Trial Outcomes & Findings for Women SHARE Study: Reducing Sexual Risk (NCT NCT03323086)
NCT ID: NCT03323086
Last Updated: 2020-01-07
Results Overview
percentage of individuals who attended their intervention
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Immediately following intervention session (post-intervention), up to 30 minutes
Results posted on
2020-01-07
Participant Flow
50 women enrolled in the trial. Two women who enrolled withdrew prior to randomization. Thus, 48 women were randomized.
Participant milestones
| Measure |
Brief Intervention (BI) With Technology Extender
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
22
|
|
Overall Study
COMPLETED
|
23
|
20
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Brief Intervention (BI) With Technology Extender
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Women SHARE Study: Reducing Sexual Risk
Baseline characteristics by cohort
| Measure |
Brief Intervention (BI) With Technology Extender
n=26 Participants
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
n=22 Participants
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
22 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Age, Continuous
|
21.28 years
STANDARD_DEVIATION 2.61 • n=5 Participants
|
24.33 years
STANDARD_DEVIATION 2.92 • n=7 Participants
|
22.67 years
STANDARD_DEVIATION 3.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately following intervention session (post-intervention), up to 30 minutesPopulation: 50 patients enrolled. 2 patients withdrew prior to randomization. Leaving 48 participants for this analysis.
percentage of individuals who attended their intervention
Outcome measures
| Measure |
Brief Intervention (BI) With Technology Extender
n=26 Participants
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
n=22 Participants
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
|---|---|---|
|
Feasibility of Providing Intervention
|
25 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Immediately following intervention session (post-intervention), up to 30 minutesPopulation: 50 patients enrolled. However, 2 patients withdrew prior to randomization and 2 withdrew post-randomization leaving a total of 46 patients who provided data at this post-intervention assessment.
Measure Name: Session Evaluation Questionnaire; Construct Assessed: Treatment Satisfaction; Minimum total scale score = 1; Maximum total scale score = 5; Scoring: averaged ratings across 4 items; Interpretation: Higher scores represent a better outcome.
Outcome measures
| Measure |
Brief Intervention (BI) With Technology Extender
n=25 Participants
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
n=21 Participants
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
|---|---|---|
|
Session Evaluation Questionnaire
|
4.65 units on a scale
Standard Deviation 0.36
|
3.98 units on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: 3-month Follow-upPopulation: 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.
The number of male partners that the participant reported having penetrative sex with.
Outcome measures
| Measure |
Brief Intervention (BI) With Technology Extender
n=23 Participants
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
n=20 Participants
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
|---|---|---|
|
Number of Sexual Partners
|
3.23 partners
Standard Deviation 3.22
|
4.00 partners
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: 3-month Follow-upPopulation: 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.
The number of occasions of condomless sex
Outcome measures
| Measure |
Brief Intervention (BI) With Technology Extender
n=23 Participants
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
n=20 Participants
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
|---|---|---|
|
Condomless Sex
|
3 events of condomless sex
Interval 2.0 to 4.0
|
5 events of condomless sex
Interval 4.0 to 6.0
|
SECONDARY outcome
Timeframe: 3-month Follow-upPopulation: 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.
The average number of drinks in a week
Outcome measures
| Measure |
Brief Intervention (BI) With Technology Extender
n=23 Participants
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
n=20 Participants
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
|---|---|---|
|
Alcohol Use Quantity
|
3.23 drinks per week
Standard Deviation 3.22
|
4.00 drinks per week
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: 3-month Follow-upPopulation: 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment.
The number of drinking occasions (single day) when 4 or more drinks are consumed
Outcome measures
| Measure |
Brief Intervention (BI) With Technology Extender
n=23 Participants
Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics.
Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders
|
Brochure
n=20 Participants
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Brochure: Brochures provided one time
|
|---|---|---|
|
Alcohol Use Binge Frequency
|
2.36 heavy episodic drinking days
Standard Deviation 3.27
|
2.00 heavy episodic drinking days
Standard Deviation 2.00
|
Adverse Events
Brief Intervention (BI) With Technology Extender
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brochure
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