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NCT06670066 | NOT YET RECRUITING | Sexual Behavior


Rigorous Evaluation of Let's Talk Birth Control
Sponsor:

Child Trends

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

Condition or disease

Sexual Behavior

Adolescent Behavior

Intervention/treatment

Let's Talk Birth Control

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 1500 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Rigorous Evaluation of Let's Talk Birth Control Among Adolescents Attending Community Health Centers
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2027-08-31
Estimated Study Completion Date : 2027-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 15 Years to 24 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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

Rigorous Evaluation of Let's Talk Birth Control

Location Details

NCT06670066


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