Long Acting Reversible ContraceptionNCT04840836
Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers
An observational study of Long Acting Reversible Contraception and Contraception Behavior, run by Columbia University at 1 site in United States.
Trial summary
This is a prospective observational cohort study that will include SBHC patients at the 6 participating SBHCs who receive a reproductive health visit as part of their care in a setting where telehealth-supported care is available. Read more about this study
- Who is it for?
- Ages 13 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Long Acting Reversible Contraception, Contraception Behavior
- What is being tested?
- Telehealth-supported LARC provision
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 22 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Based on SBHC clinical data from the full academic year (2018-19), it is estimated that, over the 12 month cohort there will be 113 telehealth consultations, defined as a visit in which an appointment is scheduled to initiate a LARC methods (Aim 1), and 102 LARC insertions (Aim 2). The SBHC patient population, as a whole, is 69% Hispanic and 26% Black (not mutually exclusive), with an average age of 16 years.
Who may be able to join
- an enrolled patient at the participating SBHC
- age 13-22 years
- female
- had a visit at the SBHC during the study period that is coded as a "reproductive health visit" including contraceptive counseling, contraceptive management, and contraceptive method initiation
Who cannot join
- are younger than age 13 years
- are older than age 22
- are not an enrolled patient of the participating SBHCs
- did not initiate a LARC method
- are a person without a uterus
- are unable to read, speak, and understand either English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: A Prospective Observational Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers
This is a prospective observational cohort study that will include SBHC patients at the 6 participating SBHCs who receive a reproductive health visit as part of their care in a setting where telehealth-supported care is available. Information will be collected during patient interviews in the follow-up observation period regarding LARC initiation, satisfaction and continuation.
Aim 1. Quantify uptake of LARC (contraceptive implant, IUD) within the SBHC network following implementation of telehealth-supported LARC provision.
Read more
Aim 2: Describe the implementation of telehealth-supported long-acting reversible contraception (LARC) service provision in school-based health centers (SBHCs) using mixed methods.
Aim 3: Quantify LARC continuation, as in absolute continuation rate 12 months post-initiation, with analyses also examining continuation at 6 months follow-up period, among LARC initiators within the SBHC network following implementation of telehealth-supported LARC provision.
Aim 4: Compare continuation rates across dimensions of telehealth experience.
Read the detailed description
Long acting reversible contraceptives (LARCs) are safe and effective for adolescents, but low rates of use among this population and early discontinuation due to method dissatisfaction limits their potential to reduce unintended pregnancy. Reducing barriers for obtaining LARCs by adolescents who want to use them is key in reducing risk of unintended pregnancy. Data will be collected from patients who are receiving same-day LARC as a part of their normal care via telehealth services in school-based health centers (SBHCs). This implementation model, therefore, has the potential for replication and scale-up with wide reach. The findings from this study, given the SBHC setting, have the potential to inform and improve LARC service delivery for adolescents far beyond New York City and the SBHC setting.
- Being tested
- Telehealth-supported LARC provision
- Keywords
- LARC
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth-supported LARC provisionBehavioural
Also called LARC method
Provision of LARC in routine care will include a hybrid model of telehealth-supported long-acting reversible contraception (LARC) service provision in a network of 6 school-based health centers (SBHCs) in New York City that serve adolescents and young adult high school students age 13-22 years (hereafter referred to as "adolescents").
| Study group | Role | What they receive |
|---|---|---|
| Telehealth-supported LARC provision | Patients who receive care at the SBHC provide informed consent for care, as well as record review for quality assurance purposes. Analyses will include female patients who have a "reproductive health visit," which includes contraceptive counseling, contraceptive management, or contraceptive method initiation, during the study period. Patients who have a telehealth consultation with a SBHC medical provider for LARC services (conservatively estimated n=113) will be considered enrolled patients once the data are extracted from the electronic health record (EHR) system. Receives: Behavioral: Telehealth-supported LARC provision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network
Among all patients who had a visit for contraceptive counseling, quantify the number of telehealth LARC consultations and LARC initiations overall, and compare by LARC type (contraceptive implant vs. IUD) using data collected from patient interviews.
Measured: Up to 20 months
Percentage of Patients Reported Being Satisfied With Telehealth-supported Care
A qualitative interview and a quantitative survey will be used to assess LARC patients' experience and satisfaction with telehealth-supported care. Patients will be assessed by investigator as satisfied or not satisfied based on their responses.
Measured: Up to 20 months
LARC Continuation Rate Over a Follow-up Period Among LARC Initiators Within the SBHC Network Following Implementation of Telehealth-supported LARC Provision
Using EHR data for all patients who initiated LARC, investigator will use Kaplan-Meier survival curves to assess LARC discontinuation overall. Continuation rate will be expressed as a percentage at 6 months post-initiation, and using Kaplan-Meier curves to model discontinuation.
