A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
Primary Purpose
HIV Infection, Substance Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trans-theoretical Process of Change Model-self
Trans-theoretical Process of Change Model - interviewer
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infection focused on measuring HIV/AIDS, substance use, club drugs, sexual risk
Eligibility Criteria
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)
Sites / Locations
- NSU Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
CAPI Intervention
ACASI Intervention
Control
Arm Description
an interviewer-administered comprehensive health and social risk assessment intervention
self-administered comprehensive health and social risk assessment intervention
waitlist control condition
Outcomes
Primary Outcome Measures
unprotected sexual intercourse events outside of primary relationships
unprotected sexual intercourse events outside of primary relationship
unprotected sexual intercourse events outside of primary relationship
Days drug use in the past 90 days
Days drug use in the past 90 days
Days drug use in the past 90 days
Secondary Outcome Measures
Full Information
NCT ID
NCT01362634
First Posted
May 26, 2011
Last Updated
December 6, 2017
Sponsor
Nova Southeastern University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT01362634
Brief Title
A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
Official Title
A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Southeastern University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Substance Abuse
Keywords
HIV/AIDS, substance use, club drugs, sexual risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAPI Intervention
Arm Type
Experimental
Arm Description
an interviewer-administered comprehensive health and social risk assessment intervention
Arm Title
ACASI Intervention
Arm Type
Experimental
Arm Description
self-administered comprehensive health and social risk assessment intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
waitlist control condition
Intervention Type
Behavioral
Intervention Name(s)
Trans-theoretical Process of Change Model-self
Intervention Description
self-administered, computer-based intervention
Intervention Type
Behavioral
Intervention Name(s)
Trans-theoretical Process of Change Model - interviewer
Intervention Description
interviewer-administered intervention
Primary Outcome Measure Information:
Title
unprotected sexual intercourse events outside of primary relationships
Time Frame
3 months
Title
unprotected sexual intercourse events outside of primary relationship
Time Frame
6 months
Title
unprotected sexual intercourse events outside of primary relationship
Time Frame
12 months
Title
Days drug use in the past 90 days
Time Frame
3 months
Title
Days drug use in the past 90 days
Time Frame
6 months
Title
Days drug use in the past 90 days
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
NSU Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
12. IPD Sharing Statement
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A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
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