A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
1 other identifier
interventional
750
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2017
CompletedDecember 7, 2017
December 1, 2017
4.3 years
May 26, 2011
December 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (3)
CAPI Intervention
EXPERIMENTALan interviewer-administered comprehensive health and social risk assessment intervention
ACASI Intervention
EXPERIMENTALself-administered comprehensive health and social risk assessment intervention
Control
NO INTERVENTIONwaitlist control condition
Interventions
self-administered, computer-based intervention
interviewer-administered intervention
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NSU Research Center
Miami, Florida, 33137, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 30, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2015
Study Completion
July 31, 2017
Last Updated
December 7, 2017
Record last verified: 2017-12