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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  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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