Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence
Condition: Opiate Dependence; HIV Infections
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

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
    

Intervention name(s): Enhanced Sexual Risk Management; Standard Sexual Risk Management
Intervention type(s): Behavioral; Behavioral
Intervention description(s): management of sexual risk; management of sexual risk
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Buprenorphine; Drug counseling; HIV risk reduction counseling; HIV Seronegativity; HIV risk behaviors