GODDESS (Gathering Online for Dialogue and Discussion to Enhance Social Support): Engaging Young African American Women in a Virtual Group App to Address Alcohol Misuse, Sexual Risk, and Pre-exposure Prophylaxis (PrEP) in North Carolina (NC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Alcohol (Biological)
研究概览
简要总结
The goal of this trial is to test a modified mobile health intervention (with a group component) relative to a mobile health intervention in a two-arm randomized trial with up to 500 young women who are human immunodeficiency virus (HIV)-negative and who misuse alcohol.
The expected outcomes are to: (1) determine the efficacy of the virtual group component in reducing alcohol use and sexual risk and increasing pre-exposure prophylaxis (PrEP) utilization; and (2) understand selected outcomes for implementation.
Participants will be randomized to receive either the mHealth app or the mHealth app plus the group component, and followed up at 3- and 6-months post-enrollment.
详细描述
Up to 500 participants who are human immunodeficiency virus (HIV)-negative who engage in heavy alcohol use will be enrolled and referred to their local health departments for pre-exposure prophylaxis (PrEP). Primary biobehavioral outcomes assessed will include reduced alcohol use (self-reported and biological, including phosphatidylethanol [PEth]), increased PrEP uptake (self-reported and biological), and reduced sexual risk (self-reported condomless sex and impaired sex and biological testing for HIV) at 3- and 6-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Selected Inclusion Criteria:
- •identify as Black/African American
- •identify as female
- •be between 18 and 30 years old
- •recent substance use
- •HIV negative and not currently on PrEP
- •have an Android or iOS-based smartphone
排除标准
- •test positive for HIV
- •participated in the previous study activities of the current study or previous related studies
研究组 & 干预措施
Standard: mHealth-Women's CoOp
Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young women. The app will be installed on each participant's smartphone by study staff after randomization.
干预措施: mHealth-Women's CoOp (Behavioral)
Enhanced: mHealth-Women's CoOp+Group
Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young women, in addition to a virtual peer group component. The app with a link to the virtual group will be installed on each participant's smartphone by study staff after randomization.
干预措施: mHealth-Women's CoOp (Behavioral)
Enhanced: mHealth-Women's CoOp+Group
Participants assigned to receive an evidence-based mHealth alcohol and other drug use and sexual risk reduction intervention for young women, in addition to a virtual peer group component. The app with a link to the virtual group will be installed on each participant's smartphone by study staff after randomization.
干预措施: Virtual Group (Behavioral)
结局指标
主要结局
Alcohol (Biological)
时间窗: 6-month
Recent alcohol (last 10 days) use will be measured by the presence of ethyl glucuronide (EtG), a breakdown product of ethanol, using an ethyl glucuronide (EtG) urine test. The One Step Ethyl Glucuronide (EtG) Test Dip Card is a lateral flow chromatographic immunoassay. Each test has a control line region to serve as a procedural control and a test line region; results with only a line in the control region and without a line in the test region are classified as positive. Urine EtG ≥300 ng/mL indicates a positive result.
Alcohol (Self-Reported)
时间窗: 6-month
Revised Risk Behavior Assessment (RRBA): Volume (grams of ethanol, accounting for different standard drink size), frequency of use, frequency of binge, heavy episodic drinking (4+ drinks/day).
Sexual Risk: HIV (Biological)
时间窗: 6-month
Number of participants living with HIV as assessed by OraQuick® ADVANCE Rapid HIV-1/2 Antibody Test with oral fluid, with an approximate 99.3% sensitivity \& 99.8% specificity, which detects antibodies to HIV-1 and HIV-2.
Sexual Risk (Self-reported)
时间窗: 6-month
Revised Risk Behavior Assessment (RRBA): Condomless vaginal or anal sex, impaired sex (AOD use prior to or during sex), casual partners, sex trading, \& concurrent partners (≥2 partners), other contraceptive use, \& perception of risk, HIV, recent STIs
PrEP Utilization (Biological)
时间窗: 6-month
Dried blood spot (DBS) samples will be analyzed by quantification of drug concentrations by liquid chromatography-tandem mass spectrometry (LC-MS/MS) technology using assays validated at the study laboratory.
PrEP Utilization (Self-Reported)
时间窗: 6-month
Revised Risk Behavior Assessment (RRBA): Self-reported past 30-day use, missed doses, and patterns of use
次要结局
- Drug Use (Biological)(6-month)
- Drug Use (Self-Reported)(6-month)
- Perceived social support(6-month)
- Violence(6-month)
研究者
Felicia A. Browne, ScD, MPH
Senior Research Social Epidemiologist
RTI International