Pilot Research as Advocacy: The Case of Sayana Press in ...

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FIELD ACTION REPORT Pilot Research as Advocacy: The Case of Sayana Press in Kinshasa, Democratic Republic of the Congo Arsene Binanga, a Jane T Bertrand b The pilot study obtained Ministry of Health approval to allow medical and nursing students to provide the injectable contraceptive Sayana Press and other methods in the community, paving the way for other task-shifting pilots including self-injection of Sayana Press with supervision by the students as well as injection by community health workers. ABSTRACT In the Democratic Republic of the Congo (DRC), the Ministry of Health authorizes only physicians and nurses to give injections, with one exceptionmedical and nursing students may also give injections if supervised by a clinical in- structor. The emergence of the injectable contraceptive Sayana Press in some African countries prompted the DRC to test the acceptability and feasibility of distributing Sayana Press and other contraceptive methods at the community level through medical and nursing students. Sayana Press is similar in formulation to the injectable contraceptive Depo-Provera but contains a lower dose and is administered subcutaneously using a single-use syringe with a short needle called the Uniject system. The Uniject system allows Sayana Press to be administered by community health workers without clinical training or by self-injection. In this pilot, the advocacy objective was to obtain approval from the Ministry of Health to allow medical and nursing students to inject Sayana Press, as a first step toward author- ization for community health workers to provide the method. The pilot described in this article documents a process whereby an innovative approach moved from concept to implementation to replication in less than 2 years. It also paved the way for testing additional progressive strategies to increase access to contraception at the community level. Because the pilot project included a research component designed to assess benefits and challenges, it provided the means to introduce the new task-shifting approach, which might not have been approved otherwise. Key pilot activ- ities included: (1) increasing awareness of Sayana Press among family planning stakeholders at a national conference on family planning, (2) enlisting the support of key decision makers in designing the pilot, (3) obtaining marketing authorization to distribute Sayana Press in the DRC, (4) implementing the pilot from July to December 2015, (5) con- ducting quantitative and qualitative studies to assess acceptability and feasibility, and (6) disseminating the findings to family planning stakeholders. Before the pilot, Sayana Press was relatively unknown in the DRC, and there was no precedent for medical and nursing students providing family planning methods or giving injections at the community level. In less than 12 months, the approach gained legitimacy and acceptance. The key Ministry of Health decision maker orchestrated the closing session of the dissemination meeting on next steps, paving the way for pilot tests of 3 new task-shifting approaches: insertion of Implanon NXT by medical and nursing students, self-injection for Sayana Press with supervision by students, and injection of Sayana Press by community health workers with no formal clinical training. BACKGROUND T he purpose of this article is to highlight the poten- tial of pilot research studies to achieve advocacy objectives. Although the concept is not new, there is little in the published literature to indicate its use as a best practice in international family planning. Research is usually viewed as a means of generating relevant data on the topic, but this case study describes a pilot study that served as the catalyst to achieving change in regulations governing family planning serv- ice delivery in the Democratic Republic of the Congo a Tulane International LLC, Kinshasa, Democratic Republic of the Congo. b Tulane School of Public Health and Tropical Medicine, New Orleans, LA, USA. Correspondence to Jane T Bertrand ([email protected]). Global Health: Science and Practice 2016 | Volume 4 | Number 4 542

Transcript of Pilot Research as Advocacy: The Case of Sayana Press in ...

FIELD ACTION REPORT

Pilot Research as Advocacy: The Case of Sayana Press inKinshasa, Democratic Republic of the CongoArsene Binanga,a Jane T Bertrandb

The pilot study obtained Ministry of Health approval to allow medical and nursing students to providethe injectable contraceptive Sayana Press and other methods in the community, paving the way for othertask-shifting pilots including self-injection of Sayana Press with supervision by the students as well asinjection by community health workers.

ABSTRACTIn the Democratic Republic of the Congo (DRC), the Ministry of Health authorizes only physicians and nurses to giveinjections, with one exception—medical and nursing students may also give injections if supervised by a clinical in-structor. The emergence of the injectable contraceptive Sayana Press in some African countries prompted the DRC totest the acceptability and feasibility of distributing Sayana Press and other contraceptive methods at the communitylevel through medical and nursing students. Sayana Press is similar in formulation to the injectable contraceptiveDepo-Provera but contains a lower dose and is administered subcutaneously using a single-use syringe with a shortneedle called the Uniject system. The Uniject system allows Sayana Press to be administered by community healthworkers without clinical training or by self-injection. In this pilot, the advocacy objective was to obtain approvalfrom the Ministry of Health to allow medical and nursing students to inject Sayana Press, as a first step toward author-ization for community health workers to provide the method. The pilot described in this article documents a processwhereby an innovative approach moved from concept to implementation to replication in less than 2 years. It alsopaved the way for testing additional progressive strategies to increase access to contraception at the community level.Because the pilot project included a research component designed to assess benefits and challenges, it provided themeans to introduce the new task-shifting approach, which might not have been approved otherwise. Key pilot activ-ities included: (1) increasing awareness of Sayana Press among family planning stakeholders at a national conferenceon family planning, (2) enlisting the support of key decision makers in designing the pilot, (3) obtaining marketingauthorization to distribute Sayana Press in the DRC, (4) implementing the pilot from July to December 2015, (5) con-ducting quantitative and qualitative studies to assess acceptability and feasibility, and (6) disseminating the findings tofamily planning stakeholders. Before the pilot, Sayana Press was relatively unknown in the DRC, and there was noprecedent for medical and nursing students providing family planning methods or giving injections at the communitylevel. In less than 12 months, the approach gained legitimacy and acceptance. The key Ministry of Health decisionmaker orchestrated the closing session of the dissemination meeting on next steps, paving the way for pilot tests of3 new task-shifting approaches: insertion of Implanon NXT by medical and nursing students, self-injection forSayana Press with supervision by students, and injection of Sayana Press by community health workers with no formalclinical training.

BACKGROUND

The purpose of this article is to highlight the poten-tial of pilot research studies to achieve advocacy

objectives. Although the concept is not new, there islittle in the published literature to indicate its useas a best practice in international family planning.Research is usually viewed as a means of generatingrelevant data on the topic, but this case study describesa pilot study that served as the catalyst to achievingchange in regulations governing family planning serv-ice delivery in the Democratic Republic of the Congo

a Tulane International LLC, Kinshasa, Democratic Republic of the Congo.b Tulane School of Public Health and Tropical Medicine, New Orleans, LA,USA.Correspondence to Jane T Bertrand ([email protected]).

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(DRC). The pilot study usedmedical and nursingstudents to provide the injectable contraceptiveSayana Press (as well as other methods) as ameans to increase family planning uptake andthe modern contraceptive prevalence rate.Ultimately, the pilot study was designed to pavethe way toward subsequent authorization forcommunity health workers to provide SayanaPress.

Advocacy addresses different audiences atdifferent levels. At the global level, family plan-ning advocacy aims to increase investmentsfrom multilateral and bilateral donors as well asthe private sector in a particular area (e.g., familyplanning in general or for a specific issue such ascontraceptive security). Global advocacy effortsalso aim to set health and development goals towhich countries will aspire, as in the process sur-rounding the Sustainable Development Goals.At national and subnational levels, advocacy isfrequently used to increase government com-mitment toward family planning objectives,such as a budget line item for contraceptive pro-curement or removal of tariffs on the import ofcontraceptives. Itmay also be directed to changesin policy or regulations that directly affect thedelivery of family planning services, includingtask shifting to enable lower-level health work-ers such as nurses to perform clinical procedurespreviously reserved for physicians.1

The global health community increasinglyconsiders advocacy an essential tool to influencefinancial and political decisions that supportaccess to and use of voluntary high-quality fam-ily planning services. Family planning advocacytoolkits present guidelines for developing com-munication strategies and materials designed toinfluence policy decisions, including developingan advocacy strategy; engaging policy makers,health sector leaders, community leaders, andthe private sector; workingwith the newsmedia;and other resources.2 Best practices indicate theneed to present reliable data that frame the issuein terms consistent with national priorities,while presenting the material in simple, easy-to-comprehend formats.

