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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01362634
Enrollment
750
Registered
2011-05-30
Start date
2011-08-31
Completion date
2017-07-31
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Substance Abuse

Keywords

HIV/AIDS, substance use, club drugs, sexual risk

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.

Interventions

BEHAVIORALTrans-theoretical Process of Change Model-self

self-administered, computer-based intervention

BEHAVIORALTrans-theoretical Process of Change Model - interviewer

interviewer-administered intervention

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Nova Southeastern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
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)

Design outcomes

Primary

MeasureTime frame
unprotected sexual intercourse events outside of primary relationships3 months
unprotected sexual intercourse events outside of primary relationship6 months
Days drug use in the past 90 days3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026