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Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence (Project RED)

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ClinicalTrials.gov Identifier: NCT00548275
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : July 9, 2014
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Lynn E. Fiellin, Yale University

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.

Condition or disease Intervention/treatment Phase
Opiate Dependence HIV Infections Behavioral: Enhanced Sexual Risk Management Behavioral: Standard Sexual Risk Management Phase 2

Detailed Description:

The profile of opioid dependence is changing in the United States. According to the 2006 National Survey on Drug Use and Health (NSDUH), 3.7 million Americans had used heroin at least once in their lifetime and over half a million individuals had used heroin within the past year. Approximately 323,000 individuals met criteria for past-year heroin abuse or dependence. While these figures are concerning, the increasing prevalence of prescription opioid abuse and dependence is also worrisome. In 2006 12.6 million reported non-medical use of prescription opioids. Of these, 1.6 million met criteria for prescription opioid abuse or dependence. Sex-related HIV risk behaviors are prevalent amongst opioid dependent individuals with one study reporting unprotected intercourse within the prior 30 days in 75% of patients. Given that 79-85% of U.S. HIV/AIDS cases are secondary to sexual transmission, as non-injecting drug use increases, the relative contribution of sex-related HIV risk behaviors will increase as well. While drug treatment with methadone, and more recently buprenorphine (BUP), a new medication effective for the treatment of opioid dependence that can be prescribed by office-based physicians, has been shown to decrease drug-related HIV risk behaviors, my prior research demonstrates that BUP does not appear to impact as significantly on sex-related HIV risk behaviors. While the process of HIV risk behavior change begins with risk assessment, studies have shown that physicians, in general, frequently do not address risky behaviors with their patients. The current literature is lacking, however, with regards to the prevalence of specific high-risk sexual behaviors in patients enrolled in BUP treatment. Interventions specifically targeted at counseling for sex-related HIV risk behaviors delivered to patients receiving BUP treatment have not been refined. The proposed research will evaluate the prevalence of specific sex-related HIV risk behaviors in patients enrolled in office-based BUP treatment and the patients' perception of their providers' screening for these behaviors (Phase 1). These results will inform the conduct of a subsequent randomized clinical trial to evaluate the efficacy of a sex-related HIV risk reduction counseling intervention (Phase 2).

Phase 1. We hypothesize that sex-related HIV risk behaviors are prevalent in opioid dependent patients enrolled in BUP treatment and that patients will report that their providers fail to screen for these behaviors. The specific aims are to determine in patients entering BUP treatment: 1) the prevalence of specific sex-related HIV risk behaviors, and 2) by patient report, their provider's screening of these behaviors.

Phase 2. We hypothesize that in opioid dependent patients receiving office-based BUP, Enhanced Sexual Risk Management (ESRM) will be more effective in increasing specific safe sex practices compared with standard physician counseling, Standard Sexual Risk Management (SSRM) and that it will demonstrate cost-effectiveness overall when compared to SSRM. The specific aims of this randomized clinical trial are 1) to determine the efficacy of ESRM compared to SSRM, in individuals enrolled in BUP treatment and 2) To compare the cost-effectiveness of ESRM versus SSRM in individuals enrolled in BUP treatment. These interventions will be adapted from existing effective interventions evaluated in two recently conducted multi-site randomized clinical trials, the CDC-funded Project RESPECT and the NIMH-funded Project Light.20, 21

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence
Study Start Date : July 2006
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
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
management of sexual risk
Active Comparator: 2
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
management of sexual risk

Primary Outcome Measures :
  1. proportion of condom use during acts of sexual intercourse [ Time Frame: 3 months ]
  2. number of unprotected vaginal/anal intercourse acts [ Time Frame: 3 months ]
  3. number of sexual partners [ Time Frame: 3 months ]
  4. recent diagnosis of an STD [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. buprenorphine treatment retention [ Time Frame: 3 months ]
  2. abstinence from illicit drug use [ Time Frame: 3 months ]
  3. health status [ Time Frame: 3 months ]
  4. patient and physician satisfaction [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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): NCT00548275

United States, Connecticut
Methadone Research Unit, The APT Foundation, Inc.
New Haven, Connecticut, United States, 06519
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Robert Wood Johnson Foundation
Principal Investigator: Lynn E Sullivan, MD Yale University

Responsible Party: Lynn E. Fiellin, Associate Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT00548275     History of Changes
Other Study ID Numbers: RWJF57412
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Lynn E. Fiellin, Yale University:
Drug counseling
HIV risk reduction counseling
HIV Seronegativity
HIV risk behaviors

Additional relevant MeSH terms:
HIV Infections
Opioid-Related Disorders
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders