Recruiting

Let's Talk Birth Control

Sponsor:

Child Trends

Code:

NCT06670066

Conditions

Sexual Behavior

Adolescent Behavior

Eligibility Criteria

Sex: Female

Age: 15 - 24

Healthy Volunteers: Not accepted

Interventions

Let's Talk Birth Control

Study Details

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

Study ID

NCT06670066

Start date

Jan 15, 2025

Status verified date

Mar, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 24

Healthy Volunteers: Not accepted

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 Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Rates of sex without a contraceptive method [ Time Frame: 9 months post-intervention ]
  • Use of preferred contraceptive method [ Time Frame: 9 months post-intervention ]

Central Contacts and Locations

Central contacts

Locations

Siouxland Community Health Center

Recruiting

Sioux City, Iowa, United States, 51105

Contacts

Signature Health

Recruiting

Mentor, Ohio, United States, 44060

Contacts

More Information

Sponsor

Child Trends

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Child Trends on 2026-03-19.