Scale-up of the DMPA-SC in Nigeria: Why policy matters.

BACKGROUND: Injectable contraceptives have contributed substantially to Nigeria's rise in modern family planning methods usage. They are one of the most commonly used and preferred means of contraception among women in the country. Enabling policies are required to assure contraceptive access, security, and use. This study aimed to investigate the policy environment and how it supports or limits Nigeria's introduction and scale-up of subcutaneous depot-medroxyprogesterone acetate (DMPA-SC). METHODS: The design of this mixed-methods study was cross-sectional. Desk reviews of policy papers, key informant interviews, and in-depth interviews were used to obtain information from respondents about the introduction of DMPA-SC in Nigeria and how existing policies influenced its scale-up. Data on DMPA-SC and other injectables were gathered from Nigeria's national electronic logistics management information system. RESULTS: The findings suggest that policies such as task-shifting and task-sharing, cost-free policies, reproductive health policies, and others created an enabling environment for the scale-up of DMPA-SC adoption in Nigeria. The inclusion of DMPA-SC on the essential medicines list and the approved patent medicines list facilitated the scale-up process by ensuring private sector participation, removing economic barriers to access, fostering greater collaboration among health worker cadres, improving intersectoral partnerships, and improving logistics and client access. Despite significant anomalies in some implementing policies, injectable contraceptive consumption data demonstrate a progressive increase in DMPA-SC use during the study period. The results also indicate that policy initiatives have a favorable impact on the use of DMPA-SC throughout the country. CONCLUSION: The existence of policies, the active participation of stakeholders, and the political will of the Nigerian health system's leadership have all aided in the scaling-up of the DMPA-SC. Understanding how to build an enabling policy climate is critical for providing women with family planning options. These lessons from Nigeria emphasize the importance of these levers, which should be considered by teams intending to introduce innovative health products, particularly in developing countries.

DMPA-SC stock: Cross-site trends by facility type.

Objectives: To measure trends in the supply of DMPA-SC in public and private health facilities and compare with other prominent modern methods. Study design: We used repeated cross-sectional data from service-delivery-point surveys in six settings: Burkina Faso, Democratic Republic of Congo (Kinshasa and Kongo Central), Nigeria (Kano and Lagos), and Uganda, each with 3-5 rounds of data collected between 2016 and 2020. We analyzed trends in DMPA-SC availability using percent of service delivery points offering the method and percent experiencing stockouts; trends were compared with those for DMPA-IM, IUD, implants, and other short-acting methods, by facility type. Results: All settings showed increased offering of DMPA-SC over time for both private and public facilities. Larger proportions of public facilities provided DMPA-SC compared to private facilities (66%-97% vs 16%-50% by 2019-2020). DMPA-SC was provided by fewer facilities than DMPA-IM (90%-100% public, 34%-69% private by 2019-2020), but comparable to implants (83%-100% public, 15%-52% private by 2019-2020) and IUDs (55%-91% public, 0%-44% private by 2019-2020). Trends of DMPA-SC stock varied by setting, with more consistent stock available in private facilities in the DRC and in public facilities in Burkina Faso and Nigeria. Uganda showed decreasing stock in public facilities but increasing stock in private facilities. Conclusion: DMPA-SC availability has been increasing since its introduction in sub-Saharan Africa, yet significant gaps in stock exist. Countries should consider alternative distribution models to address these issues. Implications: Our findings may help inform countries about the need to monitor DMPA-SC availability and to consider solutions that ensure contraceptive options are available to women who need them and disruptions to contraceptive use are minimized.

A prospective cohort study to assess the acceptability of Sayana Press among 18-49-year-old women in Nepal.

