Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users

NCT01741350 | Completed Results DMC

• 2 other identifiers: H06-2151R01DA022122-01A1
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief Summary

To conduct a randomized clinical trial (RCT) of a community-friendly behavioral intervention designed to reduce HIV risk behavior among injection drug users (IDUs) in drug treatment by comparing risk-behavior outcomes of four weekly intervention sessions with a time-and-attention-matched control condition.

Conditions

HIV; Opioid Dependence

Keywords

Methadone-maintenance; HIV; Risk behavior; Injection drug use; Condom use; Health care participation; Opioid replacement therapy

Outcome Measures

Primary Outcomes (65)

• Demonstrated Drug Risk Reduction Skills (0-100%)

  Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.

  Baseline

• Demonstrated Drug Risk Reduction Skills (0-100%)

  Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.

  Immediately Post-Intervention, at 4 weeks

• Demonstrated Drug Risk Reduction Skills (0-100%)

  Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.

  3-month follow up

• Demonstrated Drug Risk Reduction Skills (0-100%)

  Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.

  6-month follow up

• Demonstrated Drug Risk Reduction Skills (0-100%)

  Participants' HIV risk reduction skills were assessed by having participants demonstrate the steps necessary to properly clean a needle/syringe.

  12-month follow up

• Safer Drug Use (0-4)

  Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.

  Baseline

• Safer Drug Use (0-4)

  Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.

  Immediately Post-Intervention, at 4 weeks

• Safer Drug Use (0-4)

  Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.

  3-month follow up

• Safer Drug Use (0-4)

  Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.

  6-month follow up

• Safer Drug Use (0-4)

  Participants completed a self-reported assessment that asks about IV-sharing behavior and were assessed on a scale of 0-4, with higher scores indicating safer drug use.

  12-month follow up

• Drug-related HIV-risk Reduction Knowledge (0-1)

  Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles") and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge).

  Baseline

• Drug-related HIV-risk Reduction Knowledge (0-1)

  Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles") and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge).

  Immediately Post-Intervention, at 4 weeks

• Drug-related HIV-risk Reduction Knowledge (0-1)

  Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles") and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge).

  3-month follow up

• Drug-related HIV-risk Reduction Knowledge (0-1)

  Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles") and were rated on a scale of 0 to 1 (higher values representing greater risk reduction knowledge).

  6-month follow up

• Drug-related HIV-risk Reduction Knowledge (0-1)

  Participants completed an assessment that covers information about drug-related HIV-risk reduction (e.g.,"If an HIV+ person shared needles with another HIV+ person, they don't need to clean the needles").

  12-month follow up

• Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.

  Baseline

• Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.

  Immediately Post-Intervention, at 4 weeks

• Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.

  3-month follow up

• Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.

  6-month follow up

• Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce HIV risk behavior (e.g., "I plan to always use clean needles if I shoot up drugs during the next six months") and rated on a scale of 1 to 5, with higher scores indicating stronger motivation to reduce HIV-risk behavior.

  12-month follow up

• Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.

  Baseline

• Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.

  Immediately Post-Intervention, at 4 weeks

• Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.

  3-month follow up

• Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.

  6-month follow up

• Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce HIV risk behavior (e.g., "Most people who are important to me think I should always clean my needles before I share them with someone else during the next three months") and rated on a scale of 1 to 5, with higher scores indicating stronger social motivation to reduce HIV-risk behavior.

  12-month follow up

• Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.

  Baseline

• Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.

  Immediately Post-Intervention, at 4 weeks

• Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.

  3-month follow up

• Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.

  6-month follow up

• Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing HIV risk behavior (e.g., "How hard would it be for you to always use condoms") and rated on a scale of 1 to 5, with higher scores indicating greater self-efficacy to reduce HIV-risk behavior.

  12-month follow up

• Female Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.

  Baseline

• Female Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.

  Immediately Post-Intervention, at 4 weeks

• Female Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.

  3-month follow up

• Female Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.

  6-month follow up

• Female Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a female condom using a replica.

  12-month follow up

• Male Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.

  Baseline

• Male Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.

  Immediately Post-Intervention, at 4 weeks

• Male Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.

  3-month follow up

• Male Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.

  6-month follow up

• Male Condom Skills (0-100%)

  Participants' HIV risk reduction behavioral skills were assessed based on the percentage of correct necessary steps demonstrated to properly select and apply a male condom using a replica.

  12-month follow up

• Condom Use (0-4)

  Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.

  Baseline

• Condom Use (0-4)

  Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.

  Immediately Post-Intervention, at 4 weeks

• Condom Use (0-4)

  Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.

  3-month follow up

• Condom Use (0-4)

  Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.

