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

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362634
• Other study ID #: 7R01DA019048
• Status: Completed
• Phase: N/A
• First received: May 26, 2011
• Last updated: December 6, 2017
• Start date: August 2011
• Est. completion date: July 31, 2017

Study information

• Verified date: December 2017
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: July 31, 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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)

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections
• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Trans-theoretical Process of Change Model-self
self-administered, computer-based intervention
• Trans-theoretical Process of Change Model - interviewer
interviewer-administered intervention

Locations

Country	Name	City	State
United States	NSU Research Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nova Southeastern University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	unprotected sexual intercourse events outside of primary relationships		3 months
Primary	unprotected sexual intercourse events outside of primary relationship		6 months
Primary	unprotected sexual intercourse events outside of primary relationship		12 months
Primary	Days drug use in the past 90 days		3 months
Primary	Days drug use in the past 90 days		6 months
Primary	Days drug use in the past 90 days		12 months