Trial Outcomes & Findings for Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic (NCT NCT00947271)
NCT ID: NCT00947271
Last Updated: 2014-09-17
Results Overview
number of sexual partners in the past 3 months, assessed 3 months post intervention
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1010 participants
Primary outcome timeframe
Measured after 3 months
Results posted on
2014-09-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
3 Months Post Intervention
STARTED
|
254
|
252
|
254
|
250
|
|
3 Months Post Intervention
COMPLETED
|
202
|
204
|
218
|
206
|
|
3 Months Post Intervention
NOT COMPLETED
|
52
|
48
|
36
|
44
|
|
6 Months Post Intervention
STARTED
|
254
|
252
|
254
|
250
|
|
6 Months Post Intervention
COMPLETED
|
199
|
199
|
196
|
196
|
|
6 Months Post Intervention
NOT COMPLETED
|
55
|
53
|
58
|
54
|
|
9 Months Post Intervention
STARTED
|
254
|
252
|
254
|
250
|
|
9 Months Post Intervention
COMPLETED
|
184
|
192
|
193
|
191
|
|
9 Months Post Intervention
NOT COMPLETED
|
70
|
60
|
61
|
59
|
|
12 Months Post Intervention
STARTED
|
254
|
252
|
254
|
250
|
|
12 Months Post Intervention
COMPLETED
|
183
|
192
|
195
|
188
|
|
12 Months Post Intervention
NOT COMPLETED
|
71
|
60
|
59
|
62
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic
Baseline characteristics by cohort
| Measure |
DVD 1 Plus Assessment 1
n=254 Participants
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
n=252 Participants
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
n=254 Participants
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
n=250 Participants
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
n=1010 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
27.9 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
29.3 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
28.0 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
28.9 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
28.5 years
STANDARD_DEVIATION 9.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
443 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
567 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
168 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
166 Participants
n=4 Participants
|
691 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
189 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
229 Participants
n=5 Participants
|
236 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
927 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
254 participants
n=5 Participants
|
252 participants
n=7 Participants
|
254 participants
n=5 Participants
|
250 participants
n=4 Participants
|
1010 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured after 3 monthsnumber of sexual partners in the past 3 months, assessed 3 months post intervention
Outcome measures
| Measure |
DVD 1 Plus Assessment 1
n=202 Participants
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
n=204 Participants
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
n=218 Participants
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
n=206 Participants
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
|
|---|---|---|---|---|
|
Number of Sexual Partners, 3 Months Post Intervention
|
2.19 number of partners
Standard Error .13
|
2.04 number of partners
Standard Error .11
|
2.14 number of partners
Standard Error .10
|
2.13 number of partners
Standard Error .10
|
PRIMARY outcome
Timeframe: 6 months post interventionnumber of sexual partners reported in the past 3 months, assessed 6 months post intervention.
Outcome measures
| Measure |
DVD 1 Plus Assessment 1
n=199 Participants
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
n=199 Participants
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
n=196 Participants
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
n=196 Participants
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
|
|---|---|---|---|---|
|
Number of Sexual Partners, 6 Months Post Intervention
|
1.92 number of partners
Standard Error .13
|
2.18 number of partners
Standard Error .13
|
2.18 number of partners
Standard Error .11
|
2.09 number of partners
Standard Error .13
|
PRIMARY outcome
Timeframe: 9 months post interventionnumber of sexual partners in the past 3 months, assessed 9 months post intervention
Outcome measures
| Measure |
DVD 1 Plus Assessment 1
n=184 Participants
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
n=192 Participants
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
n=193 Participants
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
n=191 Participants
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
|
|---|---|---|---|---|
|
Number of Sexual Partners, 9 Months Post Intervention
|
1.98 number of partners
Standard Error .13
|
1.83 number of partners
Standard Error .10
|
2.11 number of partners
Standard Error .12
|
2.04 number of partners
Standard Error .13
|
PRIMARY outcome
Timeframe: 12 months post interventionnumber of sexual partners in the past 3 months, assessed 12 months post intervention
Outcome measures
| Measure |
DVD 1 Plus Assessment 1
n=183 Participants
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
n=192 Participants
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
n=195 Participants
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
n=188 Participants
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
|
|---|---|---|---|---|
|
Number of Sexual Partners, 12 Months Post Intervention
|
1.84 number of partners
Standard Error .10
|
1.78 number of partners
Standard Error .09
|
1.79 number of partners
Standard Error .09
|
1.90 number of partners
Standard Error .10
|
SECONDARY outcome
Timeframe: Measured throughout the 12 months post interventionPopulation: 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
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
Outcome measures
| Measure |
DVD 1 Plus Assessment 1
n=213 Participants
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
n=219 Participants
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
n=229 Participants
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
n=213 Participants
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
|
|---|---|---|---|---|
|
Sexually Transmitted Infection Incidence
|
33 participants diagnosed with any STI
|
36 participants diagnosed with any STI
|
46 participants diagnosed with any STI
|
36 participants diagnosed with any STI
|
Adverse Events
DVD 1 Plus Assessment 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DVD 1 Plus Assessment 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DVD 2 Plus Assessment 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DVD 2 Plus Assessment 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place