OBJECTIVE: We compared acceptability and continuation of Sayana Press, a subcutaneous formulation of depot-medroxyprogesteone acetate (DMPA) in a Uniject injection system, to intramuscular (IM) DMPA, among both current users of DMPA-IM and new users in Nepal. STUDY DESIGN: We recruited women seeking injectable contraception at 14 public health facilities in Nepal selected for geographic diversity. We enrolled women who self-selected either Sayana Press or DMPA-IM and used structured interviews to obtain baseline demographics and assess satisfaction and continuation rates at 1, 3, and 6 months. RESULTS: Seven hundred ninety-four women (71%) selected and received Sayana Press, while 318 women (28.6%) selected and received DMPA-IM. One hundred and seventy-eight (48%) women continuing Sayana Press injection reported that they experienced "no possible side effects" compared to 29 (22%) among DMPA-IM selectors during the previous 6 months. The continuation rate of Sayana Press at 6 months was higher than DMPA-IM (Sayana Press 46.5% vs DMPA-IM 34.4%; p < 0.001). Selection of Sayana Press method (ORadj. 1.74; 95% confidence interval 1.32-2.3) and approval from husband (ORadj. 1.59; 95% confidence interval 1.21-2.09) were associated with injection continuation. CONCLUSION: Sayana Press is acceptable to women in Nepal with the preference for Sayana Press over DMPA-IM (higher proportion chose the method when counseled and given the option, better continuation). IMPLICATIONS: The potential for self-injection with Sayana Press® may have implications for continuation and opportunity for future research and strategies to roll out this innovative technology must be explored.

Young Women's Experiences With Subcutaneous Depot Medroxyprogesterone Acetate: A Secondary Analysis of a One-Year Randomized Trial in Malawi.

PURPOSE: The purpose of this study was to compare the effectiveness, safety, and experiences with side effects of self-injected and provider-administered injectable contraception between young (18-24 years) versus older (≥25 years) women. METHODS: We conducted secondary analysis of data from a 12-month randomized controlled trial in Malawi, where a total of 731 women were randomized to receive subcutaneous depot medroxyprogesterone acetate (DMPA-SC) administered by a provider or be trained to self-inject subcutaneous depot medroxyprogesterone acetate. Data collectors contacted women after the reinjection window at 3, 6, and 9 months to collect data on discontinuation and women's experiences, including adverse events. Twelve months after enrollment or at early discontinuation, women had their final interview, including pregnancy testing. We compared continuation, pregnancy, safety, and side effects among young women versus older women. RESULTS: Among self-injectors, there were no significant differences found in continuation by age (p = .345) with continuation rates at 12 months of 79% for young women and 69% for older women. Continuation rates were lower for both age groups with provider-administered injections. In the provider-administered group, continuation rates among young women (39%) were lower than among older women (49%) (p = .047). The distribution of reasons for discontinuation did not differ significantly by age for those receiving provider injections (p = .698). However, younger self-injectors were less likely to miss the reinjection window than older self-injectors (p = .011). Age did not significantly influence pregnancy or safety. CONCLUSIONS: With evidence of potential higher impact on continuation and no safety concerns, we recommend self-injection be added to the contraception options available to young women in low-resource settings.

Trends in subcutaneous depot medroxyprogesterone acetate (DMPA-SC) use in Burkina Faso, the Democratic Republic of Congo and Uganda.

OBJECTIVES: Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) is seen as a valuable innovation in family planning, but little is known about trends in DMPA-SC use or characteristics of users. Using data from Burkina Faso, the Democratic Republic of Congo (DRC) and Uganda, we measured trends in DMPA-SC and identified characteristics associated with DMPA-SC use. STUDY DESIGN: We used repeated cross-sectional representative data collected between 2016 and 2019. First, we plotted trends in DMPA-SC use for all women and married women. Next, we presented the sociodemographic and family-planning-related characteristics of DMPA-SC users. Finally, we conducted weighted multivariate logistic regression analysis to examine how DMPA-SC users were different from women (1) using all other modern methods combined and (2) not using any modern method. RESULTS: DMPA-SC use increased monotonically in all three countries. Many DMPA-SC users were first-time users of modern contraception (54.5% in Burkina Faso, 34.6% in DRC, 50.7% in Uganda). Never-married women had lower odds than married women of using DMPA-SC (compared to other modern methods) in all three countries [Burkina Faso adjusted odds ratio (AOR) 0.40, 95% confidence interval (95% CI) 0.20-0.80; DRC AOR 0.31 95% CI 0.10-0.93; Uganda AOR 0.24; 95% CI 0.08-0.71]. Level of education was positively associated with DMPA-SC use (compared to no use) (Burkina Faso AOR 1.79; 95% CI 1.03-3.14; Uganda AOR 3.23; 95% CI 1.33-7.84). CONCLUSIONS: DMPA-SC is a rapidly growing method in these settings. Despite the comparable levels of and increases in use for all three countries, the characteristics associated with DMPA-SC use generally differed across countries. IMPLICATIONS: This is the first analysis of patterns of DMPA-SC use with representative data for African countries. Our results confirm that DMPA-SC is increasingly popular, although the profile of users varies across settings.

Continuation of injectable contraception when self-injected vs. administered by a facility-based health worker: a nonrandomized, prospective cohort study in Uganda.

OBJECTIVE: The purpose of this study was to compare 12-month continuation rates for subcutaneous depot medroxyprogesterone acetate (DMPA-SC) administered via self-injection and DMPA-IM administered by a health worker in Uganda. STUDY DESIGN: Women seeking injectable contraception at participating health facilities were offered the choice of self-injecting DMPA-SC or receiving an injection of DMPA-IM from a health worker. Those opting for self-injection were trained one-on-one. They self-injected under supervision and took home three units, a client instruction guide and a reinjection calendar. Those opting for DMPA-IM received an injection and an appointment card for the next facility visit in 3 months. We interviewed participants at baseline (first injection) and after 3 (second injection), 6 (third injection) and 9 (fourth injection) months, or upon discontinuation. We used Kaplan-Meier methods to estimate continuation probabilities, with a log-rank test to compare differences between groups. A multivariate Cox regression identified factors correlated with discontinuation. RESULTS: The 12-month continuation rate for the 561 women self-injecting DMPA-SC was .81 [95% confidence interval (CI) .78-.84], and for 600 women receiving DMPA-IM from a health worker, it was .65 (95% CI .61-.69), a significant difference at the .05 level. There were no differences in pregnancy rates or side effects. The multivariate analysis revealed that, controlling for covariates, self-injecting reduced the hazard for discontinuing by 46%. A significant interaction between injection group and age suggests that self-injection may help younger women continue injectable use. CONCLUSIONS: The significant difference in 12-month continuation between women self-injecting DMPA-SC and women receiving DMPA-IM from a health worker - which remains significant in a multivariate analysis - suggests that self-injection may improve injectable contraceptive continuation. IMPLICATIONS: While injectable contraceptives are popular throughout much of sub-Saharan Africa, they have high rates of discontinuation. This study is the second from an African country to demonstrate that self-injection may improve injectable continuation rates and may do so without increasing the risk of pregnancy or adverse events.

Acceptability of the distribution of DMPA-SC by community health workers among acceptors in the rural province of Lualaba in the Democratic Republic of the Congo: a pilot study.

OBJECTIVES: The objective of this research is to assess the acceptability of the provision of subcutaneously administered depo medroxyprogesterone acetate (DMPA-SC) by nonclinically trained community health workers (CHWs) among acceptors in the rural province of Lualaba in the Democratic Republic of the Congo (DRC). STUDY DESIGN: In 2017, 34 CHWs received training in provision of DMPA-SC. Among other methods, DMPA-SC by CHWs was offered during household visits and at community outreach events. The initial survey included questions on acceptors' demographic characteristics, contraceptive use history and experience with provision of DMPA-SC by a CHW. The follow-up included questions about side effects experienced and continuation of DMPA-SC by a CHW. RESULTS: Seventy-four percent of initial acceptors of DMPA-SC (N=252) were first-time contraception users. Almost all (96.0%) felt very comfortable with a CHW performing the injection rather than a physician or nurse, and 97.6% perceived that the CHW was very comfortable performing the injection. A total of 239 women were interviewed at follow-up. Most expressed satisfaction with the method despite some side effects experienced. Almost all acceptors (97.9%) were satisfied with the information provided by CHWs, and 93.8% were satisfied with the overall service. Most (96.4%) would choose to continue receiving DMPA-SC by a CHW rather than in a health clinic, and 95.2% would recommend DMPA-SC by a CHW to a friend. CONCLUSIONS: Overall, administration of DMPA-SC by CHWs is acceptable to users in Lualaba. DMPA-SC can be safely provided within the community after proper training. IMPLICATIONS: This study validates the use of CHWs (without clinical training) to provide DMPA-SC in a rural sub-Saharan African setting. It also represents an important step in obtaining official MOH authorization for the scale-up of this mechanism of distribution to other underserved regions in the DRC.