Measured: At 6 months post LARC initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start20 Apr 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Long Acting Reversible ContraceptionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samantha Garbers, PhD, Principal investigator, Associate Professor of Population & Family Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840836
- Sponsor's protocol ID
- AAAT6596
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2021
- Last updated
- 22 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers
- ClinicalTrials.gov ID
- NCT04840836
- Acronym / sponsor ID
- AAAT6596
- Keywords
- LARC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Posted 22 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational cohort study that will include SBHC patients at the 6 participating SBHCs who receive a reproductive health visit as part of their care in a setting where telehealth-supported care is available. Information will be collected during patient interviews in the follow-up observation period regarding LARC initiation, satisfaction and continuation.
Aim 1. Quantify uptake of LARC (contraceptive implant, IUD) within the SBHC network following implementation of telehealth-supported LARC provision.
Aim 2: Describe the implementation of telehealth-supported long-acting reversible contraception (LARC) service provision in school-based health centers (SBHCs) using mixed methods.
Aim 3: Quantify LARC continuation, as in absolute continuation rate 12 months post-initiation, with analyses also examining continuation at 6 months follow-up period, among LARC initiators within the SBHC network following implementation of telehealth-supported LARC provision.
Aim 4: Compare continuation rates across dimensions of telehealth experience.
Detailed description
Long acting reversible contraceptives (LARCs) are safe and effective for adolescents, but low rates of use among this population and early discontinuation due to method dissatisfaction limits their potential to reduce unintended pregnancy. Reducing barriers for obtaining LARCs by adolescents who want to use them is key in reducing risk of unintended pregnancy. Data will be collected from patients who are receiving same-day LARC as a part of their normal care via telehealth services in school-based health centers (SBHCs). This implementation model, therefore, has the potential for replication and scale-up with wide reach. The findings from this study, given the SBHC setting, have the potential to inform and improve LARC service delivery for adolescents far beyond New York City and the SBHC setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth-supported LARC provision | – | Behavioral: Telehealth-supported LARC provisionPatients who receive care at the SBHC provide informed consent for care, as well as record review for quality assurance purposes. Analyses will include female patients who have a "reproductive health visit," which includes contraceptive counseling, contraceptive management, or contraceptive method initiation, during the study period. Patients who have a telehealth consultation with a SBHC medical provider for LARC services (conservatively estimated n=113) will be considered enrolled patients once the data are extracted from the electronic health record (EHR) system. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Based on SBHC clinical data from the full academic year (2018-19), it is estimated that, over the 12 month cohort there will be 113 telehealth consultations, defined as a visit in which an appointment is scheduled to initiate a LARC methods (Aim 1), and 102 LARC insertions (Aim 2). The SBHC patient population, as a whole, is 69% Hispanic and 26% Black (not mutually exclusive), with an average age of 16 years.
Key inclusion criteria (4 listed)
- an enrolled patient at the participating SBHC
- age 13-22 years
- female
- had a visit at the SBHC during the study period that is coded as a "reproductive health visit" including contraceptive counseling, contraceptive management, and contraceptive method initiation
Key exclusion criteria (6 listed)
- are younger than age 13 years
- are older than age 22
- are not an enrolled patient of the participating SBHCs
- did not initiate a LARC method
- are a person without a uterus
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 |
|---|---|---|
| Telehealth-supported LARC provisionAlso: LARC methodProvision of LARC in routine care will include a hybrid model of telehealth-supported long-acting reversible contraception (LARC) service provision in a network of 6 school-based health centers (SBHCs) in New York City that serve adolescents and young adult high school students age 13-22 years (hereafter referred to as "adolescents"). | Behavioural | Telehealth-supported LARC provision |
Primary outcome
Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network
Time frame: Up to 20 months
Among all patients who had a visit for contraceptive counseling, quantify the number of telehealth LARC consultations and LARC initiations overall, and compare by LARC type (contraceptive implant vs. IUD) using data collected from patient interviews.
Percentage of Patients Reported Being Satisfied With Telehealth-supported Care
Time frame: Up to 20 months
A qualitative interview and a quantitative survey will be used to assess LARC patients' experience and satisfaction with telehealth-supported care. Patients will be assessed by investigator as satisfied or not satisfied based on their responses.
LARC Continuation Rate Over a Follow-up Period Among LARC Initiators Within the SBHC Network Following Implementation of Telehealth-supported LARC Provision
Time frame: At 6 months post LARC initiation
Using EHR data for all patients who initiated LARC, investigator will use Kaplan-Meier survival curves to assess LARC discontinuation overall. Continuation rate will be expressed as a percentage at 6 months post-initiation, and using Kaplan-Meier curves to model discontinuation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Samantha Garbers, PhD principal investigator
Associate Professor of Population & Family Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long Acting Reversible Contraception and Contraception Behavior, run by Columbia University at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 22 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Telehealth and Non-Telehealth LARC Device Initiations Within the SBHC Network (time frame: Up to 20 months). The study lists 3 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 22 Jun 2025.