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

Nova Southeastern University (NSU)

Status: Completed

Conditions: HIV Infection; Substance Abuse

Treatments: Behavioral: Trans-theoretical Process of Change Model-self; Behavioral: Trans-theoretical Process of Change Model - interviewer

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01362634

7R01DA019048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 3 patient groups

CAPI Intervention

Experimental group

Description:

an interviewer-administered comprehensive health and social risk assessment intervention

Treatment:

Behavioral: Trans-theoretical Process of Change Model - interviewer

ACASI Intervention

Experimental group

Description:

self-administered comprehensive health and social risk assessment intervention

Treatment:

Behavioral: Trans-theoretical Process of Change Model-self

Control

No Intervention group

Description:

waitlist control condition