Pilot-test of an mHealth Black Men Who Have Sex With Men (MSM) in Couples Intervention (LetSync v1.0, v2.0)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- HIV/AIDS
- 发起方
- University of California, San Francisco
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Proportion of Urine Samples Returned by Participants
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The Pilot Test (AKA Study B) will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the investigators will make refinements based on participants' data to produce LetSync v2.0. Then, participants in the waitlist-control arm will receive LetSync v2.0, use it for 6 months, and provide acceptability and feasibility data. The intervention arm will continue using LetSync v1.0, for a total of 14 months. Based on acceptability and feasibility data from waitlist control arm participants between T3 and T4, the investigators will develop LetSync v3.0, which will be used for efficacy testing in a full RCT trial in the future.
研究者
入排标准
入选标准
- •Individuals are eligible if they:
- •Self-identify as racial/ethnic minority
- •Self-identify as a cisgender man
- •Are HIV-Positive themselves, or are the partner of someone who is living with HIV
- •Are age 18 or older
- •Have a primary relationship partner, defined as someone to whom the participant is committed above anyone else for three or more months
- •Uses and owns a personal smartphone
- •Willing and able to provide informed consent
- •Partners are eligible if they:
- •Self-identify as a cisgender man
排除标准
- •Report fear of intimate partner violence (IPV) resulting from participation
- •Are unwilling or unable to disclose HIV status to primary partner
- •Present evidence of severe cognitive impairment that would prevent comprehension of study procedures assessed during informed consent
结局指标
主要结局
Proportion of Urine Samples Returned by Participants
时间窗: 8 months
The investigators will use self-collected urine samples as another objective measure of drug adherence for participants living with HIV. The investigators will mail participants a urine sample collection kit with necessary supplies and detailed instructions via online demonstration video. Participants will self-collect and administer the urine sample and send a photo of the results to study staff. Urine test results were collected between baseline (T0) and 8 months (T4) as proportion of samples returned.
Levels of Antiretroviral (ARV, TFVDP) Concentration in Dried Blood Spot (DBS) Samples
时间窗: 8 months
The investigators will use the UNC Pharmacology Lab to analyze ARV levels in dried blood spot (DBS) samples as an objective measure of drug adherence and exposure for HIV-infected participants. The investigators will mail participants a DBS sample collection kit with necessary supplies, detailed instructions via online demonstration video, and a prepaid return envelope. DBS samples will be collected and analyzed between baseline (T0) and 8 months (T4). ARV levels of TFVDP will be measured as nanograms per milligram (ng/mg) of DBS will be log-transformed for data analysis. Changes since Baseline of ARV levels will be measured.
Self-reported Measure of Care Engagement
时间窗: 8 months
Self-reported care engagement will be measured with the 10-item Index of Engagement in HIV Care rated on a Likert-type scale ranging from 1 to 5, 'Strongly disagree' to 'Strongly agree'. The minimum summed score is 10, the maximum summed score is 50. A score will be calculated is the sum of all items without missing responses, with a higher score representing better care engagement and lower score representing worse care engagement.
次要结局
- Number of Participants Retained(8 months)