Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ]
  Hide Outcome Measure 7

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 
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 ]

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
  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
No text entered.


  More Information