Continuation of subcutaneous or intramuscular injectable contraception when administered by facility-based and community health workers: findings from a prospective cohort study in Burkina Faso and Uganda.

OBJECTIVE: The aim of this study was to examine continuation of subcutaneous and intramuscular depot medroxyprogesterone acetate (DMPA-SC and DMPA-IM) when administered by facility-based health workers in Burkina Faso and Village Health Teams (VHTs) in Uganda. STUDY DESIGN: Participants were family planning clients of health centers (Burkina Faso) or VHTs (Uganda) who had decided to initiate injectable use. Women selected DMPA-SC or DMPA-IM and study staff followed them for up to four injections (providing 12 months of pregnancy protection) to determine contraceptive continuation. Study staff interviewed women at their first injection (baseline), second injection, fourth injection and if they discontinued either product. RESULTS: Twelve-month continuation in Burkina Faso was 50% for DMPA-SC and 47.4% for DMPA-IM (p=.41, N=990, 492 DMPA-SC and 498 DMPA-IM). Twelve-month continuation in Uganda was 77.8% for DMPA-SC and 77.4% for DMPA-IM (p=.85, N=1224, 609 DMPA-SC and 615 DMPA-IM). Reasons for discontinuation of DMPA across groups in Burkina Faso included side effects (90/492, 18.3%), being late for injection (68/492, 13.8%) and refusal of spouse (51/492, 10.4%). Reasons for discontinuation in Uganda included being late for injection (65/229, 28.4%), received from non-VHT (50/229, 21.8%) and side effects (34/229, 14.8%). Increased age (adjusted hazard ratio=0.98, p=.01) and partner acceptance of family planning (adjusted hazard ratio=0.48, p<.001) had protective effects against discontinuation in Burkina Faso; we did not find statistically significant variables in Uganda. CONCLUSIONS: There is no difference in 12-month continuation (through four injections) between DMPA-SC and DMPA-IM whether from facility-based health workers in Burkina Faso or VHTs in Uganda. Continuation was higher through community-based distribution in Uganda than health facilities in Burkina Faso. IMPLICATIONS: The subcutaneous formulation of depot medroxyprogesterone acetate (DMPA-SC) is increasingly available in Family Planning 2020 countries. Use of DMPA-SC does not appear to change continuation relative to traditional intramuscular DMPA. Growing evidence of DMPA-SC's suitability for community-based distribution and self-injection may yield indirect benefits for contraceptive continuation and help reach new users.

Designing a global monitoring system for pilot introduction of a new contraceptive technology, subcutaneous DMPA (DMPA-SC).

In collaboration with ministries of health, PATH and key partners launched the first pilot introductions of subcutaneous depot medroxyprogesterone acetate (DMPA-SC, brand name Sayana® Press) in Burkina Faso, Niger, Senegal, and Uganda from July 2014 through June 2016. While each country implemented a unique introduction strategy, all agreed to track a set of uniform indicators to chart the effect of introducing this new method across settings. Existing national health information systems (HIS) were unable to track new methods or delivery channels introduced for a pilot, thus were not a feasible source for project data. We successfully monitored the four-country pilot introductions by implementing a four-phase approach: 1) developing and defining global indicators, 2) integrating indicators into existing country data collection tools, 3) facilitating consistent reporting and data management, and 4) analyzing and interpreting data and sharing results. Project partners leveraged existing family planning registers to the extent possible, and introduced new or modified data collection and reporting tools to generate project-specific data where necessary. We routinely shared monitoring results with global and national stakeholders, informing decisions about future investments in the product and scale up of DMPA-SC nationwide. Our process and lessons learned may provide insights for countries planning to introduce DMPA-SC or other new contraceptive methods in settings where stakeholder expectations for measureable results for decision-making are high.

