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Research Article
Revised

Introduction of subcutaneous depot medroxyprogesterone acetate through use of community-based distributors in Zambia

[version 2; peer review: 1 approved, 1 approved with reservations, 1 not approved]
PUBLISHED 04 Jun 2020
Author details Author details

This article is included in the International Conference on Family Planning gateway.

Abstract

Background: The majority of women in Sub-Saharan countries including Zambia use intramuscular Depot Medroxyprogesterone Acetate (DMPA IM) as their preferred method of contraception. However, nearly one-third of the women who start on DMPA IM discontinue within 12 months due to access barriers.  Sayana® Press, low-dose, prefilled subcutaneous depot medroxyprogesterone acetate (DMPA-SC), suitable for even lower-level healthcare providers and potential for self-injection administration, has been developed.  This pilot aimed to understand the feasibility of DMPA-SC in Zambia through use of community-based distributors (CBDs).
Methods: The pilot was implemented from May 2017 to July 2017 in 29 public health facilities in three districts. A total of 161 CBDs received a comprehensive training in DMPA-SC, which included counselling about the method, potential side effects, correct administration and waste management. Post-training mentorship and supervision was conducted. Routine client level data was collected through Ministry of Health management information system.
Results: During the pilot, 12,818 clients were provided with modern voluntary FP methods, with 16.4% (2,100) opting for DMPA-SC. The age range of clients opting for DMPA-SC was between 15 and 50 years, with an average of 31 years. Slightly less than half (43%) of DMPA-SC clients were adolescents and young women, with 11% aged 15–19 and 32% aged 20–24. No adverse events were reported during or immediately subsequent to the introduction of DMPA-SC administration by CBDs.
Conclusion: The pilot demonstrated that CBDs can safely provide DMPA-SC at the community level with appropriate public sector coordination and oversight.

Keywords

Feasibility, Introduction, Distribution, DMPA-SC, Community level, Zambia

Revised Amendments from Version 1

Following key edits were made to the manuscript prompted by peer review comments:
1. Clarity in  the Pilot description
2. Details of CBD profiles before the beginning of the pilot
3. Clarity on definition of a 'model facility' and 'adverse event'
4. Deletion and replacement of Figure 2 to show the age groups of clients who switched from other methods to DMPA-SC
5. Clarity on the results and conclusion for the determination that CBDs were safely able to administer DMPA-SC
6. Reviewed the manuscript for typos, as well as rewording of some sentences/paragraphs.

See the authors' detailed response to the review by Julie Hernandez
See the authors' detailed response to the review by Anthony K. Mbonye
See the authors' detailed response to the review by Jenny Liu

Introduction

Over the last decade, the modern contraceptive prevalence rate (mCPR) in Zambia has increased from 25% to 45%. Despite this increase, unmet need for family planning (FP) stands at 21%1. Like other Sub-Saharan countries, injectable contraceptives are the most widely used modern method among currently married women in Zambia13. However, nearly one-third of the women who start on contraceptive injectables discontinue within the first year of use, partly due to access barriers such as long distances between a woman’s home and a health facility4. In response to the aforementioned, the Zambian Ministry of Health (MoH) introduced community-based distribution of short-term FP methods, including administering of injectable contraceptives by community-based distributors (CBDs)2.

Subcutaneous depot medroxyprogesterone acetate (DMPA-SC), brand name Sayana® Press, is a contraceptive injectable that uses a combination of low-dose DMPA in a pre-filed Uniject® system that eliminates preparation of needle and syringe5. With its unique Uniject® feature coupled with minimum level of training and supervision, DMPA-SC can be easily transported and safely administered by lower-level healthcare providers, including community health workers, and even self-administered by women themselves; thus, it may increase access to injectable contraceptives and improve method continuation, and ultimately address unmet need for FP4. Evidence from other similar pilots has shown that DMPA-SC is safe, acceptable and feasible in low- and middle-income country (LMIC) settings610.

In 2017, Society for Family Health – Zambia (SFH) a non-governmental organization in partnership with the Zambian MoH, Population Services International (PSI), ChildFund International and Development Aid from People to People (DAPP), conducted a pilot introduction of DMPA-SC in Zambia. This pilot was part of a five-year (2015–2020) United States Agency for International Development (USAID)-funded project titled Sexual and Reproductive Health for All Initiative (SARAI). The pilot aimed at understanding the feasibility of introduction community-based distribution of DMPA-SC in the community through use of CBDs.

