Original research articleIncreased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood
Introduction
The overall family planning goal for Healthy People 2020 is to “Improve pregnancy planning and spacing, and prevent unintended pregnancy” [1]. This in response to estimates that nearly half of all pregnancies in the United States are unintended and one-third are mistimed [2]. The most effective way to reduce unintended pregnancy is to increase consistent use of effective contraception [3].
Data from the National Survey of Family Growth show that approximately 4.5% of U.S. contraceptive users ages 15–44 were relying on injectables as their contraceptive method in 2012, an estimated 1.5 million women [4]. Among Planned Parenthood patients use is higher: 15% of female contraceptive clients were using injectables in 2015, roughly 290,000 women and adolescents [5].
Depo-Provera®, the intramuscular (IM) form of depot medroxyprogesterone acetate (DMPA), has been available in the U.S. since 1992. A subcutaneous formulation of depo-subQ provera 104™ (DMPA-sc) became available in 2004, providing the same efficacy with a lower dose and greater ease of administration [6]. Traditionally, patients return to a health center for DMPA administration within 12–14 weeks of the previous injection. For some women the time and expense of a clinic appointment may outweigh the other advantages of DMPA, which may lead them to choose less reliable contraceptive methods. Self-administration of DMPA-sc outside the clinic setting may therefore be an attractive option for some women, offering increased contraceptive access and autonomy and reduced healthcare-related costs.
Self-administration of DMPA-sc is feasible, acceptable, and effective. Beasley et al. (2014) conducted a randomized trial with 137 women to evaluate DMPA-sc self-administration versus clinic administration and confirmed the therapeutic effect by measuring trough serum concentrations [7]. Ninety of 91 women were able to correctly self-inject and continuation rates were 71% in the self-administration group and 63% in the clinic administration group at 12 months. All women had serum concentration in the therapeutic range, confirming their ability to administer injections successfully at home.
A previous single-arm pilot study of self-administered DMPA-sc found a one-year continuation rate of 74% [8]. Eighty-seven percent of women in this study reported self-injection to be easy, and 94% would be likely to recommend it to others. One study included adolescent DMPA users and found that most were interested and able to self-administer successfully [9].
In a UK study most health professionals (86%) were comfortable teaching women DMPA-sc self-injection, but 45% were concerned about unintended pregnancies [10]. In this non-randomized study of DMPA users, 80% of self-injections were given on time (and no injections were given beyond the 14-week interval). The majority of women who wanted to use DMPA-sc at home were able to do so; however, 20% reported some difficulty with one or more injections (e.g., resistance to the medication passing through the needle).
Other feasibility studies also confirm women's interest in DMPA self-injection [11], [12]. A survey conducted in family planning clinics found that 21% of all patients would be interested in self-administration; interest was higher (40%) among DMPA users [13].
Sayana® Press, a newer subcutaneous DMPA delivery system, is approved in many countries worldwide and is specifically labeled for self-administration in a number of markets in Europe; studies conducted outside of the U.S. show promise for improving access to and continuation of DMPA-sc [14], [15]. Sayana® Press is not available in the United States and thus was not available for use in the present study.
Building upon prior studies, we conducted a randomized controlled trial to compare one-year continuation of DMPA-sc between women randomized to self-administration versus clinic administration. Secondary objectives included assessment of feasibility and patient satisfaction.
Section snippets
Study design
We conducted an open-label, randomized parallel group clinical trial using DMPA-sc (depo-subQ provera 104™) at three Planned Parenthood health centers located in Texas and New Jersey. Female patients ages 15–44 requesting DMPA were randomized to either self-administration or clinic administration in a 1:1 allocation from August 2015–February 2016. We compared method continuation and patient satisfaction between arms based on follow-up surveys at six and 12 months. The study was approved by the
Results
A total of 401 participants were randomized. Of those, 336 participants (84%) completed the 12-month survey; 316 completed both six- and 12-month surveys (an 80% complete response rate excluding eight subjects who withdrew from the study). Response rates and loss-to-follow-up were similar between study arms (82% responded to both follow-up surveys in the clinic group vs. 79% in the self-administration group, p=.44). Four participants crossed over from the self-administration to clinic arm
Discussion
We observed increased continuation of DMPA-sc among women randomized to self-administration at both 6 and 12 months post-enrollment. Previous studies found trends in this direction, but none had adequate statistical power to detect this effect. Similar to other studies, we found that women randomized to self-administration were able to successfully self-inject and they found it easy to do so. Women were largely satisfied with self-administration, wished to continue, and would be likely to
Acknowledgments
We would like to thank the staff of Planned Parenthood of Northern, Central & Southern New Jersey and Planned Parenthood Gulf Coast, especially Allison Howe, Tanya Vialet, Joan Moore, Christina Aquino, Yvonne Walsh, Alice Robinson, LaShonda Crane, and Melissa Farrell. We would also like to thank Zoe Unger and Stephanie Serafino for research assistance.
Funding
This work was supported by the Tara Health Foundation. Pfizer, Inc. provided study drug through an investigator-initiated research grant.
References (20)
- et al.
Understanding the decline in adolescent fertility in the United States, 2007–2012
J Adolesc Health
(2016) - et al.
Contraceptive efficacy and safety of DMPA-SC
Contraception
(2004) - et al.
Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate
Contraception
(2014) - et al.
Self-administration of subcutaneous depot medroxyprogesterone acetate for contraception: feasibility and acceptability
Contraception
(2012) - et al.
Self-administration of subcutaneous depot medroxyprogesterone acetate by adolescent women
Contraception
(2013) - et al.
Pilot study of home self-administration of subcutaneous depo-medroxyprogesterone acetate for contraception
Contraception
(2012) - et al.
The acceptability of self-administration of subcutaneous depo-provera
Contraception
(2005) - et al.
Self-injection of monthly combined hormonal contraceptive
Contraception
(2006) - et al.
Interest in self-administration of subcutaneous depot medroxyprogesterone acetate in the United States
Contraception
(2016) - et al.
Home-based administration of Sayana® press: review and assessment of needs in low-resource settings
Contraception
(2014)
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Short-acting hormonal contraceptive continuation among low-income postpartum women in Texas
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