Adolescent Subcutaneous (SQ) Injection Video Validation

NCT04997499 | Active Not Recruiting

• 1 other identifier: 00001518
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 injection. Self administration can be done at home and therefore offers an alternative to traveling to a medical office.

Conditions

Medication Compliance; Contraception; Self-Evaluation

Keywords

adolescent medication self-administration; subcutaneous depot-medroxyprogesterone; video instruction

Outcome Measures

Primary Outcomes (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.

  12-18 months

Secondary Outcomes (1)

• Sustained self-injection

  12-18 months

Study Arms (1)

Teaching video

EXPERIMENTAL

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.

Behavioral: watch an instructional video

Interventions

watch an instructional video BEHAVIORAL

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

Teaching video

Eligibility Criteria

• Age: Up to 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• pregnancy
• ward of the state
• prisoner

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02110, United States

Location

Related Publications (7)

• 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.

  PMID: 32650856 BACKGROUND

• 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.

  PMID: 20194281 BACKGROUND

• 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.

  PMID: 29615385 BACKGROUND

• 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.

  PMID: 31179026 BACKGROUND

• 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.

  PMID: 23294549 BACKGROUND

• 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.

  PMID: 22079602 BACKGROUND

• 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.

  PMID: 27174304 BACKGROUND

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 9, 2021
• Study Start: September 29, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)