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NCT Number: NCT06670066

Rigorous Evaluation of Let's Talk Birth Control

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

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Key information

Age range

15 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Siouxland Community Health Center, Sioux City, Iowa, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rates of sex without a contraceptive method

    Time frame: 9 months post-intervention

    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".

  2. Use of preferred contraceptive method

    Time frame: 9 months post-intervention

    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.

Secondary outcomes

  1. Self-efficacy to discuss contraception with a provider

    Time frame: 1 week post-intervention

    Confident they can talk about birth control with their doctor or health care provider (yes/no, "Strongly agree" vs other responses).

  2. Self-efficacy to make informed decisions about contraception

    Time frame: 1 week post-intervention

    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)

  3. Intentions to use contraception

    Time frame: 1 week post-intervention

    Intends to use contraception if chooses to have penile-vaginal sex in the next 3 months (yes/no, "Yes, definitely" vs other responses)

  4. Self-efficacy to use contraception

    Time frame: 1 week post-intervention

    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)

  5. Knowledge of contraceptive methods

    Time frame: 1 week after post-intervention

    Knowledge of contraceptive methods (% correct out of 6 items)

  6. Attitudes about contraception

    Time frame: 1 week post-intervention

    6-item Contraceptive Concerns and Beliefs Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Welti, MPP

CONTACT

[email protected]

202-744-2413

Riley Steiner, Mph, PhD

CONTACT

[email protected]

202-478-8515

Sponsors and collaborators

Lead sponsor

Child Trends

Other

Collaborators

  • Power to Decide
  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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