Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
Study NCT ID:
NCT06670066
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rigorous Evaluation of Let's Talk Birth Control
Sponsor:
Child Trends
Organization:
Study Overview
Official Title:
Rigorous Evaluation of Let's Talk Birth Control Among Adolescents Attending Community Health Centers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TP22023001568 | OTHER_GRANT | Office of Population Affairs | View |