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

Not Applicable

Completed

• Conditions: HIV Infection; Substance Abuse
• Interventions: Behavioral: Trans-theoretical Process of Change Model - interviewer; Behavioral: Trans-theoretical Process of Change Model-self

• Registration Number: NCT01362634
• Lead Sponsor: Nova Southeastern University

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.

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 Timeline

• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-30
• Study Start: 2011-08
• Primary Completion: 2015-12
• Study Completion: 2017-07-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-06
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAPI Intervention	Trans-theoretical Process of Change Model - interviewer	an interviewer-administered comprehensive health and social risk assessment intervention
ACASI Intervention	Trans-theoretical Process of Change Model-self	self-administered comprehensive health and social risk assessment intervention

Primary Outcome Measures

Name	Time	Method
Days drug use in the past 90 days	12 months
unprotected sexual intercourse events outside of primary relationships	3 months
unprotected sexual intercourse events outside of primary relationship	12 months

Trial Locations

Locations (1)

NSU Research Center; 🇺🇸 Miami, Florida, United States