Skip to content

Rigorous Evaluation of Let's Talk Birth Control

Rigorous Evaluation of Let's Talk Birth Control Among Adolescents Attending Community Health Centers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06670066
Enrollment
1500
Registered
2024-11-01
Start date
2025-01-15
Completion date
2027-08-31
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Sexual Behavior

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

Interventions

BEHAVIORALLet's Talk Birth Control

Let'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.

Sponsors

Child Trends
Lead SponsorOTHER
University of California, San Francisco
CollaboratorOTHER
Power to Decide
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

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.

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 24 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Rates of sex without a contraceptive method9 months post-interventionPenile-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 method9 months post-interventionCurrently 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

MeasureTime frameDescription
Self-efficacy to discuss contraception with a provider1 week post-interventionConfident 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 contraception1 week post-interventionStrongly 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 contraception1 week post-interventionIntends 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 contraception1 week post-intervention4-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 methods1 week after post-interventionKnowledge of contraceptive methods (% correct out of 6 items)
Attitudes about contraception1 week post-intervention6-item Contraceptive Concerns and Beliefs Scale

Countries

United States

Contacts

CONTACTKate Welti, MPP
kwelti@childtrends.org202-744-2413
CONTACTRiley Steiner, Mph, PhD
rsteiner@powertodecide.org202-478-8515

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026