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Completed

NCT Number: NCT04840836

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.

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.

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Key information

Conditions

Long Acting Reversible Contraception Behavior Contraception Behavior Reproductive Behavior

Age range

13 year–22 year

Sex eligibility

Female

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

(specifically for Aims 2 and 3):

  • 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

Treatment and study plan

Telehealth-supported LARC provision

Behavioral

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").

Other names: LARC method

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. Continuation Rate Across Dimensions of Telehealth Experience

    Time frame: Up to 20 months

    Merging electronic health record (EHR) data on method continuation with baseline survey data on the telehealth experience, we will compare, using Cox proportional hazard models, continuation (overall and within LARC type): by telehealth experience (e.g. satisfaction with telehealth).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

A Prospective Observational Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 12, 2021
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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