Positive Choice: Prevention for Positive Health

NCT ID: NCT00447707

Last Updated: 2017-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 497 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2006-09-30

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.

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.

Conditions

HIV Infections; Sexual Risk Behavior; Substance Use Risks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Interventions

Positive Choice

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Principal Investigators

Barbara Gerbert, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Adult Immunology Clinic, Highland Hospital

Oakland, California, United States

AIDS Project East Bay (APEB)

Oakland, California, United States

East Bay AIDS Center (EBAC), Alta Bates Hospital

Oakland, California, United States

Kaiser Permanente Medical Center

San Francisco, California, United States

Adult Immunology Clinic, Fairmont Hospital

San Leandro, California, United States

Countries

United States

References

Gerbert B, Danley DW, Herzig K, Clanon K, Ciccarone D, Gilbert P, Allerton M. Reframing "prevention with positives": incorporating counseling techniques that improve the health of HIV-positive patients. AIDS Patient Care STDS. 2006 Jan;20(1):19-29. doi: 10.1089/apc.2006.20.19.

Reference Type: BACKGROUND

PMID: 16426152 (View on PubMed)

Gilbert P, Ciccarone D, Gansky SA, Bangsberg DR, Clanon K, McPhee SJ, Calderon SH, Bogetz A, Gerbert B. Interactive "Video Doctor" counseling reduces drug and sexual risk behaviors among HIV-positive patients in diverse outpatient settings. PLoS One. 2008 Apr 23;3(4):e1988. doi: 10.1371/journal.pone.0001988.

Reference Type: DERIVED

PMID: 18431475 (View on PubMed)

Other Identifiers

R01DA015016

Identifier Type: NIH

Identifier Source: org_study_id

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