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

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

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
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
  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  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
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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  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
  Hide More Information

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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael P. Carey, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00947271     History of Changes
Other Study ID Numbers: R01MH068171-06 ( US NIH Grant/Contract Award Number )
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