Sexual BehaviorNCT06670066
Rigorous Evaluation of Let's Talk Birth Control
A study of Sexual Behavior and Adolescent Behavior, run by Child Trends at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 24 years, women only
- Conditions the study is for
- Sexual Behavior, Adolescent Behavior
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Signature Health
Mentor, Ohio, 44060
Kate Welti, 202-744-2413, kwelti@childtrends.org
- Recruiting
Siouxland Community Health Center
Sioux City, Iowa, 51105
Kate Welti, 202-744-2413, kwelti@chiltrends.org
About this study
Official title: Rigorous Evaluation of Let's Talk Birth Control Among Adolescents Attending Community Health Centers
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:
Read more
- 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
- Conditions
- Sexual Behavior, Adolescent Behavior
- Being tested
- Let's Talk Birth Control
- Medical subject headings
- Sexual Behavior, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Talk Birth ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents receiving Let's Talk Birth Control | Experimental | Participants in the Let's Talk Birth Control condition receive access to the CDA materials, contraceptive counseling with trained healthcare providers, and asynchronous access to the Bedsider ME web platform. Receives: Behavioral: Let's Talk Birth Control |
| Adolescents receiving standard reproductive and sexual health care services | No intervention | Participants in the control condition receive standard health care services from their medical provider. Health centers in the control condition will not be using an adolescent-focused sexual and reproductive health CDA or contraceptive counseling initiative. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 9 months post-intervention
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.
Measured: 9 months post-intervention
Secondary outcomes (6)
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).
Measured: 1 week post-intervention
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)
Measured: 1 week post-intervention
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)
Measured: 1 week post-intervention
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)
Measured: 1 week post-intervention
Knowledge of contraceptive methods
Knowledge of contraceptive methods (% correct out of 6 items)
Measured: 1 week after post-intervention
Attitudes about contraception
6-item Contraceptive Concerns and Beliefs Scale
Measured: 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start15 Jan 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Child Trends
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Power to Decide
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670066
- Sponsor's protocol ID
- TP22023001568
- Other IDs
- TP22023001568
- Status last verified
- Mar 2026
- First submitted
- 28 Oct 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rigorous Evaluation of Let's Talk Birth Control Among Adolescents Attending Community Health Centers
- ClinicalTrials.gov ID
- NCT06670066
- Acronym / sponsor ID
- TP22023001568
- Conditions
- Sexual Behavior, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Child TrendsUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Power to Decide
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adolescents receiving Let's Talk Birth Control | Experimental | Behavioral: Let's Talk Birth ControlParticipants in the Let's Talk Birth Control condition receive access to the CDA materials, contraceptive counseling with trained healthcare providers, and asynchronous access to the Bedsider ME web platform. |
| Adolescents receiving standard reproductive and sexual health care services | No intervention | –Participants in the control condition receive standard health care services from their medical provider. Health centers in the control condition will not be using an adolescent-focused sexual and reproductive health CDA or contraceptive counseling initiative. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
- Seeking sexual and reproductive services or general wellness exams at an enrolled community health center
Key exclusion criteria (9 listed)
- 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
- Does not agree to be in study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let's Talk Birth ControlLet'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. | Behavioural | Adolescents receiving Let's Talk Birth Control |
Primary outcome
Rates of sex without a contraceptive method
Time frame: 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
Time frame: 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.
6 secondary outcomes
Self-efficacy to discuss contraception with a provider
Time frame: 1 week post-intervention
Self-efficacy to make informed decisions about contraception
Time frame: 1 week post-intervention
Intentions to use contraception
Time frame: 1 week post-intervention
Self-efficacy to use contraception
Time frame: 1 week post-intervention
Knowledge of contraceptive methods
Time frame: 1 week after post-intervention
Attitudes about contraception
Time frame: 1 week post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Sexual Behavior and Adolescent Behavior, run by Child Trends at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Welti, MPP (202-744-2413, kwelti@childtrends.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of sex without a contraceptive method (time frame: 9 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.