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
  Purpose

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.


Condition Intervention
HIV Infections
Sexual Risk Behavior
Substance Use Risks
Behavioral: Positive Choice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Educational/Counseling/Training
Official Title: Positive Choice: Prevention for Positive Health

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Elimination of risky drinking, illicit alcohol use, unprotected sex, and non-disclosure of HIV status to sex partners.

Secondary Outcome Measures:
  • Measures of change in risky alcohol use, illicit drug use, unprotected sex, and non-disclosure of HIV status to sex partners.

Estimated Enrollment: 497
Study Start Date: December 2003
Estimated Study Completion Date: September 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447707

Locations
United States, California
Adult Immunology Clinic, Highland Hospital
Oakland, California, United States, 94602
AIDS Project East Bay (APEB)
Oakland, California, United States, 94607
East Bay AIDS Center (EBAC), Alta Bates Hospital
Oakland, California, United States, 94609
Kaiser Permanente Medical Center
San Francisco, California, United States, 94115
Adult Immunology Clinic, Fairmont Hospital
San Leandro, California, United States, 94578
Sponsors and Collaborators
Investigators
Principal Investigator: Barbara Gerbert, PhD University of California, San Francisco
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00447707     History of Changes
Other Study ID Numbers: R01DA15016
Study First Received: March 13, 2007
Last Updated: April 2, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Substance use
Unprotected sex
Behavioral intervention
HIV care
Prevention with Positives
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 22, 2014