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Medication ComplianceNCT04997499

Adolescent Subcutaneous (SQ) Injection Video Validation

A study testing watch an instructional video in people with Medication Compliance and Contraception, run by Tufts Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages Up to 19 years, women onlyHealthy volunteers can take part
What is being tested?
watch an instructional video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
29 Sep 2021to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Up to 19 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • assigned females at birth aged 19 years and younger
  • must have previously received at least one injection of depot medroxyprogesterone

Who cannot join

  • never received a prior dose of depot medroxyprogesterone.
  • any history of self-administered injectable medication (either intramuscular or subcutaneous)
  • inability to understand written or spoken English
  • no parent or guardian to sign consent if under age 18
  • inability to watch the instructional video
  • cognitive impairment
Show all 9Show fewer
  • pregnancy
  • ward of the state
  • prisoner

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Tufts Medical Center

    Boston, Massachusetts, 02110

Other trials in United States

About this study

Official title: Validation of a Video Teaching Tool for Adolescent Self Administration of Subcutaneous Depot-medroxyprogesterone

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.

Read the detailed description

Means of providing health education are rapidly evolving. Telemedicine has become an important modality to provide healthcare and improve access, and will likely be increasingly utilized beyond the COVID-19 pandemic. Telemedicine can effectively provide care and counseling to all age groups, including adolescents. Studies have demonstrated that over 80 percent of adolescents between the ages of 11 and 18 spend one to four hours a day online; searches for health-related information are common. Nevertheless, adolescents may face obstacles when previously familiar aspects of their medical care are abruptly moved online, particularly when discussing contraception. Although traditionally administered in the clinical space, injectable contraception has been shown to be attractive, effective, and well-tolerated by adolescents when subcutaneously self-administered, and can lead to improved continuation rates. The investigators have found that remotely teaching a patient how to self-administer a subcutaneous injection is challenging. The provider may be in a home office, and may not have access to the actual medication or the supplies to demonstrate technique. The patient may struggle to understand verbal instruction without a visual demonstration, resulting in ineffective medication administration. Instructional videos currently available online are not specific to adolescents who use self-administered injectable contraception. Peer education can be relatable and effective for adolescent patients. The investigators propose that self-administration of subcutaneous injectable contraception may be taught using a peer-to-peer video as a synchronous or asynchronous adjunct to consultation with the healthcare professional. Adolescents may be instructed to watch the video demonstration to help inform them about proper technique and ensure safe administration of their medication while at home. This study aims to validate an existing video as an effective teaching tool by assessing metrics such as clarity of the instructions, rate of error, and satisfaction with the video teaching method to the investigators' target population. The video was filmed in accordance with Tufts Medical Center Department of Marketing and Communications policies and the adolescent participant in the video was appropriately consented by a parent/guardian. The video was presented as an oral abstract at the North American Society for Pediatric and Adolescent Gynecology Annual Meeting in March 2021.

Procedure:

  1. Clinic schedules for the medical providers on the research team will be reviewed in advance and any patient that is under the age of 20 and receiving depot-medroxyprogesterone will be contacted by telephone in advance to offer participation in the project.
  2. The telephone call will follow the attached script. Two attempts will be made to call patients.
  3. If subject is interested in participating, a prescription for the subcutaneous version of depot-medroxyprogesterone will be sent to their pharmacy to be picked up by the subject prior to the office visit.
  4. Subjects under 18 will be instructed that they must be accompanied by a parent or guardian. At the office visit, written consent/assent will be obtained. 5. Subject will be shown the instructional video, which is approximately 3 minutes long. Subject may view as many times as subject chooses.
  5. Once ready, the healthcare provider from the research team will observe, without giving verbal instruction, the subject self administer a subcutaneous depot-medroxyprogesterone injection.
  6. If at any point the provider feels that the subject is not performing the injection safely or correctly the healthcare provider will intervene to ensure that the medication is given correctly, and this will be recorded within the REDCap survey.
  7. After the injection is given, the subject will fill out the REDCap survey, and the study team member administering injection will input observational data into REDCap.
  8. Subject will be asked to repeat another questionnaire in REDCap at the time of the next injection which will be scheduled for 12 weeks later. The next visit is as per standard of care scheduling (this medication is routinely administered at approximately 12-week intervals). If the subject comes into the same office for the injection, the survey will be filled out in person. If the subject does not come into the same office, a link to the follow-up REDCap survey will be emailed to the subject with instructions on how to access the survey. Email addresses will be confirmed at the time of the first visit, as is routine for medical care.
Being tested
watch an instructional video
Keywords
adolescent medication self-administration, subcutaneous depot-medroxyprogesterone, video instruction
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • watch an instructional videoBehavioural

    watch instructional video and then perform self injection of subcutaneous depot-medroxyprogesterone based on the video teaching

