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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947271
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : September 17, 2014
Last Update Posted : September 17, 2014
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Prevention
Conditions HIV
Sexually Transmitted Diseases
HIV Infections
Interventions Behavioral: DVD 1
Behavioral: DVD 2
Enrollment 1010
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Hide Arm/Group Description

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

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

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

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

Period Title: 3 Months Post Intervention
Started 254 252 254 250
Completed 202 204 218 206
Not Completed 52 48 36 44
Period Title: 6 Months Post Intervention
Started 254 252 254 250
Completed 199 199 196 196
Not Completed 55 53 58 54
Period Title: 9 Months Post Intervention
Started 254 252 254 250
Completed 184 192 193 191
Not Completed 70 60 61 59
Period Title: 12 Months Post Intervention
Started 254 252 254 250
Completed 183 192 195 188
Not Completed 71 60 59 62
Arm/Group Title DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2 Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 254 252 254 250 1010
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 254 participants 252 participants 254 participants 250 participants 1010 participants
27.9  (8.9) 29.3  (9.7) 28.0  (9.2) 28.9  (10.0) 28.5  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 252 participants 254 participants 250 participants 1010 participants
Female
107
  42.1%
100
  39.7%
129
  50.8%
107
  42.8%
443
  43.9%
Male
147
  57.9%
152
  60.3%
125
  49.2%
143
  57.2%
567
  56.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 252 participants 254 participants 250 participants 1010 participants
American Indian or Alaska Native
3
   1.2%
1
   0.4%
2
   0.8%
2
   0.8%
8
   0.8%
Asian
0
   0.0%
1
   0.4%
3
   1.2%
0
   0.0%
4
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
2
   0.8%
2
   0.8%
0
   0.0%
4
   0.4%
Black or African American
168
  66.1%
180
  71.4%
177
  69.7%
166
  66.4%
691
  68.4%
White
49
  19.3%
43
  17.1%
43
  16.9%
54
  21.6%
189
  18.7%
More than one race
18
   7.1%
14
   5.6%
23
   9.1%
17
   6.8%
72
   7.1%
Unknown or Not Reported
16
   6.3%
11
   4.4%
4
   1.6%
11
   4.4%
42
   4.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 252 participants 254 participants 250 participants 1010 participants
Hispanic or Latino
25
   9.8%
16
   6.3%
17
   6.7%
24
   9.6%
82
   8.1%
Not Hispanic or Latino
229
  90.2%
236
  93.7%
237
  93.3%
225
  90.0%
927
  91.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.4%
1
   0.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 254 participants 252 participants 254 participants 250 participants 1010 participants
254 252 254 250 1010
1.Primary Outcome
Title Number of Sexual Partners, 3 Months Post Intervention
Hide Description number of sexual partners in the past 3 months, assessed 3 months post intervention
Time Frame Measured after 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 202 204 218 206
Least Squares Mean (Standard Error)
Unit of Measure: number of partners
2.19  (.13) 2.04  (.11) 2.14  (.10) 2.13  (.10)
2.Primary Outcome
Title Number of Sexual Partners, 6 Months Post Intervention
Hide Description number of sexual partners reported in the past 3 months, assessed 6 months post intervention.
Time Frame 6 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 199 199 196 196
Least Squares Mean (Standard Error)
Unit of Measure: number of partners
1.92  (.13) 2.18  (.13) 2.18  (.11) 2.09  (.13)
3.Primary Outcome
Title Number of Sexual Partners, 9 Months Post Intervention
Hide Description number of sexual partners in the past 3 months, assessed 9 months post intervention
Time Frame 9 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 184 192 193 191
Least Squares Mean (Standard Error)
Unit of Measure: number of partners
1.98  (.13) 1.83  (.10) 2.11  (.12) 2.04  (.13)
4.Primary Outcome
Title Number of Sexual Partners, 12 Months Post Intervention
Hide Description number of sexual partners in the past 3 months, assessed 12 months post intervention
Time Frame 12 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 183 192 195 188
Least Squares Mean (Standard Error)
Unit of Measure: number of partners
1.84  (.10) 1.78  (.09) 1.79  (.09) 1.90  (.10)
5.Secondary Outcome
Title Sexually Transmitted Infection Incidence
Hide Description number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up
Time Frame Measured throughout the 12 months post intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who provided a urine sample for STI testing at any study follow up (3, 6, 9, or 12 months) OR who had STI testing performed at the STI clinic during the 12 months post intervention were included in these analyses
Arm/Group Title DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Hide Arm/Group Description:

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

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

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

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

Overall Number of Participants Analyzed 213 219 229 213
Measure Type: Number
Unit of Measure: participants diagnosed with any STI
33 36 46 36
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Hide Arm/Group Description

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

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

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

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

All-Cause Mortality
DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/254 (0.00%)   0/252 (0.00%)   0/254 (0.00%)   0/250 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DVD 1 Plus Assessment 1 DVD 1 Plus Assessment 2 DVD 2 Plus Assessment 1 DVD 2 Plus Assessment 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/254 (0.00%)   0/252 (0.00%)   0/254 (0.00%)   0/250 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Carey
Organization: The Miriam Hospital
Phone: 401-793-8218
EMail: michael_carey@brown.edu
Layout table for additonal information
Responsible Party: Michael P. Carey, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00947271     History of Changes
Other Study ID Numbers: R01MH068171-06 ( U.S. NIH Grant/Contract )
R01MH068171-06 ( U.S. NIH Grant/Contract )
PCC: DAHBR 9A-ASPQ
First Submitted: July 27, 2009
First Posted: July 28, 2009
Results First Submitted: August 25, 2014
Results First Posted: September 17, 2014
Last Update Posted: September 17, 2014