Rigorous Evaluation of Let's Talk Birth Control

Child Trends

Status: Not yet enrolling

Conditions: Sexual Behavior; Adolescent Behavior

Treatments: Behavioral: Let's Talk Birth Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06670066

TP22023001568 (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this cluster-level randomized controlled trial is to evaluate the impacts of Let's Talk Birth Control, a clinical decision support intervention for adolescents that consists of a printed contraceptive decision aid (CDA), contraceptive counseling, and a QR code to the Bedsider.org Method Explorer (ME). The goal of Let's Talk Birth Control is to reduce rates of sex without a contraceptive method among adolescent patients, increase use of preferred contraceptive method, as well as to increase self-efficacy to discuss, obtain, and correctly use contraceptive methods

The primary research questions are:

• Does receiving care from a health center participating in Let's Talk Birth Control reduce rates of sex without a contraceptive method among adolescent patients compared to those visiting a standard of care control health center?
• Does receiving care from a health center participating in Let's Talk Birth Control increase use of preferred contraceptive method among adolescent patients compared to those visiting a standard of care control health center?

The evaluation will focus on the impacts of receiving the Let's Talk Birth Control intervention, as compared to receiving standard health care services.

As part of this study:

• All participants will be asked to complete baseline, 1-week post-intervention, and 9-month follow-up surveys.
• Participants at health centers randomized to receive the Let's Talk intervention, will be asked to:
• Review the Let's Talk CDA independently prior to meeting with their healthcare provider
• Participate in an observation focused on the provider's use of the CDA for contraceptive counseling during the healthcare visit (select participants only)
• Participate in a focus group discussing their perceptions of the Let's Talk Birth Control intervention (select participants only)

Staff at health centers randomized to receive the Let's Talk intervention will be asked to:

• Complete a 45-60 minute online asynchronous training covering patient-centered contraceptive counseling (PCCC) for adolescents and using the CDA
• Use the Let's Talk CDA to facilitate patient-centered contraceptive counseling with patients that have enrolled in the study

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 15 to 24 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Health Centers:

• Serve 400+ patients assigned female at birth (AFAB) aged 15-24 receiving sexual and reproductive health (SRH) services or general wellness exams annually. Although the project team may enroll rural health centers with smaller populations
• Have not implemented an adolescent SRH patient-centered training recently
• Do not utilize a contraceptive decision aid (CDA) designed for adolescent patients

Participants:

• Assigned female at birth
• Seeking sexual and reproductive services or general wellness exams at an enrolled community health center
• Have had penile-vaginal sex in the past year or are interested in discussing birth control with their provider
• Agree to be in study

Exclusion criteria

Health Centers

• Does not serve at least 400 AFAB aged 15-24 receiving SRH services or general wellness exams annually
• Has recently implemented an adolescent SRH training
• Currently using a CDA designed for adolescent patients

Participants:

• Does not agree to be in study
• Is pregnant or is trying to become pregnant
• Does not have access to a phone to receive text messages
• Does not speak English or Spanish

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Adolescents receiving Let's Talk Birth Control

Experimental group

Description:

Participants in the Let's Talk Birth Control condition receive access to the CDA materials, contraceptive counseling with trained healthcare providers, and asynchronous access to the Bedsider ME web platform.

Treatment:

Behavioral: Let's Talk Birth Control

Adolescents receiving standard reproductive and sexual health care services

No Intervention group

Description:

Participants in the control condition receive standard health care services from their medical provider. Health centers in the control condition will not be using an adolescent-focused sexual and reproductive health CDA or contraceptive counseling initiative.