30 Participants Needed

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)

Trial Summary

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 data supports the effectiveness of the drug self-administration of subcutaneous depot medroxyprogesterone?

Research shows that women find self-administering subcutaneous depot medroxyprogesterone acetate (DMPA-SC) to be feasible and acceptable, which suggests that they are likely to continue using it effectively. Additionally, a study on text messaging support for users of a similar injectable contraceptive found that reminders can improve appointment attendance, indicating that support tools may enhance adherence to this drug.12345

Is self-administered subcutaneous depot medroxyprogesterone safe for humans?

Self-administered subcutaneous depot medroxyprogesterone is generally considered safe for humans, but some users may experience menstrual irregularities, such as prolonged bleeding, which can lead to discontinuation of use.13678

How does the video instruction treatment for medication adherence differ from other treatments?

The video instruction treatment is unique because it focuses on improving how well patients stick to their medication schedule by using video guidance, which is different from traditional methods that may rely more on written instructions or in-person counseling.49101112

What is the purpose of this trial?

This is a study to determine if a video that utilizes a peer to teach self administration of subcutaneous depot medroxyprogesterone is both effective and well accepted by adolescent patients who are already receiving ongoing treatment with depot medroxyprogesterone by a medical provider via an inter muscular injection. Self administration can be done at home and therefore offers an alternative to traveling to a medical office.

Eligibility Criteria

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

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)

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Teaching videoExperimental Treatment1 Intervention
This is a single arm interventional study wherein the subjects enrolled will all participate in the study in the same way by watching the teaching video and then will be asked to self inject subcutaneous depot-medroxyprogesterone as per the protocol. All participants will then be asked to answer survey questions. All health care providers that participate in the study will likewise be asked to answer survey questions.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials
264
Recruited
264,000+

Findings from Research

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]
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]
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]

References

Women's satisfaction, use, storage and disposal of subcutaneous depot medroxyprogesterone acetate (DMPA-SC) during a randomized trial. [2019]
Combined Oral Contraceptive Adherence and Pregnancy Rates. [2023]
Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate. [2022]
Treatment adherence in the Estonian postmenopausal hormone therapy (EPHT) trial [ISRCTN35338757]. [2013]
Text Messaging Support for Urban Adolescents and Young Adults Using Injectable Contraception: Outcomes of the DepoText Pilot Trial. [2022]
Compliance with depot medroxyprogesterone acetate: a randomized, controlled trial of intensive reminders. [2019]
Self-administration of injectable contraceptives. [2022]
Depo-Provera: use of a long-acting progestin injectable contraceptive in Turkish women. [2015]
Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer. [2023]
Improving compliance and persistence to adjuvant tamoxifen and aromatase inhibitor therapy. [2022]
Understanding Breast Cancer Survivors' Beliefs and Concerns About Adjuvant Hormonal Therapy: Promoting Adherence. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Prospective investigation of social support, coping, and depressive symptoms: A model of adherence to endocrine therapy among women with breast cancer. [2019]
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