Study groups in NCT04997499
Study groupRoleWhat they receive
Teaching videoExperimentalThis 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.
Receives: Behavioral: watch an instructional video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Supervised self-injection

    This measure is coded 1 if the patient successfully completes self-injection at the first session after watching the video. Otherwise, the measure is coded 0. Incomplete attempts, such preparing for but not completing the injection, will be coded 0.

    Measured: 12-18 months

Secondary outcomes (1)
  1. Sustained self-injection

    This measure will be a count of self reported self injections in the 10-14 weeks following initial visit. This information will be collected through a self reported electronic REDCap survey that is administered once after the initial survey.

    Measured: 12-18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2021
  2. Study start29 Sep 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Subjects will be current users of depot-medroxyprogesterone via intramuscular injection and will be asked to watch a video to instruct them on how to self administer a subcutaneous injection of the same medication
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04997499
Sponsor's protocol ID
00001518
Status last verified
Jun 2025
First submitted
20 Jul 2021
Last updated
6 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang CJ, Ma J, Zuckerman B, Car J. The Opportunities for Telehealth in Pediatric Practice and Public Health. Pediatr Clin North Am. 2020 Aug;67(4):603-611. doi: 10.1016/j.pcl.2020.03.001.

    PubMed 32650856
  • Strasburger VC, Jordan AB, Donnerstein E. Health effects of media on children and adolescents. Pediatrics. 2010 Apr;125(4):756-67. doi: 10.1542/peds.2009-2563. Epub 2010 Mar 1.

    PubMed 20194281
  • Park E, Kwon M. Health-Related Internet Use by Children and Adolescents: Systematic Review. J Med Internet Res. 2018 Apr 3;20(4):e120. doi: 10.2196/jmir.7731.

    PubMed 29615385
  • Kennedy CE, Yeh PT, Gaffield ML, Brady M, Narasimhan M. Self-administration of injectable contraception: a systematic review and meta-analysis. BMJ Glob Health. 2019 Apr 2;4(2):e001350. doi: 10.1136/bmjgh-2018-001350. eCollection 2019.

    PubMed 31179026
  • Williams RL, Hensel DJ, Fortenberry JD. Self-administration of subcutaneous depot medroxyprogesterone acetate by adolescent women. Contraception. 2013 Sep;88(3):401-7. doi: 10.1016/j.contraception.2012.11.019. Epub 2013 Jan 4.

    PubMed 23294549
  • Cameron ST, Glasier A, Johnstone A. Pilot study of home self-administration of subcutaneous depo-medroxyprogesterone acetate for contraception. Contraception. 2012 May;85(5):458-64. doi: 10.1016/j.contraception.2011.10.002. Epub 2011 Nov 12.

    PubMed 22079602
  • Patton GC, Sawyer SM, Santelli JS, Ross DA, Afifi R, Allen NB, Arora M, Azzopardi P, Baldwin W, Bonell C, Kakuma R, Kennedy E, Mahon J, McGovern T, Mokdad AH, Patel V, Petroni S, Reavley N, Taiwo K, Waldfogel J, Wickremarathne D, Barroso C, Bhutta Z, Fatusi AO, Mattoo A, Diers J, Fang J, Ferguson J, Ssewamala F, Viner RM. Our future: a Lancet commission on adolescent health and wellbeing. Lancet. 2016 Jun 11;387(10036):2423-78. doi: 10.1016/S0140-6736(16)00579-1. Epub 2016 May 9. No abstract available.

    PubMed 27174304

Questions about this trial

What is this clinical trial studying?

A study testing watch an instructional video in people with Medication Compliance and Contraception, run by Tufts Medical Center 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 2 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 6 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?

This study is still under way. Results are not available in the source record yet.

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?

Supervised self-injection (time frame: 12-18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04997499, which also lists 7 linked publications.

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 6 Jun 2025.

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