Telehealth for Contraception

Overseen By Women's Health Research Unit Department of Ob/Gyn

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Anticoagulants, Corticosteroids

Disqualifiers: Pregnancy, Ectopic pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth method for providing contraception, targeting individuals at risk of pregnancy who wish to avoid it in the next year. The research aims to determine if advanced provision of certain medications can effectively manage contraception needs. Participants will engage in a telemedicine visit and complete follow-up surveys. This trial suits sexually active individuals not using long-term birth control and residing in Oregon or Washington. Participants must be willing to receive phone calls and complete online surveys. As an unphased trial, this study offers the chance to contribute to innovative contraceptive solutions through telehealth.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking anticoagulants or long-term corticosteroids, you may not be eligible to participate.

What prior data suggests that this telehealth method is safe for contraception?

Research has shown that telehealth for contraceptive care is safe and effective. Studies have found that telehealth services for medication abortion are as safe as in-person care, indicating that telehealth for contraceptive services is well-received and no riskier than traditional methods.

Additionally, telehealth for women's preventive services, such as contraception, yields results similar to in-person visits. This confirms that using telehealth for contraception is as safe as visiting a clinic. Overall, past patients have reported positive experiences, making telehealth a reliable choice for those considering this option for contraceptive care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using telehealth for contraception because it offers a convenient and private way for individuals to access contraceptive care without needing to visit a clinic in person. Unlike traditional methods that require face-to-face consultations, telehealth can provide more immediate and flexible access to healthcare professionals via digital communication tools. This approach not only saves time but also expands access to contraception for people in remote or underserved areas, potentially reducing barriers to effective family planning.

What evidence suggests that this trial's treatments could be effective for contraception?

Research has shown that telehealth can effectively provide contraceptive care. In this trial, participants will receive contraceptive care through a telehealth visit. Some studies have found that telehealth users for contraception achieve similar results to those visiting a doctor in person. Other research suggests telehealth is particularly useful when in-person appointments are difficult to attend. However, the evidence is mixed, and effectiveness can vary by individual. Overall, telehealth offers a convenient option, but its success depends on factors such as personal health needs and preferences. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-40 who are at risk of unintended pregnancy, not currently pregnant, and would choose to end a pregnancy within the next year. They must be sexually active without permanent contraception or LARC, have regular menstrual cycles, and plan to stay in Oregon or Washington for one year.

Inclusion Criteria

Self-reported a history of regular menses (>24 and <38 days) in the past 3 years (other than during pregnancy)

Anatomically capable of pregnancy

I would choose to end a pregnancy within the next year and prefer not to have an in-office procedure.

Exclusion Criteria

I would not consider terminating a pregnancy if I became pregnant in the next year.

I don't have bleeding disorders, long-term steroid use, porphyria, or allergies to specific medications.

Currently pregnant or desiring pregnancy in the next year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Telehealth Visit

Participants receive counseling via telemedicine and advanced provision of medications

1 visit

1 visit (virtual)

Follow-up

Participants are monitored for satisfaction and confidence in medication use through follow-up surveys

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Provision of Care
• Telehealth Visit

Trial Overview

The study tests advanced provision of anti-progestin with prostaglandin via telehealth visits for those who may need it within the next year but do not wish to become pregnant now.

How Is the Trial Designed?

Group I: Telehealth Visit Experimental Treatment 1 Intervention

telemedicine visit and follow-up surveys

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

The use of the MedWatcher app, combined with outreach to a Facebook patient community, significantly reduced the time to submit adverse event reports for the Essure device, averaging only 11.4 minutes compared to the typical 40 minutes for traditional methods.

Patients reported a high number of serious adverse events (77.6% of submissions), including hospitalization and permanent damage, and the reports submitted via the app were found to be 15 times more frequent than those through traditional reporting channels, indicating improved engagement and reporting quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US. Bahk, CY., Goshgarian, M., Donahue, K., et al.[2019]

A comparison of adverse event reports (AERs) for mifepristone abortions from 2009 to 2010 revealed significant discrepancies, with Cleland et al. documenting 1530 cases while the FDA's FAERS reported only 664 total AERs.

The findings suggest that the FAERS system may be inadequate for accurately assessing the safety of mifepristone abortions, as it reported only a fraction of ongoing pregnancies (95) compared to Cleland's documentation (1158).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act. Cirucci, CA., Aultman, KA., Harrison, DJ.[2022]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

A survey of 81 fertility patients revealed that 81.4% were satisfied with telehealth for fertility care, highlighting its usefulness, ease of use, and effectiveness.

Despite high satisfaction with telehealth, 60.5% of patients preferred in-person visits for their initial consultation, suggesting that while telehealth is effective, many still value face-to-face interactions for starting their fertility journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives of telehealth for fertility care: a national survey. Lersten, I., Fought, A., Yannetsos, C., et al.[2023]

The SmartVax SMS-based system effectively monitored adverse events following immunization (AEFI) in a diverse population of 276 participants in Switzerland, achieving a high response rate of 90.3%.

The study found that 29.8% of immunization visits reported at least one AEFI, with the Shingrix® vaccine showing the highest rate of reactions, indicating that SmartVax can be a reliable tool for real-time vaccine safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based active vaccine safety surveillance (SmartVax) at a Swiss adult vaccination clinic - a pilot study. Guedel, DS., Peters, IJ., Banderet, F., et al.[2021]

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK581513/

Results - Effectiveness of Telehealth for Women's ... - NCBI

Evidence of effectiveness of telehealth interventions for contraceptive care was low for contraceptive use at 6 months, low for sexually transmitted infection ( ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0010782424000726

Use of telemedicine to obtain contraception among young ...

Our analytic sample included 6465 observations from 1630 individuals. Participants reported using a contraceptive method obtained through telemedicine in just 6 ...

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aafp.org

aafp.org/pubs/afp/issues/2023/0500/ahrq-telehealth-womens-preventive-services.html

Effectiveness of Telehealth for Women's Preventive Services

Telehealth interventions used to supplement usual care resulted in similar outcomes for contraceptive use at six months and had similar rates of sexually ...

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kff.org

kff.org/womens-health-policy/who-uses-telecontraception-and-why-a-closer-look-at-clients-of-four-telecontraception-companies/

Who Uses Telecontraception and Why? A Closer Look ...

One in five (20%) telecontraception respondents report they have never had an in-person birth control visit (Figure 20). Higher shares of ...

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ajph.aphapublications.org

ajph.aphapublications.org/doi/10.2105/AJPH.2022.306886

Telehealth for Contraceptive Care During the COVID-19 ...

Among respondents receiving a contraceptive service, 17% reported using telehealth (8% with a provider, 9% online) at their most recent visit, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9110325/

Telehealth for Contraceptive Services During the COVID-19 ...

Telehealth use rapidly increased during the COVID-19 pandemic, including for contraceptive care (e.g., counseling and method provision).

7.

nature.com

nature.com/articles/s41591-024-02834-w

Effectiveness and safety of telehealth medication abortion ...

Telehealth medication abortion is effective, safe and comparable to published rates of in-person medication abortion care.

8.

effectivehealthcare.ahrq.gov

effectivehealthcare.ahrq.gov/sites/default/files/product/pdf/cer-256-telehealth-women-preventive-services.pdf

Effectiveness of Telehealth for Women's Preventive Services

This report is based on research conducted by the Pacific Northwest Evidence-based Practice. Center (EPC) under contract to the Agency for Healthcare ...