Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence

NCT00548275 | Completed Phase 2

• 1 other identifier: 0609001848
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

The major goal is to determine in patients entering buprenorphine treatment, the prevalence of specific sex-related HIV risk behaviors, their physician's screening of these behaviors and to evaluate the impact of risk reduction counseling.

Conditions

Opiate Dependence; HIV Infections

Keywords

Buprenorphine; Drug counseling; HIV risk reduction counseling; HIV Seronegativity; HIV risk behaviors

Outcome Measures

Primary Outcomes (4)

• proportion of condom use during acts of sexual intercourse

  3 months

• number of unprotected vaginal/anal intercourse acts

  3 months

• number of sexual partners

  3 months

• recent diagnosis of an STD

  3 months

Secondary Outcomes (4)

• buprenorphine treatment retention

  3 months

• abstinence from illicit drug use

  3 months

• health status

  3 months

• patient and physician satisfaction

  3 months

Study Arms (2)

1

EXPERIMENTAL

Enhanced Sexual Risk Management (ESRM): Patients assigned to ESRM will attend 4 individual gender-specific interactive counseling sessions, once weekly over a four-week period. They will attend 2 sessions (20 minutes, weeks 2 and 3) followed by 2 sessions (40 minutes, weeks 4 and 5) that will be gender-specific to the patient and gender-matched with the study physicians (one female and one male) who will be trained in HIV testing and risk counseling. Sessions will include skill-building in condom use, safer sex negotiation, self-control of triggers and coping skills, didactic materials, and distribution of written material and address self-perception of risk, barriers to risk reduction, and negotiation of a risk-reduction plan.

Behavioral: Enhanced Sexual Risk Management

2

ACTIVE COMPARATOR

Standard Sexual Risk Management (SSRM): In SSRM, patients will attend two 10-minute gender non-specific individual educational sessions about HIV/AIDS provided by one of the study physicians who will be trained in HIV testing and risk counseling. Session 1 will coincide with the physician visit at the time of randomization. The patient will receive pre-test counseling at this time and undergo HIV antibody testing. Session 2 will take place 7 days later when the patient returns to receive their HIV test results and post-test counseling. In addition, subjects will receive didactic prevention messages about HIV relevant to their reported risks and will be asked if they have questions regarding this information.

Behavioral: Standard Sexual Risk Management

Interventions

Enhanced Sexual Risk Management BEHAVIORAL

management of sexual risk

1

Standard Sexual Risk Management BEHAVIORAL

management of sexual risk

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects meeting DSM-IV criteria for current opioid dependence
• HIV risk behaviors

You may not qualify if:

• current dependence on benzodiazepines or sedatives
• current suicide or homicide risk
• current psychotic disorder or untreated major depression
• inability to read or understand English
• unstable medical problems

Sponsors & Collaborators

• Yale University: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (2)

Methadone Research Unit, The APT Foundation, Inc.

New Haven, Connecticut, 06519, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; HIV Infections

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lynn E Sullivan, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2007
• First Posted: October 23, 2007
• Study Start: July 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

US (2)