Clinical trial NCT01362634: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infection
Substance Abuse
Keywords: HIV/AIDS
substance use
club drugs
sexual risk
Lead sponsor: Nova Southeastern University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-05-30
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

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)

Primary outcomes:
measure: unprotected sexual intercourse events outside of primary relationships
timeFrame: 3 months
measure: unprotected sexual intercourse events outside of primary relationship
timeFrame: 6 months
measure: unprotected sexual intercourse events outside of primary relationship
timeFrame: 12 months
measure: Days drug use in the past 90 days
timeFrame: 3 months
measure: Days drug use in the past 90 days
timeFrame: 6 months
measure: Days drug use in the past 90 days
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: NSU Research Center
state: Florida
Study officials:
References: