September 3, 2014 Sayana Press intrductin plan PATH/Will Base Uganda summary MAILING ADDRESS PO Bx 900922 Seattle, WA 98109 USA ADDRESS 2201 Westlake Avenue Suite 200 Seattle, WA, USA TEL: 206.285.3500 FAX: 206.285.6619 www.path.rg
I. Key milestnes 2014 Milestne Cmpleted Sayana Press training prgram fficer (PATH) hired January Regulatry apprval received April Sayana Press rder placed May First frmal partner meeting held May Natinal VHT training curriculum apprved by MOH July District rientatins cmpleted (PATH, Pathfinder) July Trainers selected (PATH, Pathfinder) July Mnitring tls finalized with partners August Sayana Press units arrived in cuntry August 26 First training f district trainers (PATH, Pathfinder) September 3-6 II. Family planning landscape: Uganda Family planning cmmitments. At the July 2012 Lndn Summit n Family Planning, the gvernment f Uganda cmmitted t lwering unmet cntraceptive need frm its current 34 percent t 10 percent by 2020. In late July 2014, the Uganda Ministry f Health (MOH) cnvened the first natinal cnference n family planning at which President Yweri Museveni made strng supprtive statements abut the imprtance f family planning. Ttal fertility rate (TFR) and mdern cntraceptive use. The TFR in Uganda remains high at 6.2 children per wman; the use f mdern cntraceptive methds has increased substantially, frm 14 t 26 percent, between 2006 and 2011 (DHS 2011). Family planning methd mix. The injectable is the mst ppular methd, representing ver half the mdern methd mix (54 percent), and is used by 14 percent f married wmen (11 percent f all wmen). Currently, the intramuscular frmulatin f dept medrxyprgesterne acetate (DMPA- IM) is distributed fr free in the public sectr. A scially marketed brand f Dep-Prvera is als distributed and sld natinally thrugh pharmacies, drug shps and clinics. Unmet need fr family planning. Over ne-third f married wmen (34 percent) have an unmet need fr cntraceptin, with higher levels f unmet need in rural areas (37 percent). Cmmunity-based distributin (CBD) f injectables. Uganda initiated scale-up f cmmunitybased distributin (CBD) f injectables, and an estimated 1,000 Village Health Teams (VHTs) in up t 15 (f 112) districts currently ffer the intramuscular (IM) frmulatin f DMPA (FHI 360, 2013). Plicy envirnment. Pilt prjects in Uganda have demnstrated that cmmunity health wrkers (CHWs) can safely and effectively deliver injectable cntraceptives. 1 Uganda s MOH has prduced Dep-Prvera is a registered trademark f Pfizer Inc. 1 Stanback J, Mbnye AK, Bekiita M. Cntraceptive injectins by cmmunity health wrkers in Uganda: a nnrandmized cmmunity trial. Bulletin f the Wrld Health Organizatin. 2007;85:768 773. Available at: http://www.wh.int/bulletin/vlumes/85/10/07-040162.pdf. 2
written plicy and service-delivery guidelines, as well as training curricula, that supprt VHTs t deliver injectable cntraceptives. 2 These same guidelines indicate the types f service prviders wh are authrized t administer injectable cntraceptives. Althugh pharmacists and drug shp wrkers are nt frmally permitted t administer injectable cntraceptives, research indicates that the practice is cmmn. The MOH, FHI 360, and Advance Family Planning (AFP) are cllabrating t cnsider safe and effective appraches t utilizing drug shps t increase access t injectable cntraceptives. 3 The utcme f AFP s wrk may have an impact n the ptential fr drug shps t serve as delivery channels fr Sayana Press thrugh the private cmmercial sectr. III. Sayana Press intrductin strategy The Uganda MOH is participating in the Sayana Press pilt intrductin prject fr the fllwing reasns: T supprt the achievement f Uganda s Family Planning 2020 (FP2020) gals. T address persistently high ttal fertility rate and unmet need fr cntraceptives. T ffer an injectable cntraceptive methd that can be used easily by Uganda s CHWs in the VHT system. T build n experience gained frm the 2012 Sayana Press acceptability study and peratinal assessment in Mubende and Nakasngla districts. The Sayana Press intrductin strategy fr Uganda, as endrsed by the Uganda MOH, includes public and private intrductin (Maternal-Child Health Cluster meeting, Kampala, June 2013). The MOH s strategy includes the delivery f Sayana Press thrugh the VHTs. VHTs are Uganda s natinal cadre f public-sectr CHWs wh rutinely deliver preventive health services such as family planning, malaria preventin, HIV/AIDS supprt, and clinic referrals. The MOH reprts an estimated 100,000 VHTs natinally with varied levels f training and functinality. Mst VHTs wh ffer family planning services distribute cndms and ral cntraceptives. The public-sectr Sayana Press strategy supprts the Uganda MOH s plicy f scaling up delivery f injectable cntraceptives amng VHTs by training an estimated 2,560 VHTs t deliver Sayana Press and DMPA-IM. Mst f the VHTs t be trained are nt currently delivering DMPA-IM. Sayana Press is being intrduced in 29 districts in the public sectr, as shwn in Figure 1. PATH will als train clinic-based prviders t deliver Sayana Press in five additinal service delivery sites in tw f these Sayana Press is a registered trademark f Pfizer Inc. 2 Knwledge fr Health (K4Health) Prject. Plicy Guidelines and Service Delivery Standards fr Cmmunity Based Prvisin f Injectable Cntraceptin in Uganda. Baltimre, MD: K4Health; 2010. Available at: http://www.k4health.rg/sites/default/files/uganda_cbd_guidelines_signed_0.pdf. 3 FHI 360. Uganda Prgram Brief: Using Drug Shps t Increase Family Planning Access and Methd Chice in Uganda. Durham, NC: FHI 360; 2013. Available at: www.fhi360.rg/sites/default/files/media/dcuments/brief3- drug-shps-uganda.pdf. 3
districts (Gulu and Mubende), with the ultimate gal f establishing these as future sites fr research n hme and self-injectin f Sayana Press. The private-sectr Sayana Press strategy supprts Reprductive Health Uganda (RHU) t strengthen their capacity t deliver injectable cntraceptin in Gulu, with a fcus n yuth. PATH will train RHU s prviders, including RHU s clinic-based prviders and utreach wrkers, t deliver Sayana Press. Sayana Press will be included amng RHU s standard methd fferings in Gulu. The riginal Uganda intrductin apprach supprted by the MOH als included ptential Sayana Press intrductin thrugh scial marketing, which is still t be determined. IV. Gegraphic fcus PATH, Pathfinder Uganda, Marie Stpes Uganda (MSU), and FHI 360 wrked with the MOH in 2013 t priritize districts fr the pilt intrductin where there is high unmet need fr family planning, challenges t health system access, and the presence f strng implementing partners. Gulu was added in 2014 due t strng ptential t reach yuth there with family planning interventins. Figure 1: Map f Uganda shwing 29 districts fr Sayana Press public-sectr intrductin. 4
Nte: In ne district, Mityana, MSU has already trained VHTs, and FHI 360 will plan t train additinal VHTs mving ahead. V. Implementing partners and rles PATH Uganda leads cuntry-level crdinatin f intrductin activities. PATH Uganda cnvenes a partner crdinatin grup n a mnthly basis t mnitr prgress n key milestnes and address prblems in real time as they arise. The partner crdinatin grup includes Pathfinder Uganda, RHU, Uganda Health Marketing Grup (UHMG), FHI 360, MSU, WellShare Internatinal, and the Cmmunicatin fr Develpment Fundatin Uganda (CDFU). Representatives f the reprductive health divisin f the MOH, United Natins Ppulatin Fund (UNFPA) Uganda, and US Agency fr Internatinal Develpment (USAID) Uganda are invited t participate quarterly. The partner crdinatin grup prepared an integrated Sayana Press intrductin wrk plan t assure ptimal crdinatin acrss all f the wrk t be undertaken by the individual partners. PATH als attends regular MOH Maternal-Child Health Cluster meetings t represent the Sayana Press prject. Table 1: Key partners in intrductin f Sayana Press in Uganda and descriptin f primary rles. 5
Key partner Ministry f Health Uganda Bill & Melinda Gates Fundatin Children s Investment Fund Fundatin (CIFF) US Agency fr Internatinal Develpment (USAID) United Natins Ppulatin Fund (UNFPA) New Yrk and Cpenhagen United Natins Ppulatin Fund (UNFPA) Uganda UK Department fr Internatinal Develpment (DFID) PATH Uganda Pathfinder Uganda District Health Teams Uganda Health Marketing Grup (UHMG) Primary rle Prvide administrative and technical versight thrugh the MOH s Maternal-Child Health Cluster (MCH Cluster) wrking grup. Manage public-sectr prvisin thrugh VHTs. Serve as decisin-making authrity. Supprt PATH multi-cuntry prject crdinatin and research. Prvide funds t UNFPA fr prduct prcurement, and t PATH fr implementatin activities (training, end-user cmmunicatin, and distributin). Prvide strategic and prgrammatic guidance. Supprt PATH multi-cuntry prject crdinatin and research. Prvide funds t PATH fr implementatin activities, with an emphasis n training VHTs and yuthfriendly intrductin. Prvide strategic and prgrammatic guidance. Prvide funds t FHI 360 Uganda, MSU, and WellShare fr training VHTs. Prvide strategic and prgrammatic guidance. Prcure Sayana Press frm Pfizer Inc. fr public-sectr distributin (multiple cuntries). Serve as Uganda cnsignee fr the Sayana Press prduct. Oversee prduct rder and delivery. Liaise with MOH t prepare rder (quantificatin exercise). Prvide technical and prgram supprt t cuntry implementatin. Prvide funds t UNFPA fr prduct prcurement (multiple cuntries). Crdinate cuntry activities and partners, liaising with the Uganda MOH and cuntry ffices f Sayana Press dnr cnsrtium partners. Crdinate regulatry applicatin, prcurement, and distributin. Fund training, cmmunicatin, distributin, and yuth-friendly nngvernmental rganizatin (NGO) intrductin partner. Train 700 VHTs in 5 districts t administer DMPA-IM and Sayana Press and design, fund, and supervise mnitring data cllectin. Train 500 VHTs in 5 districts t administer DMPA-IM and Sayana Press and cllect mnitring data. Wrk with PATH t establish and maintain wrking relatinships with the District Health Teams (DHTs) in the target districts. Crdinate district health activities and versee prviders at Health Centre II and III, wh will supervise and supprt the VHTs t prvide Sayana Press and DMPA-IM in cmmunities. Prvide strage and inventry cntrl f Sayana Press units prcured by UNFPA. In cllabratin with the DHTs, PATH, Pathfinder Uganda, FHI 360, Marie Stpes Uganda, and WellShare, distribute prduct t public-sectr service prvisin pints. Marie Stpes Uganda (MSU) Train 140 VHTs in 3 districts and share mnitring data with PATH.. 6
FHI 360 Uganda Train 1060 VHTs in 15 districts and share mnitring data with PATH. WellShare Internatinal Reprductive Health Uganda (RHU) Cmmunicatin fr Develpment Fundatin Uganda (CDFU) Train 160 VHTs in 2 districts and share mnitring data with PATH (cntingent n prject apprval). Intrduce Sayana Press thrugh their clinic, utreach wrkers, and affiliated VHTs in Gulu, with an emphasis n reaching yuth. Develp and implement a Sayana Press cmmunicatin strategy. Prepare family planning prmtinal materials. Disseminate in 10 districts where PATH and Pathfinder are training VHTs. VI. Prduct registratin, prcurement, and distributin Sayana Press was registered by the Uganda Natinal Drug Authrity (NDA) n April 23, 2014; Pfizer Inc. submitted Sayana Press fr regulatry apprval by the Uganda NDA in February 2013. The first rder f 331,000 Sayana Press units arrived in Uganda n August 26, 2014. The units were rdered frm Pfizer Inc. by UNFPA in May 2014 using DFID funds. It is prjected that mre than 200,000 mre units f Sayana Press will be rdered in 2015, dependent n uptake during the first tw t three quarters f pilt intrductin. The initial rder quantity is based n the current intrductin strategy and VHT training plans prepared by PATH and Pathfinder Uganda. This initial rder quantity will als be used t cver FHI 360 s, MSU s, and WellShare s initial prduct requirements (thse partners are still finalizing their demand estimates). Sayana Press cnsumptin in Uganda was estimated using a prvider-based mdel. This mdel used the number f prviders (VHTs) t be trained and their distributin settings t estimate ptential cnsumptin f Sayana Press. Mre detail n the mdel is available in the Octber 2013 Uganda Cuntry Summary. The UNFPA Uganda cuntry ffice serves as the cnsignee fr the Sayana Press units imprted int the cuntry n behalf f the Uganda MOH, and is handling imprtatin and clearing f the prduct with assistance frm PATH Uganda and the prject s distributin partner, UHMG. This prcess has made it pssible t imprt the Sayana Press units fr the pilt intrductin prject int Uganda duty free. Upn clearing, the Sayana Press units were delivered t UHMG. UHMG has in place an agreement with the MOH, UNFPA, USAID, and DFID t act as a backup distributin partner fr the MOH, wrking with NGO partners that cllabrate with the MOH fr delivery f family planning services. Therefre, UHMG already has public-sectr supplies f DMPA-IM in stck fr use by NGO partners. UHMG s distributin rle fr the pilt intrductin f Sayana Press is endrsed by the MOH as an extensin f UHMG s existing agreement with the MOH and the dnrs. The Uganda Natinal 7
Medical Stres will be the MOH s distributin partner in the future if Sayana Press is prcured n a larger scale fr distributin natinally. UHMG s public-sectr distributin scpe fr the pilt intrductin f Sayana Press includes the fllwing activities: Prduct clearing, strage, and inventry cntrl fr Sayana Press units entering Uganda fr the pilt intrductin. Making Sayana Press available t training partners and the facilities and district health teams participating in the pilt intrductin during the training phase. Assuring delivery f Sayana Press units t primary distributin pints (HC II and III; tw NGO clinics), beginning 1 t 2 mnths after initial distributin has been made by training partners. T maintain and prvide accurate recrds t PATH regarding Sayana Press inventries, cllectin f expired prduct, deliveries, and receipts fr each participating facility. Warehusing and inventry cntrl at central level, maintaining a first-in, first-ut (FIFO) distributin system. The training partners (PATH, Pathfinder, FHI 360, MSU, WellShare) are respnsible fr btaining Sayana Press units frm UHMG and distributing the initial prduct stck t Health Centres II and III in their respective districts; the Health Centres are respnsible fr stcking the Sayana Press and DMPA-IM units t be used by the VHTs n an nging basis. VII. Service-delivery pints Sayana Press is initially being intrduced thrugh VHTs, many f whm have been previusly trained in basic family planning. Althugh the exact number f VHTs delivering Sayana Press per health facility is unknwn, intrductin will be clustered in areas where PATH and the partners have identified the greatest pprtunity fr intrductin, based n district visits by PATH, Pathfinder, MSU, and FHI 360 in 2013. The prject priritizes sub-cunties and health centers (specifically HC IIs, the lwest level f health facility) that have nging family planning distributin f cndms and pills thrugh VHTs in rder t leverage an already-functining distributin system. RHU s clinic in Gulu will serve as a private NGO intrductin site in Uganda fcused n reaching yuth. PATH will train RHU prviders based at the Gulu clinic, ne f whm will specifically versee integratin f Sayana Press int RHU s utreach activities in Gulu. In rder t establish apprpriate sites fr planned research n hme and self-injectin (HSI), t be implemented by the MOH and PATH, PATH is training facility-based prviders at tw additinal public-sectr sites in Gulu (Gulu Hspital and Lar HCIII), and three additinal public-sectr sites in Mubende (Kasambya HCIII, Kasanda HCIV, and Mubende Hspital). 8
VIII. Training PATH, Pathfinder Internatinal Uganda, FHI 360, MSU, and WellShare are training the 2,560 VHTs participating in the pilt intrductin f Sayana Press (see Table 2). All VHTs are being trained in family planning, including bth Sayana Press and DMPA-IM. Training in bth methds helps assure methd sustainability if Sayana Press is nt available after the pilt prject. Table 2: Training update fr Uganda, by implementing partner. Organizatin Number f VHTs Number f districts Status FHI 360 1,060 15 Upcming in Octber 2014 MSU 140 3 Cmpleted (ptentially mre upcming) PATH 700 5 In prcess thrugh January 2015 Pathfinder 500 5 In prcess thrugh January 2015 WellShare 160 2 Upcming (pending apprval) Ttal 2,560 29 (nte ne shared district between FHI 360 and MSU) PATH and Pathfinder are delivering the VHT training fr injectable cntraceptives (DMPA-IM and Sayana Press) in seven days, based n a streamlined versin f the Uganda MOH family planning curriculum fr VHTs which integrates PATH s cre training curriculum fr Sayana Press. The curriculum als includes additinal cntent n yuth reprductive health and rights. This adapted 7- day curriculum was apprved by the Uganda MOH in July 2014 and has been frmally adpted as the MOH s natinal curriculum fr VHTs. PATH and Pathfinder are using a standardized training-f-trainers (TT) apprach acrss the 10 districts t implement the full training prgram between September 2014 and January 2015. PATH and Pathfinder have identified trainers in each district using a set f established eligibility criteria, including sufficient family planning knwledge and training experience. The VHT supervisrs at the Health Centre II levels in each district are als being trained. MSU cmpleted training VHTs in DMPA-IM and Sayana Press using the previus MOH 10-day VHT curriculum earlier this year, prir t apprval f the new curriculum in July. MSU used a standard TT apprach t train VHTs. MSU may receive additinal funds fr further training. FHI 360 is emplying a 2-phase training apprach ver 2 years starting in Q4 2014. In the first phase, VHTs will be trained in general family planning (including DMPA-IM), and in the secnd phase they will be trained in Sayana Press. FHI 360 plans t train 350 VHTs in the first year, likely starting in Octber 2014. 9
WellShare has already trained VHTs in DMPA-IM, and will begin training the VHTs n Sayana Press nce their prject and funding are frmally apprved. They plan t use a cascade mdel, thrugh which they will train District Health staff. In turn, the District Health staff will train health wrkers, wh will then train VHTs. IX. Cmmunicatins Fr the 10 districts in which PATH and Pathfinder are leading Sayana Press intrductin, CDFU is develping an end-user cmmunicatin strategy which aims t increase awareness and uptake f Sayana Press amng target cmmunities thrugh cmmunity-based channels. Specifically, CDFU will mbilize, create awareness, and prmte uptake/use f all family planning methds (including Sayana Press) amng cmmunities in the participating 10 districts. Cmmunicatins activities will include: Mapping t identify infrmal grups (especially wmen s grups) within the cmmunities and key influencers that CDFU will wrk with as agents f change. Interpersnal cmmunicatin appraches thrugh equipping the VHTs trained by PATH and Pathfinder Internatinal with skills t cnduct hme visits, ne-n-ne sessins, and utreach visits. Develpment and distributin f flyers and leaflets, bklets, MOH flipcharts fr use by VHTs during utreaches, and psters fr health facilities and ther public venues. Radi prgrams, including interactive talk shws in lcal languages n at least five ppular radi statins cvering the target districts and featuring testimnies/messages frm lcal key influencers. Experiential activatins using puppetry, frum theatre, and drama skits t mbilize cmmunities and educate them abut Sayana Press as an alternative family planning ptin. CDFU will target market days r ther events within the cmmunities. Cnducting cmmunity dialgue sessins thrugh VHTs r ther cmmunity vlunteers. Wrkshp with RHU n yuth-friendly family planning utreach. Use f CDFU s Tll-free Htline. The cmmunicatin activities will be intrduced shrtly after Sayana Press training activities begin and will cntinue fr apprximately 1 year after the training has been initiated in each district. The prpsed timing will ensure that prduct stcks are in place befre any new demand-creatin activities begin. 10
X. Mnitring PATH develped and is verseeing a lcally apprpriate mnitring plan fr the 10 districts where PATH and Pathfinder are leading intrductin, guided by the prject s essential indicatrs. Additinal data n Sayana Press users by age (<20, 20-24) will be cllected in Uganda. The mnitring system in these 10 districts cllects family planning data frm VHT service prvisin at the lwest level f the health system; the current gvernment HMIS des nt cllect disaggregated data frm VHTs. This Sayana Press-specific mnitring system allws the analysis f VHT-level data by PATH and partners; the data will als be incrprated int the gvernment HMIS, thus nt disrupting existing public-sectr data cllectin systems. Pathfinder and UHMG are utilizing the PATH-develped mnitring plan and tls and will reprt rutine mnitring data t PATH at mnthly Sayana Press partners meetings. PATH has shared data cllectin plans and tls with training partners FHI 360, MSU, and WellShare, wh have agreed t incrprate key indicatrs in their wn systems t the extent feasible and t share data with PATH at the mnthly partner meetings as well. Each training partner is respnsible fr cnducting quality cntrl visits in their assigned intrductin districts. XI. Key next steps Q4 2014 Next step Target date First tw VHT trainings and initial prduct distributin September 10-18 in thse lcatins (PATH, Pathfinder) Finalize training curriculum based n first trainings September 19 Secnd training f district trainers (PATH, Pathfinder) September 23-26 Remaining VHT trainings, initial prduct distributin September 30 January 31, 2015 (PATH, Pathfinder) Facility-based prvider training in Gulu, Mubende Octber (PATH, RHU) First FHI 360 VHT trainings Octber Finalize and launch cmmunicatins strategy Octber Distributin f Sayana Press in districts Onging Mnitring and supervisin Onging Mnthly partner meetings Onging First WellShare VHT trainings TBD (pending prject/funding apprval) 11