Effect of self-administration versus provider-administered injection of subcutaneous depot medroxyprogesterone acetate on continuation rates in Malawi: a randomised controlled trial
Injectable contraceptives are the most popular modern contraceptive method in sub-Saharan Africa because of their effectiveness, long-acting nature, potential for discrete use, and reversibility.1x1Staveteig, S, Mallick, L, and Winter, R. Uptake and discontinuation of long-acting reversible contraceptives (LARCS) in low-income countries. DHS analytical studies No. 54. ICF International,
Google ScholarSee all References Of the options available, a formulation of depot medroxyprogesterone acetate (DMPA) that is delivered subcutaneously (DMPA-SC) in a prefilled, auto-disabled Uniject injection system known as Sayana Press (Pfizer, New York, NY, USA)2x2Pfizer. Pfizer’s Sayana Press becomes first injectable contraceptive in the United Kingdom available for administration by self-injection. http://www.pfizer.com/news/press-release/press-release-detail/pfizer_s_sayana_press_becomes_first_injectable_contraceptive_in_the_united_kingdom_available_for_administration_by_self_injection; Sept 24, 2015. ()
Google ScholarSee all References is gaining recognition as an easy-to-use injectable contraceptive that is suitable for administration by community health workers (CHWs), and potentially by women themselves. In studies in Uganda and Senegal,3x3Burke, HM, Mueller, MP, Packer, C et al. Provider acceptability of Sayana® Press: results from community health workers and clinic-based providers in Uganda and Senegal. Contraception. 2014; 89: 368–373
Summary | Full Text | Full Text PDF | PubMed | Scopus (11) | Google ScholarSee all References,4x4Burke, HM, Mueller, MP, Perry, B et al. Observational study of the acceptability of Sayana® Press among intramuscular DMPA users in Uganda and Senegal. Contraception. 2014; 89: 361–367
Summary | Full Text | Full Text PDF | PubMed | Scopus (15) | Google ScholarSee all References most women and health-care providers (≥80%) preferred DMPA-SC over the usual DMPA intramuscular (DMPA-IM) injection, suggesting that the introduction of DMPA-SC into family planning programmes—including administration by trained CHWs—could expand contraceptive options and access.
Evidence before this study
We conducted a literature search, and found that evidence to date suggests that, although side-effects are the most commonly reported reason for discontinuation of depot medroxyprogesterone acetate (DMPA) among women still in need of family planning, access to services is also an important factor in low-income and middle-income countries (LMICs) in sub-Saharan Africa. Subcutaneous DMPA (DMPA-SC) offers a potential solution to the access issue because its simplified delivery system and subcutaneous administration route enable DMPA to be delivered by health workers with less training and potentially by women themselves. Existing evidence shows that self-administration of DMPA-SC is safe, acceptable, and feasible, and in high-income countries is associated with continuation rates similar to those of provider-administered DMPA. However, the potential for self-injection to increase DMPA continuation rates had never been assessed in LMIC settings, and the safety and feasibility of self-injection had never been assessed in the context of community-based distribution of injectable contraceptives, which is the current standard practice in Malawi and many other countries in sub-Saharan Africa.
Added value of this study
Our study is, to our knowledge, the first to provide evidence on the important global public health question of whether self-injection improves DMPA continuation rates in an LMIC setting and we used the gold-standard design (a randomised controlled trial) to do so. We noted a strong effect of self-administration of DMPA-SC on continuation rates compared with administration by a provider. The effect was robust to a more lenient different definition of continuation in a sensitivity analysis, increasing our confidence in the findings. Moreover, since the study took place in a real-world setting, with Ministry of Health providers and community health workers, this study will contribute to the growing body of knowledge around community-based access to injectable contraceptives. It is also the first study to provide evidence on the safety and feasibility of community-based provision of injectable contraceptives for home and self-injection.
Implications of all the available evidence
Other studies have found self-administration of DMPA-SC to be safe, acceptable, and feasible in LMIC settings. Our findings contribute by showing that self-administration can improve continuation rates compared with provider-administered DMPA-SC and provide evidence that community health workers can safely and effectively train women to self-inject DMPA-SC in LMIC settings. A barrier to the rapid programmatic uptake of DMPA-SC is its anticipated higher cost relative to intramuscular DMPA; however, costs might be substantially reduced if DMPA-SC is self-administered. Self-administration might attract new users of family planning, including through the private sector, pharmacies, and drug shops and could reduce the cost of serving existing DMPA users by decreasing operational costs and more efficiently using resources such as the providers’ time. Moreover, the opportunity costs for women would be reduced through the removal of the need to travel as often to receive re-injections from health-care providers. Given the advantages we and others have found, DMPA-SC self-administration could be adopted by a substantial number of users which, in turn, might drive down the cost, a key factor in adoption of any contraception in LMICs.
Although many women start to use them, discontinuation rates are high, placing women at risk of unintended pregnancy and adverse maternal health outcomes. In a study of discontinuation rates in 19 countries, including five in sub-Saharan Africa, injectables had the shortest duration of use compared with other modern methods.5x5Castle, S and Askew, I. Contraceptive discontinuation: reasons challenges and solutions. Population Council,
New York; 2015
Google ScholarSee all References In two prospective studies, the 12-month discontinuation rates among injectable users were 25% in Kenya,6x6Ruminjo, JK, Sekadde-Kigondu, CB, Karanja, JG, Rivera, R, Nasution, M, and Nutley, T. Comparative acceptability of combined and progestin-only injectable contraceptives in Kenya. Contraception. 2005; 72: 138–145
Summary | Full Text | Full Text PDF | PubMed | Scopus (16) | Google ScholarSee all References 24% in Zimbabwe,7x7Nanda, K, Morrison, CS, Kwok, C et al. Discontinuation of oral contraceptives and depot medroxyprogesterone acetate among women with and without HIV in Uganda, Zimbabwe and Thailand. Contraception. 2011; 83: 542–548
Summary | Full Text | Full Text PDF | PubMed | Scopus (12) | Google ScholarSee all References and 27% in Uganda.7x7Nanda, K, Morrison, CS, Kwok, C et al. Discontinuation of oral contraceptives and depot medroxyprogesterone acetate among women with and without HIV in Uganda, Zimbabwe and Thailand. Contraception. 2011; 83: 542–548
Summary | Full Text | Full Text PDF | PubMed | Scopus (12) | Google ScholarSee all References The findings of a retrospective study of Demographic and Health Survey data from 21 countries showed a 12 month discontinuation rate of 32% for injectable users overall1x1Staveteig, S, Mallick, L, and Winter, R. Uptake and discontinuation of long-acting reversible contraceptives (LARCS) in low-income countries. DHS analytical studies No. 54. ICF International, Rockville; 2015
Google ScholarSee all References and a 2015–16 discontinuation rate of 41% in Malawi.8x8National Statistical Office [Malawi] and ICF. Malawi demographic and health survey 2015–16. National Statistical Office [Malawi] and ICF, Zomba and Rockville; 2017
Google ScholarSee all References
Malawi has made great strides in increasing the prevalence of modern contraceptive use, from 7% in 1992 to 58% in 2015–16, primarily through increased use of injectable contraceptives.8x8National Statistical Office [Malawi] and ICF. Malawi demographic and health survey 2015–16. National Statistical Office [Malawi] and ICF,
Zomba and Rockville; 2017
Google ScholarSee all References Injectables are the most widely used modern method in Malawi: nearly a third of currently married women (30%) who practised modern family planning in 2015–16 used injectables. However, according to findings from a study in rural Malawi,9x9Dasgupta, ANZ, Zaba, B, and Crampin, AC. Contraceptive dynamics in rural northern Malawi: a prospective longitudinal study. Int Perspect Sex Reprod Health. 2015; 41: 145–154
Crossref | PubMed | Google ScholarSee all References only half of new users received their first follow-up injection within 13 weeks, and method switching is not common among women who discontinue for method-related reasons.5x5Castle, S and Askew, I. Contraceptive discontinuation: reasons challenges and solutions. Population Council, New York; 2015
Google ScholarSee all References In a study from 2012, 38% of women in Malawi who did not switch to another method after discontinuing for method-related reasons became pregnant and more than half of those pregnancies were either mistimed or unwanted.10x10Ali, MM, Cleland, J, and Shah, IH. Causes and consequences of contraceptive discontinuation: evidence from 60 demographic and health surveys. World Health Organization, Geneva; 2012
Google ScholarSee all References Many women in Malawi would benefit from innovations to increase the continuation rate of injectables.
Although method-related concerns, such as side-effects, are the most commonly reported reasons for discontinuation of modern contraceptives among women still in need of family planning, access to services is also an important factor in low-income and middle-income countries (LMICs) in sub-Saharan Africa.5x5Castle, S and Askew, I. Contraceptive discontinuation: reasons challenges and solutions. Population Council,
New York; 2015
Google ScholarSee all References In Malawi, discontinuation was more likely among users of injectables than of other modern methods because of poor access to re-injection.8x8National Statistical Office [Malawi] and ICF. Malawi demographic and health survey 2015–16. National Statistical Office [Malawi] and ICF, Zomba and Rockville; 2017
Google ScholarSee all References Furthermore, women in rural areas with better access—defined by distance and supply reliability—were significantly more likely to use injectables than were women with worse access.11x11Skiles, MP, Cunningham, M, Inglis, A et al. The effect of access to contraceptive services on injectable use and demand for family planning in Malawi. Int Perspect Sex Reprod Health. 2015; 41: 20–30
Crossref | PubMed | Scopus (7) | Google ScholarSee all References This finding suggests that injectables are failing to meet the contraceptive needs of women, especially those with poor access who would otherwise like to use them. Specifically, the need for quarterly clinic visits, which increases the cost of and time spent on contraceptive use, might contribute to discontinuation of injectables. Furthermore, although community-based provision of injectables by CHWs is a safe, acceptable, and effective way to increase access to family planning in LMICs, studies of such interventions in Kenya and Zambia found relatively high 12 month discontinuation rates of 32% and 37%, respectively.12x12Stanback, J, Spieler, J, Shah, I, and Finger, WR. Community-based health workers can safely and effectively administer injectable contraceptives: conclusions from a technical consultation. Contraception. 2010; 81: 181–184
Summary | Full Text | Full Text PDF | PubMed | Scopus (23) | Google ScholarSee all References,13x13Olawo, AA, Bashir, I, Solomon, M, Stanback, J, Ndugga, BM, and Malonza, I. “A cup of tea with our CBD agent…”: community provision of injectable contraceptives in Kenya is safe and feasible. Glob Health Sci Pract. 2013; 1: 308–315
Crossref | PubMed | Scopus (5) | Google ScholarSee all References,14x14Chin-Quee, D, Bratt, J, Malkin, M et al. Building on safety, feasibility, and acceptability: the impact and cost of community health worker provision of injectable contraception. Glob Health Sci Pract. 2013; 1: 316–327
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A 2013 Cochrane review of interventions to increase continuation rates of hormonal methods of contraception15x15Halpern, V, Lopez, LM, Grimes, DA, Stockton, LL, and Gallo, MF. Strategies to improve adherence and acceptability of hormonal methods of contraception. Cochrane Database Syst Rev. 2013;
Google ScholarSee all References identified only one study with a positive effect on continuation; however, the evidence for this intensive counselling intervention, which provided women with audiovisual messaging at each follow-up visit, was categorised as “low grade”.15x15Halpern, V, Lopez, LM, Grimes, DA, Stockton, LL, and Gallo, MF. Strategies to improve adherence and acceptability of hormonal methods of contraception. Cochrane Database Syst Rev. 2013; 10 ()
Google ScholarSee all References Another study identified in that review examining the role of counselling on oral contraceptive continuation found an effect only when counselling was coupled with phone calls. Even if intensive counselling interventions were found to be effective, they would require highly trained staff and increased resources—conditions that are rarely feasible in most LMICs.
To overcome challenges to accessibility that result in discontinuation of injectables, there has been an increase in efforts to explore the feasibility of self-injection of DMPA-SC in the form of both Sayana Press and depo-subQ provera 104 (medroxyprogesterone acetate injectable suspension 104 mg in 0·65 mL in a prefilled glass syringe; Pfizer). As of August, 2017, Sayana Press was registered for self-injection in 18 countries, including seven in sub-Saharan Africa (Radola A, Pfizer, personal communication). Proponents of self-injection cite the potential for improved contraceptive use due to increased timeliness of re-injection;16x16Kim, CR, Fønhus, MS, and Ganatra, B. Self-administration of injectable contraceptives: a systematic review. BJOG. 2017;
Crossref | PubMed | Scopus (2) | Google ScholarSee all References self-injection would also eliminate the barrier of having to visit the clinic or CHW. Indeed, previous research in high-income countries has shown that self-injection of DMPA-SC is feasible and safe. In a trial in New York (NY, USA),17x17Beasley, A, White, KO, Cremers, S, and Westhoff, C. Randomized clinical trial of self versus clinical administration of subcutaneous depot medroxyprogesterone acetate. Contraception. 2014; 89: 352–356
Summary | Full Text | Full Text PDF | PubMed | Scopus (15) | Google ScholarSee all References in which women were randomly assigned to self-administration or clinic administration of DMPA-SC, the continuation rates and MPA serum concentrations were similar between the self-administered (71%) and clinic-administered (63%) groups. Similarly, results from a non-comparative study at Planned Parenthood clinics in Florida (USA) showed high continuation (74%) of self-injected DMPA-SC at the fourth injection.18x18Prabhakaran, S and Sweet, A. Self-administration of subcutaneous depot medroxyprogesterone acetate for contraception: feasibility and acceptability. Contraception. 2012; 85: 453–457
Summary | Full Text | Full Text PDF | PubMed | Scopus (23) | Google ScholarSee all References In a study done at a large family planning clinic in Edinburgh (UK), self-administration of DMPA-SC was feasible and associated with similar continuation rates and satisfaction as clinician-administered DMPA-IM, and all self-injections were given within the appropriate interval.19x19Cameron, ST, Glasier, A, and Johnstone, A. Pilot study of home self-administration of subcutaneous depo-medroxyprogesterone acetate for contraception. Contraception. 2012; 85: 458–464
Summary | Full Text | Full Text PDF | PubMed | Scopus (19) | Google ScholarSee all References Studies in sub-Saharan Africa are yielding similarly promising results: findings from studies assessing the feasibility of self-injection showed that 87% of Senegalese participants20x20Cover, J, Ba, M, Lim, J, Drake, JK, and Daff, BM. Evaluating the feasibility and acceptability of self-injection of subcutaneous depot medroxyprogesterone acetate (DMPA) in Senegal: a prospective cohort study. Contraception. 2017; 96: 203–210
Summary | Full Text | Full Text PDF | PubMed | Scopus (0) | Google ScholarSee all References and 88% of Ugandan participants21x21Cover, J, Namagembe, A, Tumusiime, J, Lim, J, Drake, JK, and Mbonye, AK. A prospective cohort study of the feasibility and acceptability of depot medroxyprogesterone acetate administered subcutaneously through self-injection. Contraception. 2017; 95: 306–311
Summary | Full Text | Full Text PDF | PubMed | Scopus (1) | Google ScholarSee all References could competently self-inject DMPA-SC 3 months after being trained.
We did the first study in an LMIC setting to investigate whether self-administration of DMPA-SC could improve continuation rates and whether community-based provision of injectable contraceptives for self-injection is safe and feasible. Our primary objective was to compare continuation rates between women who self-inject DMPA-SC and women who receive DMPA-SC from a provider, including CHWs, within the context of family planning in Malawi’s public sector.