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Positive Choice: Prevention for Positive Health

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ClinicalTrials.gov Identifier: NCT00447707
Recruitment Status : Completed
First Posted : March 15, 2007
Last Update Posted : January 12, 2017
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
HIV Infections Sexual Risk Behavior Substance Use Risks Behavioral: Positive Choice

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 497 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Positive Choice: Prevention for Positive Health
Study Start Date : December 2003
Estimated Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447707

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
National Institute on Drug Abuse (NIDA)
Principal Investigator: Barbara Gerbert, PhD University of California, San Francisco
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00447707     History of Changes
Other Study ID Numbers: R01DA015016 ( U.S. NIH Grant/Contract )
First Posted: March 15, 2007    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: March 2007

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases