HIVNCT01741350

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

A study testing Community-friendly Health Recovery Program in people with HIV and Opioid Dependence, run by University of Connecticut at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV, Opioid Dependence
What is being tested?: Community-friendly Health Recovery Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 304 participants
Where: 1 siteUnited States
Study dates: Sep 2006to Jun 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

APT Foundation
New Haven, Connecticut, 06519

Other trials in United States

About this study

Read the 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.

Conditions: HIV, Opioid Dependence
Being tested: Community-friendly Health Recovery Program, Time-and-Attention-Matched Control Condition
Keywords: Methadone-maintenance, HIV, Risk behavior, Injection drug use, Condom use, Health care participation, Opioid replacement therapy
Medical subject headings: Opioid-Related Disorders, Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Community-friendly Health Recovery ProgramBehavioural
Also called CHRP
Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).
Time-and-Attention-Matched Control ConditionBehavioural
Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

Study groups in NCT01741350
Study group	Role	What they receive
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). Receives: 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). Receives: Behavioral: Time-and-Attention-Matched Control Condition

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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").
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Jun 2012

First posted4 Dec 2012 (estimated)
Study startSep 2006
Primary completionMay 2011
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01741350
Sponsor's protocol ID: H06-215
Other IDs: 1R01DA022122-01A1
Status last verified: Aug 2026
First submitted: 30 Nov 2012
Last updated: 2 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
PubMed 1594721
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/
PubMed 25101381

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing a Community-Friendly Risk Reduction Intervention for Injection Drug Users
ClinicalTrials.gov ID: NCT01741350
Acronym / sponsor ID: H06-215
Conditions: HIV, Opioid Dependence
Keywords: Methadone-maintenance, HIV, Risk behavior, Injection drug use, Condom use, Health care participation, Opioid replacement therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 304 participants (actual)
Lead sponsor: University of ConnecticutUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), APT Foundation, Inc.
Study start: Sep 2006
Primary completion: May 2011 (actual)
Study completion: Jun 2012 (actual)
First posted: 4 Dec 2012 (estimated)
Results: Posted 27 Feb 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
CHRP Group	Experimental	Behavioral: Community-friendly Health Recovery ProgramPatients 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).
Control Condition	Active comparator	Behavioral: Time-and-Attention-Matched Control ConditionThe 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (0 listed)

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
Community-friendly Health Recovery ProgramAlso: CHRPFour weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).	Behavioural	CHRP Group
Time-and-Attention-Matched Control ConditionFour weekly support groups and routine clinical services (i.e., daily methadone and case management).	Behavioural	Control Condition

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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").
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 27 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CHRP Group	149	149
Control Condition	155	155

Primary outcome: Demonstrated Drug Risk Reduction Skills (0-100%)

Time frame: Baseline. Mean (Standard Error). Unit: Percentage of correct steps

Measure	CHRP Group n = 97	Control Condition n = 92
Value	40.60 (1.99)	42.75 (2.09)

Primary outcome: Demonstrated Drug Risk Reduction Skills (0-100%)

Time frame: Immediately Post-Intervention, at 4 weeks. Mean (Standard Error). Unit: Percentage of correct steps

Measure	CHRP Group n = 97	Control Condition n = 92
Value	76.37 (2.03)	53.11 (2.14)

Primary outcome: Demonstrated Drug Risk Reduction Skills (0-100%)

Time frame: 3-month follow up. Mean (Standard Error). Unit: Percentage of correct steps

Measure	CHRP Group n = 97	Control Condition n = 92
Value	69.59 (2.04)	60.34 (2.15)

Primary outcome: Demonstrated Drug Risk Reduction Skills (0-100%)

Time frame: 6-month follow up. Mean (Standard Error). Unit: Percentage of correct steps

Measure	CHRP Group n = 97	Control Condition n = 92
Value	74.12 (1.97)	63.12 (2.07)

Adverse events

Time frame: March 2007 through August 2011.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CHRP Group	0 of 149 (0%)	0 of 149 (0%)	Not reported
Control Condition	0 of 155 (0%)	0 of 155 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1594721Fisher JD, Fisher WA. Changing AIDS-risk behavior. Psychol Bull. 1992 May;111(3):455-74. doi: 10.1037/0033-2909.111.3.455.
Background: PubMed 25101381Institute 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/
Center for Health, Intervention, and PreventionLink provided by the sponsor.

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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.

Michael C Copenhaver, Ph.D. principal investigator

University of Connecticut

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Community-friendly Health Recovery Program in people with HIV and Opioid Dependence, run by University of Connecticut at 1 site 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 6 inclusion and 0 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Demonstrated Drug Risk Reduction Skills (0-100%) (time frame: Baseline). The study lists 65 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741350, which also lists 2 linked publications.

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 2 Sep 2026.