The Effect Of A Continuous Quality Improvement .

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SUPPLEMENT ARTICLEThe Effect of a Continuous Quality ImprovementIntervention on Retention-In-Care at 6 Months Postpartumin a PMTCT Program in Northern Nigeria: Results ofa Cluster Randomized Controlled StudyBolanle Oyeledun, MD, MPH, MSc,* Abimbola Phillips, MBChB, MPH,† Frank Oronsaye, MHM,*Oluwafemi David Alo, MSc,* Nathan Shaffer, MD,‡ Bamidele Osibo, PGD,* Collins Imarhiagbe, PGD,*Francis Ogirima, MBBS,* Abiola Ajibola, MHM,* Obioma Ezebuka, MSc,* Bebia Ojong-Etta, BSc,*Adaobi Obi, MSc,* John Falade, BSc,* Adunbi Kareem Uthman, MSc,* Busuyi Famuyide, MSc,*Deborah Odoh, MBBS, MPH,§ and Renaud Becquet, MPH, PhDkBackground: Retention in care is critical for improving HIVinfected maternal outcomes and reducing vertical transmission. Healthsystems’ interventions such as continuous quality improvement (CQI)may support health services to address factors that affect the deliveryof HIV-related care and thereby influence rates of retention-in-care.Methodology: We evaluated the effect of a CQI intervention onretention. There was no significant difference in retention at 6months between the intervention and control arms [44% vs. 41%,relative risk: 1.08; 95% confidence interval (CI): 0.78 to 1.49].Initiation of ARV prophylaxis among infants within 72 hours wasnot different by study arm (66.0% vs. 74.7%, relative risk 0.95;95% CI: 0.84 to 1.07) but rates of early infant testing at 4–6 weekswere higher in intervention sites (48.8% vs. 25.3%, adjusted relativerisk: 1.76; 95% CI: 1.27 to 2.42).retention-in-care at 6 months postpartum of pregnant women andmothers living with HIV who had been started on lifelong antiretroviral treatment. Thirty-two health care facilities were randomized toeither implement the intervention or not. We considered women fullyretained in care when they attended the 6-month postpartum visit anddid not miss any previous scheduled visit by more than 30 days.Conclusions: CQI as implemented in this study did not differacross study arms in the rates of retention. Several interventiondesign or implementation issues or other contextual constraints mayexplain the absence of effect.Results: Five hundred eleven women living with HIV attendingKey Words: retention-in-care, quality improvement, HIV, healthsystems, Nigeriaantenatal clinics at 26 facilities were included in the analysis. Medianage at enrolment was 27 years and gestational age was 20 weeks.Seventy-one percent of women were seen at 6-month postpartumirrespective of missing any scheduled visit. However, 43% ofwomen were fully retained at 6-month postpartum and did not missany scheduled visit based on our stringent study definition ofFrom the *Center for Integrated Health Programs (CIHP), Abuja, Nigeria;†Department of Community Health, Obafemi Awolowo University Ife,Osun State, Nigeria; ‡Technical Consultant, Atlanta, GA; §National AIDSand STIs Control Programme (NASCP), Department of Public Health,Federal Ministry of Health, Abuja, Nigeria; and kUniversity of Bordeaux,Inserm, Bordeaux Population Health Research Center, team IDLIC, UMR1219, Bordeaux, France.Supported by the World Health Organization through an award for theINtegrating and Scaling up Pmtct through Implementation REsearch(INSPIRE) initiative from Global Affairs Canada.The authors have no conflicts of interest to disclose.Protocol ID: C6-TSA-037; Clinical Trial number: NCT02214875.Supplemental digital content is available for this article. Direct URL citationsappear in the printed text and are provided in the HTML and PDFversions of this article on the journal’s Web site (www.jaids.com).Correspondence to: Bolanle Oyeledun, MD, MPH, MSc, Center forIntegrated Health Programs (CIHP), Plot 1129, Kikuyu Close, OffNairobi Crescent, Wuse 2, Abuja, Nigeria 900288 (e-mail: boyeledun@cihpng.org).Copyright 2017 Wolters Kluwer Health, Inc. All rights reserved.S156 www.jaids.com(J Acquir Immune Defic Syndr 2017;75:S156–S164)INTRODUCTIONThe successful delivery of health services to improvethe health of women living with HIV and prevent mother-tochild transmission of HIV (PMTCT) is pivotal for achievingan HIV/AIDS-free generation.1 In 2014, there were anestimated 210,000 pregnant women living with HIV inNigeria and yet coverage of PMTCT services remained lowat 29%.2 Nigeria began offering lifelong antiretroviraltreatment (ART) to all pregnant and breastfeeding womenliving with HIV regardless of CD4 cell count or clinical stagein 2016 (Option B )—though a number of demonstrationsites started in 2014.3 However, many women living withHIV are commonly lost along the cascade of PMTCTservices, which reduces the likelihood of achieving viralsuppression in women and increases the risk of mother-tochild transmission. Although the definition of retention-incare is not standardized,4,5 reports from Nigeria suggest thatbetween 62% and 76% of persons living with HIV remain inHIV-related care.6,7Although household and community factors are important, the quality of interactions between health systems andJ Acquir Immune Defic Syndr Volume 75, Supplement 2, June 1, 2017Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

