Clinical trial NCT00548275: Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence
Official title: Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opiate Dependence
HIV Infections
Keywords: Buprenorphine
Drug counseling
HIV risk reduction counseling
HIV Seronegativity
HIV risk behaviors
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2007-10-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: proportion of condom use during acts of sexual intercourse
timeFrame: 3 months
measure: number of unprotected vaginal/anal intercourse acts
timeFrame: 3 months
measure: number of sexual partners
timeFrame: 3 months
measure: recent diagnosis of an STD
timeFrame: 3 months
Secondary outcomes:
measure: buprenorphine treatment retention
timeFrame: 3 months
measure: abstinence from illicit drug use
timeFrame: 3 months
measure: health status
timeFrame: 3 months
measure: patient and physician satisfaction
timeFrame: 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Methadone Research Unit, The APT Foundation, Inc.
state: Connecticut
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Lynn E Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References: