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Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic

This study has been completed.
Sponsor:
Collaborators:
University of Rochester
Brown University
Syracuse University
Information provided by (Responsible Party):
Michael P. Carey, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00947271
First received: July 27, 2009
Last updated: September 10, 2014
Last verified: September 2014
Results First Received: August 25, 2014  
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
Sexually Transmitted Diseases
HIV Infections
Interventions: Behavioral: DVD 1
Behavioral: DVD 2

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
DVD 1 Plus Assessment 1

Participants will view educational DVD 1 and complete the first version of the study assessment.

DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health

DVD 1 Plus Assessment 2

Participants will view educational DVD 1 and complete the second version of the study assessment.

DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health

DVD 2 Plus Assessment 1

Participants will view educational DVD 2 and complete the first version of the study assessment.

DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health

DVD 2 Plus Assessment 2

Participants will view educational DVD 2 and complete the second version of the study assessment.

DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health


Participant Flow for 4 periods

Period 1:   3 Months Post Intervention
    DVD 1 Plus Assessment 1     DVD 1 Plus Assessment 2     DVD 2 Plus Assessment 1     DVD 2 Plus Assessment 2  
STARTED     254     252     254     250  
COMPLETED     202     204     218     206  
NOT COMPLETED     52     48     36     44  

Period 2:   6 Months Post Intervention
    DVD 1 Plus Assessment 1     DVD 1 Plus Assessment 2     DVD 2 Plus Assessment 1     DVD 2 Plus Assessment 2  
STARTED     254     252     254     250  
COMPLETED     199     199     196     196  
NOT COMPLETED     55     53     58     54  

Period 3:   9 Months Post Intervention
    DVD 1 Plus Assessment 1     DVD 1 Plus Assessment 2     DVD 2 Plus Assessment 1     DVD 2 Plus Assessment 2  
STARTED     254     252     254     250  
COMPLETED     184     192     193     191  
NOT COMPLETED     70     60     61     59  

Period 4:   12 Months Post Intervention
    DVD 1 Plus Assessment 1     DVD 1 Plus Assessment 2     DVD 2 Plus Assessment 1     DVD 2 Plus Assessment 2  
STARTED     254     252     254     250  
COMPLETED     183     192     195     188  
NOT COMPLETED     71     60     59     62  



  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
DVD 1 Plus Assessment 1

Participants will view educational DVD 1 and complete the first version of the study assessment.

DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health

DVD 1 Plus Assessment 2

Participants will view educational DVD 1 and complete the second version of the study assessment.

DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health

DVD 2 Plus Assessment 1

Participants will view educational DVD 2 and complete the first version of the study assessment.

DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health

DVD 2 Plus Assessment 2

Participants will view educational DVD 2 and complete the second version of the study assessment.

DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health

Total Total of all reporting groups

Baseline Measures
    DVD 1 Plus Assessment 1     DVD 1 Plus Assessment 2     DVD 2 Plus Assessment 1     DVD 2 Plus Assessment 2     Total  
Number of Participants  
[units: participants]
  254     252     254     250     1010  
Age  
[units: years]
Mean ± Standard Deviation
  27.9  ± 8.9     29.3  ± 9.7     28.0  ± 9.2     28.9  ± 10.0     28.5  ± 9.5  
Gender  
[units: participants]
         
Female     107     100     129     107     443  
Male     147     152     125     143     567  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     3     1     2     2     8  
Asian     0     1     3     0     4  
Native Hawaiian or Other Pacific Islander     0     2     2     0     4  
Black or African American     168     180     177     166     691  
White     49     43     43     54     189  
More than one race     18     14     23     17     72  
Unknown or Not Reported     16     11     4     11     42  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     25     16     17     24     82  
Not Hispanic or Latino     229     236     237     225     927  
Unknown or Not Reported     0     0     0     1     1  
Region of Enrollment  
[units: participants]
         
United States     254     252     254     250     1010  



  Outcome Measures
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1.  Primary:   Number of Sexual Partners, 3 Months Post Intervention   [ Time Frame: Measured after 3 months ]

2.  Primary:   Number of Sexual Partners, 6 Months Post Intervention   [ Time Frame: 6 months post intervention ]

3.  Primary:   Number of Sexual Partners, 9 Months Post Intervention   [ Time Frame: 9 months post intervention ]

4.  Primary:   Number of Sexual Partners, 12 Months Post Intervention   [ Time Frame: 12 months post intervention ]

5.  Secondary:   Sexually Transmitted Infection Incidence   [ Time Frame: Measured throughout the 12 months post intervention ]


  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: Dr. Michael Carey
Organization: The Miriam Hospital
phone: 401-793-8218
e-mail: michael_carey@brown.edu


Publications:

Responsible Party: Michael P. Carey, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00947271     History of Changes
Other Study ID Numbers: R01 MH068171-06, R01MH068171-06, PCC: DAHBR 9A-ASPQ
Study First Received: July 27, 2009
Results First Received: August 25, 2014
Last Updated: September 10, 2014
Health Authority: United States: Federal Government