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CompletedNCT01362634Updated Dec 7, 2017

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

An interventional study of Trans-theoretical Process of Change Model-self and Trans-theoretical Process of Change Model - interviewer in HIV Infection and Substance Abuse, sponsored by Nova Southeastern University. Completed at 1 site in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by Nova Southeastern University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
750
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • HIV Infection
  • Substance Abuse

Keywords

  • HIV/AIDS
  • substance use
  • club drugs
  • sexual risk
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 750 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Nova Southeastern University is the lead sponsor of 80 studies on the registry; 18 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
750 participants (actual)

Study arms

  • Experimental
    CAPI Intervention

    an interviewer-administered comprehensive health and social risk assessment intervention

    Behavioral: Trans-theoretical Process of Change Model - interviewer

  • Experimental
    ACASI Intervention

    self-administered comprehensive health and social risk assessment intervention

    Behavioral: Trans-theoretical Process of Change Model-self

  • No intervention
    Control

    waitlist control condition

Interventions

  • BehavioralTrans-theoretical Process of Change Model-self

    self-administered, computer-based intervention

  • BehavioralTrans-theoretical Process of Change Model - interviewer

    interviewer-administered intervention

06

What researchers measure

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

07

Study locations

1 site
  • NSU Research Center
    Miami, Florida 33137, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01362634
Lead sponsor
Nova Southeastern University
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Steven Kurtz, Ph.D. (Professor, Nova Southeastern University) — Principal investigator
First posted
May 30, 2011
Start date
Aug 2011
Primary completion
Dec 2015
Completion
Jul 31, 2017
Last update
Dec 7, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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