A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
NCT ID: NCT01362634
Last Updated: 2017-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
750 participants
INTERVENTIONAL
2011-08-31
2017-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CAPI Intervention
an interviewer-administered comprehensive health and social risk assessment intervention
Trans-theoretical Process of Change Model - interviewer
interviewer-administered intervention
ACASI Intervention
self-administered comprehensive health and social risk assessment intervention
Trans-theoretical Process of Change Model-self
self-administered, computer-based intervention
Control
waitlist control condition
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Trans-theoretical Process of Change Model-self
self-administered, computer-based intervention
Trans-theoretical Process of Change Model - interviewer
interviewer-administered intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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)
18 Years
39 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Drug Abuse (NIDA)
NIH
Nova Southeastern University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Steven Kurtz, Ph.D.
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NSU Research Center
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.