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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infection, Substance Abuse

Intervention / Treatment
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* Behavioral: Trans-theoretical Process of Change Model-self
* Behavioral: Trans-theoretical Process of Change Model - interviewer


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAPI Intervention<br>an interviewer-administered comprehensive health and social risk assessment intervention | Behavioral: Trans-theoretical Process of Change Model - interviewer<br>* interviewer-administered intervention<br>|
| Experimental: ACASI Intervention<br>self-administered comprehensive health and social risk assessment intervention | Behavioral: Trans-theoretical Process of Change Model-self<br>* self-administered, computer-based intervention<br>|
| No Intervention: Control<br>waitlist control condition | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, substance use, club drugs, sexual risk