A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV

This study is currently recruiting participants.
Verified March 2014 by Nova Southeastern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Kurtz, Ph.D., Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT01362634
First received: May 26, 2011
Last updated: March 7, 2014
Last verified: March 2014

May 26, 2011
March 7, 2014
August 2011
June 2015   (final data collection date for primary outcome measure)
  • unprotected sexual intercourse events outside of primary relationships [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • unprotected sexual intercourse events outside of primary relationship [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • unprotected sexual intercourse events outside of primary relationship [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Days drug use in the past 90 days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Days drug use in the past 90 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Days drug use in the past 90 days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01362634 on ClinicalTrials.gov Archive Site
Not Provided
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A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV

The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, HIV pretest counseling and test administration, and collection of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.

The specific aims of the 5-year study are to:

  1. identify the covariates of baseline substance abuse and sexual risks (including demographics, social risk measures, peer norms, abuse history, and mental health status) among a sample of 750 heterosexually active, not-in-treatment, club and prescription drug users ages 18 to 39 in Miami, Florida.
  2. evaluate, through random assignment, the relative effectiveness of two intervention conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-, 6- and 12-month follow-ups:

    • Arm 1, an interviewer-administered comprehensive health and social risk assessment intervention (CAPI Intervention) similar to the baseline instrument used in the parent grant;
    • Arm 2, an identical self-administered comprehensive assessment intervention (ACASI Intervention); and
    • Arm 3, a waitlist control condition (Control). Outcome measures, including past 90-day counts of unprotected sex acts and days' drug use, will be obtained from brief risk behavior inventories at baseline and follow-ups.
  3. conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infection
  • Substance Abuse
  • Behavioral: Trans-theoretical Process of Change Model-self
    self-administered, computer-based intervention
  • Behavioral: Trans-theoretical Process of Change Model - interviewer
    interviewer-administered intervention
  • Experimental: CAPI Intervention
    an interviewer-administered comprehensive health and social risk assessment intervention
    Intervention: Behavioral: Trans-theoretical Process of Change Model - interviewer
  • Experimental: ACASI Intervention
    self-administered comprehensive health and social risk assessment intervention
    Intervention: Behavioral: Trans-theoretical Process of Change Model-self
  • No Intervention: Control
    waitlist control condition
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
750
July 2016
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • heterosexually active
  • ongoing club and prescription drug use
  • between 18-39 years of age
  • must go to local clubs at least two times per month

Exclusion Criteria:

  • no current working phone number or e-mail address
  • no intention to remain in South Florida for the next 12 months
  • new HIV diagnosis in the past 90 days
  • currently participating in a drug treatment program (excluding 12-step programs such as Alcoholics Anonymous)
Both
18 Years to 39 Years
No
Not Provided
United States
 
NCT01362634
7R01DA019048
Yes
Steven Kurtz, Ph.D., Nova Southeastern University
Nova Southeastern University
National Institute on Drug Abuse (NIDA)
Not Provided
Nova Southeastern University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP