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Completed

NCT Number: NCT01362634

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.

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Key information

About this study

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

  • 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.
  • 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.
  • conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Trans-theoretical Process of Change Model-self

Behavioral

self-administered, computer-based intervention

Trans-theoretical Process of Change Model - interviewer

Behavioral

interviewer-administered intervention

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Nova Southeastern University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2017
First posted
May 30, 2011
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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