to assess the effectiveness of Amp, an mHealth app designed to improve outcomes along the HIV care continuum for YBMSM living with HIV. HIV care continuum (linkage to care, retention, viral suppression), quality of life and self efficacy outcomes will be compared after a 4-month period between the intervention group (use Amp and standard of care) and the control group (standard of care only).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Black or African-American AND;
- •18-29 years old AND;
- •Diagnosed with HIV during the study period (From April 1, 2024-August 31 2024) OR;
- •Diagnosed with HIV in the year prior to the study period (April 1, 2023-March 31, 2024) OR;
- •HIV positive but not linked into care OR;
- •Fallen out of care (no HIV care visits within last 6 months) OR;
- •Currently in care but NOT virally suppressed (viral load ≥200 copies/mL)
- •AND, Online access through a mobile device AND;
- •Ability to read and write English.
排除标准
- •Currently participating in another HIV care continuum or mobile health intervention
- •Plan to leave the study site within the study period
- •Cognitively impaired at recruitment or baseline testing
- •Has a self-reported health issue that prohibits them from participating
研究组 & 干预措施
Standard of Care
Standard of care (SOS) linkage to care services typically provided by linkage specialists, health navigators, or case workers.
Amp mHealth App
Amp, video-based, virtual support system on an mHealth platform with resources and tools to help YBMSM living with HIV become and stay virally suppressed.
干预措施: Amp (Behavioral)
结局指标
主要结局
Viral Suppression
时间窗: 4 months
HIV viral load is less than 200 copies per microliter based on labs in patient EMR data. Viral suppression (viral load is less than 200 copies per microliter) is the better outcome.
HIV Stigma
时间窗: 4 months
Composite agreement score on 13 HIV related stigma statements as measured by items derived from the Berger HIV Stigma Scale. Agreement from 1 (Strongly Disagree) to 5 (Strongly Agree). Lower scores indicate lower stigma (better outcome). Range of composite scores will be from 13 to 65.
次要结局
- Self-Reported Medical Visits(4 months)
- HIV status disclosure(4 months)
- HIV and Anti-retroviral knowledge(4 months)
- Anxiety symptoms(4 months)
- Time to Treatment Initiation(4 months)
- Discussion of PrEP with Sex Partners(4 months)
- Anti-retroviral medication adherence(4 months)
- Adherence barriers(4 months)
- Linkage to HIV Care(4 months)
- Social support(4 months)
- Depressive symptoms(4 months)
- Discussion of U=U with Sex Partners(4 months)
- Medical Visits Record based on EMR(4 months)
- Substance use(4 months)
- HIV Self-Management(4 months)
- Resilience(4 months)