NEW YORK (Reuters Health) – Women are more likely to continue depot medroxyprogesterone acetate (DMPA), a contraceptive, when they self-administer it by subcutaneous (SC) injection than when they have to see a provider for injections, according to a randomized trial done in Malawi.
“I was not surprised to find a positive effect of self-administration on DMPA-SC continuation rates, but I was surprised by the magnitude of the effect,” said Dr. Holly M. Burke from FHI 360, a nonprofit in Durham, North Carolina.
“We found that self-administration led to a more than 50 percent increase in continuous DMPA-SC pregnancy protection through 12 months compared with provider-administered injection,” she told Reuters Health by email.
The injectable contraceptive DMPA-SC, delivered in a prefilled, auto-disabled injection system, is suitable for administration by community health workers and potentially by women themselves.
Many women start DMPA-SC, but discontinuation rates have been around 25% in sub-Saharan Africa and as high as 41% in Malawi, at least partly because of poor access to reinjection every 12-14 weeks.
Dr. Burke’s team investigated 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 in their open-label, randomized controlled trial done at six Ministry of Health clinics in rural Malawi.
By the end of the study, 99 of 364 women in the self-administered group had discontinued the intervention, compared with 199 of 367 women in the provider-administered group, the researchers report in The Lancet Global Health, online March 8.
Through 12 months of contraceptive use, the continuation rate was much higher for women in the self-injection group than in the provider-administered group (73% vs. 45%, P<0.0001).
Discontinuation tended to occur earlier in the provider-administered group, but both groups struggled with missing reinjection windows throughout the entire study period. Nearly half of the women who discontinued because of missing the window (83/178, 47%) said they still wanted to continue using DMPA; only 13% said they wanted to stop.
Side effect rates did not differ between the two groups.
“Our findings demonstrate that DMPA-SC self-injection is a highly effective solution that can address the stubborn problem of early discontinuation of contraception,” Dr. Burke said. “The study also provides evidence that community-based health workers can safely train women to self-inject DMPA-SC. We can say with more certainty that the community-based provision of injectables for self-injection in low-resource settings is safe and feasible and that DMPA-SC for self-injection should be made widely available as another contraceptive option for women.”
“I would expect similar results in other settings for two reasons,” she said. “First, to increase the generalizability of the findings, we implemented the trial under real-world conditions by having public sector or government-funded health care providers and community health workers train women to self-inject as part of their daily routine. In addition, the study took place in rural communities that have many resource constraints. We selected Mangochi District, Malawi because in-country partners felt that if the study could succeed there, it could work anywhere in Malawi. Second, there has been research on self-injection conducted in other countries which have also shown promising results.”
“These results have implications for other areas of global health, especially as new drug delivery technologies allow for self-administration,” Dr. Burke added. “Self-injection of other medications may improve other health conditions affecting disadvantaged populations around the world. Adherence to medication is a global health problem that affects the entire medical field.”
Dr. Julia Kohn of Planned Parenthood Federation of America, who wrote an accompanying editorial, told Reuters Health by email, “While many women may prefer to return to a provider for their shots, others may be willing and excited to try self-administration. In our Planned Parenthood study in the U.S., providers were surprised at how interested patients were in this option.”
“The evidence shows that women who are given the option to self-administer are more likely to continue using the birth-control shot, and are therefore less at risk for unintended pregnancy,” she said. “All providers want the best for their patients. So, while it may seem like a hurdle to offer something new, I hope providers will take this evidence and put it into practice by offering depot self-administration as an option for their patients.”
“It’s critical that we do everything we can to make birth control more accessible, especially at a time when politicians are doing everything they can to make it more difficult,” Dr. Kohn said. “Planned Parenthood is incorporating the evidence on self-administration into its national medical guidelines, which are updated regularly to reflect new evidence and research on best practices, so that health centers can make at-home administration of depot an option for patients.”
Dr. Ushma Upadhyay of the UCSF Bixby Center for Global Reproductive Health, in San Francisco, said, “This is convincing evidence that family-planning programs around the world can trust women to manage their own contraception. We should be in continuous pursuit of making contraceptive methods more client-centered and client-directed so that they have more control over their reproductive lives. Enhancing women’s reproductive autonomy should be our ultimate goal.”
“Providers of contraception should never underestimate the difficulties clients face in returning to the clinic or doctor’s office for resupply,” Dr. Upadhyay, who was not involved in the study, told Reuters Health by email. “Interest in self-injection is primarily driven by a desire to eliminate unnecessary return visits to a facility for repeat injections.”
Dr. Jane Cover of PATH, a nonprofit based in Seattle, Washington, who has conducted similar studies in Senegal and Uganda, told Reuters Health by email, “In more rural areas in low-resource settings, a woman may walk for miles to reach services, and then arrive at the clinic only to find that no one is available to assist her due to competing responsibilities. It stands to reason that removing access barriers by offering self-injection as an option would enable women to use the injectable more consistently.”
“What I find particularly interesting in this study is the prominent role of community health workers in training women to self-inject,” she said. “We know from our own research at PATH that teaching a woman to self-inject can be time consuming. While it saves time for health workers in the long run (reduced future visits), busy clinic providers may be reluctant to take the time in the short term. Demonstrating that community health workers can provide this training offers great potential to advance self-injection as a delivery option, particularly in settings that face heavy human resource constraints.”
“Women, including those with limited education, are more capable of managing their own health care than we sometimes imagine,” said Dr. Cover, who also was not involved in the new work. “We should be empowering women to take charge of their reproductive health through self-care, including innovations such as contraceptive self-injection, home pregnancy tests, HIV self-testing, and self-sampling for human papillomavirus DNA. These advancements and others like them put women in control of their own reproductive health and free up health care providers to focus on conditions that require their medical expertise, such as treating disease.”
The study had no commercial funding.
SOURCE: http://bit.ly/2poBAms and http://bit.ly/2GGE5sH
Lancet Glob Health 2018.
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