J Acquir Immune Defic Syndr Volume 75, Supplement 2, June 1, 2017women living with HIV are opportunities to influencea woman’s likelihood to remain in care and thereby protecther health and survival.8 Suboptimal patient care andmanagement, prolonged waiting times, drug stock outs, andinsufficient trained staff all undermine patient’s confidenceand satisfaction and hence the effectiveness of services.9,10Continuous quality improvement (CQI) is a healthsystems’ intervention methodology that uses serial reviews oflocal facility data to test solutions to barriers for consistenthigh-quality service delivery.11–13 The Breakthrough Series(BTS) is a specific CQI approach that, in addition to facilitylevel data review and action cycles, also includes collaborationswhereby staff from several health facilities meet regularly tojointly review and share ideas to seek improvements.14,15 BTSCQI has achieved sustained improvements in other areas ofpatient care11,14 but has not been substantially used in thecontext of PMTCT services or to improve retention-in-care.We implemented a cluster randomized controlled study toexamine whether a BTS-CQI intervention can improveretention-in-care, defined as attendance at 6 months postpartumwhile not missing previous scheduled visits, among mothersliving with HIV who have started lifelong ART.METHODSDetails of the study, called Lafiyan Jikin Mata or“Excellent Health for Mothers” in Hausa, have been published4 and are summarized below.Study Sites and ParticipantsTwo hundred forty-one health facilities in Benue andKaduna states in northern Nigeria, and supported by the Centerfor Integrated Health Programs with funding from the USCenter for Disease Control and Prevention, were considered forinclusion. Facilities were eligible if they had offered PMTCTservices for more than 6 months, regularly identified .1pregnant woman per month, provided onsite delivery andpostpartum care, and had at least 2 trained community healthextension workers. Thirty-two facilities (20 primary and 12secondary health level), stratified by location and level ofhealth care, were randomly selected and allocated to eitherintervention or control arms using computer-generated randomnumbers (Fig. 1).All pregnant women attending their first antenatalbooking were offered HIV testing. Women diagnosed withHIV infection or known to be HIV infected were enrolled ifthe gestational age was 34 weeks or less, they were ARTnaive, agreed to start lifelong ART, and provided writteninformed consent to participate in the study. CQI training andimplementation started in March 2014, enrollment started inJuly 2014, and 6-month postpartum follow-up of all subjectswas completed in October 2016.Effect of CQI on PMTCT Retention in Nigeriaamong mothers living with HIV (see figure, SupplementalDigital Content 1, http://links.lww.com/QAI/A992). The maindrivers for low retention-in-care were identified as long waitingtimes, poor quality of services, and poor uptake of services.Three areas of interaction between women and facilities werethereafter identified for improvement: time spent receivingservices at facilities, attitude of health workers and clientsatisfaction, and access to ART on same day as Antenatal care(ANC)/postnatal clinic visits. Local Government and Statelevel CQI teams were established to oversee the initiative.Intervention ArmAt intervention facilities, CQI teams were established tobe composed of the facility head/medical officer, studynurses/community health extension workers, and laboratorytechnicians. Teams agreed priority areas for improvementrelated to the 3 main drivers and then used the Plan-DoStudy-Act model to formulate action plans, agree on indicators, collate and analyze facility data, and thereby test ideasfor improving these specific areas. CQI coaches visited every2 weeks to guide implementation of change ideas, includinghow to measure the process and indicators of change ideasbeing tested, plot run-charts and provide structured assessment and response tools16; technical assistance was alsoprovided by phone. Facility CQI teams developed simple“run charts” (line