Rigorous Evaluation of Let's Talk Birth Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-24
SponsorChild Trends
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Assigned female at birth
Disqualifiers
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
Does not agree to be in study
Trial design
Design model
Parallel
Treatments tested in this trial
Let's Talk Birth Control
BehavioralLet'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.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Adolescents receiving Let's Talk Birth ControlExperimental treatment 1 intervention
Group B: Adolescents receiving standard reproductive and sexual health care servicesNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Rates of sex without a contraceptive method
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".
Time frame
9 months post-intervention2
Use of preferred contraceptive method
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.
Time frame
9 months post-interventionSecondary outcomes
1
Self-efficacy to discuss contraception with a provider
Confident they can talk about birth control with their doctor or health care provider (yes/no, "Strongly agree" vs other responses).
Time frame
1 week post-intervention2
Self-efficacy to make informed decisions about contraception
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)
Time frame
1 week post-intervention3
Intentions to use contraception
Intends to use contraception if chooses to have penile-vaginal sex in the next 3 months (yes/no, "Yes, definitely" vs other responses)
Time frame
1 week post-intervention4
Self-efficacy to use contraception
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)
Time frame
1 week post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Child Trends
Lead sponsor
University of California, San Francisco
Collaborator
Power to Decide
Collaborator
Source ClinicalTrials.gov