A prospective cohort study of the feasibility and acceptability of depot medroxyprogesterone acetate administered subcutaneously through self-injection.

OBJECTIVES: Evidence on contraceptive self-injection from the United States and similar settings is promising, and the practice may increase access. There are no published studies on the feasibility of contraceptive self-injection in sub-Saharan Africa to date. The purpose of this study was to assess feasibility of subcutaneous depot medroxyprogesterone acetate self-injection in Uganda, with specific objectives to (a) measure the proportion of participants who self-injected competently, (b) measure the proportion who self-injected on time 3 months after training (defined conservatively as within 7 days of their reinjection date) and (c) assess acceptability. STUDY DESIGN: In this prospective cohort study, 380 18-45-year-old participants completed self-injection training by licensed study nurses, guided by a client instruction booklet, and practiced injection on prosthetics until achieving competence. Nurses supervised participants' self-injection and evaluated injection technique using an observation checklist. Those judged competent were given a Sayana® Press unit, instruction booklet and reinjection calendar for self-injection at home 3 months later. Participants completed an interview before and after self-injection. Nurses visited participants at home following reinjection dates; during the follow-up visit, participants demonstrated self-injection on a prosthetic, injection technique was reevaluated, and a postreinjection interview was completed. RESULTS: Of 368 participants followed up 3 months posttraining, 88% [95% confidence interval (CI)=84-91] demonstrated injection competence, and 95% (95% CI=92-97) reinjected on time, while 87% (95% CI=84-90) were both on time and competent. Nearly all (98%) expressed a desire to continue. CONCLUSIONS: Self-injection is feasible and highly acceptable among most study participants in Uganda. IMPLICATIONS: The first research results on contraceptive self-injection in sub-Saharan Africa indicate initial feasibility and acceptability of the practice 3 months after women received one-on-one training and a highly visual training and memory aid. Results can inform self-injection programs which aim to increase women's autonomy and access to injectable contraception.

Acceptability of the community-level provision of Sayana® Press by medical and nursing students in Kinshasa, Democratic Republic of the Congo.

OBJECTIVES: The objectives were to assess acceptors' attitudes toward Sayana® Press as a method and toward the mechanism of community-based distribution by medical and nursing (M/N) students, known locally as "DBCs," in Kinshasa, Democratic Republic of the Congo, and to evaluate the experience of these DBCs. STUDY DESIGN: In 2015, surveys were conducted among (1) acceptors of Sayana® Press on the day of the initial injection, (2) these same acceptors 3 months later and (3) the DBCs providing community-based services. The analysis was descriptive and involved no significance testing. RESULTS: Acceptors of Sayana® Press expressed high levels of satisfaction with the method, despite some pain experienced at injection and subsequent side effects. Although most were satisfied with the counseling and services received from the DBCs, less than one third realized that the providers were M/N students. The DBCs expressed satisfaction in serving as community-based distributors; more than 95% would recommend it to others. Their primary complaints were lack of remuneration, stockouts and need for greater supervision. CONCLUSIONS: Consistent with results from previous pilot introductions of Sayana® Press in three African countries, clients were highly satisfied with Sayana® Press as a method. The reported preference for resupply at health centers may reflect a lack of client awareness that the DBCs administering methods near the health center were not in fact staff from the health center. The pilot served to gain acceptance for the use of M/N students in community-based distribution, paving the way for additional task-shifting pilots in Kinshasa. IMPLICATIONS: Sayana® Press represents a promising new method for increasing access to modern contraception in low-income countries. The Kinshasa experience is the first to test the use of medical and nursing students as providers at the community level. The study reports high levels of satisfaction on three counts: acceptors of the contraceptive method, acceptors of the mode of service delivery, and DBCs in their role as providers of contraception at the community level. However, many clients were not aware that the DBCs were students. The study represents an important contribution to the literature on task-shifting, especially in a country with chronic shortages of healthcare personnel.