graphs used to identify and display trendsover time)17,18 to track changes in performance over time aschange ideas were implemented and tested. Changes werethen adopted, adapted, or abandoned by the facility staffbased on the trends or shifts of the run charts. For example,one facility tested the use of a staff “clock-in” register tostimulate early attendance of staff and reduce time spent byclients in the facility. Weekly run-charts presented the timeswhen staff were in attendance alongside average times ofclients to access services (Fig. 2). The run charts showed thatwaiting time reduced when staff started their work earlier; asa result, “clock-in” registers were adopted.Facility teams also met together in quarterly BTScollaborative learning sessions.14During the BTS collaborative sessions, teams sharedlearning experiences of change ideas implemented, examplesof run charts and progress including how they proposed toadapt and implement changes. Additionally, facility CQIteams regularly communicated with each other by telephoneand cross-site visits to strengthen learning and exchangeof ideas.Control ArmFacilities randomized to the control arm received theroutine support as specified in the Nigeria Ministry of Healthguidelines and supervision.19CQI DesignGeneral PMTCT Program SupportMeetings were convened with health managers andimplementers and driver diagrams developed to understandthe primary and secondary drivers for low retention-in-careAll sites received technical assistance every 3–6 monthsfrom Center for Integrated Health Programs team includingthe following: Data Quality Assurance assessments thatCopyright 2017 Wolters Kluwer Health, Inc. All rights reserved.www.jaids.com S157Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

Oyeledun et alJ Acquir Immune Defic Syndr Volume 75, Supplement 2, June 1, 2017FIGURE 1. Lafiyan Jikin Mata study flow diagram.reviewed the accuracy, completeness, and reliability offacility data20; Standard of Care reviews that evaluatedservice quality using predefined indicators; and Model ofCare reviews that assessed the system, structure, andprocedures at site level.20Routine facility data were abstracted from clinicregisters to determine adherence to appointments and calculate rates of retention-in-care. In addition, descriptive datarelated to health facilities and study participants weredocumented. At all facilities, client satisfaction and waitingtimes were recorded at the beginning and end of the study.Ten women (not necessarily study participants) attendingantenatal clinics at each site were systematically included; ifless than 10 women attended on the day of assessment, thenall women were included. Pregnant women were asked tocomplete a 12-point client satisfaction questionnaire withLikert rating scales.21 Waiting time from arrival at the clinicuntil last service received was documented. In addition,intervention facilities collected real-time data on waitingtimes (weekly or monthly depending on the change idea)and used these data to develop run charts to track the effect ofthe idea being tested (Fig. 2). Date of visits by CQI coachesand collaborative meetings were routinely recorded andevaluated against planned schedules.Unanticipated industrial strike actions and civil unrestoccurred several times during the study period. CalendarS158Copyright 2017 Wolters Kluwer Health, Inc. All rights reserved.Data Collection www.jaids.comCopyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

J Acquir Immune Defic Syndr Volume 75, Supplement 2, June 1, 2017Effect of CQI on PMTCT Retention in NigeriaFIGURE 2. Sample run charts from change ideas tested at 2 intervention health facilities.months when facilities were unable to provide routine servicedelivery for at least 1 day were identified. These data wereused to estimate exposure to disrupted services for (1)individual women (months with disrupted services duringan individual woman’s enrolment/months of individual enrolment) and (2) facilities (months with disrupted services/months of study implementation).Primary and Secondary OutcomesThere primary outcome was retention-in-care at 6months postpartum. A study participant was regarded as: fully retained-in-care at 6 months postpartum if the womanattended the 6-month postpartum visit (630 days) and didnot miss any previous scheduled visit by more than 30 days(starting from ANC booking). partially retained-in-care at 6 months postpartum if the womanattended the 6-month postpartum visit (630 days) but missed1 or more earlier scheduled visits by more than 30 days. not retained in care at 6 months postpartum if the womandid not attend the 6-month postpartum