Rigorous Evaluation of Let's Talk Birth Control
- Conditions
- Sexual BehaviorAdolescent Behavior
- Registration Number
- NCT06670066
- Lead 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 1500
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
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rates of sex without a contraceptive method 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".Use of preferred contraceptive method 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 Outcome Measures
Name Time Method Self-efficacy to discuss contraception with a provider 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).
Self-efficacy to make informed decisions about contraception 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)
Intentions to use contraception 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)
Self-efficacy to use contraception 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)
Knowledge of contraceptive methods 1 week after post-intervention Knowledge of contraceptive methods (% correct out of 6 items)
Attitudes about contraception 1 week post-intervention 6-item Contraceptive Concerns and Beliefs Scale
Citation: Rocca, C.H., Muñoz, I., Rao, L. et al. Measuring a Critical Component of Contraceptive Decision Making: The Contraceptive Concerns and Beliefs Scale. Matern Child Health J 28, 847-857 (2024).