Development of a Behavioral Economic Intervention to Improve HIV-related Behaviors Among Sexual Minority Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Dried Blood Spot Analysis for PrEP adherence
研究概览
简要总结
This research study is testing a new behavioral therapy called Episodic Future Thinking or EFT can help people reduce drug use and risky sexual behaviors while helping them adhere to their HIV prevention medication (PrEP). Participants will be randomly assigned to one of two groups. One group will receive standard care, which includes counseling on HIV prevention, drug use reduction, and sexual health. The other group will receive standard care plus a new program called Episodic Future Thinking (EFT), where participants will think about and plan for their future goals using a mobile app and counseling sessions. Study procedures that are not part of regular care include filling out surveys, providing blood, urine, and swab samples for testing, and using the EFT app.
详细描述
Phase 1 of the study will involve a formative evaluation of the Episodic Future Thinking (EFT) intervention among (n=10) sexual minority individuals (SMIs) utilizing qualitative interviews. (This phase of the study data will not be reported on ClinicalTrials.gov, since it is not part of the randomized controlled trial).
Phase 2 of the study will utilize a two-arm pilot randomized controlled trial of Episodic Future Thinking plus standard of care (intervention) vs. standard of care only (control) condition to improved HIV-related behaviors (PrEP adherence, sexual risk behaviors and methamphetamine use) among sexual minority individuals.
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
- Single (Investigator)
盲法说明
Although it is not possible to fully blind participants due to the nature of the EFT intervention, research staff responsible for outcome assessments (e.g., PrEP adherence, methamphetamine use, and sexual risk behaviors) will be blinded to the participants' group assignment to minimize assessment bias.
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 - 34 years of age
- •HIV negative (assessed via Rapid HIV Antibody Test)
- •Identify as gay, or bisexual
- •Recent (past 3 months) methamphetamine use
- •Currently prescribed and taking HIV PrEP medication
- •Self-reported HIV PrEP nonadherence in the past three months
- •Urine screen test for PrEP nonadherence
- •Self-reported condomless anal sex or a STI in the past three months
- •Able to attend all study visits
- •Fluent in English
排除标准
- •Currently receiving treatment for any substance use disorder,
- •HIV positive
- •Having a medical or psychiatric illness that in the opinion of the PI would interfere with study participation
- •Unable to provide informed consent
- •Unable to attend protocol directed study visits
- •Any plans that would preclude study completion (e.g. surgery, major medical treatments such as chemotherapy, incarceration, travel/moving out of San Antonio, Texas)
结局指标
主要结局
Dried Blood Spot Analysis for PrEP adherence
时间窗: Day 1 to Day 180
Blood spots will be collected and assessed for PrEP adherence. Number of subjects adhering to PrEP will be reported.
Urine Collection for Drug Screening
时间窗: Day 1 to Day 180
Urine will be tested for drug screening. Number of subjects that result in a negative drug screening will be reported.
Urine Collection for Sexually Transmitted Infections (STIs)
时间窗: Day 1 to Day 180
Urine will be tested for STIs. Number of subjects that test negative for STIs will be reported.
Rectal Swab for STI testing
时间窗: Day 1 to Day 180
A rectal swab will be obtained for STI. Number of subjects that test negative for STIs will be reported.
Pre-exposure Prophylaxis (PrEP) Related Intentions
时间窗: Day 1 to Day 180
A 3-item scale to measure PrEP-related intentions (e.g., "During the next three months, I will talk to a health care provider about PrEP"; "During the next three months, I will seek out more information about PrEP" and "During the next three months, I will get a prescription for PrEP"). Response options will be 1 = No, definitely not; 2 = No, probably not; 3 = Yes, probably and 4=Yes, definitely. A total range of scores is 3-12 with a higher score indication a greater intention of taking preventative measures.
PrEP Attitudes
时间窗: Day 1 to Day 180
A 5-item scale to evaluate attitudes regarding PrEP use (e.g., "People who take PrEP are responsible"; "Taking PrEP is safe"). Response options will range from 1=strongly disagree to 5=strongly agree. Total scores will range between 5 and 25, with higher scores indicating more favorable attitudes toward PrEP use.
PrEP Stigma
时间窗: Day 1 to Day 180
A 5-item scale to assess PrEP stigma (e.g., "People who take PrEP are promiscuous"). Responses will be on a 5-point scale, ranging from 1=strongly disagree to 5=strongly disagree. The total range of scores is 5-25, where higher scores denote greater stigma associated with PrEP.
PrEP Self-efficacy
时间窗: Day 1 to Day 180
Participants will self-report the level of difficulty they anticipate in performing 8 behaviors associated with PrEP use (e.g., "How difficult would it be for you to seek out more information about PrEP to decide if it is right for you?"). Responses will be on a scale from 1=very hard to do to 4=very easy to do. Total scores range from 8-32, where higher scores suggest higher levels of self-efficacy.
次要结局
- Rapid HIV test(Day 30 to Day 180)
- Delayed Discounting(Day 1 to Day 180)
- Demand(Day 1 to Day 180)
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-5-TR Self-rated Level 1(Day 1 to Day 180)
- Generalized Anxiety Disorder Screener (GAD-7)(Day 1 to Day 180)
研究者
Chukwuemeka Okafor
Assistant Professor
The University of Texas Health Science Center at San Antonio