visit (630 days),regardless of whether she attended or missed any otherscheduled visit.The was no national standardized schedule of ARTvisits and therefore the date of next scheduled visit as givenby the health worker for the individual client was used todetermine adherence and therefore the primary outcomemeasure. This was defined as the documented date given bythe health worker for the woman to come for her nextappointment, including ARV drug pick-up.Secondary outcomes were the proportion of HIVexposed infants born to enrolled mothers who: (1) startedantiretroviral (ARV) prophylaxis within 72 hours of birth; (2)received co-trimoxazole prophylaxis at 6–10 weeks of age;(3) had a dried blood spot (DBS) collected for early infantCopyright 2017 Wolters Kluwer Health, Inc. All rights reserved.diagnosis (EID) of HIV between 6 and 10 weeks of age; and(4) proportion of pregnant women living with HIV initiatingART within 2 weeks of enrolment.Women were considered to have “transferred out” ifthere was documentation they had explicitly relocated.Sample Size EstimationNo data on rates of retention-in-care based on a standardized definition to inform estimates were available from Nigeria.We therefore used program data on the percentage of pregnantwomen who missed their last 3 months’ appointment to informassumptions. Based on these data, we assumed baselineretention-in-care to be 40% at 6 months postpartum.The sample size was calculated, using the WindowsProgram for Epidemiologists,22 to be able to detect a 20%absolute difference (ie, 60% vs. 40%) with a 95% significancelevel (2-sided) at 80% power. The minimum sample sizeneeded under individual randomization to detect this absolutedifference was 94 participants for each group (interventionand control). This sample size was inflated to account forintrasite variability. An inflation factor (IF) was calculated asfollows: IF 1 (n 2 1) ro, where n is the number ofparticipants recruited at each site and ro is the internalvariability within each site. Ro was assumed to be equal to0.10; assuming a total number of 16 clusters, the sample sizehad to be inflated by a multiple of 2.9. A minimum sample of272 participants was therefore estimated; however, allowingfor 20% incomplete data or attrition, an estimated sample sizeof 327 pregnant women living with HIV being enrolled perstudy arm was agreed.Statistical AnalysisDescriptive statistics were used to summarize facilityand individual characteristics and cluster-adjusted x2 test andwww.jaids.com S159Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

J Acquir Immune Defic Syndr Volume 75, Supplement 2, June 1, 2017Oyeledun et alt test analyses were used to determine associations. The effectof the intervention on primary and secondary outcomes wasexamined through an intention-to-treat analysis that includedall enrolled women except those who withdrew their consent.Effects were modeled using log binomial regression withgeneralized estimating equation with an independent correlation structure and robust standard errors. Crude and adjustedodds ratios were obtained from the generalized estimatingequation as a measure of association, adjusting for explanatory variables. Statistical significance was set at 0.05. Allstatistical analyses were performed using STATA 14.23A per-protocol analysis was also conducted in whichwomen who died; whose pregnancy resulted in stillbirth,miscarriage, neonatal, or infant death; or who transferred outto another facility were excluded.Ethics ApprovalThe study protocol and amendments were approved by theNigerian National Health Research Ethics Committee and theWorld Health Organization Ethics Review Committee, Geneva.RESULTSTwenty-six facilities—14 intervention and 12 control—contributed data to the analyses (Fig. 1). Six facilities wereexcluded because less than 2 pregnant women living withHIV were recruited during the enrolment period. Twenty-onewomen withdrew from the study, leaving a total of 511women eligible for analyses.Baseline characteristics of health facilities and studyparticipants are detailed in Table 1. The median ageof women at enrollment was 27 years (interquartile range,23–50 years). Nearly all were married and more than halfhad at least a secondary education. All government-ownedhealth facilities experienced service disruption for about20% (interquartile range, 15%–40%) of the study period(see table, Supplemental Digital Content 2, http://links.lww.com/QAI/A992).Primary OutcomesOverall, 441 of 511 participants (86%) were in care atthe time of delivery and 311 of 511 participants (61%)attended their 6-month postpartum clinic appointment; 155 of511 participants (30%) missed