Advocacy generally employs a combinationof evidence and emotional triggers. Advocatesseek to gather and analyze existing data (e.g.,Demographic and Health Surveys, MultipleIndicator Cluster Surveys, and other country-level studies) to inform their strategies, ratherthan generating their own data.2 Informationalone, however, rarely achieves an advocacy

objective. Qualitative research and the stories ofthose most affected by a specific policy or pro-grammatic barrier usually complement quanti-tative data. Well-known and highly respectedpersonalities can bring attention to an issue anddeliver messages to a larger and wider audience(e.g., Angelina Jolie as a U.N. Ambassador).According to a 2006 survey in sub-SaharanAfrica, respondents trusted faith-based organiza-tions more than they trusted their own nationalgovernments; religious leaders are thereforeuniquely positioned to reach both men andwomen to promote family planning and healthyreproductive behaviors.3

Despite available guidance on how to usefamily planning advocacy to achieve objectives,there is limited documentation on the resultsof these efforts. According to Smith and col-leagues,4 no studies have specifically investi-gated decision makers’ views on and use offamily planning research and advocacy.

THE ADVOCACY OBJECTIVE OF THE DRCPILOT STUDYIn early 2011 Sayana Press emerged as a promis-ingmeans of increasing access tomodern contra-ception at the community level in developingcountries.5 Although its formulation (104 mg ofdepot medroxyprogesterone acetate per 0.65mLdose) is similar to Depo-Provera, it contains alower dose and is administered subcutaneouslyusing a single-use syringe with a short needlecalled the Uniject system, which can be adminis-tered by trained community health workers andclients.

AWorld Health Organization (WHO) consul-tation in 2009 approved the use of injections bycommunity health workers, even before SayanaPress became available,6 and successful pilotsusing Depo-Provera have been reported fromother countries.7–9 Studies in Senegal andUganda have explored acceptability and feasibil-ity of introducing Sayana Press using commu-nity health workers,10 and a study in Ethiopiaexplored attitudes toward self-injection.11

In the DRC, a regulation limiting the provi-sion of injections to only physicians and nursesrepresented a major barrier to community-leveldelivery of Sayana Press. An important excep-tion, however, provided an open door to test aninnovative approach—medical and nursing stu-dents are allowed to give injections if supervisedby a clinical instructor. Thus, in the case study

Effective advocacyefforts usuallyrequirequantitative datacomplemented byqualitativeresearch andstories.

Sayana Press issimilar to Depo-Provera, butcontains a lowerdose and isadministeredsubcutaneouslyusing a single-use syringe with ashort needle,which can beadministered bycommunity healthworkers.

The first objectiveof the pilot was toobtain approvalfrom the DRCMinistry of Healthto allowmedicaland nursingstudents todistribute SayanaPress at thecommunity level.

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presented here, the advocacy objective was toobtain approval from the DRCMinistry of Healthto distribute Sayana Press—a new method thatwas not currently part of the approved methodmix—at the community level using medical andnursingstudents,asa first steptowardsubsequenttesting and eventual authorization for commu-nity health workers to provide this method.Not only would this mechanism contribute toincreasing access to this newmethod in the shortterm, it would also give future doctors andnursesa solid foundation in contraceptive technologyand servicedelivery.

PLANNING PHASEBefore the pilot began, a series of key activitiespaved the way to making it a reality: (1) a com-mitment to community-based distribution ofcontraception in the national strategic plan forfamily planning, (2) increased awareness of thenew Sayana Press method among stakeholders,(3) the support of key decision makers in thedesign of the pilot, (4) legal authorization fromthe Ministry of Health to distribute SayanaPress, and (5) a donation of 60,000 doses fromPfizer through the United Nations PopulationFund (UNFPA).

Commitment to Community-BasedDistributionThe Multisectoral Strategic Plan for FamilyPlanning in the DRC: 2014–2020 identifiedcommunity-based distribution as a key strategyfor the country to accelerate achievement of itsobjective of 19% modern contraceptive preva-lence use by 2020. This call for expansion ofcommunity-based distribution by the familyplanning stakeholder community was an impor-tant first step leading to the pilot.

Increased Awareness of Sayana PressIn the months leading up to the pilot, TulaneUniversity, the organization responsible forits implementation, sought opportunities toincrease awareness of this new contraceptivemethod and the studies taking place in othersub-Saharan African countries. At the ThirdNational Conference on Repositioning FamilyPlanning in the DRC in December 2014, theresearchers who also participated in organizingthe conference seized the opportunity to widelydiffuse information about Sayana Press and

present the pilot experiences in other countriesto the community of family planning stakehold-ers in the DRC. A physician from Senegal leadingthe Sayana Press initiative in that country gavean overview of the new contraceptive methodat one of the early plenary sessions, and aUNFPA consultant working in Burkina Faso ledamore clinically oriented session on themethod.Seminars were organized in parallel with theconference for the local obstetrics and gyne-cology, nursing, and midwives societies to fur-ther disseminate information about this newmethod, including the ease of application bynon-clinically trained personnel.

Support of Key Decision MakersBecause of the regulation that only physiciansand nurses can give injections in the DRC, it wasunclear whether the Ministry of Health wouldgive its approval to pilot test the use of medicaland nursing students to give injections at thecommunity level. It was therefore essential toenlist the support of the Ministry of Health, andin particular 2 departments (Directions) thathad jurisdiction over the organizations invol-ved in the pilot: the 10th Direction (10èmeDirection) which oversees the National Programof Reproductive Health (Programme National laSanté de la Reproduction, or PNSR), and the 6thDirection (6ème Direction), which oversees thetraining institutes for nursing through thecountry.

The researchers obtained agreement fromthe director of the 10th Direction that he wouldchair a meeting of key stakeholders in January2015. The objectives of the meeting were to(1) present the implementation and study designplans for the pilot introduction of Sayana Press;(2) solicit feedback from stakeholders; (3) en-courage an open exchange of opinions on thebenefits and challenges of this approach; and(4) obtain buy-in among family planning stake-holders for the pilot. Organizing the pilot as aresearch study that would assess the benefitsand limitations of the approach enabled thedecision makers to authorize this innovativeapproach to service delivery, but on a limitedscale; further expansion of the approach woulddepend on the results of the research. Stake-holders were supportive overall and providedvaluable feedback and opinions; however, theycalled for several changes to the plans, includingthe inclusion of both urban and rural health

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zones to make the results more generalizablefor subsequent replication. At a follow-upmeeting in February 2015, the director of the10th Direction approved the research pilot.

Given that the research team intended towork through local medical and nursing schools,another key decision maker enlisted for supportwas the 6th Direction, which oversees nursingtraining institutes throughout the country. Theproposed pilot was expected to appeal to the 6thDirection in several ways. Medical and nursingtraining institutes traditionally use a curriculumthat focuses primarily on clinical care in hospitalsand health facilities. The proposed activitywouldprovide students with the experience of workingat the community level, thus preparing them fora broader array of tasks in the future. Moreover,it would put students in direct contact with cli-ents and enhance their skills in both counselingand service provision.

A local NGO, Association de Santé etDévéloppement (Association for Health andDevelopment), was hired to implement the pilotand entered into discussions with the director ofthe 6th Direction. The initial inquiries met withconsiderable enthusiasm, for the reasons notedabove. The director’s support was so enthusiasticthat he offered the NGOaffordable office space tooversee the initiative in the same building.

Legal Authorization to Distribute SayanaPressAt a roundtable for government, donors, andpartner organizations in December 2014 (in con-junction with the Third National Conference onRepositioning Family Planning in the DRC), theminister of health publicly announced a 1-yearapproval (also called awaiver) to allow the distri-bution of Sayana Press in the DRC. In that samemonth, the 3rd Direction (responsible for phar-maceutical products) issued the marketing au-thorization (known as AMM, l’autorisation demise sur le marché) for a 12-month period. Withthis authorization in place, Pfizer donated60,000 doses of Sayana Press in March 2015 forthe pilot.

IMPLEMENTATIONIn early 2015, 10 medical and nursing traininginstitutes were selected to participate in the pilot.Each one nominated a member of its clinical fac-ulty to serve as a focal point to supervise the stu-dents involved in the pilot.Members of the PNSR

and several family planning implementingorganizations developed the training curriculumand materials. In April and May 2015, 135 med-ical and nursing students received 7 days oftraining on multiple aspects of service delivery:contraceptive technology, management of sideeffects, eligibility and delivery of 4 methods(condoms, pills, CycleBeads, and Sayana Press),and procedures for referring interested clients toa nearby health center for clinical methods (e.g.,intrauterine devices and implants). The studentsalso participated in a 1-day field practicum, inwhich they gave family planning counseling,screened clients for eligibility, provided the4 contraceptive methods to interested clients,and made referrals in a real-life communitysetting.12

The pilot officially began in July 2015. Thedelivery of contraceptive methods took severalforms: (1) campaign days, in which a group ofapproximately 15 to 20 medical and nursing stu-dents provided counseling and contraception towomen from the community who had beeninformed of the opportunity to get free contra-ceptive services on a specific day; (2) house-to-house visits to counsel women and couples onthe use of family planning (with delivery ofmethods to interested, eligible women); and(3) distribution of contraception on campuses orother sites in the community.12 The medical andnursing studentswere referred to as community-based distribution agents (distributeurs à basecommunautaire, or DBC). When given the choiceof 4 methods available on-site and others avail-able through referral to a nearby health facility,approximately one-quarter of clients choseSayana Press on-site.

During the implementation of the pilot andrelated research, the researchers regularly up-dated the directors of the 6th and 10th Direc-tions, but did not involve them directly in theroutineoperationsof thepilot.

KEY FINDINGS FROM THE RESEARCHCOMPONENTThe research component of the pilot used mixedmethods. The quantitative research consisted of3 surveys: one among acceptors of Sayana Press(n = 374) who were interviewed directly afterreceiving Sayana Press, a second among 252 ofthe original 374 respondents at a 3-monthfollow-up, and a third among 124 of the135 medical and nursing students who had

10medical andnursing traininginstitutes wereselected toparticipate in thepilot.

Service provisiontook severalforms: throughspecific campaigndays, house-to-house visits, anddistribution oncampuses orother communitysites.

Criticalmilestones for thepilot includedtemporary legalauthorizationfrom theMinistryof Healthallowingdistribution ofSayana Press,marketingauthorization forthemethod, anda donation of60,000 dosesfrom Pfizer.

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participated, to assess their experience ascommunity-based distributors. The qualitativecomponent consisted of in-depth interviewswith 29 key informants: Ministry of Health per-sonnel in decision-making positions, the chiefmedical officers for selected health zones, nursesin fixed facilities, and staff from the organiza-tions that implemented the pilot.

Key findings from the quantitative surveysand qualitative in-depth interviews are summar-ized below. Full results from the quantitativesurveys will be published separately.

Acceptors of Sayana PressAmong all Sayana Press acceptors, 51.6% hadnever used contraception, including traditionalmethods. Overall, their experience with SayanaPress was positive; 87.4% encountered no prob-lems. Just over half (58.5%) felt some pain at thetime of the injection, but only 9.7% reportedpain afterward and 3.4% had side effects.Among acceptors who attended their follow-upappointment 3 months after the first injection,92.3% received a second injection. The largema-jority was satisfied with the counseling and serv-ices received from the medical and nursingstudents.

Medical and Nursing StudentsSix months after implementation began, 92% ofstudents were still participating in the project. Ofthese, 46.8% were medical students and 53.2%were nursing students. The median age was22 years old and most of the students (71.8%)were women. More than 90% reported that thecommunity was favorable toward their services.The vast majority expressed satisfaction in serv-ing as community-based distributors, and morethan 95% would recommend it to others. Theirprimary complaint was lack of remuneration,followed by insufficient supervision and contra-ceptive stock-outs.

Key InformantsOverall, key informants in decision-makingpositions (Ministry of Health personnel, chiefmedical officers for health zones, nurses, andstaff from implementing organizations) res-ponded positively to the pilot study and the strat-egy of using medical and nursing students ascommunity-based distributors. They had notheard of opposition specifically directed towardSayana Press or the pilot introduction, although

there was a low level of opposition to familyplanning in general. Key informants stressedthe need for careful training of community-based distributors. Zonal health authoritieswere also amenable to the community-baseddistribution method and were unaware of oppo-sition at the community level. All favored expan-sion to other health zones, especially those thatare heavily populated. The key informants citedseveral challenges: scheduling conflicts betweenstudents’ academic program and the pilot, recur-rent issues with contraceptive resupply of thecommunity-based distributors, incomplete re-porting of service statistics by the students onthe distribution of products, and uneven respon-siveness of the focal points in different traininginstitutes. Despite these challenges, the staffinvolved in implementing the pilot were uni-formly supportive of this method of usingstudents to distribute contraception at the com-munity level and encouraged its expansion toother training schools and other provinces.

DISSEMINATION OF THE FINDINGSIn December 2015, the research team held a1-day dissemination event at a hotel in Kinshasawithmore than 80 participants. The audience forthis event included the primary family planningstakeholders: representatives from the PNSRand the Programme National de Santé del’Adolescent (National Program for AdolescentHealth), other Ministry of Health authorities,family planning implementing organizations,military and police, faith-based-organizations,donors (e.g., U.S. Agency for InternationalDevelopment [USAID], UNFPA,WHO), and uni-versity researchers, among others.

The moderator was a well-known and highlyrespected figure in the local family planningcommunity, which enabled the director of the10th Direction to focus on presentations andprovide commentary during the event. The pro-gram covered a series of topics: Sayana Press asa newmethod, details about the pilot implemen-tation process, testimonials of focal points(supervisors) from several training institutes,and testimonials of 4 participating medical andnursing students. In later sessions, the researchteam presented highlights from the surveys ofacceptors (on the day of the injection and3 months later), the survey of students partici-pating in the pilot, and a summary of the key in-formant interviews. From the tone of the

Among allSayana Pressacceptors, abouthalf had neverusedcontraception,includingtraditionalmethods.

The vast majorityof medical andnursing studentsexpressedsatisfaction inserving ascommunity-based agents,andmore than95%wouldrecommend it toothers.

Key decisionmakers in familyplanning weresupportive of thepilot overall andfavored itsexpansion.

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discussion, the majority of the audience seemedamenable to the use of medical and nursing stu-dents to deliver Sayana Press.

A highlight of the advocacy process was inthe final session of the dissemination event onnext steps, led by the director of the 10thDirection. Rather than having the director orresearch team outline possible next steps, thedirector encouraged stakeholders to recommendpossible variations for further testing. The audi-ence collectively volunteered 17 approaches, forexample, replicating the model in other provin-ces, using a similar approach in military andpolice health zones, having community-basedworkers (who receive short-term training to per-form a specific task) deliver Sayana Press at thecommunity level, piloting self-injection of

Sayana Press, and conducting a similar pilotintroduction of Implanon NXT (a contracep-tive implant preloaded in a disposable applica-tor) by medical and nursing students, amongothers. Participants publicly endorsed the useof students as distributors of Sayana Press atthe community level and called for the pilot-ing of additional approaches that were veryprogressive by local standards. The director ofthe 10th Direction implicitly endorsed thepilot by encouraging the audience to recom-mend related pilots. Moreover, the final reportof the research results for the pilot was issuedwith his signature.

Figure 1 summarizes the sequence of stepsthat led to the achievement of the advocacyobjective: the DRC government approval of

FIGURE 1. Steps Leading to the Democratic Republic of the Congo Government’s Approval ofCommunity-Based Provision of Sayana Press by Medical and Nursing Students, December2014–December 2015

Result: Medical and nursing students implement pilot introduction of Sayana Press

July–December 2015

Third National Conference on Repositioning Family Planning, Sayana Press Presentation, December 2014

Ministry of Health (MOH) authorizes registration and marketing of Sayana Press

December 2014

Meetings on Sayana Press gain support of MOH,

Directions, technical partners, and donors

January–February 2015

Meetings with medical and nursing schools urge

provision of Sayana Press by medical and nursing

students

February–March 2015

Pfizer donates 60,000 doses for Sayana Press pilot

March 2015

10 supervisors and 135 medical and nursing students recruited and trained to provide

Sayana Press at community level

April 2015

At an event todisseminate thefindings of thepilot, 80 keyfamily planningstakeholderspublicly endorsedthe use ofstudents asdistributors ofSayana Press atthe communitylevel and calledfor replicatingvariations of thepilot.

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community-based provision of Sayana Press bymedical and nursing students. Figure 2 illustrateshow this type of policy change influences accessto contraception and increases contraceptiveuptake.

RAPID DIFFUSION, REPLICATION, ANDTESTING

In early 2015 before the pilot, Sayana Press wasrelatively unknown, and there was no precedentfor having medical and nursing students giveinjections at the community level. In less than ayear, the approach gained legitimacy and accep-tance. Both the 6th and 10th Directions wereanxious to know what plans were under way toexpand the use of students as community-basedproviders of Sayana Press (and other contracep-tive methods) and when the next round of pilotintroductions would begin. Within 12 months ofthe results dissemination, multiple activitieswere under way that built on the original pilot:

� Institutionalizing the use of medicaland nursing students within the 6thDirection. A private donor came forward tofund the institutionalization of the approachthrough the 6th Direction, which will involvedeveloping a more comprehensive module oncontraceptive technology as part of preservicetraining and making community-level serviceprovision a routine part of the students’ train-ing and as part of the health informationsystem.

� Replicating the approach in anotherprovince. In October 2016, 119 nursing stu-dents received training as community-baseddistributors in Matadi, provincial capital ofKongo Central, and began providing SayanaPress, Implanon NXT, pills, male condoms,and CycleBeads at the community level.

� Recruiting similar cadres of workers todistribute Sayana Press. Several organiza-tions funded by USAID recruited students

FIGURE 2. Pilot Program in the Democratic Republic of the Congo Prompts Policy Change andIncreased Access to and Use of Sayana Press, 2015

Sayana Press pilot results presentedunder the

auspices of the Ministry of

Health Additional funding enables scale-up of Sayana Press

provision

Increased access to and use of Sayana

Press

Sources of validation for policy changes: Pilot study report, Secretary General for Health authorization of community-based distribution by medical and nursing students in subsequent pilots, number of students recruited and trained, PMA2020 data.

Sayana Press pilot leads to training of additional medical and nursing students

Abbreviation: PMA2020, Performance Monitoring and Accountability 2020.

The pilot beganwith aninnovativeapproach andmoved fromconcept toimplementationto replication inless than 2 years.

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and similar cadres (Red Cross workers) inother provinces to undertake community-level work in their projects.

� Conducting additional pilot researchprojects. Two new research pilots began inKinshasa in late 2016 to test the use ofmedicaland nursing students to (1) train women inself-injection of Sayana Press, and (2) insertImplanon NXT at the community level. Athird pilot will begin in early 2017 to test theuse of community health workers (whoreceive short-term training to perform specifictasks) to provide Sayana Press as part of anongoing community-based distribution pro-gram. The Secretary General for Healthauthorized these 3 new pilots in a letter datedJune 29, 2016 (NoMS.1251/SG/GM/1486/MK/2016).

� Trainingmedical andnursing students todeliver an expanded package of services.A major donor came forward with additionalfunding to test the effectiveness of studentsin the provision of integrated maternal andchild health and family planning services forfirst-time mothers ages 15 to 24. This gender-transformative project also incorporates thefathers of the babies as part of the populationthat would benefit from the intervention.

There were other positive outcomes from theSayana Press pilot. The inclusion of the largerfamily planning stakeholder community in theinitial deliberations over the pilot engenderedsupport for and use of the final results. The posi-tive findings from the pilot encouraged 2 majorcontraceptive donors—USAID and UNFPA—toprocure larger quantities of the product torespond to the potential large demand forSayana Press generated through other pro-jects. The 2 social marketing projects based inKinshasa also intensified their promotion ofSayana Press following the pilot.

KEY SUCCESS FACTORSThere is nothing novel in the concept of doinglocal research on issues that have beenresearched elsewhere as a means of obtaininglocal buy-in for innovative approaches. What isremarkable in this particular pilot is how fastthe change took place. Although one cannot saywith certainty what triggered the rapid change,several factors appear to have played a role.

First, the environment was ripe for innova-tion in the area of family planning. Since 2012,the DRC government has shown increasing po-litical will toward family planning.13 The PrimeMinister’s Office has repeatedly linked thedemographic dividend to the country’s aspira-tions to be an emerging nation by 2030. Theinternational donor community has reactedvery favorably, both in terms of additional finan-cial support to family planning initiatives andvisibility in international fora (e.g., the invitationof the prime minister to address the closingplenary session at the 2016 InternationalConference on Family Planning in Nusa Dua,Indonesia.)14 The DRC has often lagged in devel-opment initiatives, as reflected by its highmater-nal and infant mortality rates. Yet in familyplanning, the DRC is emerging as a regionalleader. The momentum around family planningin the DRC created an environment that was ripefor another progressive step in family planning:authorization of the distribution of Sayana Pressat the community level.

Second, the research component of the pilotallowed for experimentation with the approachon a limited basis without requiring a large-scalepolicy change. Policy makers could reduce theirpolitical liability by withholding authorizationon a larger scale, pending results of the pilot. Ifsuccessful, they had evidence with which to sup-port the expansion of the approach beyond thepilot sites. If unsuccessful, they could withholdapproval, either entirely or pending modifica-tions to the design.

LESSONS LEARNEDAdvocacy efforts require tailoring to specificcountries because of differences in political,social, legal, and economic contexts. However,certain lessons from this experience in Kinshasaare likely applicable to other advocacy efforts:

1. There was clear political commitment tofamily planning and to community-baseddistribution as reflected in the NationalMultisectoral Strategic Plan for FamilyPlanning: 2014–2020, which called forcommunity-based distribution as a means toincrease contraceptive access and thusincrease the modern contraceptive preva-lence rate to 19% by 2020.

Other outcomesof the pilotincluded theprocurement oflarger quantitiesof Sayana Pressby 2majorcontraceptivedonors andintensified effortsamong socialmarketingprojects inKinshasa topromote themethod.

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2. A clear and achievable advocacy objectivewas set and informed by a group of influentialand knowledgeable stakeholders.

3. Relevant decisionmakers were identified andenlisted from the start, not only to participatebut to take a lead role in shaping the design ofthe research pilot.

4. The involvement of family planning stake-holders (including policymakers) in develop-ing consensus on the design contributed tothe success of this pilot and opened doors tonext steps.

5. The research team cleared the necessarylegal hurdles (obtaining authorization forthe entry of Sayana Press into the localpharmaceutical market) with the supportof local officials.

6. The pilot involved 3 Directions within theMinistry of Health, all of whom played a keyrole in its success.

7. The design lent itself to replication to otherprovinces and institutionalization within theMinistry of Health.15

FINAL REFLECTIONSWeacknowledge that advocacyhas limitations. Itrelies on a range of expertise to inform objectivesand to implement policies and programs. Rarelydo we have a counterfactual of what would havehappened in the absence of the advocacy initia-tive. Moreover, serendipitous events can occurthat either facilitate or hinder an advocacy effort.As a result, evaluation of the role of advocacy inimproving health conditions may not be defini-tive. For example, Figure 2 points to plausiblepathways by which advocacy influences behav-ioral outcomes among the target population, butit doesnotdemonstrate cause andeffect.

Curiously, the strength of this pilotwas not intheprecise findings it obtainedbut rather thepro-cess used in designing, implementing, research-ing, and disseminating the results publicly to alarge group of relevant stakeholders. This beingsaid, it is essential that the researchmethodologyused to support advocacy objectives be of thehighest quality, and that results—both positiveandnegative—bedisseminated.

Acknowledgments: This article was developed under grant#OPP1117997 awarded to the Tulane University School of PublicHealth and Tropical Medicine by the Bill & Melinda Gates Foundation.

The findings and conclusions contained within are those of the authorsand do not necessarily reflect positions or policies of the Bill & MelindaGates Foundation. The authors wish to thank Perri Sutton for herdiligent oversight of the work under this grant. Beth Fredrick and KateBarrett of the Advance Family Planning Project at the Johns HopkinsBloomberg School of Public Health provided valuable editorialsuggestions to this article.

Competing Interests:None declared.

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Peer Reviewed

Received: 2016 Jul 23; Accepted: 2016 Oct 28; First Published Online: 2016 Dec 15

Cite this article as: Binanga A, Bertrand JT. Pilot research as advocacy: the case of sayana press in Kinshasa, Democratic Republic of the Congo.Glob Health Sci Pract. 2016;4(4):542–551. http://dx.doi.org/10.9745/GHSP-D-16-00236

© Binanga and Bertrand. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permitsunrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly cited. To view a copy of thelicense, visit http://creativecommons.org/licenses/by/3.0/. When linking to this article, please use the following permanent link: http://dx.doi.org/10.9745/GHSP-D-16-00236

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Global Health: Science and Practice 2016 | Volume 4 | Number 4 551