"Vasectomy: Right for Me?" Decision Support Tool
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21-55
SponsorUniversity of Pittsburgh
About this trial
The goal of this trial is to learn if a web-based decision aid designed to provide evidence-based information about vasectomy and other birth control options helps improve users' decision-making about birth control. The main questions it aims to answer are:
* Do people who use the decision aid have better knowledge about vasectomy? * Do people who use the decision aid have lower conflict with their decision?
Participants will:
* Use the decision aid (if they are assigned to the intervention arm). * Answer survey questions about their knowledge, decision-making, interest in vasectomy, and healthcare navigation experiences.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are assigned male at birth
21-55 years of age
Comfortable reading in English or Spanish
Live in the United States
Disqualifiers
Are not assigned male at birth
Are less than 21 or more than 55 years of age
Is not comfortable reading English nor Spanish
Do not live in the United States
Trial design
Design model
Parallel
Treatments tested in this trial
"Vasectomy: Right for Me?" decision aid
BehavioralThe vasectomy decision aid is a web-based decision aid designed to help men make informed and value-concordant decisions about vasectomy.
Treatment groups
750 Participants
are divided into 2 treatment groupsGroup A: Decision Aid ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Participant knowledge about vacectomy
Participant responses to 10 True/False items adapted from previously published studies of vasectomy knowledge and informed by in-depth interviews with men about vasectomy decision making. Items assess knowledge about vasectomy and alternative contraception options and will be coded as correct vs. incorrect, with "Don't Know" being coded as an incorrect response. The percentage of correct responses across the 10 questions will be calculated for each participant. The score range is 0 to 100%.
Time frame
Up to 45 minutes2
Participant decisional conflict in contraceptive choice
Assessed by participant responses to the low literacy version of the Decisional Conflict Scale (DCS). The DCS is a validated measure to assess participants' decisional conflict in medical decision-making. The DCS low literacy version includes 10 items about experience of conflict, with "Yes" = 0, "unsure" = 2 and "No" = 4. All 10 items are a) summed; b) divided by 10; and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Time frame
Up to 45 minutesSecondary outcomes
1
Interest in vasectomy
Assessed by participant responses to the question, "Which of the following best describes how you feel about getting a vasectomy?" Answers will consist of a 5-point Likert scale where 1="Definitely want a vasectomy" and 5="Definitely do not want a vasectomy." A summary score is calculated as an average of all items with a range of 1-5, with a higher score reflecting a lower level of interest in vasectomy.
Time frame
Up to 45 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Resound Research for Reproductive Health
Collaborator
Source ClinicalTrials.gov