VasectomyNCT07451067
"Vasectomy: Right for Me?" Decision Support Tool
A study testing "Vasectomy: Right for Me?" decision aid in people with Vasectomy and Contraception, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years, men only
- Conditions the study is for
- Vasectomy, Contraception, Contraception Behavior
- What is being tested?
- "Vasectomy: Right for Me?" decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jun 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
CONVERGE Toward Sexual and Reproductive Health Equity
Pittsburgh, Pennsylvania, 15213
Michaella Wu, MPH, 704-502-3395, mlw160@pitt.edu
Sonya Borrero, MD, MS
- Recruiting
Resound Research for Reproductive Health, a project of the Tides Center
San Francisco, California, 94129
Jeanette Cunningham Rottas, MA, 202-271-2607, jeanetterottas@resoundrh.org
Kari White, PhD, MPH
About this study
Official title: 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.
Read the 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.
- Being tested
- "Vasectomy: Right for Me?" decision aid
- Keywords
- Vasectomy, Decision aid
- Medical subject headings
- Contraception Behavior, Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Vasectomy: Right for Me?" decision aidBehavioural
The vasectomy decision aid is a web-based decision aid designed to help men make informed and value-concordant decisions about vasectomy.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid Arm | Experimental | Participants will use the web-based decision aid. Receives: Behavioral: "Vasectomy: Right for Me?" decision aid |
| Control Arm | No intervention | Participants will be asked to take their T1 survey directly after randomization, without using the decision aid. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Up to 45 minutes
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).
Measured: Up to 45 minutes
Secondary 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.
Measured: Up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start20 Jun 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasectomyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Resound Research for Reproductive Health
- Responsible party
- Principal investigator, Sonya Borrero, University of Pittsburgh
- Investigators
- Sonya Borrero, MD, MS, Principal investigator, University of PittsburghKari White, PhD, MPH, Principal investigator, Resound Research for Reproductive Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451067
- Sponsor's protocol ID
- STUDY23070159
- Other IDs
- R01HD110557
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Factors Related to Disparities in Vasectomy
- ClinicalTrials.gov ID
- NCT07451067
- Acronym / sponsor ID
- STUDY23070159
- Keywords
- Vasectomy, Decision aid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Resound Research for Reproductive Health
- Study start
- 20 Jun 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid Arm | Experimental | Behavioral: "Vasectomy: Right for Me?" decision aidParticipants will use the web-based decision aid. |
| Control Arm | No intervention | –Participants will be asked to take their T1 survey directly after randomization, without using the decision aid. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Are assigned male at birth
- 21-55 years of age
- Comfortable reading in English or Spanish
- Live in the United States
- Are considering vasectomy
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Vasectomy: Right for Me?" decision aidThe vasectomy decision aid is a web-based decision aid designed to help men make informed and value-concordant decisions about vasectomy. | Behavioural | Decision Aid Arm |
Primary outcome
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%.
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).
1 secondary outcome
Interest in vasectomy
Time frame: Up to 45 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sonya Borrero, MD, MS principal investigator
University of Pittsburgh
Kari White, PhD, MPH principal investigator
Resound Research for Reproductive Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Vasectomy: Right for Me?" decision aid in people with Vasectomy and Contraception, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sonya Borrero, MD, MS (412-216-1104 ext. +1, borrsp@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant knowledge about vacectomy (time frame: Up to 45 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.