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Positive Choice: Prevention for Positive Health

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00447707
First received: March 13, 2007
Last updated: April 2, 2007
Last verified: March 2007

March 13, 2007
April 2, 2007
December 2003
Not Provided
Elimination of risky drinking, illicit alcohol use, unprotected sex, and non-disclosure of HIV status to sex partners.
Same as current
Complete list of historical versions of study NCT00447707 on ClinicalTrials.gov Archive Site
Measures of change in risky alcohol use, illicit drug use, unprotected sex, and non-disclosure of HIV status to sex partners.
Same as current
Not Provided
Not Provided
 
Positive Choice: Prevention for Positive Health
Positive Choice: Prevention for Positive Health

This is a randomized, controlled trial of Positive Choice, an interactive multimedia computer program, to determine whether it can detect and reduce risky behaviors among HIV-positive adults. The behaviors of interest are: unprotected anal or vaginal intercourse, illicit drug use, risky alcohol drinking, and failure to disclose HIV status to sex partners. The Positive Choice program is integrated into the routine operations of outpatient HIV clinics, where participating patients complete an in-depth risk assessment (computerized health questionnaire) before a regularly scheduled medical appointment. Participants assigned to the intervention arm receive brief, interactive risk-reduction counseling by an actor-portrayed Video Doctor and an educational worksheet. Their health care provider receives as summary cueing sheet, alerting them to the patient's risky behavior and readiness to change. Control participants complete the computerized risk assessment and receive the clinic's usual care. Three months after a baseline visit, intervention and control group patients are invited back to complete an additional risk assessment. The intervention group also receives a “booster” intervention. Six months after baseline, both groups complete a final risk assessment.

A preliminary analysis of baseline data was conducted in January 2006, which indicated that the Positive Choice intervention achieved significant reductions in drug use. These findings were reported in a poster presentation at the XVI International AIDS Conference in Toronto, Canada, in August 2006. A final analysis of outcomes data was conducted in fall 2006 (September – December). Aggregate results from all five study sites are summarized below.

We found a high prevalence of risky behaviors in our sample (497/918, or 54%) and achieved high retention for follow-up in both groups (>80%). We found significant elimination of any drug use in the intervention group at both follow-ups. Among all participants who reported drug use at baseline, 66% of intervention participants continued their drug use at 3-month follow-up compared to 85% of control participants (OR 0.356, p<0.01). At 6-month follow-up, 59% of intervention participants continued their drug use compared to 88% of the control group (<0.001). Among participants who reported methamphetamine use at baseline, 58% continued their methamphetamine use at 3-month follow-up compared to 83% of control participants (OR 0.285, p=0.02). At 6-month follow-up, 53% of intervention participants continued their methamphetamine use compared to 73% of the control group (OR 0.344, p=0.03). We also found significantly less unprotected sex with casual partners by intervention participants at 3-month follow up (69% vs. 87%, OR 0.313, p=0.04), and fewer intervention participants who exceeded the recommended number of drinks per week at 3-months (53% vs. 78%, OR 0.310, p=0.02) Our findings indicate that the Positive Choice program was effective at reducing important behavioral risks among HIV-positive adults in care. Positive Choice is an appropriate and effective adjunct to routine medical care for HIV-positive adults.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
  • HIV Infections
  • Sexual Risk Behavior
  • Substance Use Risks
Behavioral: Positive Choice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
497
September 2006
Not Provided

Inclusion Criteria:

  • 18 years or older,
  • HIV-positive 3 months or longer,
  • English speaking; and
  • Receiving medical care at a participating clinic.

Exclusion Criteria:

  • Less than 18 years old,
  • HIV-positive less than 3 months,
  • Non-English speaking; and
  • Not receiving medical care at a participating clinic.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00447707
R01DA15016
No
Not Provided
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Barbara Gerbert, PhD University of California, San Francisco
National Institute on Drug Abuse (NIDA)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP