Rigorous Evaluation of Let's Talk Birth Control

Rigorous Evaluation of Let's Talk Birth Control Among Adolescents Attending Community Health Centers

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

Study Overview

• Status: Recruiting
• Conditions: Sexual Behavior; Adolescent Behavior
• Intervention / Treatment: Behavioral: Let's Talk Birth Control

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kate Welti, MPP; Phone Number: 202-744-2413; Email: kwelti@childtrends.org
• Study Contact Backup: Name: Riley Steiner, Mph, PhD; Phone Number: 202-478-8515; Email: rsteiner@powertodecide.org

Study Locations

• United States
  • Iowa
    • Sioux City, Iowa, United States, 51105
      • Recruiting
      • Siouxland Community Health Center
      • Contact: Kate Welti; Phone Number: 202-744-2413; Email: kwelti@chiltrends.org
  • Ohio
    • Mentor, Ohio, United States, 44060
      • Recruiting
      • Signature Health
      • Contact: Kate Welti; Phone Number: 202-744-2413; Email: kwelti@childtrends.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adolescents receiving Let's Talk Birth Control; 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; 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.
No Intervention: Adolescents receiving standard reproductive and sexual health care services; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy to discuss contraception with a provider	Confident they can talk about birth control with their doctor or health care provider (yes/no, "Strongly agree" vs other responses).	1 week post-intervention
Self-efficacy to make informed decisions about contraception	Strongly agree that they 1) feel sure about the best birth control option for their needs and 2) have received enough support and advice to make a choice about birth control methods (yes/no, "Strongly agree" to both items vs other responses)	1 week post-intervention
Intentions to use contraception	Intends to use contraception if chooses to have penile-vaginal sex in the next 3 months (yes/no, "Yes, definitely" vs other responses)	1 week post-intervention
Self-efficacy to use contraception	4-item Likert scale capturing 1) confidence in starting a new method of birth control if they want, 2) using birth control correctly, 3) knowing the steps needed to continue a birth control method, and 4) avoiding unintended pregnancy (1-5 scale)	1 week post-intervention
Knowledge of contraceptive methods	Knowledge of contraceptive methods (% correct out of 6 items)	1 week after post-intervention
Attitudes about contraception	6-item Contraceptive Concerns and Beliefs Scale	1 week post-intervention

Collaborators and Investigators

• Sponsor: Child Trends
• Collaborators: University of California, San Francisco; Power to Decide

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: October 28, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Sexual Behavior; Adolescent Behavior
• Other Study ID Numbers: TP22023001568 (Other Grant/Funding Number: Office of Population Affairs)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No