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FASTLANE II: Reducing Sex, Drug, and Mental Health Risk (FLII)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109014
Recruitment Status : Not yet recruiting
First Posted : September 30, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Alice Cepeda, University of Southern California

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Methamphetamine Abuse HIV/AIDS Depression Sex, Unsafe Other: FASTLANE II Not Applicable

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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)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resident of San Antonio, Texas
  • Female
  • 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

Exclusion Criteria:

  • Not a resident of San Antonio, Texas
  • Male
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Alice Cepeda, PhD 213.821.6464 alicecep@usc.edu
Contact: Esmeralda Ramirez, MA 210.452.5991 esmerami@usc.edu

Sponsors and Collaborators
University of Southern California
University of California, San Diego
Investigators
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Principal Investigator: Alice Cepeda, PhD University of Southern California

Publications:
Ennis, S., M. Rios-Vargas, & N.G. Albert, The Hispanic Population 2010. 2011.
Motel, S.E.P., Hispanics of Mexican Origin in the United States, 2010. 2012, Pew Research Center.
Telles, E.E.V.O., Generations of Exclusion: Mexican Americans, Assimilation, and Race. 2008, Russell Sage Foundation.
United States Census Bureau, DP-1-Profile of General Population and Housing Characteristics: 2010. 2010.
Economic Innovation Group, The 2016 Distressed Communities Index: An Analysis of Community Well- Being Across the United States. Economic Innovation Group.
Pitpitan, E.V., et al., Cognitive behavioral therapy for HIV-negative heterosexual meth users: the FASTLANE II intervention. Cognitive and Behavioral Practice, 2014. 21(2): p. 176-190.
Beck, A., R. Steer, and G. Brown, Manual for the BDI-II. 1996, San Antonio, TX: Psychological Corporation.
Corbin, J.M. and A. Strauss, Grounded theory research: Procedures, canons, and evaluative criteria. Qualitative sociology, 1990. 13(1): p. 3-21.
Glaser, B. and A. Strauss, Discovery of grounded theory: Strategies for qualitative review. 1967, Chicago, IL: Aldine De Gruyter.
LeCompte, M.D. and J.J. Schensul, Analyzing & interpreting ethnographic data. 1999: Rowman Altamira.
Ragin, C.C., The Comparative Method: Moving Beyond Qualitative and Quantitative Strategies. 1987, Los Angeles: University of California Press.
Spradley, J., The Ethnographic Interview. New York, NY: Holt, Rinehart and Winston. Inc, 1979.

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Responsible Party: Alice Cepeda, Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT04109014    
Other Study ID Numbers: UP-15-00628
First Posted: September 30, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alice Cepeda, University of Southern California:
Cognitive Behavioral
Qualitative Interviews
Motivational Interviewing
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders