A Network & Dyad HIV Prevention Intervention for IDU's - 1

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Information provided by (Responsible Party):
Carl Latkin, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00218335
First received: September 16, 2005
Last updated: March 7, 2013
Last verified: March 2013
Results First Received: January 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: HIV
Hepatitis
Interventions: Behavioral: Intervention Condition
Behavioral: Control Condition

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was conducted from March 2004 to March 2006. Two types of participants were recruited: Index and Risk Network Members. Recruitment methods for Index included: street-based outreach, word of mouth, ads and referrals from community agencies. During the Index’s baseline interview, a list of Risk Network Members was generated.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two types of participants were enrolled in the study- index and networks. Networks did not go through the intervention or control condition. Index participants had to refer a network member AND show up for randomization in order to be enrolled in the intervention or control condition.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Participant Flow:   Overall Study
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
STARTED     114     113     373     424  
6 Month Follow-up     103     99     219     301  
12 Month Follow-up     95     102     244     303  
18 Month Follow-up     101     108     296     368  
COMPLETED     108     110     319     388  
NOT COMPLETED     6     3     54     36  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
Total Total of all reporting groups

Baseline Measures
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members     Total  
Number of Participants  
[units: participants]
  114     113     373     424     1024  
Age  
[units: participants]
         
<=18 years     0     0     1     0     1  
Between 18 and 65 years     114     113     372     422     1021  
>=65 years     0     0     0     2     2  
Age  
[units: years]
Mean ± Standard Deviation
  43.9  ± 8     43.0  ± 7     42.4  ± 9     43.7  ± 8     43.2  ± 8  
Gender  
[units: participants]
         
Female     51     52     130     170     403  
Male     63     61     243     254     621  
Region of Enrollment  
[units: participants]
         
United States     114     113     373     424     1024  



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Any Sex Risk   [ Time Frame: 6 months ]

Measure Type Primary
Measure Title Any Sex Risk
Measure Description No text entered.
Time Frame 6 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  101     98     217     298  
Any Sex Risk  
[units: participants]
  48     62     119     179  

No statistical analysis provided for Any Sex Risk



2.  Primary:   Talked About HIV-related Topics With Drug Buddies (in the Past Month)   [ Time Frame: 6 months ]

Measure Type Primary
Measure Title Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Measure Description No text entered.
Time Frame 6 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  95     87     206     252  
Talked About HIV-related Topics With Drug Buddies (in the Past Month)  
[units: participants]
  80     54     108     104  

No statistical analysis provided for Talked About HIV-related Topics With Drug Buddies (in the Past Month)



3.  Primary:   Showed a Needleless Syringe to Drug Buddies   [ Time Frame: 6 months ]

Measure Type Primary
Measure Title Showed a Needleless Syringe to Drug Buddies
Measure Description No text entered.
Time Frame 6 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  103     99     219     300  
Showed a Needleless Syringe to Drug Buddies  
[units: participants]
  85     18     32     49  

No statistical analysis provided for Showed a Needleless Syringe to Drug Buddies



4.  Primary:   Talked About Responding to Overdose to Drug Buddies   [ Time Frame: 6 months ]

Measure Type Primary
Measure Title Talked About Responding to Overdose to Drug Buddies
Measure Description No text entered.
Time Frame 6 months  
Safety Issue No  

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.
Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Participants Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Participants Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.

Measured Values
    Intervention Participants     Control Participants  
Number of Participants Analyzed  
[units: participants]
  101     95  
Talked About Responding to Overdose to Drug Buddies  
[units: participants]
  2     21  

No statistical analysis provided for Talked About Responding to Overdose to Drug Buddies



5.  Primary:   Any Injection Risk (Monthly Versus Never)   [ Time Frame: 12 months ]

Measure Type Primary
Measure Title Any Injection Risk (Monthly Versus Never)
Measure Description No text entered.
Time Frame 12 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  70     76     191     138  
Any Injection Risk (Monthly Versus Never)  
[units: participants]
  15     27     79     53  

No statistical analysis provided for Any Injection Risk (Monthly Versus Never)



6.  Primary:   Number of Needle or Cooker Sharers (2 or More Versus None)   [ Time Frame: 12 months ]

Measure Type Primary
Measure Title Number of Needle or Cooker Sharers (2 or More Versus None)
Measure Description No text entered.
Time Frame 12 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  82     82     212     280  
Number of Needle or Cooker Sharers (2 or More Versus None)  
[units: participants]
  5     17     37     31  

