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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00447707 |
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: | Educational/Counseling/Training, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Positive Choice: Prevention for Positive Health |
| Estimated Enrollment: | 497 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | September 2006 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Adult Immunology Clinic, Highland Hospital | |
| Oakland, California, United States, 94602 | |
| Adult Immunology Clinic, Fairmont Hospital | |
| San Leandro, California, United States, 94578 | |
| AIDS Project East Bay (APEB) | |
| Oakland, California, United States, 94607 | |
| Kaiser Permanente Medical Center | |
| San Francisco, California, United States, 94115 | |
| East Bay AIDS Center (EBAC), Alta Bates Hospital | |
| Oakland, California, United States, 94609 | |
| Principal Investigator: | Barbara Gerbert, PhD | University of California, San Francisco |
More Information
| Study ID Numbers: | R01DA15016 |
| Study First Received: | March 13, 2007 |
| Last Updated: | April 2, 2007 |
| ClinicalTrials.gov Identifier: | NCT00447707 |
| Health Authority: | United States: Federal Government |
|
Substance use Unprotected sex Behavioral intervention |
HIV care Prevention with Positives HIV seronegativity |
|
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
|
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |
