"Vasectomy: Right for Me?" Decision Support Tool

University of Pittsburgh

Status: Not yet enrolling

Conditions: Vasectomy; Contraception; Contraception Behavior; Reproductive Behavior

Treatments: Behavioral: "Vasectomy: Right for Me?" decision aid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07451067

R01HD110557 (U.S. NIH Grant/Contract)

STUDY23070159

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: Male

Ages: 21 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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750 participants in 2 patient groups

Decision Aid Arm

Experimental group

Description:

Participants will use the web-based decision aid.

Treatment:

Behavioral: "Vasectomy: Right for Me?" decision aid

Control Arm

No Intervention group

Description:

Participants will be asked to take their T1 survey directly after randomization, without using the decision aid.