Clinical trial NCT06670066: Rigorous Evaluation of Let's Talk Birth Control
Official title: Rigorous Evaluation of Let's Talk Birth Control Among Adolescents Attending Community Health Centers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sexual Behavior
Adolescent Behavior
Lead sponsor: Child Trends
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Power to Decide
First posted: 2024-11-01
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This research project will use a cluster-level randomized control trial design in which a participating health center is randomized to either the experimental condition (Let's Talk Birth Control) or the control condition (standard health services). All participants enrolled at health centers randomized to the experimental condition should receive the Let's Talk Birth Control intervention while all participants enrolled at health centers randomized to the control condition should receive health services as usual.
Primary purpose: PREVENTION

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

Primary outcomes:
measure: Rates of sex without a contraceptive method
timeFrame: 9 months post-intervention
measure: Use of preferred contraceptive method
timeFrame: 9 months post-intervention
Secondary outcomes:
measure: Self-efficacy to discuss contraception with a provider
timeFrame: 1 week post-intervention
measure: Self-efficacy to make informed decisions about contraception
timeFrame: 1 week post-intervention
measure: Intentions to use contraception
timeFrame: 1 week post-intervention
measure: Self-efficacy to use contraception
timeFrame: 1 week post-intervention
measure: Knowledge of contraceptive methods
timeFrame: 1 week after post-intervention
measure: Attitudes about contraception
timeFrame: 1 week post-intervention
Other outcomes:
Locations:
Study officials:
References: