Abstract
Objectives
The need for quarterly clinic visits is a barrier to use of subcutaneous depot medroxyprogesterone
acetate (DMPA-SC) contraception. The ability to self-inject at home may enhance method
acceptance. Since efficacy depends on proper administration, we evaluated whether
women could correctly perform simulated injections of DMPA-SC in a Uniject™ injection
system using printed Instructions for Use (IFU), with and without hands-on training.
Study design
Adult female volunteers (N=120) injected DMPA-SC into a rubber trainer at two visits, 3 months apart. Women were
randomly assigned to receive hands-on training before the first injection or no training.
The primary outcome was the proportion of women who successfully operated the injection
system. An attempt was defined as successful if the participant correctly performed
all critical steps in the injection procedure (getting ready, selecting an injection
area, preparing the injector, mixing the medicine, activating the injector, injecting
the dose) and expelled the dose without unexpected interruption. The success rate
at month 3 was considered the primary endpoint. A one-sided 95% confidence limit >80% was used to declare the delivery system and IFU “fit for purpose.”
Results
With training, the success rate (one-sided 95% confidence limit) was 90.0% (81.8%)
at day 1 and 96.7% (90.4%) at month 3; without training, rates were 76.7% (66.7%)
and 88.3% (79.8%), respectively. The trained (96.4%) and untrained (92.2%) groups
successfully completed injecting into the trainer at first injection, the final critical
step of the injection procedure, despite the fact that about one third of participants
considered expelling depot medroxyprogesterone acetate (one component of this step)
to be difficult.
Conclusion
Most participants understood the IFU and successfully operated the injection system.
Initial hands-on training improved success rates at both visits. For women interested
in self-injection, providers should review all steps of the IFU, provide a demonstration,
supervise initial injection(s) and ensure that the patient is aware of future injection
dates. The potential for self-injection to improve adherence should be studied.
Implications
After initial training, women performed simulated self-injections of DMPA-SC in the
Uniject system proficiently using printed instructions. Women who are motivated and
demonstrate competent injection technique during training can be relied upon to self-inject
correctly at home. DMPA-SC users not suitable for self-injection should continue receiving
injections at the clinic.
Keywords
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References
- Package insert.Pfizer, Inc., New York, NY2015
- Subcutaneous DMPA vs. intramuscular DMPA: a 2-year randomized study of contraceptive efficacy and bone mineral density.Contraception. 2009; 80: 7-17
- Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate.Contraception. 2014; 89: 352-356
- Pilot study of home self-administration of subcutaneous depo-medroxyprogesterone acetate for contraception.Contraception. 2012; 85: 458-464
- Self-administration of subcutaneous depot medroxyprogesterone acetate by adolescent women.Contraception. 2013; 88: 401-407
- The acceptability of self-administration of subcutaneous depo-Provera.Contraception. 2005; 72: 14-18
- Self-administration of subcutaneous depot medroxyprogesterone acetate for contraception: feasibility and acceptability.Contraception. 2012; 85: 453-457
- Lesson 2 what is Uniject™? PATH.([Accessed October 21, 2015])
- Frequently asked questions about Sayana® press. PATH.([Accessed June 19, 2015])
- Uniject as a delivery system for the once-a-month injectable contraceptive Cyclofem in Brazil.Contraception. 1996; 53: 115-119
- The effects, safety and acceptability of compact, pre-filled, autodisable injection devices when delivered by lay health workers.Trop Med Int Health. 2013; 18: 1002-1016
- Home delivery of heat-stable vaccines in Indonesia: outreach immunization with a prefilled, single-use injection device.Bull World Health Organ. 1999; 77: 119-126
- Usability and acceptability of the Abatacept pre-filled Autoinjector for the subcutaneous treatment of rheumatoid arthritis.Adv Ther. 2016; 33: 199-213
- A comparison of 4 epinephrine autoinjector delivery systems: usability and patient preference.Ann Allergy Asthma Immunol. 2010; 104: 172-177
- Summary of product characteristics. Pfizer Ltd, Kent, United Kingdom2014
- Self-administration with UniJect of the once-a-month injectable contraceptive Cyclofem.Contraception. 1997; 56: 301-304
- Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE).Br J Dermatol. 2015; 172: 484-493
- Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, phase IIIb study.BMC Neurol. 2010; 10: 28
- Patient self-injection: a new approach to administering luteinizing hormone-releasing hormone analogues.BJU Int. 2000; 86: 840-842
- Needle with a novel attachment versus conventional screw-thread needles: a preference and ease-of-use test among children and adolescents with diabetes.J Diabetes Sci Technol. 2011; 5: 1480-1487
- Initiation of therapy with a subcutaneously administered antiretroviral in treatment-experienced HIV-infected patients: understanding physician and patient perspectives.AIDS Care. 2008; 20: 1029-1038
- Evaluation of a pen device for self-administration of recombinant human FSH in clomiphene citrate-resistant anovulatory women undergoing ovulation induction.Reprod Biomed Online. 2004; 9: 373-380
- Low molecular weight heparin self-injection training: assessment of feasibility, tolerance and economic analysis in emergency departments.Eur J Emerg Med. 2006; 13: 264-269
- Administration of recombinant human FSH (solution in cartridge) with a pen device in women undergoing ovarian stimulation.Reprod Biomed Online. 2003; 7: 319-326
- Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE).J Eur Acad Dermatol Venereol. 2015; 29: 1082-1090
- The recombinant human chorionic gonadotropin prefilled pen: results of patient and nurse human factors usability testing.Expert Opin Drug Deliv. 2012; 9: 893-900
- Single-use autoinjector for peginterferon-beta1a treatment of relapsing–remitting multiple sclerosis: safety, tolerability and patient evaluation data from the phase IIIb ATTAIN study.Expert Opin Drug Deliv. 2014; 11: 1713-1720
- A questionnaire-based survey to assess patient satisfaction, ease-of-learning, ease-of-use, injection site pain and overall patient satisfaction of the follitropin-alpha (Gonal-f) filled-by-mass (FbM) prefilled pen compared with other systems of gonadotrophin administration.Reprod Biol Endocrinol. 2012; 10: 93
- Results from the single-use autoinjector for self-administration of subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis (MOSAIC) study.Expert Opin Drug Deliv. 2011; 8: 1543-1553
- Patients' assessment of adalimumab self-injection for Crohn's disease: a multicenter questionnaire survey (the PEARL survey).Hepatogastroenterology. 2014; 61: 1654-1660
- Results of a human factors experiment of the usability and patient acceptance of a new autoinjector in patients with rheumatoid arthritis.Patient Prefer Adherence. 2014; 8: 199-209
- Home-based administration of Sayana(R) press: review and assessment of needs in low-resource settings.Contraception. 2014; 89: 344-351
- Perceptions of home and self-injection of Sayana(R) Press in Ethiopia: a qualitative study.Contraception. 2014; 89: 379-384
- Mobile phone-based interventions for improving contraception use.Cochrane Database Syst Rev. 2015; 6: CD011159
- Compliance with depot medroxyprogesterone acetate: a randomized, controlled trial of intensive reminders.Am J Obstet Gynecol. 1998; 179: 583-585
Article info
Publication history
Published online: May 27, 2016
Accepted:
May 22,
2016
Received in revised form:
April 8,
2016
Received:
December 15,
2015
Footnotes
☆Author Disclosures: I. Kaplan, K. Wolter, D. Ross, F. Hilton and D. Morgenstern are employees and shareholders of Pfizer.
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
