Contraception, Contraception Behavior, Reproductive Behavior, Vasectomy
Conditions
Keywords
Vasectomy, Decision aid
Brief summary
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.
Detailed description
This study seeks to test a web-based decision support tool developed to enhance men's ability to make informed decisions about vasectomy that align with their preferences, values and reproductive goals. Half of participants will take their T1 survey immediately following randomization, while the other half will first use the web-based decision aid. The investigators hypothesize that compared to men who do not use the decision aid, men randomized to the decision aid arm will have greater knowledge about vasectomy and alternative options, lower decisional conflict, and will report greater interest in getting a vasectomy.
Interventions
BEHAVIORAL"Vasectomy: Right for Me?" decision aid
The vasectomy decision aid is a web-based decision aid designed to help men make informed and value-concordant decisions about vasectomy.
Sponsors
University of Pittsburgh
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Resound Research for Reproductive Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
21 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Are assigned male at birth * 21-55 years of age * Comfortable reading in English or Spanish * Live in the United States * Are considering vasectomy * Have not had a vasectomy
Exclusion criteria
* 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 * Are not considering vasectomy * Have had a vasectomy * Once a racial or economic sub-group recruitment number has been reached, no other subjects fitting that ethnicity or income group will be enrolled.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant knowledge about vacectomy | Up to 45 minutes | 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%. |
| Participant decisional conflict in contraceptive choice | Up to 45 minutes | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interest in vasectomy | Up to 45 minutes | 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. |
Countries
United States
Contacts
CONTACTSonya Borrero, MD, MS
CONTACTKari White, PhD, MPH
PRINCIPAL_INVESTIGATORSonya Borrero, MD, MS
University of Pittsburgh
PRINCIPAL_INVESTIGATORKari White, PhD, MPH
Resound Research for Reproductive Health
Outcome results
None listed