Benefits, anxieties, acceptance, and barriers to the new injectable contraceptive DMPA-SC (Sayana Press): Clients’ perceptions in Sindh, Pakistan [version 1; peer review: awaiting peer review]

Background: Injections are Pakistan's third most preferred contraceptive method because of their convenience. They represent a 2.5% share of the contraceptive prevalence rate (CPR) and contribute 10% to the current CPR. However, injections require a clinical setting or a healthcare provider for administration. A new method of subcutaneous presentation of depot medroxyprogesterone acetate (DMPA-SC), namely Sayana Press in Uniject™, has been introduced, which can be administered in nonclinical settings or self-administered by trained women. This study examined clients’ perceptions of the current depot medroxyprogesterone acetate-intramuscular injection (DMPA-IM) and its accessibility, availability, affordability, advantages, and disadvantages. In addition, it explored the benefits, barriers, and challenges regarding the new method of DMPA-SC (Sayana Press), especially considering self-injection. Methods: The study was conducted in Sindh, Pakistan. Three focus group discussions were conducted with 9–13 female participants with different demographic characteristics. A semi-structured questionnaire was used. The discussion was recorded, transcribed, and translated from Urdu or


Introduction
Pakistan has the fifth-highest population worldwide, with 207 million people 1 . The rising trend of population growth has continued since the country's independence. Subsequently, family planning (FP) programs were introduced by a non-government organization, the Family Planning Association of Pakistan (FPAP). However, during the regime of General Ayoub Khan, the government officially included FP as a program in the national policy and planning during the second five-year plan (1960-65) 2 . Nevertheless, approximately 60 years after the program's inception, Pakistan's contraceptive prevalence rate (CPR) has not significantly increased. It remained almost static for 10 years, at 34%. The demand for FP remains high in Pakistan: four million (17%) married women of reproductive age have not yet received FP services. According to the Pakistan Demographic and Health Survey (PDHS) 2017-18, the total demand for FP is 52% among married women of reproductive age (MWRA); eight million (34.2%) MWRA are currently using FP methods, among whom approximately six million (25%) MWRA are using modern methods, whereas the remaining 9% are using traditional FP methods. Male condoms (9.2%) and female sterilization (8.8%) are the most common methods, encompassing 72% of the modern contraceptive prevalence rate. Injection (2.5%) is the third most popular method of FP among women using modern contraceptives, with a higher rate than the long-term method of an intrauterine contraceptive device (2.1%). It makes up 10% of the modern CPR 3 .
The current injection method, depot medroxyprogesterone acetate-intramuscular injection (DMPA-IM), has limited service access, as it requires a clinical setting or the assistance of a trained healthcare service provider to deliver this method of contraception 4 . The subcutaneous presentation of DMPA (Sayana Press) is a 104-mg single dose of medroxyprogesterone acetate in 0.65-ml volume, sterilely packaged in the Uniject™ device. Uniject™ is a pre-filled, non-reusable blister injection system comprising a bubble reservoir with an integral, ultra-thin needle, believed to be a notable advancement in the field 5 . It has several features that add advantages to the new injectable method. Community health workers, for example, female health and family welfare workers or women desiring to inject a contraceptive themselves after training, can administer it in nonclinical settings. Accepting Uniject™ as a self-injection can meet demand in all situations, particularly when access is restricted because of natural disasters, during public health emergencies such as the coronavirus disease 2019, and for remote administration under the self-care model. After the stipulated training, female clients can easily selfadminister the injection with complete privacy. The product's shelf life is also adjustable following Pakistan's climate conditions and can be easily stored at an average room temperature (15-30°C).
The Sayana Press summary of product characteristics, under "Section 4.8 Undesirable effects," states that commonly reported injection-site reactions include persistent injection-site atrophy, indentation, or dimpling; injection-site nodules or lumps; and injection-site pain or tenderness (occurring in ≥ 1/100 to < 1/10 cases). Lipodystrophy (acquired) is rarely reported (occurring in ≥ 1/10 000 to < 1/1000 cases) in patients receiving subcutaneous DMPA (DMPA-SC) 6 . According to Pfizer Limited, the product's manufacturer, evidence suggests a minute increased risk of cardiovascular events among women with hypertension or lipid disorders who used progestogenonly injectables. If hypertension occurs during Sayana Press administration or its increase cannot be adequately controlled using antihypertensive medication, its administration is risky. Additional risk factors for arterial thrombotic disorders include hypertension, smoking, age, lipid disorders, migraine, obesity, positive family history, cardiac valve disorders, and atrial fibrillation 7 . The company also claimed that patients with the above risk factors should use the Sayana Press method cautiously.
The Sayana Press is a new contraceptive method in its inception phase in Pakistan, with support from the public sector in Sindh province. Initially, Sayana Press was discussed in the costed implantation plan (CIP) regarding FP for Sindh in 2015 for its introduction and implantation 8 . DMPA-SC (Sayana Press) was introduced in Sindh, Pakistan, in 2019 after a randomized control trial comprehensive study 9 provided evidence that lady health workers can safely and effectively administer injectable contraception, including DMPA-IM and DMPA-SC, to their clients after training. The CIP unit of the population welfare department, the Government of Sindh, with help from RIZ Consulting, also conducted a pilot study on DMPA-SC self-injection 10 . Considering its results, the Government of Sindh developed a rollout plan for self-injection through its CIP. Sayana Press can pave a significant trajectory for modern FP methods with self-injection features because it provides safety and ease of subcutaneous injection use. Like the Government of Sindh, health and FP ministries of other countries, for example, Nigeria and Senegal, have enacted policies allowing community health workers to administer the product and even permit drug stores and shopkeepers to engage in direct sales 11 . This product, which expands the availability of contraceptives, can increase FP services, specifically in communities where access to FP services, especially injectables, is limited. The government's and donor agencies' efforts to increase the use of Sayana Press show its impact. However, understanding of Sayana Press is limited, specifically regarding client perceptions. Sayana Press has new self-injection features. Therefore, learning about clients' experiences and perceptions regarding this change is crucial. Hence, this study addresses this deficit by collecting insights from end users.

Study aims
The study primarily aimed to gain insight from clients to understand women's perceptions of the current form of injection (administered by a trained healthcare provider) and the new injection method DMPA-SC, considering the objectives given below: ▪ Obtain clients' perspectives regarding the current contraceptive injection (DMPA-IM) use, considering accessibility, availability, affordability, advantages, and disadvantages.
▪ Obtain clients' perceptions regarding the new method of DMPA-SC as self-injection, considering benefits, fears regarding self-injecting, potential challenges or barriers that clients face, and their perceptions of Uniject™, especially concerning self-injection. informed the participants about the research objectives in their native language, and verbal consent for participation and data publication was obtained before proceeding to the discussion. After their consent was obtained, which the interviewer recorded in interview forms, the discussion was recorded for future transcription. The respondents of the study belonged to different demographic backgrounds (geographical Rural, Urban, and education) and participants did not want to disclose their identity in any way. Verbal consent was approved by the Research Ethics Review Committee.

Study design
This qualitative study used the focus group discussion (FGD) method by adopting a purposive sample technique instead of a statistically representative sample of a broader population 11 to gain an in-depth understanding of social issues. FGD serves to solicit information regarding participants' attitudes and perceptions, knowledge and experiences, and practices shared during interactions with different people. The technique assumes that during FGD, group dynamics will be activated to help identify and clarify shared knowledge among group members, which would otherwise be challenging to obtain through individual interviews 12 . Participants were recruited following the guidance in "How to conduct FGD Methodological Manual" by Peter van Eeuwijk and Zuzanna Angehrn 12 . Furthermore, they were recruited according to the inclusion criteria of being married, with the help of social mobilizers providing FP services in these areas. The number of participants was finalized considering the manual 12 , and in each FGD, 9-13 women with different demographic characteristics, including education, parity, profession, and age, were included. According to a previous study, three FGDs are sufficient to reach saturation of codes 13 . Hence, three FGDs were conducted for this study.
The Government of Sindh introduced Sayana Press DMPA-SC in a few selected districts. The selection of areas for study from districts (Karachi, Hyderabad, and Sukkur) was intended to ensure adequate representation of urban and rural participation. The FGDs were conducted using a semi-structured field guide comprising an open-ended questionnaire developed through available literature. Its contents and face validity were evaluated, and a pilot test was performed through an internal testing process, as outlined by DeVon et al. 14 . First, the tool kit was finalized in English. It was then translated into Urdu and Sindhi. Considering cultural constraints, female data collectors with expertise in the above languages were engaged to conduct FGDs, during which they encouraged respondents to participate in the study. The participants were recruited with help from field workers during the last week of March 2021 at three sites, and data were collected and completed from April to May 2021. The researchers informed the participants about the research objectives in their native language and obtained their consent before proceeding to the discussion. After their consent was obtained, the discussion was recorded for future transcription. The total duration of all three FGDs was 143 minutes (not including the general introduction and rapport-building process, which were not recorded). The audio was initially transcribed in the original recorded language (Sindhi and Urdu) and later translated into English and cross-checked by professional linguists.
The researchers used the guidelines by Braun and Clark 15 and followed the following six defined steps: Stage 1: Familiarity with the data The guidelines indicate that the researcher should become familiar with the dataset before starting the analysis. In the current study, the researchers had direct experience in the FP field and belonged to the local community. In this case, having a substantial understanding of the subject and the language used by the respondents was ensured. The researchers repeatedly read the transcripts and listened to the audio recordings to understand the responses in-depth.

Stage 2: Generating initial codes
Following the guidance of Braun and Clark 15 , this study used a top-down method for developing initial codes aligned with the research questions and objectives, applying a deductive approach. Each data segment relevant to the research objectives was evaluated and assigned codes. Open coding was used and modified throughout the process. This strategy helped to clarify how participants provided feedback regarding their access to the FP services, especially concerning the DMPA-IM injection and the side effects or disadvantages of the injection method.

Stage 3: Preparing themes
Generally, themes are patterns relevant and notable to the research objectives. As Braun and Clarke provided no specific rules for themes except for using the nearest associations, this study created two major themes, considering the comparison between the two injection methods, one each for DMPA-IM and DMPA-SC, and recorded the coding in each area. The details of the coding are provided in Table 1. This approach is used when a study is driven by research questions 16 .

Stage 4: Reviewing themes
After gathering the codes in two broader areas, those with closer associations were grouped to develop subthemes aligned with the research objectives. This review process was performed considering specific vital questions, as discussed by Maguire and Delahunt 16 .
• Do the themes make sense?
• Do the data support the themes?
• Am I trying to fit too much into a theme?
• If the themes overlap, are they actually separate themes?
• Are there other themes within the data?
The details of the reviewed themes and subthemes were summarized following the codes, their meaning, and close associations, avoiding overlapping and considering the research objectives, as provided in Table 2.

Stage 5: Defining themes
This stage required the final refinement of the themes by identifying the essence of each theme. It primarily addressed the following questions: It is affordable between PRK 200 to 300 It will save doctor fees Private practitioners will be against this method This will reduce the business of Baji (LHV) The doctor will not accept it

Government doctors promote this method
The community already accepts the injection method No reaction in the society The government provides this method for free

It would be good if lady health workers would inject this
It is easy once we learn the self-injection How will doctors accept this because it reduces their income • What theme is presented?
• If subthemes exist, do these interact and narrate according to the central theme?
• Do the themes correlate with each other?
These questions were examined and applied accordingly.

Stage 6: Write up
The final stage involved writing the study results, including its findings, conclusions, and recommendations. Next, the data were analyzed using NVivo software version 11 (RRID: SCR_014802) (free alternative, Taguette), as this has been used for similar research objectives that necessitated deductive and inductive codes, requiring deeper involvement in the analysis process. In addition, this method was utilized because it allowed an in-depth understanding of the data and the issue under investigation, which is paramount in qualitative research 17 . Finally, the results were recorded and presented accordingly.

Results and Discussion
The participants were recruited from diverse demographic backgrounds to meet this study's research objectives. After receiving approval from the ethical committee, the participants were recruited with help from local field workers. It was found that even in the presence of substantial information regarding family planning methods in the community, it is still difficult to get agreement from female clients to start contraception. This perspective aligned with a previous study's findings that women find accepting the FP method and its cost challenging 21 . According to a participant: Notably, women appreciated the role of health workers in mobilizing clients and helping them decide whether to access FP services. Advantages and disadvantages of injection (DMPA-IM) services Most participants shared that injectables can readily be accessed, while some reported that a shortage of supplies and perceived side effects are significant disadvantages. The injection method was preferred among participants. A few of the crucial benefits, according to the participants, included the following: "Injection means three months of relaxation." (FGD-Kar; Participant E).
"As I have observed, the injection is effective because I had also used pills, but it caused menstrual cycle two or three times in a month." (FGD-Hyd; Participant A) The leading client perception regarding existing DMPA-IM included changes in the menstrual cycle as disadvantages of injection, aligning with previous studies 21 . According to participants: "There is a problem; I heard that the injections available in the government hospitals are not of good quality and are less effective. My aunt shared with me about her health and weakness, similar to what I felt, especially blood pressure problems, after using the injection method." (FGD-Hyd; Participant C) "Women do not get periods after taking an injection. In a month, we are fine for 10 days, but after 20 days, we start feeling ill." (FGD-Suk; Participant G).

Perspectives of the new product (DMPA-SC)
Fear regarding self-administration of DMPA-SC We found that participants in all settings showed moderate fear of self-injection. Information regarding the new method is minimal. Moreover, even those aware may not know about its self-injection features. After presenting a demonstration of the new method and observing Sayana Press physically, participants shared their concerns regarding self-injection, specifically the risk of an inaccurate prick, aligning with other studies conducted worldwide that revealed such fear associated with self-injection 11,21 . Participants lacked information about the new method and its self-injection features. However, they showed a willingness to use the self-injection method after adequate training. According to participants: "It will be beneficial for us since we are busy with in-house chores; if I forget the injection date, I start feeling fearful, and another point is that if we get an injection by a doctor, we feel ill or unhealthy. If we receive an injection for self-use, we will feel good. However, about the concern of self-administration, after a few times, it will be easy to perform, and finally, the fear will be over." (FGD-Kar; Participant D).
Pricing for DMPA-SC Most participants appreciated the free services at the public sector health facilities. However, economically compromised clients have difficulty paying private providers to access the injection at a private facility. In addition, we found that the affordability of DMPA-SC is challenging in the private sector, especially for low-income clients. Participants also assumed that DMPA-SC must be expensive. According to participants: This viewpoint is similar to the perceptions of Nigerian clients; the perceived cost to clients was among the most significant concerns 23 . Participants in this study agreed to pay between PKR 50 and 300 (equivalent to 1 USD) as service charges to private providers. Others agreed to pay transportation costs to receive free public sector health facility services.
Acceptance of DMPA-SC Clients preferred the self-injection method to avoid private providers' transportation and service charges after adequate training. According to a participant: "To avoid transportation issues, especially for those women who go outside for services, home-based service is better." (FGD-Kar; Participant C) This opinion aligns with findings from a study in Ghana, where women preferred a home-based self-injection method to avoid transportation costs, waiting time at service providers, privacy, and unavailability of providers during their visit 24 .
In addition, most participants shared that accepting DMPA-SC is not concerning, especially at the community level. However, acceptance and threats from private providers were found in the current study. According to participants: The present study confirms the perceived likelihood of threat from the service providers for self-injections, aligning with the findings of Spieler 5 , who suggested that doctors, nurses, ministries of health, and midwives may feel threatened (because, historically, a medical doctor administers injections) and create a backlash against using a product that is self-injected 5 .
Affordability and readiness to pay for DMPA-SC Most participants agreed to pay private providers PKR 50-300 (approximately 1 USD) as service charges. By contrast, others agreed to pay for the transportation cost if they did not have options for other methods. According to participants: This study thus demonstrates the need for accurate information and counseling regarding FP methods and side effects for the successful implementation of DMPA-SC. In addition, in some countries, increased knowledge of self-injection is high; however, the uptake is low 28 . Hence, service access must be increased by engaging service providers, medical students, and community workers to improve the utility of Sayana Press, especially by promoting self-injection.

Conclusions
DMPA-SC can be a valuable asset and have a catalytic effect on the uptake of FP services, given adequate counseling. After training, the clients were willing to use this self-injection approach with the providers' assistance. Additionally, they agreed to pay the transportation cost to obtain the contraceptive for free at public sector health facilities or without any transportation within communities through health workers. Clients preferred the self-injection method after training to avoid transportation and private provider service charges. Future studies must be conducted with clients who avail themselves of the services of DMAP-SC from service providers and use the self-injection method.

Practical implications
The This study's findings can help the Government of Sindh and other stakeholders with decision-making and implementing DMPA-SC provider assistance and self-injection as they apply the scale-up plan. In particular, the present study will help policymakers address challenges regarding the fear of pain and inaccurate pricking during self-injection. Further, the information related to the affordability of new contraceptive methods will assist the government and private sector in keeping the price within clients' budgets.