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临床试验/NCT04109014
NCT04109014已完成不适用

Depression, Meth Use, and Safe Sex Behaviors: Assessing the Feasibility and Acceptability of an HIV Cognitive Behavioral Intervention for Young Adult Latina Women

University of Southern California1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Methamphetamine Use

研究概览

简要总结

The study uses a repeated measures, single group pretest-posttest design methodology to examine the feasibility, acceptability, and preliminary effectiveness of the FASTLANE II intervention aimed at decreasing risky sex behaviors among active methamphetamine using women. The study's methodology consists of two phases: 1) The feasibility and evaluation of recruitment capability and intervention effectiveness, and 2) qualitative acceptability interviews.

详细描述

Specific Aims Methamphetamine use among young adult Latina women with histories of intimate partner violence are at disproportionate risk for Human Immunodeficiency Virus (HIV) and sexually transmitted infection (STI). Studies demonstrate that these women are also at extremely high risk for a myriad of mental health conditions, including depression. There is promising support that addressing the co-occurrence of drug use and depression can lead to increased safe sex behaviors, positive outcomes and HIV/STI risk reduction. However, there are countless systemic barriers to engaging drug using young adult women who face high rates of psychological, interpersonal relationship and legal problems into safe sex interventions.

In response to the University of Southern California (USC) Clinical and Translational Science Institute (CTSI) Clinical and Community Research Award, this application proposes to assess the feasibility of an integrated HIV behavioral intervention, FASTLANE II that has preliminary evidence of efficacy in increasing safer sex behaviors and simultaneously targeting depressive symptoms among active drug users. FASTLANE II utilizes cognitive behavioral therapy (CBT) and incorporates motivational interviewing (MI) techniques as well as central theoretical components from the theory of reasoned action. The study will deliver FASTLANE II for a new population and new setting and obtain initial data on its feasibility, acceptability and preliminary outcome data. Specifically, the proposed application builds upon an on-going National Institute on Drug Abuse (NIDA) funded R01, "Proyecto San Antonio Latina Trajectory Outcomes (SALTO) - 5R01DA039269-04, a longitudinal community-based study examining long-term health outcomes of drug and partner violence victimization trajectories for a cohort of Mexican American women in San Antonio, Texas (SAT). Findings demonstrate a high-needs population with high rates of STIs, illicit drug use and depression confounded by low rates of access and utilization of health care. The investigators will employ a quasi- experimental, single group pretest-posttest study design and qualitative interviews to evaluate feasibility, acceptability and effect. Specifically, the investigators plan to pursue the following specific aims:

  1. To assess the feasibility of recruiting and retaining active methamphetamine using Mexican American women in SAT;
  2. Obtain outcome data (depression, sex risk and methamphetamine use) for a new population in a new setting;
  3. Explore participant's perceptions of the acceptability of the FASTLANE II intervention.

This study will provide preliminary data that would inform a future randomized controlled trial (RCT) to implement a promising HIV intervention for this underserved vulnerable population using National Institute of Health (NIH) Funding Opportunity Announcement Number PAR-17-490/ PAR-17-491 "Implementing the Most Successful Interventions to Improve HIV/AIDS Outcomes in US Communities". Moreover, the study takes advantage of a unique team of collaborators including: 1) the University of Incarnate Ward San Antonio; 2) the University of California San Diego and 3) the University of Southern California.

Research Strategy Significance Research has demonstrated the heightened risk for HIV/STI infection among methamphetamine users engaged in unprotected sexual behaviors. Studies demonstrate significantly more sex partners, engagement in anal sex behavior, engagement in prostitution or exchange of sex for drugs and less likely to use condoms. Despite this, few interventions exists to increase safer sex behaviors among populations of methamphetamine users. This is particularly important given that curtailing and/or changing drug use behaviors is a time-intensive specialized process and often times not a realistic goal for active users engaged in sexual risk behaviors. Thus, the proposed study will add to the limited interventions that exist in reducing sexual risks in the context of active drug (methamphetamine) using women.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Resident of San Antonio, Texas
  • •Mexican-American
  • •HIV-negative
  • •18 years of age or older
  • •Self-identify as heterosexual
  • •Have had unprotected sex with at least one opposite sex partner during the previous 2 months
  • •Indicate that they have snorted or smoked methamphetamine at least once during the previous 2 months

排除标准

  • •Not a resident of San Antonio, Texas
  • •Not Mexican-American
  • •HIV-positive
  • •Younger than 18 years of age
  • •Do not self-identify as heterosexual
  • •Have not had unprotected sex with at least one opposite sex partner during the previous 2 months
  • •Indicate that they have not snorted or smoked methamphetamine at least once during the previous 2 months

研究组 & 干预措施

FASTLANE II Group

Other

Participants will participate in the FASTLANE II Intervention. Counseling sessions will focus on: 1) depressive symptoms, 2) methamphetamine use, and 3) sexual risk behaviors. Three sessions will be devoted to each topic area. Trained staff will use a client-centered approach and develop a goal for each area alongside the participant. Counseling sessions will remain confidential and will not be audio recorded.

干预措施: FASTLANE II (Other)

结局指标

主要结局

Methamphetamine Use

时间窗: 9-12 weeks

Asked to report number of days and grams (or preferred unit) of methamphetamine used in the past 30 days. They will be asked how often they snort, smoked, injected, injected in combination with another drug, or used in any other way in the past 2 months. Response options 0 = never, 1 = once in a while, 2 = fairly often, and 3 = very often. The items will be summed to create a summary score of "frequency of meth use across different methods in the past 2 months." Amount responses will be converted to grams using a standard formula (e.g., 8 ball ¼ 3.5 g; ounce ¼ 28 g). Converted values will be multiplied by number of times used to calculate the number of grams of methamphetamine used in the past 30 days.

Negotiating Self-Efficacy for Safer Sex

时间窗: 9-12 weeks

Seven questions pertaining to self-efficacy for negotiation of safer sex, including perceived ability to bring up the topic of safer sex with any partner, negotiate condom use with any partner, and convince a partner to use a condom if he or she resisted. Participants presented with a statement about being able to negotiate safer sex (e.g., ''I can persuade partners to try different types of condoms'') and rate agreement ranging from 1 (strongly disagree) to 4 (strongly agree). Total sum score with higher scores greater self-efficacy.

Depression

时间窗: 9-12 weeks

Participants will be asked to complete the Beck Depression Inventory (BDI-II) scale. A total of 21 items assess depressive symptoms over the past 2 weeks (including today), and are summed to create a summary score (alpha = 0.91). We used established cutoffs for minimal (0-13), mild (14-19), moderate (20-28), and severe depressive symptoms (29-63).

Sex Practices

时间窗: 9-12 weeks

Assesses number of times participants engaged in sexual behavior, (vaginal, oral, and anal sex). Follow-up questions assess number of times these sexual acts were protected. Use of condoms or oral dams or nonpenetrative (e.g., manual sex) excluding oral sex. Using these data, three outcome variables will be used: (a) total protected sex acts, (b) total unprotected sex acts, and (c) percentage of safer sex behaviors (i.e., ratio) by dividing protected sex behaviors by the total number of sex behaviors over the past 2 months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alice Cepeda

Associate Professor

University of Southern California

研究点 (1)

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