NCT00447707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Dec 2003

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2007

Completed
Last Updated

January 12, 2017

Status Verified

March 1, 2007

First QC Date

March 13, 2007

Last Update Submit

January 11, 2017

Conditions

HIV InfectionsSexual Risk BehaviorSubstance Use Risks

Keywords

Substance useUnprotected sexBehavioral interventionHIV carePrevention with PositivesHIV seronegativity

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Positive ChoiceBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Less than 18 years old,
  • HIV-positive less than 3 months,
  • Non-English speaking; and
  • Not receiving medical care at a participating clinic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Adult Immunology Clinic, Highland Hospital

Oakland, California, 94602, United States

Location

AIDS Project East Bay (APEB)

Oakland, California, 94607, United States

Location

East Bay AIDS Center (EBAC), Alta Bates Hospital

Oakland, California, 94609, United States

Location

Kaiser Permanente Medical Center

San Francisco, California, 94115, United States

Location

Adult Immunology Clinic, Fairmont Hospital

San Leandro, California, 94578, United States

Location

Related Publications (2)

  • 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.

    PMID: 16426152BACKGROUND

  • 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.

    PMID: 18431475DERIVED

MeSH Terms

Conditions

HIV InfectionsSubstance-Related DisordersUnsafe Sex

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesChemically-Induced DisordersMental DisordersSexual BehaviorBehavior

Study Officials

  • Barbara Gerbert, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 15, 2007

Study Start

December 1, 2003

Study Completion

September 1, 2006

Last Updated

January 12, 2017

Record last verified: 2007-03

Locations

US(5)