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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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 Phase
HIV Infection
Substance Abuse
Behavioral: Trans-theoretical Process of Change Model-self
Behavioral: Trans-theoretical Process of Change Model - interviewer
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Nova Southeastern University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 750
Study Start Date: August 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 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
Genders Eligible for Study:   Both
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 Recruiting
Miami, Florida, United States, 33137
Contact: Gustavo Aguilera, BA    305-672-6649    gustavo.aguilera@nova.edu   
Sponsors and Collaborators
Nova Southeastern University
  More Information

No publications provided

Responsible Party: Steven Kurtz, Ph.D., Professor, Nova Southeastern University
ClinicalTrials.gov Identifier: NCT01362634     History of Changes
Other Study ID Numbers: 7R01DA019048
Study First Received: May 26, 2011
Last Updated: March 7, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Nova Southeastern University:
HIV/AIDS
substance use
club drugs
sexual risk

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Slow Virus Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014