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

HIV Infections Clinical Trial

— Project RED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00548275
• Other study ID #: 0609001848
• Status: Completed
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: June 2011

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections
• Opiate Dependence
• Opioid-Related Disorders

Intervention

Behavioral:
• Enhanced Sexual Risk Management
management of sexual risk
• Standard Sexual Risk Management
management of sexual risk

Locations

Country	Name	City	State
United States	Methadone Research Unit, The APT Foundation, Inc.	New Haven	Connecticut
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of condom use during acts of sexual intercourse		3 months
Primary	number of unprotected vaginal/anal intercourse acts		3 months
Primary	number of sexual partners		3 months
Primary	recent diagnosis of an STD		3 months
Secondary	buprenorphine treatment retention		3 months
Secondary	abstinence from illicit drug use		3 months
Secondary	health status		3 months
Secondary	patient and physician satisfaction		3 months