A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infection Substance Abuse |
Behavioral: Trans-theoretical Process of Change Model-self Behavioral: Trans-theoretical Process of Change Model - interviewer |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Self-Assessment Intervention for Young Adult Polydrug Users at Risk for HIV |
- unprotected sexual intercourse events outside of primary relationships [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- unprotected sexual intercourse events outside of primary relationship [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- unprotected sexual intercourse events outside of primary relationship [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Days drug use in the past 90 days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Days drug use in the past 90 days [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Days drug use in the past 90 days [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 750 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CAPI Intervention
an interviewer-administered comprehensive health and social risk assessment intervention
|
Behavioral: Trans-theoretical Process of Change Model - interviewer
interviewer-administered intervention
|
|
Experimental: ACASI Intervention
self-administered comprehensive health and social risk assessment intervention
|
Behavioral: Trans-theoretical Process of Change Model-self
self-administered, computer-based intervention
|
|
No Intervention: Control
waitlist control condition
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 39 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Florida | |
| NSU Research Center | Recruiting |
| Miami Beach, Florida, United States, 33140 | |
| Contact: Gustavo Aguilera, BA 305-672-6649 gustavo.aguilera@nova.edu | |
More Information
No publications provided
| Responsible Party: | Steven Kurtz, Ph.D., Professor, Nova Southeastern University |
| ClinicalTrials.gov Identifier: | NCT01362634 History of Changes |
| Other Study ID Numbers: | 7R01DA019048 |
| Study First Received: | May 26, 2011 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Nova Southeastern University:
|
HIV/AIDS substance use club drugs sexual risk |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Substance-Related Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mental Disorders |
ClinicalTrials.gov processed this record on June 13, 2013