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

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ClinicalTrials.gov Identifier: NCT01362634
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infection Substance Abuse Behavioral: Trans-theoretical Process of Change Model-self Behavioral: Trans-theoretical Process of Change Model - interviewer

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 750 participants
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
Study Start Date : August 2011
Primary Completion Date : December 2015
Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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): 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 )
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 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