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

January 10, 2014 updated by: University of Connecticut
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.

Study Overview

Detailed Description

This research study will test the effects of CHRP, a community-friendly risk reduction intervention, which is based on the Information-Motivation-Behavioral Skills model of health behavior change (IMB; Fisher & Fisher, 1992), and, thus, is designed to enhance knowledge, motivation, and behavior skills for reducing drug- and sex-related HIV risk behaviors. Outcomes assessed will include urine toxicology screens, self-reported HIV drug- and sex-related HIV risk behavior, HIV/AIDS knowledge, risk reduction motivation, and risk reduction behavioral skills.

To measure the effects of CHRP, the investigators are proposing a two-condition (standard of care plus the CHRP intervention vs. standard of care plus a time-and-attention matched control condition) randomized design, balancing for participant gender. The investigators will assess participants at baseline, immediately post-intervention (i.e., at 4 weeks), and at 3-, 6-, and 12-month measurement points following the intervention. This assessment approach will allow the investigators to examine the trajectory of HIV risk reduction change including the decay or emergence of intervention effects.

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • APT Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHRP Group
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).
Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).
Other Names:
  • CHRP
Active Comparator: Control Condition
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).
Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrated Drug Risk Reduction Skills (0-100%)
Time Frame: Baseline
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%)
Time Frame: Immediately Post-Intervention, at 4 weeks
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%)
Time Frame: 3-month follow up
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%)
Time Frame: 6-month follow up
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%)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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%)
Time Frame: Baseline
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%)
Time Frame: Immediately Post-Intervention, at 4 weeks
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%)
Time Frame: 3-month follow up
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%)
Time Frame: 6-month follow up
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%)
Time Frame: 12-month follow up
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%)
Time Frame: Baseline
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%)
Time Frame: Immediately Post-Intervention, at 4 weeks
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%)
Time Frame: 3-month follow up
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%)
Time Frame: 6-month follow up
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%)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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)
Time Frame: Baseline
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)
Time Frame: Immediately Post-Intervention, at 4 weeks
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)
Time Frame: 3-month follow up
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)
Time Frame: 6-month follow up
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)
Time Frame: 12-month follow up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael C Copenhaver, Ph.D., University of Connecticut

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 30, 2012

First Submitted That Met QC Criteria

December 3, 2012

First Posted (Estimate)

December 4, 2012

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

January 10, 2014

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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