Video Instruction for Medication Adherence

AF
VI
Overseen ByVidya Iyer
Age: < 65
Sex: Female
Trial Phase: Academic
Sponsor: Tufts Medical Center
Must be taking: Depot medroxyprogesterone
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a video tutorial can help young people learn to self-administer a specific birth control shot at home. A peer in the video explains how to give a subcutaneous depot medroxyprogesterone shot, typically administered by a doctor. The trial aims to determine if this method is effective and well-received compared to the traditional approach. Teens assigned female at birth, who have already received at least one of these shots from a doctor, are suitable candidates for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative healthcare delivery methods.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the study focuses on teaching self-administration of a specific medication, it seems unlikely that you would need to stop other medications.

What prior data suggests that this method is safe for self-administration?

Research shows that subcutaneous depot medroxyprogesterone (DMPA-SC) is generally safe to use. The FDA has approved this injectable birth control for use in the United States. In studies, users reported that this method is easy to tolerate, and many teenagers can successfully administer it themselves without visiting a clinic.

Additional safety information indicates that the medication does not irritate the eyes or skin and is not harmful in short-term use, based on animal studies. This suggests it is safe for humans when used as directed. Some studies have also examined self-administration, revealing that many find it a convenient and acceptable way to prevent pregnancy. Overall, the evidence supports the safety of using DMPA-SC for self-injection.12345

Why are researchers excited about this trial?

Researchers are excited about the self-administration of subcutaneous depot medroxyprogesterone because it offers a new, patient-empowered way to manage contraception. Unlike traditional methods that require a healthcare provider for administration, this approach allows individuals to self-inject the medication after watching a teaching video. This not only enhances convenience and privacy but also has the potential to improve medication adherence by making the process more accessible and flexible for users.

What evidence suggests that this video instruction is effective for medication adherence?

Research shows that self-administering depot medroxyprogesterone, a type of birth control, under the skin can be very effective. Studies have found that women who self-inject this medication tend to use it more regularly than those who receive the shot from a healthcare provider. This suggests that individuals might adhere better to their birth control plan when they can administer it at home. Additionally, injections under the skin usually pose fewer risks than intramuscular ones. Many teenage girls express interest in using this method outside of a clinic and are capable of doing so. Overall, self-administration of this medication offers a promising option for those seeking an effective and convenient form of birth control.45678

Are You a Good Fit for This Trial?

This trial is for young individuals assigned female at birth, aged 19 or younger, who have had at least one injection of depot medroxyprogesterone. They must not be wards of the state or prisoners and should have a guardian to consent if under 18. They can't join if they've self-injected before, never had this medication, are pregnant, don't understand English, can't watch the video or have cognitive issues.

Inclusion Criteria

I am a female under 20 years old.
I have received at least one depot medroxyprogesterone injection.

Exclusion Criteria

Inability to understand written or spoken English
I am under 18 and do not have a parent or guardian to sign consent.
I have experience giving myself injections.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
2 attempts (telephone)

Initial Visit and Training

Participants watch a peer-to-peer instructional video and perform a supervised self-injection of subcutaneous depot-medroxyprogesterone

1 day
1 visit (in-person)

Follow-up

Participants complete a follow-up survey and self-report on sustained self-injection practices

12 weeks
1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Self-administration of subcutaneous depot medroxyprogesterone
Trial Overview The study tests whether an instructional video with a peer demonstrating how to self-administer subcutaneous depot medroxyprogesterone is effective and acceptable for adolescents as an alternative to getting shots in a medical office.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Teaching videoExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials
264
Recruited
264,000+

Published Research Related to This Trial

Compliance with adjuvant endocrine therapy for breast cancer is generally high in clinical trials, but real-world data shows a significant drop in persistence after 12 months, with declines of up to 50% in ongoing therapy.
Strategies to improve adherence include enhancing healthcare access, managing side effects, providing patient education, and fostering strong communication between patients and healthcare providers.
Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy.Hadji, P.[2022]
In a study of 693 young women with hormone receptor-positive breast cancer, 9% did not start oral adjuvant endocrine therapy (ET) within 18 months, with Black women showing higher odds of non-initiation.
Among those who started ET, 20% were non-persistent, with factors like younger age and marital status influencing adherence; however, non-persistence was linked to lower recurrence rates, suggesting that decision-making support could enhance adherence.
Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer.Rosenberg, SM., Zheng, Y., Gelber, S., et al.[2023]
A 12-month randomized controlled trial with 731 women in Malawi showed that 92% of those trained to self-inject depot medroxyprogesterone acetate (DMPA-SC) found it easy to do, indicating high feasibility for self-administration in low-resource settings.
Both self-injectors and those receiving provider-administered DMPA-SC reported high satisfaction levels, suggesting that scaling up self-injection programs could be beneficial for improving access to contraceptive methods.
Women's satisfaction, use, storage and disposal of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) during a randomized trial.Burke, HM., Chen, M., Buluzi, M., et al.[2019]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/29526707/
Effect of self-administration versus provider-administered ...Women who self-injected DMPA-SC had significantly higher rates of continuation than those receiving provider-injected DMPA-SC.
Self-administration of subcutaneous depot ...Our data demonstrate that many adolescent women are interested in DMPA availability outside of the clinical setting, and are able to self-administer DMPA-SC ...
Self-administration of subcutaneous depot ...Subcutaneous injections have fewer risks than intramuscular injections, and therefore, it is routine for patients to self-administer medications via ...
ContraceptionDepot medroxyprogesterone acetate (DMPA) is a highly-effective, injectable contraceptive method that requires injections every 12 to 15 weeks.
Self Administration of Subcutaneous Depot ...The purpose of this study is to assess continuation rates and patient satisfaction with self administration subcutaneous depot medroxyprogesterone acetate.
MATERIAL SAFETY DATA SHEETAdditional Hazard Information: Short Term: Not an eye irritant ; Not a skin irritant ; Not acutely toxic (based on animal data) . Long Term:.
Update to U.S. Selected Practice Recommendations for ...Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) is an FDA-approved injectable contraceptive method available in the United States. What ...
Review article The safety of subcutaneously administered ...Self-administration of subcutaneous depot medroxyprogesterone acetate for contraception: feasibility and acceptability. Contraception, 85 (2012), pp. 453-471.
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