"Vasectomy: Right for Me?" Decision Support Tool

May 5, 2026 updated by: Sonya Borrero, University of Pittsburgh

Addressing Factors Related to Disparities in Vasectomy

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sonya Borrero, MD, MS
  • Phone Number: +1 412-216-1104
  • Email: borrsp@upmc.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94129
        • Resound Research for Reproductive Health, a project of the Tides Center
        • Contact:
        • Principal Investigator:
          • Kari White, PhD, MPH
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • CONVERGE Toward Sexual and Reproductive Health Equity
        • Contact:
        • Principal Investigator:
          • Sonya Borrero, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decision Aid Arm
Participants will use the web-based decision aid.
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.
No Intervention: Control Arm
Participants will be asked to take their T1 survey directly after randomization, without using the decision aid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant knowledge about vacectomy
Time Frame: 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%.
Up to 45 minutes
Participant decisional conflict in contraceptive choice
Time Frame: 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).
Up to 45 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interest in vasectomy
Time Frame: 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.
Up to 45 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Resound Research for Reproductive Health

Investigators

  • Principal Investigator: Sonya Borrero, MD, MS, University of Pittsburgh
  • Principal Investigator: Kari White, PhD, MPH, Resound Research for Reproductive Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

February 27, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY23070159
  • R01HD110557 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data will be used for publication. De-identified survey data will be made available, and NIH policies and procedures that permit and encourage open access to study data will be followed. The survey data will be de-identified and sent to the NIH program officer for distribution as a data set within four years after the completion of data collection. For outside investigators to fully utilize the survey data correctly, we will provide assistance whenever feasible. Additionally, the study statistician will annotate, document, and merge datasets generated from this proposal for data archiving to facilitate the use of study data.

IPD Sharing Time Frame

Publication of results will occur upon completion of the study. De-identified survey data will be made available within four years after the completion of data collection. No end date.

IPD Sharing Access Criteria

De-identified participant data will be used for publication. Access to de-identified data may be granted to other investigators whose proposed use of the data has been approved by an independent review committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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