Opiate DependencePhase 2Project REDNCT00548275
Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence
A Phase 2 study testing Enhanced Sexual Risk Management and Standard Sexual Risk Management in people with Opiate Dependence and HIV Infections, run by Yale University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opiate Dependence, HIV Infections
- What is being tested?
- Enhanced Sexual Risk Management and Standard Sexual Risk Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2006to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects meeting DSM-IV criteria for current opioid dependence
- HIV risk behaviors
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Methadone Research Unit, The APT Foundation, Inc.
New Haven, Connecticut, 06519
Yale-New Haven Hospital
New Haven, Connecticut, 06519
About this study
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.
Read the 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
- Conditions
- Opiate Dependence, HIV Infections
- Being tested
- Enhanced Sexual Risk Management, Standard Sexual Risk Management
- Keywords
- Buprenorphine, Drug counseling, HIV risk reduction counseling, HIV Seronegativity, HIV risk behaviors
- Medical subject headings
- Opioid-Related Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Sexual Risk ManagementBehavioural
management of sexual risk
Standard Sexual Risk ManagementBehavioural
management of sexual risk
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Sexual Risk Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of condom use during acts of sexual intercourse
Measured: 3 months
number of unprotected vaginal/anal intercourse acts
Measured: 3 months
number of sexual partners
Measured: 3 months
recent diagnosis of an STD
Measured: 3 months
Secondary outcomes (4)
buprenorphine treatment retention
Measured: 3 months
abstinence from illicit drug use
Measured: 3 months
health status
Measured: 3 months
patient and physician satisfaction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2007 (estimated)
- Study startJul 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Lynn E Sullivan, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00548275
- Sponsor's protocol ID
- 0609001848
- Acronym
- Project RED
- Status last verified
- Apr 2020
- First submitted
- 19 Oct 2007
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Sex-Related HIV Risk Behaviors in Patients Receiving Treatment for Opioid Dependence
- ClinicalTrials.gov ID
- NCT00548275
- Acronym / sponsor ID
- Project RED / 0609001848
- Conditions
- Opiate Dependence, HIV Infections
- Keywords
- Buprenorphine, Drug counseling, HIV risk reduction counseling, HIV Seronegativity, HIV risk behaviors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jul 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Enhanced Sexual Risk ManagementEnhanced 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. |
| 2 | Active comparator | Behavioral: Standard Sexual Risk ManagementStandard 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects meeting DSM-IV criteria for current opioid dependence
- HIV risk behaviors
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Sexual Risk Managementmanagement of sexual risk | Behavioural | 1 |
| Standard Sexual Risk Managementmanagement of sexual risk | Behavioural | 2 |
Primary outcome
proportion of condom use during acts of sexual intercourse
Time frame: 3 months
number of unprotected vaginal/anal intercourse acts
Time frame: 3 months
number of sexual partners
Time frame: 3 months
recent diagnosis of an STD
Time frame: 3 months
4 secondary outcomes
buprenorphine treatment retention
Time frame: 3 months
abstinence from illicit drug use
Time frame: 3 months
health status
Time frame: 3 months
patient and physician satisfaction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn E Sullivan, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enhanced Sexual Risk Management and Standard Sexual Risk Management in people with Opiate Dependence and HIV Infections, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of condom use during acts of sexual intercourse (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.