FASTLANE II: Reducing Sex, Drug, and Mental Health Risk (FLII)
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|ClinicalTrials.gov Identifier: NCT04109014|
Recruitment Status : Not yet recruiting
First Posted : September 30, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Abuse HIV/AIDS Depression Sex, Unsafe||Other: FASTLANE II||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Quasiexperimental, single group pretest-posttest study design and qualitative interviews to evaluate feasibility, acceptability and effect.|
|Masking:||None (Open Label)|
|Official Title:||Depression, Meth Use, and Safe Sex Behaviors: Assessing the Feasibility and Acceptability of an HIV Cognitive Behavioral Intervention for Young Adult Latina Women|
|Estimated Study Start Date :||November 2020|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
FASTLANE II Group
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.
Other: FASTLANE II
The intervention will consist of nine weekly hour-long individual counseling sessions. The FL II sessions utilize a combination of Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) to reduce sexual risk behaviors and mental health symptoms. Thus, individuals develop a "toolbox" for mood self-management to improve emotional self-regulation and reduce maladaptive coping mechanisms to minimize drug and sex risk behavior. Participants will be considered as completing the FASTLANE Intervention upon completion of the nine weeks of sessions.
- Depression [ Time Frame: 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 [ Time Frame: 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.
- Negotiating Self-Efficacy for Safer Sex [ Time Frame: 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.
- Methamphetamine Use [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109014
|Contact: Alice Cepeda, PhDfirstname.lastname@example.org|
|Contact: Esmeralda Ramirez, MAemail@example.com|
|Principal Investigator:||Alice Cepeda, PhD||University of Southern California|