Evaluating the feasibility and acceptability of self-injection of subcutaneous depot medroxyprogesterone acetate (DMPA) in Senegal: a prospective cohort study.

OBJECTIVES: Expanding contraceptive options through self-injection may improve access and confidentiality. There are few published studies on contraceptive self-injection in sub-Saharan Africa and none in West Africa, a region with high unmet need. This study was performed to assess feasibility of subcutaneous DMPA self-injection in Senegal; objectives were to (1) measure the proportion of participants who self-injected competently 3 months after training, (2) measure the proportion who self-injected on time (defined conservatively as within 7 days of reinjection date), and (3) assess acceptability of self-injection. STUDY DESIGN: In this prospective cohort study, 378 women aged 18-49 years were trained to self-inject by study nurses. Three months later, women returned unprompted to the clinic to self-inject, and technique and visit timing were evaluated. Women continuing with a third self-injection were followed up at home after their next scheduled injection date. At each interaction, participants were interviewed to learn about their experience; additional questions during the final home visit focused on storage and disposal practices, and acceptability. RESULTS: Among the 337 participants followed up 3 months post-training, 310 self-injected, and 87% did so competently. Factoring in women who declined to self-inject, electing to have the provider administer the injection instead, a total of 80% [95% confidence interval (CI)=75-84%] self-injected competently 3 months post-training, and 84% [95% CI=80-88%] reinjected on time, while 72% [95% CI=67-77%] were both on time and competent. The vast majority (93%) expressed a desire to continue. CONCLUSIONS: Self-injection is feasible and acceptable among most study participants in Senegal. IMPLICATIONS: These first research results on contraceptive self-injection in West Africa indicate initial feasibility and acceptability of the practice. Results underscore the importance of designing self-injection programs that empower and support women, including those with limited education.

Estimating demand for a new contraceptive method: projections for the introduction of Sayana Press.

OBJECTIVE: To describe a demand estimation exercise conducted in response to an initiative to introduce Sayana Press in Sub-Saharan Africa and South Asia. METHODS: Secondary data sources were used to develop estimates of the number of Sayana Press units needed for countrywide introductions in 12 countries. To estimate uptake, the number of women who had stated an intention to use injectables was calculated. Two sets of assumptions (one conservative, one more ambitious) were used to assess conversion to actual use. RESULTS: Even with the use of very conservative assumptions, and assuming no method switching, Sayana Press was estimated to have the potential to cumulatively reach 3-6million women by 2016. CONCLUSION: This projected uptake in a relatively short period and at the very beginning of an adoption curve suggests that Sayana Press has promise for countries looking to expand their list of contraceptive choices.

Home-based administration of Sayana® Press: review and assessment of needs in low-resource settings.

A new presentation of the subcutaneous (SC) injectable contraceptive depot medroxyprogesterone acetate (DMPA) increases the possibilities for home and self-administration of this popular contraceptive method. Sayana® Press is DMPA-SC in the prefilled Uniject™ injection system and consists of one dose that provides 3 months of contraceptive protection. Studies indicate that lay caregiver and self-injection of various medications, including other injectable presentations of DMPA-SC, are acceptable and effective. Introduction of Sayana® Press in developing countries could extend injectable contraceptive delivery safely and effectively beyond the clinic and, eventually, into the home, allowing lay caregiver or self-administration. Research needs for low-resource settings include assessing the acceptability and feasibility of self-injection with Sayana® Press. Feasibility studies necessary for implementing a sustainable home-based delivery program include assessment of training, health systems, policies, infrastructure needs and programmatic considerations to optimize women's ability to manage their self-injection schedule.