A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00183456
First received: September 13, 2005
Last updated: June 24, 2013
Last verified: June 2013
Results First Received: September 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: HIV Infections
Sexually Transmitted Diseases
Interventions: Behavioral: Peer-oriented intervention
Behavioral: Group cognitive behavioral therapy (CBT)

  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
The sample consisted of women and their social network members. Index participants were recruited through street outreach as well as at health clinics, and other local community agencies. Social network members were recruited by index participants after completion of the index's baseline visit. Recruitment took place from September 2005-July 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Those index participants that did not recruit a network member or did not show up to be randomized into a study condition were not assigned to a study condition. Network participants completed study interviews but were not assigned to a study condition and did not participate in the intervention.

Reporting Groups
  Description
Intervention Condition: CHAT Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
Comparison Condition: Standard of Care The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Network Participants Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
Non-randomized Baseline Index Participants This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.

Participant Flow:   Overall Study
    Intervention Condition: CHAT     Comparison Condition: Standard of Care     Network Participants     Non-randomized Baseline Index Participants  
STARTED     85     84     329     248  
6 Month Follow-up     74     77     278     175  
12 Month Follow-up     76     74     267     186  
18 Month Follow-up     80     81     303     207  
COMPLETED     82 [1]   83 [2]   313 [3]   220 [4]
NOT COMPLETED     3     1     16     28  
[1] total # of intervention participants that completed any follow-up (6, 12, or 18 month Follow-up)
[2] total # of comparison condition participants that completed any follow-up
[3] total # of network participants that completed any follow-up
[4] total # of non-randomized index participants that completed any follow-up



  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.
No text entered.

Reporting Groups
  Description
Intervention Condition: CHAT Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
Comparison Condition: Standard of Care The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Network Participants Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
Non-randomized Baseline Index Participants This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
Total Total of all reporting groups

Baseline Measures
    Intervention Condition: CHAT     Comparison Condition: Standard of Care     Network Participants     Non-randomized Baseline Index Participants     Total  
Number of Participants  
[units: participants]
  85     84     329     248     746  
Age  
[units: participants]
         
<=18 years     0     0     2     1     3  
Between 18 and 65 years     85     84     323     247     739  
>=65 years     0     0     4     0     4  
Age  
[units: years]
Mean ± Standard Deviation
  42.1  ± 7     43.3  ± 7     42.9  ± 10     40.6  ± 8     42  ± 9  
Gender  
[units: participants]
         
Female     85     84     150     248     567  
Male     0     0     179     0     179  
Region of Enrollment  
[units: participants]
         
United States     85     84     329     248     746  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)   [ Time Frame: 6 months ]

2.  Primary:   Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)   [ Time Frame: 12 months ]

3.  Primary:   Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)   [ Time Frame: 18 month ]

4.  Primary:   Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)   [ Time Frame: 18 months ]

5.  Primary:   Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)   [ Time Frame: 18 months ]

6.  Primary:   Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)   [ Time Frame: 18 months ]

7.  Primary:   Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)   [ Time Frame: 18 months ]

8.  Secondary:   HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)   [ Time Frame: 6 months ]

9.  Secondary:   HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)   [ Time Frame: 12 months ]

10.  Secondary:   HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)   [ 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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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Carl Latkin, PhD
Organization: Johns Hopkins Bloomberg School of Public Health
e-mail: clatkin@jhsph.edu


No publications provided


Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00183456     History of Changes
Other Study ID Numbers: R01 MH066810, R01MH066810, DAHBR 9A-ASI
Study First Received: September 13, 2005
Results First Received: September 14, 2012
Last Updated: June 24, 2013
Health Authority: United States: Federal Government