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

This study has been completed.
Sponsor:
Collaborators:
APT Foundation, Inc.
Information provided by (Responsible Party):
University of Connecticut
ClinicalTrials.gov Identifier:
NCT01741350
First received: November 30, 2012
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: November 20, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV
Opioid Dependence
Interventions: Behavioral: Community-friendly Health Recovery Program
Behavioral: Time-and-Attention-Matched Control Condition

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 648 participants were screened from March 2007 through August 2010 from a methadone maintenance program in New Haven, Connecticut.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
292 participants did not meet the study's inclusion criteria, 36 participants missed the initial interview appointment, and 16 participants were ineligible due to already being enrolled in another study.

Reporting Groups
  Description
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).

Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).

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).

Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management).


Participant Flow for 5 periods

Period 1:   Study Intervention
    CHRP Group     Control Condition  
STARTED     149     155  
COMPLETED     149     155  
NOT COMPLETED     0     0  

Period 2:   Post Intervention Assessment (at Week 4)
    CHRP Group     Control Condition  
STARTED     149     155  
COMPLETED     135     141  
NOT COMPLETED     14     14  

Period 3:   3-Month Follow-up Assessment
    CHRP Group     Control Condition  
STARTED     135     141  
COMPLETED     129     119  
NOT COMPLETED     6     22  

Period 4:   6-Month Follow-up Assessment
    CHRP Group     Control Condition  
STARTED     129     119  
COMPLETED     114     111  
NOT COMPLETED     15     8  

Period 5:   12-Month Follow-up Assessment
    CHRP Group     Control Condition  
STARTED     114     111  
COMPLETED     111     109  
NOT COMPLETED     3     2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only participants who completed all 5 time points on drug-risk reduction knowledge and personal motivation for safer drug use were included in the analysis (i.e., 95 participants for the intervention group and 90 participants for the control group). For all other variables, the participants analyzed for the two groups were 97 and 92, respectively.

Reporting Groups
  Description
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).

Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).

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).

Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management).

Total Total of all reporting groups

Baseline Measures
    CHRP Group     Control Condition     Total  
Number of Participants  
[units: participants]
  149     155     304  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     149     155     304  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  34.26  ± 9.939     33.50  ± 9.141     33.87  ± 9.532  
Gender  
[units: participants]
     
Female     76     81     157  
Male     73     74     147  
Region of Enrollment  
[units: participants]
     
United States     149     155     304  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Demonstrated Drug Risk Reduction Skills (0-100%)   [ Time Frame: Baseline ]

2.  Primary:   Demonstrated Drug Risk Reduction Skills (0-100%)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

3.  Primary:   Demonstrated Drug Risk Reduction Skills (0-100%)   [ Time Frame: 3-month follow up ]

4.  Primary:   Demonstrated Drug Risk Reduction Skills (0-100%)   [ Time Frame: 6-month follow up ]

5.  Primary:   Demonstrated Drug Risk Reduction Skills (0-100%)   [ Time Frame: 12-month follow up ]

6.  Primary:   Safer Drug Use (0-4)   [ Time Frame: Baseline ]

7.  Primary:   Safer Drug Use (0-4)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

8.  Primary:   Safer Drug Use (0-4)   [ Time Frame: 3-month follow up ]

9.  Primary:   Safer Drug Use (0-4)   [ Time Frame: 6-month follow up ]

10.  Primary:   Safer Drug Use (0-4)   [ Time Frame: 12-month follow up ]

11.  Primary:   Drug-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: Baseline ]

12.  Primary:   Drug-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

13.  Primary:   Drug-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: 3-month follow up ]

14.  Primary:   Drug-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: 6-month follow up ]

15.  Primary:   Drug-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: 12-month follow up ]

16.  Primary:   Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: Baseline ]

17.  Primary:   Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

18.  Primary:   Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 3-month follow up ]

19.  Primary:   Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 6-month follow up ]

20.  Primary:   Personal Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 12-month follow up ]

21.  Primary:   Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: Baseline ]

22.  Primary:   Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

23.  Primary:   Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 3-month follow up ]

24.  Primary:   Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 6-month follow up ]

25.  Primary:   Social Motivation to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 12-month follow up ]

26.  Primary:   Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: Baseline ]

27.  Primary:   Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

28.  Primary:   Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 3-month follow up ]

29.  Primary:   Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 6-month follow up ]

30.  Primary:   Self-efficacy to Reduce Drug-related HIV-Risk Behavior (1-5)   [ Time Frame: 12-month follow up ]

31.  Primary:   Female Condom Skills (0-100%)   [ Time Frame: Baseline ]

32.  Primary:   Female Condom Skills (0-100%)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

33.  Primary:   Female Condom Skills (0-100%)   [ Time Frame: 3-month follow up ]

34.  Primary:   Female Condom Skills (0-100%)   [ Time Frame: 6-month follow up ]

35.  Primary:   Female Condom Skills (0-100%)   [ Time Frame: 12-month follow up ]

36.  Primary:   Male Condom Skills (0-100%)   [ Time Frame: Baseline ]

37.  Primary:   Male Condom Skills (0-100%)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

38.  Primary:   Male Condom Skills (0-100%)   [ Time Frame: 3-month follow up ]

39.  Primary:   Male Condom Skills (0-100%)   [ Time Frame: 6-month follow up ]

40.  Primary:   Male Condom Skills (0-100%)   [ Time Frame: 12-month follow up ]

41.  Primary:   Condom Use (0-4)   [ Time Frame: Baseline ]

42.  Primary:   Condom Use (0-4)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

43.  Primary:   Condom Use (0-4)   [ Time Frame: 3-month follow up ]

44.  Primary:   Condom Use (0-4)   [ Time Frame: 6-month follow up ]

45.  Primary:   Condom Use (0-4)   [ Time Frame: 12-month follow up ]

46.  Primary:   Sex-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: Baseline ]

47.  Primary:   Sex-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

48.  Primary:   Sex-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: 3-month follow up ]

49.  Primary:   Sex-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: 6-month follow up ]

50.  Primary:   Sex-related HIV-risk Reduction Knowledge (0-1)   [ Time Frame: 12-month follow up ]

51.  Primary:   Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: Baseline ]

52.  Primary:   Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

53.  Primary:   Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 3-month follow up ]

54.  Primary:   Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 6-month follow up ]

55.  Primary:   Personal Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 12-month follow up ]

56.  Primary:   Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: Baseline ]

57.  Primary:   Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

58.  Primary:   Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 3-month follow up ]

59.  Primary:   Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 6-month follow up ]

60.  Primary:   Social Motivation to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 12-month follow up ]

61.  Primary:   Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: Baseline ]

62.  Primary:   Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: Immediately Post-Intervention, at 4 weeks ]

63.  Primary:   Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 3-month follow up ]

64.  Primary:   Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 6-month follow up ]

65.  Primary:   Self-efficacy to Reduce Sex-related HIV- Risk Behavior (1-5)   [ Time Frame: 12-month follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Michael M. Copenhaver, Ph.D.
Organization: University of Connecticut
phone: 860 208-3632
e-mail: michael.copenhaver@uconn.edu


Publications:

Responsible Party: University of Connecticut
ClinicalTrials.gov Identifier: NCT01741350     History of Changes
Other Study ID Numbers: H06-215, 1R01DA022122-01A1
Study First Received: November 30, 2012
Results First Received: November 20, 2013
Last Updated: January 10, 2014
Health Authority: United States: Federal Government