Methods

Ethics statement

Ethics approval (REF No. 006-12-13) to conduct the pilot was obtained from The University of Zambia Biomedical Research Ethics Committee (UNZAREC) to analyse routine client-level data on reproductive health. On consideration that SARAI was already being implemented in the pilot health facilities and that FP clients would be served as per routine by CBDs during project implantation, the ethics committee waived the need for participant consent. ‘Participant’ in this context refers to CBDs who were already volunteering for the project as well as clients who would receive DMPA-SC as an additional choice to the FP method mix that existed at the time.

Pilot description

The pilot was conducted from May 2017 to July 2017 in 29 SARAI-supported public health facilities across three districts (Kalulushi, Mafinga and Kawambwa). Voluntary FP services were routinely offered with established community-based distribution programs in which CBDs provided Intramuscular depot medroxyprogesterone acetate (DMPA-IM), oral pills and condoms.

At the time of the pilot, CBDs in Zambia were only authorized to distribute contraceptives other than condoms to returning clients only. This was a deliberate regulation by the Ministry of Health to ensure that only eligible clients, assessed by professional health workers were provided with appropriate FP services as new users. CBDs were part of community volunteers, who could read and write in English without necessarily having any medical or clinical background. They were provided with basic training and were observed for competence in provision of a particular health service within the catchment of their communities. In cases where CBDs encountered clients who had never used any modern contraception before, they provided general sexual and reproductive health counselling and refer such clients to a nearest health facility for eligibility assessment and possible commencement of FP services.

Sample selection

The pilot was implemented only in public health facilities that met the criteria of a “model facility” under SARAI. The project defined a model facility as one that encompasses the key components and systems needed at the community level to respond effectively to the family planning needs of the population. These systems included, skilled service providers; expanded method mix; client-centered care offering age appropriate information, outreach to vulnerable populations; supervision; mentoring for health care providers; youth and adolescent reproductive health services; community involvement through organized and trained community members who mostly are volunteers and data collection and analysis to track progress. Model facilities were selected because the project had already established necessary structures at facility and district levels to monitor and supervise community-based distribution of FP commodities. The CBD model under SARAI in Zambia is implemented in a way that CBDs operate in the peripherals of the catchment area of a health facility to distribute FP commodities and messaging. Each CBD is accountable to a nearby supervising facility and they submit monthly distribution and stock reports to the supervisors. All CBDs (163) in all model health facilities (29) supported by SARAI were selected to participate in the pilot.

Training

A cascaded training approach was implemented which allowed introduction of DMPA-SC at all levels of the health system. In November 2016, prior to the pilot a 3-day training session for 25 national-level MoH master trainers drawn from all 10 provinces of Zambia was conducted. DMPA-SC master trainers with SRH expertise and experience drawn from key departments of the ministry of health were engaged to train 35 CBD supervisors drawn from three pilot implementing districts namely Kalulushi (13 supervisors), Kawambwa (12 supervisors) and Mafinga (10 supervisors). These supervisors included MoH health facility-based CBD supervisors and district-level supervisors with the following roles:

  • i. Post-training supervision to ensure CBDs attain proficiency

  • ii. Ensure CBDs adhere to injection safety standards

  • iii. Facilitate accurate data management and record keeping

  • iv. Commodity stock management

  • v. Monitoring and management of adverse events

There was 3 days of DMPA-SC training for 163 CBDs from implementing facilities, representing an average of five CBDs per facility, conducted. This training was in addition to the DMPA-IM training which was conducted prior to the pilot.

Post-training mentorship and supervision

Each CBD was attached to a health facility, where he/she was to provide at least five DMPA-SC injections under supervision before being allowed to practice in the community. The standard MoH DMPA-SC injection step by step procedure was used to assess CBD competency in injection safety. Supervisors also conducted regular field-level supervision, which focused on data management and safe disposal of clinical waste. once a week for facility-based and twice a month for district health office-based supervisors. This supervision focused on safety of clients and CBDs during the administration of injections, data management and safe disposal of clinical waste. In order to comprehensively assess the pilot and draw lessons from the pilot, the National Family Planning Technical Working Group (NFPTWG) under the ministry of health conducted onsite monitoring visits to all implanting districts. The NFPTWG observed CBDs administering injections to clients, inspected storage sites for commodities stored by CBDs and assessed the clinical waste disposal process from the point of generation to the point of final disposal. The assessment measured safety of clients and CBDs based absence of injury during administration of injections, absence of AEs as well as safe disposal of clinical waste. The NFPTWG also conducted in-person interviews with CBD supervisors as well as clients to obtain their views on the pilot.

Stock management

Stock consumption data obtained from the health information management system of the ministry of health for the three months (February-April 2017) that preceded the pilot showed that on average, each CBD administered 10 doses of DMPA-IM per month. Therefore, based on that precedence, each CBD was issued with 10 doses of DMPA-SC as initial post training stock. In order to avoid possible commodity stock out, each facility was given 30 doses as buffer stock. All CBDs were advised to re-order once 50% of stock on hand was used up. In addition, all CBDs were supplied with stock-tracking forms and were given lockable wooden boxes for storing commodities. Throughout the three months of the pilot, a total of 6,530 DMPA-SC doses were issued to implementing districts.

Waste management

All trained CBDs were provided with supplies for waste management, including sharps boxes, buckets and bin liners. In line with MOH policy, CBDs ferried all waste generated during service provision to the nearest health facility for final disposal once the bin liners were three quarters full.

Adverse event (AE) management

The pilot developed a framework for identifying, monitoring and real time reporting of AE’s. CBDs received training to identify, analyze and classify AEs in terms of nature and cause. An adverse event in this context refers to severe side effects from using the method. A referral system was established between the CBDs and the nearest health facility to link clients with suspected AEs.

Data collection and analysis

CBDs captured client level data on clients receiving DMPA-SC doses using standard MoH registers, which had been adapted to include DMPA-SC as a new FP method. Demographic (i.e., age) and service information (i.e., client type and switching behaviours) for clients that voluntarily opted for reproductive health services, particularly DMPA-SC, were extracted from the registers and entered into Microsoft Excel software. For analysis, the study used data without personal identifying information for clients and were part of routine data collection during project implementation. IRB approval to use this level of data was obtained. Data analysis which included generation of descriptive statistics through tables, graphs cross-tabulations and frequencies was conducted using Statistical Package for Social Sciences (SPSS) version 21. CBDs characteristics data were collected by the project upon completion of the initial FP service provision training which was conducted prior to the pilot and were updated at the time of DMPA-SC training.

Pilot Limitations

The pilot only focused on SARAI supported facilities that met the prescribed criteria for a ‘mode facility’, therefore, findings may not be generalized.

Results

Of the 163 CBDs, 161 successfully completed the training; two CBDs discontinued due to personal reasons.

CBD characteristics

All the CBDs trained had previous training in FP counselling, distribution of oral pills and condoms and administration of DMPA-IM and were providing these services in the catchment of their communities prior to the pilot period. Below are the characteristics of the CBDs. Characteristics of CBDs that completed training are shown in Table 1.

Table 1. Community-based distributor (CBD) characteristics.

VariableCBDs, N*
Total trained in DMPA-SC161
Gender
     Male66
     Female95
Education
     Primary21
     Secondary140
Average age, years 35
Previous trained in DMPA-IM161

*Unless indicated. DMPA-IM, intramuscular depot medroxyprogesterone acetate.

FP Provision during pilot period

A total of 12,818 clients were provided with various FP methods/products during the pilot period as shown in Figure 1.

62856f0e-0338-4f1b-9ec1-a6b52c734922_figure1.gif

Figure 1. Percentage distribution of clients provided with family planning methods (N=12,818).

The majority of the clients (37%) were provided with male condoms while combined oral contraceptives at 5% accounted for the least method provided. DMPA-SC clients accounted for 16% of all the clients seen during the pilot period. Overall, clients that received injectable contraceptives (i.e., DMPA IM & SC) accounted for nearly half (i.e. 48%) of all the clients provided with FP methods/products during the pilot period.

Pilot results showed a 17% increase in the number of injectable DMPA (IM and SC) doses provided during the pilot period compared to the total for the three months preceding the pilot. Table 2 below compares FP provision before and during the DMPA-SC pilot.

Table 2. Family planning provision before and after subcutaneous depot medroxyprogesterone acetate (DMPA-SC) introduction.

VariablePrior to pilot
(3 months)
Pilot period
(3 months)
DMPA-SC dosesN/A2,100
DMPA-IM doses5,2844,090
Total DMPA5,2846,190
# of CBDs163161
Avg. DMPA doses/3 months3238
Avg. DMPA doses/month1113

DMPA-IM, intramuscular DMPA; CBD, community-based distributor.

Before the DMPA-SC pilot was introduced, each CBD distributed an average of 10 doses of injectable DMPA-IM per month. After the DMPA-SC pilot was introduced, each CBD provided an average of 13 doses of injectable DMPA per month (i.e., DMPA-SC=5, DMPA IM=8).

