NCT06670066 Rigorous Evaluation of Let's Talk Birth Control
| NCT ID | NCT06670066 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Child Trends |
| Condition | Sexual Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2025-01-15 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06670066 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 24 Years, studying Sexual Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06670066 currently recruiting?
Yes, NCT06670066 is actively recruiting participants. Contact the research team at kwelti@childtrends.org for enrollment information.
Where is the NCT06670066 trial being conducted?
This trial is being conducted at Sioux City, United States, Mentor, United States.
Who is sponsoring the NCT06670066 clinical trial?
NCT06670066 is sponsored by Child Trends. The trial plans to enroll 1,500 participants.