NCT07451067

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started May 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
May 2026Apr 2027

First Submitted

Initial submission to the registry

February 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 6, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 27, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

VasectomyDecision aid

Outcome Measures

Primary Outcomes (2)

  • 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%.

    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).

    Up to 45 minutes

Secondary Outcomes (1)

  • Interest in vasectomy

    Up to 45 minutes

Study Arms (2)

Decision Aid Arm

EXPERIMENTAL

Participants will use the web-based decision aid.

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.

Interventions

The vasectomy decision aid is a web-based decision aid designed to help men make informed and value-concordant decisions about vasectomy.

Decision Aid Arm

Eligibility Criteria

Age21 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Are assigned male at birth
  • years of age
  • Comfortable reading in English or Spanish
  • Live in the United States
  • Are considering vasectomy
  • Have not had a vasectomy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Resound Research for Reproductive Health, a project of the Tides Center

San Francisco, California, 94129, United States

Location

CONVERGE Toward Sexual and Reproductive Health Equity

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Contraception BehaviorReproductive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Sonya Borrero, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Kari White, PhD, MPH

    Resound Research for Reproductive Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonya Borrero, MD, MS

CONTACT

Kari White, PhD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 5, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

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.
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.

Locations