No statistical analysis provided for Number of Needle or Cooker Sharers (2 or More Versus None)



7.  Primary:   Talked About HIV-related Topics With Drug Buddies (in the Past Month)   [ Time Frame: 12 months ]

Measure Type Primary
Measure Title Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Measure Description No text entered.
Time Frame 12 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  83     90     215     231  
Talked About HIV-related Topics With Drug Buddies (in the Past Month)  
[units: participants]
  60     46     98     105  

No statistical analysis provided for Talked About HIV-related Topics With Drug Buddies (in the Past Month)



8.  Primary:   Showed a Needleless Syringe to Drug Buddies   [ Time Frame: 12 months ]

Measure Type Primary
Measure Title Showed a Needleless Syringe to Drug Buddies
Measure Description No text entered.
Time Frame 12 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  94     100     244     302  
Showed a Needleless Syringe to Drug Buddies  
[units: participants]
  78     16     35     55  

No statistical analysis provided for Showed a Needleless Syringe to Drug Buddies



9.  Primary:   Any Injection Risk (Monthly Versus Never)   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Any Injection Risk (Monthly Versus Never)
Measure Description No text entered.
Time Frame 18 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  81     83     227     166  
Any Injection Risk (Monthly Versus Never)  
[units: participants]
  12     25     63     46  

No statistical analysis provided for Any Injection Risk (Monthly Versus Never)



10.  Primary:   Shared Cooker When Preparing Drugs   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Shared Cooker When Preparing Drugs
Measure Description No text entered.
Time Frame 18 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  35     58     145     111  
Shared Cooker When Preparing Drugs  
[units: participants]
  18     36     84     66  

No statistical analysis provided for Shared Cooker When Preparing Drugs



11.  Primary:   Number of Needle or Cooker Sharers (2 or More Versus None)   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Number of Needle or Cooker Sharers (2 or More Versus None)
Measure Description No text entered.
Time Frame 18 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  93     93     251     328  
Number of Needle or Cooker Sharers (2 or More Versus None)  
[units: participants]
  5     17     45     23  

No statistical analysis provided for Number of Needle or Cooker Sharers (2 or More Versus None)



12.  Primary:   Injecting Drugs   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Injecting Drugs
Measure Description No text entered.
Time Frame 18 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  99     107     281     354  
Injecting Drugs  
[units: participants]
  35     58     143     108  

No statistical analysis provided for Injecting Drugs



13.  Primary:   Talked About HIV-related Topics With Drug Buddies (in Past Month)   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Talked About HIV-related Topics With Drug Buddies (in Past Month)
Measure Description No text entered.
Time Frame 18 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  68     84     219     265  
Talked About HIV-related Topics With Drug Buddies (in Past Month)  
[units: participants]
  44     35     96     106  

No statistical analysis provided for Talked About HIV-related Topics With Drug Buddies (in Past Month)



14.  Primary:   Showed a Needleless Syringe to Drug Buddies   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Showed a Needleless Syringe to Drug Buddies
Measure Description No text entered.
Time Frame 18 months  
Safety Issue No  

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.
The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Condition Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
Non-Randomized Baseline Index Participants Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
Risk Network Members Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant

Measured Values
    Intervention Condition     Control Condition     Non-Randomized Baseline Index Participants     Risk Network Members  
Number of Participants Analyzed  
[units: participants]
  100     107     286     360  
Showed a Needleless Syringe to Drug Buddies  
[units: participants]
  84     22     37     67  

No statistical analysis provided for Showed a Needleless Syringe to Drug Buddies



15.  Primary:   Talked About Hepatitis to Drug Buddies   [ Time Frame: 18 months ]

Measure Type Primary
Measure Title Talked About Hepatitis to Drug Buddies
Measure Description No text entered.
Time Frame 18 months  
Safety Issue No  

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.
Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Reporting Groups
  Description
Intervention Participants Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Participants Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.

Measured Values
    Intervention Participants     Control Participants  
Number of Participants Analyzed  
[units: participants]
  95     100  
Talked About Hepatitis to Drug Buddies  
[units: participants]
  51     29  

No statistical analysis provided for Talked About Hepatitis to Drug Buddies




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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