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.

Study Overview

• Status: Completed
• Conditions: HIV Infection; Substance Abuse
• Intervention / Treatment: Behavioral: Trans-theoretical Process of Change Model - interviewer; Behavioral: Trans-theoretical Process of Change Model-self

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 Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33137
      • NSU Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
unprotected sexual intercourse events outside of primary relationships	3 months
unprotected sexual intercourse events outside of primary relationship	6 months
unprotected sexual intercourse events outside of primary relationship	12 months
Days drug use in the past 90 days	3 months
Days drug use in the past 90 days	6 months
Days drug use in the past 90 days	12 months

Collaborators and Investigators

• Sponsor: Nova Southeastern University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: May 26, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 6, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: HIV/AIDS; substance use; sexual risk; club drugs
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 7R01DA019048 (U.S. NIH Grant/Contract)