Rigorous Evaluation of Let's Talk Birth Control

NCT06670066 | Recruiting

• 1 other identifier: TP22023001568
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Sexual Behavior; Adolescent Behavior

Outcome Measures

Primary Outcomes (2)

• Rates of sex without a contraceptive method

  Penile-vaginal sex without any contraception (including condom) in the past 3 months (yes/no). Yes if had sex in the past 3 months and did not use a contraceptive method "all the time". No if did not have sex or used a contraceptive method "all the time".

  9 months post-intervention

• Use of preferred contraceptive method

  Currently using preferred birth control method (yes/no). Respondents are coded as No if they report there is a method of birth control that they would like to be using right now but are not currently using. Otherwise, they are coded as Yes.

  9 months post-intervention

Secondary Outcomes (6)

• Self-efficacy to discuss contraception with a provider

  1 week post-intervention

• Self-efficacy to make informed decisions about contraception

  1 week post-intervention

• Intentions to use contraception

  1 week post-intervention

• Self-efficacy to use contraception

  1 week post-intervention

• Knowledge of contraceptive methods

  1 week after post-intervention

Study Arms (2)

Adolescents receiving Let's Talk Birth Control

EXPERIMENTAL

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.

Behavioral: Let's Talk Birth Control

Adolescents receiving standard reproductive and sexual health care services

NO INTERVENTION

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.

Interventions

Let's Talk Birth Control BEHAVIORAL

Let's Talk is an innovative, multi-level intervention addressing adolescents and providers that includes both in-person and online components and is feasible to implement in clinical settings. The three core components are: (1) a printed contraceptive decision aid (CDA) with a QR code linking to the Method Explorer (ME) page on Power to Decide's online birth control website, Bedsider; (2) the Bedsider ME, with information on the full range of contraceptive methods and a personalized method comparison feature; and (3) an online training for providers on Patient-centered Contraceptive Counseling (PCCC), including use of the CDA to support shared decision-making with adolescents.

Adolescents receiving Let's Talk Birth Control

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Child Trends: lead
• University of California, San Francisco: collaborator
• Power to Decide: collaborator

Study Sites (2)

Siouxland Community Health Center

Sioux City, Iowa, 51105, United States

RECRUITING

Signature Health

Mentor, Ohio, 44060, United States

RECRUITING

MeSH Terms

Conditions

Sexual Behavior; Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Kate Welti, MPP

CONTACT

202-744-2413; kwelti@childtrends.org

Riley Steiner, Mph, PhD

CONTACT

202-478-8515; rsteiner@powertodecide.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This research project will use a cluster-level randomized control trial design in which a participating health center is randomized to either the experimental condition (Let's Talk Birth Control) or the control condition (standard health services). All participants enrolled at health centers randomized to the experimental condition should receive the Let's Talk Birth Control intervention while all participants enrolled at health centers randomized to the control condition should receive health services as usual.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 1, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)