  6-month follow up

• Condom Use (0-4)

  Participants were asked: "In the past week, how much of the time did you use a condom or other latex protection when you had oral, anal, or vaginal sex?" and rated on scale of 0 to 4, with indicating greater condom use.

  12-month follow up

• Sex-related HIV-risk Reduction Knowledge (0-1)

  Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.

  Baseline

• Sex-related HIV-risk Reduction Knowledge (0-1)

  Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.

  Immediately Post-Intervention, at 4 weeks

• Sex-related HIV-risk Reduction Knowledge (0-1)

  Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.

  3-month follow up

• Sex-related HIV-risk Reduction Knowledge (0-1)

  Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.

  6-month follow up

• Sex-related HIV-risk Reduction Knowledge (0-1)

  Participants' knowledge of sex-related HIV-risk reduction was assessed by being asked: "If an HIV positive person only has sex with another HIV positive person, they don't need to use condoms" and rated on a scale of 0 to 1, with a higher score indicating greater HIV-risk reduction knowledge.

  12-month follow up

• Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.

  Baseline

• Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.

  Immediately Post-Intervention, at 4 weeks

• Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.

  3-month follow up

• Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.

  6-month follow up

• Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their personal motivation to reduce sex-related HIV-risk behavior (e.g., "Always using condoms during sexual intercourse during the next three months would be good") and were rated on a scale of 1 to 5, with a higher score indicating greater personal motivation to reduce HIV-risk behavior.

  12-month follow up

• Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.

  Baseline

• Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.

  Immediately Post-Intervention, at 4 weeks

• Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.

  3-month follow up

• Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.

  6-month follow up

• Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their social motivation to reduce sex-related HIV-risk behavior (e.g., "Most people who are important to me think I should always use condoms during sexual intercourse in the next three months") and were rated on a scale of 1 to 5, with a higher score indicating stronger social motivation to reduce HIV-risk behavior.

  12-month follow up

• Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.

  Baseline

• Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.

  Immediately Post-Intervention, at 4 weeks

• Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.

  3-month follow up

• Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.

  6-month follow up

• Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)

  Participants completed a questionnaire assessing their self-efficacy about reducing sex-related HIV-risk behavior (e.g., "If asked, I am confident I could demonstrate how to use male condom and female condoms correctly") and were rated on a scale of 1 to 5, with a higher score indicating greater self-efficacy to reduce sex-related HIV-risk behavior.

  12-month follow up

Study Arms (2)

CHRP Group

EXPERIMENTAL

Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).

Behavioral: Community-friendly Health Recovery Program

Control Condition

ACTIVE COMPARATOR

The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).

Behavioral: Time-and-Attention-Matched Control Condition

Interventions

Community-friendly Health Recovery Program BEHAVIORAL

Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).

Also known as: CHRP

CHRP Group

Time-and-Attention-Matched Control Condition BEHAVIORAL

Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Opioid-dependent and seeking methadone maintenance treatment
• Report drug- or sex-related HIV risk behavior in previous 6 months
• Able to read and understand the questionnaires, Audio Computer Assisted Self Interview (ACASI), and consent form
• Available for the full duration of the study with no anticipated circumstances impeding participation (e.g., jail term)
• Not actively suicidal, homicidal, or psychotic as assessed by trained research staff under the supervision of a licensed clinical psychologist

Sponsors & Collaborators

• University of Connecticut: lead
• National Institute on Drug Abuse (NIDA): collaborator
• APT Foundation, Inc.: collaborator

Study Sites (1)

APT Foundation

New Haven, Connecticut, 06519, United States

Location

Related Publications (2)

• Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.

  PMID: 1594721 BACKGROUND

• Institute of Medicine (US) Committee on Community-Based Drug Treatment; Lamb S, Greenlick MR, McCarty D, editors. Bridging the Gap between Practice and Research: Forging Partnerships with Community-Based Drug and Alcohol Treatment. Washington (DC): National Academies Press (US); 1998. Available from http://www.ncbi.nlm.nih.gov/books/NBK230402/

  PMID: 25101381 BACKGROUND

Related Links

• Center for Health, Intervention, and Prevention

MeSH Terms

Conditions

Opioid-Related Disorders; Risk-Taking

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Limitations and Caveats

The drug-risk reducing effects of methadone may have restricted our ability to detect intervention effects on drug-related outcomes. Participants may have also been reluctant to report HIV risk related behaviors.

Results Point of Contact

• Title: Dr. Michael M. Copenhaver, Ph.D.
• Organization: University of Connecticut

michael.copenhaver@uconn.edu

860 208-3632

Study Officials

• Michael C Copenhaver, Ph.D.

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2006
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2012
• Last Updated: February 27, 2014
• Results First Posted: February 27, 2014

Record last verified: 2014-01

Locations

US (1)