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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Steven Kurtz, Ph.D., Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT01362634
First received: May 26, 2011
Last updated: March 27, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
HIV Infection Substance Abuse Behavioral: Trans-theoretical Process of Change Model-self Behavioral: Trans-theoretical Process of Change Model - interviewer

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV

Resource links provided by NLM:


Further study details as provided by Steven Kurtz, Ph.D., Nova Southeastern University:

Primary Outcome Measures:
  • unprotected sexual intercourse events outside of primary relationships [ Time Frame: 3 months ]
  • unprotected sexual intercourse events outside of primary relationship [ Time Frame: 6 months ]
  • unprotected sexual intercourse events outside of primary relationship [ Time Frame: 12 months ]
  • Days drug use in the past 90 days [ Time Frame: 3 months ]
  • Days drug use in the past 90 days [ Time Frame: 6 months ]
  • Days drug use in the past 90 days [ Time Frame: 12 months ]

Estimated Enrollment: 750
Study Start Date: August 2011
Estimated Study Completion Date: July 2017
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAPI Intervention
an interviewer-administered comprehensive health and social risk assessment intervention
Behavioral: Trans-theoretical Process of Change Model - interviewer
interviewer-administered intervention
Experimental: ACASI Intervention
self-administered comprehensive health and social risk assessment intervention
Behavioral: Trans-theoretical Process of Change Model-self
self-administered, computer-based intervention
No Intervention: Control
waitlist control condition

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362634

Locations
United States, Florida
NSU Research Center
Miami, Florida, United States, 33137
Sponsors and Collaborators
Nova Southeastern University
National Institute on Drug Abuse (NIDA)
  More Information

Responsible Party: Steven Kurtz, Ph.D., Professor, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT01362634     History of Changes
Other Study ID Numbers: 7R01DA019048 ( U.S. NIH Grant/Contract )
Study First Received: May 26, 2011
Last Updated: March 27, 2017

Keywords provided by Steven Kurtz, Ph.D., Nova Southeastern University:
HIV/AIDS
substance use
club drugs
sexual risk

Additional relevant MeSH terms:
HIV Infections
Substance-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2017