Number of clients who switched from other methods to DMPA-SC

Out the 2,100 clients who were provided with DMPA-SC, 2,037 substituted their previous methods with DMPA-SC while the rest were new acceptors with no previous method. Figure 2 below shows the number of clients who switched from other FP methods to DMPA-SC disaggregated by age group.

62856f0e-0338-4f1b-9ec1-a6b52c734922_figure2.gif

Figure 2. No. of Clients who switched from other FP methods to DMPA-SC (N = 2,037).

IM, intramuscular.

DMPA-SC clients by age distribution

Nearly half (43%) of the DMPA-SC clients were adolescents and young women below the age of 25. Figure 3 shows DMPA clients by age distribution.

62856f0e-0338-4f1b-9ec1-a6b52c734922_figure3.gif

Figure 3. Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) clients by age distribution (N=2,100).

DMPA-SC provided by client type

The Majority of DMPA-SC clients (about 97%) were revisits on FP, while only 3% of DMPA-SC users were new acceptors, as indicated inn Figure 4.

62856f0e-0338-4f1b-9ec1-a6b52c734922_figure4.gif

Figure 4. Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) provided by client type (N=2,100).

Proportion of clients switching to DMPA-SC

Figure 5 shows the proportion of FP clients (re-visiting) that switched to DMPA-SC.

62856f0e-0338-4f1b-9ec1-a6b52c734922_figure5.gif

Figure 5. Proportion of family planning (FP) clients that switch to Subcutaneous depot medroxyprogesterone acetate (DMPA-SC) (N=2,043).

IM, intramuscular.

About 80% of FP clients switched from DMPA-IM to DMPA-SC, while 20% of the clients switched from other FP methods to DMPA-SC.

AE management

A robust AE reporting system was established in all 29 implementing facilities. Routine monitoring data revealed that no AEs were reported following DMPA-SC administration at all service delivery sites.

Discussion

These findings provided useful insights to inform development of the national road map for the national scale-up of DMPA-SC in Zambia. This was the first study in Zambia to explore introduction of DMPA-SC in the community through use of CBDs. According to assessments carried out by CBD supervisors and the NFPTWG, trained CBDs were able to safely administer and appropriately store DMPA-SC, they were also able to dispose of resultant waste according to laid down procedures.

Similar to other DMPA-SC pilots conducted in Niger, Senegal and Uganda, this pilot revealed that nearly half DMPA-SC doses were administered to women younger than 25 years of age11. This was however a continuation of the similar trend for DMPA-IM even before the pilot. Each CBD distributed five doses of DMPA-SC doses per month on average compared to similar pilot in other countries (Senegal, Niger and Uganda), where each provider administered three doses per month11. Therefore, it is evident that DMPA-SC has the potential to provide an additional contraception choice for women especially the adolescents thereby reducing unintended pregnancies. Despite DMPA-SC being only available in the community, some facility-based CBD supervisors/FP providers in a few facilities included the method during FP counselling. Hence, new FP users who opted for DMPA-SC were assessed for eligibility and referred to CBDs for service provision. Due to policy differences between Zambia and other countries on FP service provision by CBDs and definition of ‘new acceptors of FP’, this finding contradicted with pilot results from other countries that showed a substantial number of women categorised as (“new users”) choosing DMPA-SC11.

Conclusion

The DMPA-SC Pilot demonstrated that CBDs can safely provide DMPA-SC within the existing family planning method mix. Secondly, the pilot demonstrated that DMPA-SC has potential to be a method of choice for adolescent and young women.

Data availability

Open Science Framework: DMPA SC dataset. https://doi.org/10.17605/OSF.IO/X23FE12.

Underlying data are available in file Dataset.zip, which contains the following data:

  • DMPA SC aggregated dataset.xlsx (aggregated data from all locations).

  • KALULUSHI data.xlsx (underlying data from Kalulushi).

  • KAWAMBWA data.xlsx (underlying data from Kawambwa).

  • MAFINGA data (underlying data from Mafinga).

Extended data

Figshare: CBD Profiles Dataset. https://doi.org/10.6084/m9.figshare.11829534.v113

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

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Version 2
VERSION 2 PUBLISHED 28 May 2019
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Phiri J, Smith GM, Tembo F et al. Introduction of subcutaneous depot medroxyprogesterone acetate through use of community-based distributors in Zambia [version 2; peer review: 1 approved, 1 approved with reservations, 1 not approved]. Gates Open Res 2020, 3:1474 (https://doi.org/10.12688/gatesopenres.13020.2)
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Version 2
VERSION 2 PUBLISHED 28 May 2019
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Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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