at least 1 scheduled visitbefore 6 months postpartum by more than 30 days (Table 2).About 71% (364/511) of women attended the clinic fora scheduled visit within the 90 days before the 6-monthpostpartum visit. There were no differences in these patternsby study arm based on national definition.According to study definitions, 43% (219/511) ofparticipants were fully retained at 6 months across both arms(ie, attended 6-month visit and did not miss any previousscheduled visit); there was no significant difference betweenintervention (44%) and control facilities (41%) [adjustedrelative risk (ARR) 1.08; 95% confidence interval (CI):0.78 to 1.49] (Table 3), and there was similarly no effect onthe distribution of participants between full, partial, and notS160 www.jaids.comTABLE 1. Baseline Characteristics of Facility and EnrolledWomen Living With HIV, by Study ArmStudy ArmFacilityCharacteristics(N 26)Facility typePrimary level*Secondary level†Managing cility locationRuralSemiurbanUrbanNumber of beds;median, IQR, rangeFirst ANC bookings permonth;median, IQR, rangeStudy womencharacteristics atenrolment (N 511)Age group, yrsMedian (IQR)15–1920–2425 Marital statusMarriedOthers§Highest level of educationLess than secondarySecondaryTertiaryGestational age atenrolment, wkBelow 1313–2728–34Parity01–23 or tner tested for HIV(reported)NoYesPlace of deliveryOutside facilityIn facilityControl(n 12)Intervention(n 14)N (%)N (%)7 (58)5 (42)9 (64)5 (36)9 (75)3 (25)10 (71)4 (29)6 (50)2 (17)4 (33)20, 6–120, 6–2004 (29)4 (29)6 (43)16.5, 6–30, 0–9855, 23–176, 6–56272.5, 28–214, 14–303n 247n 26427 (23–30)12 (4.9)74 (30.0)161 (65.2)27 (23–30)11 (4.2)79 (30.0)174 (65.9)231 (93.5)16 (6.5)250 (94.7)14 (5.3)115 (46.6)101 (40.9)31 (12.6)99 (37.5)143 (54.2)22 (8.3)36 (14.6)148 (59.9)63 (25.5)32 (12.1)166 (62.9)66 (25)60 (24.3)117 (47.4)70 (28.3)83 (31.4)100 (37.9)81 (30.7)200 (81)45 (18.2)2 (0.8)204 (77.3)57 (21.6)3 (1.1)165 (66.8)82 (33.2)190 (72)74 (28)89 (36.0)158 (64.0)117 (44.3)147 (55.7)*Primary health care facilities.†General hospitals and comprehensive health facilities.‡Owned by private or religious body.§Others single, divorced, separated, or widowed.IQR, interquartile range.Copyright 2017 Wolters Kluwer Health, Inc. All rights reserved.Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

J Acquir Immune Defic Syndr Volume 75, Supplement 2, June 1, 2017TABLE 2. Six-Month Postpartum Retention and SecondaryOutcomes (N 511)Women who remained in care atdelivery†‡YesNoTotalAttended 6-month postpartum visitYesNoTotalMissed 1 or more scheduled visitsby more than 30 days(excluding 6-month visit)YesNoTotalHad a visit within 90 daysbefore 6-month postpartum visitYesNoTotal6-Month retention§Fully retainedPartially retainedNot retainedTotalWoman initiated ART within2 weeks of enrolmentYesNoTotalInfant ARV prophylaxisinitiated within 72 hoursof birth (N 403)kYesNoTotalInfant CTX initiated within6–10 weeks of age (N 403)kYesNoTotalInfant DBS obtained within6–10 weeks (N uency(%)208 (84.2)39 (15.8)247 (100.0)231 (87.5)33 (12.5)264 (100.0)0.286146 (59.1)101 (40.9)247 (100.0)165 (62.5)99 (37.5)264 (100.0)0.14474 (30.0)173 (70.0)247 (100.0)81 (30.7)183 (69.3)264 (100.0)0.900169 (68.4)78 (31.6)247 (100.0)196 (74.2)68 (25.8)264 )(100.0)0.902261 (98.9)3 (1.1)264 (100.0)0.406P*Effect of CQI on PMTCT Retention in Nigeriaretained. This remained true even after adjusting for women’sexposure to service disruptions and facility strike score (Table3). There were no differences in any measure of retention inthe per-protocol analysis (see tables, Supplemental DigitalContent 3–5, http://links.lww.com/QAI/A992).Secondary Outcome Analysis(41.3)(17.8)(40.9)(100.0)233 (94.3)14 (5.7)247 (100.0)Nearly all women were started on ART within 2 weeksof enrolment in both intervention (98.9%) and control(94.3%) arms (Table 2). Infant ARV prophylaxis initiationwithin 72 hours was not different by study arm (66%intervention arm vs. 74.7% control, ARR 0.95; 95% CI:0.84 to 1.07) (Table 3 and Supplemental Digital Content 6,http://links.lww.com/QAI/A992) although it was significantlyassociated with place of delivery, that is, 51% more likelyamong infants born in health facilities compared to those thatwere born elsewhere (78% vs. 22%, ARR 1.51; 95% CI:1.20 to 1.91) (Table 3). DBS collection within 6–10 weeks ofage was only 37.5% overall but was more likely amonginfants born to women attending intervention health facilitiescompared to those in control health facilities (48.8% vs.25.3%, ARR 1.76; 95% CI: 1.27 to 2.42) (Table 3). DBScollection at 6–10 weeks of age was also positively associatedwith women who had secondary or higher education (relativerisk 1.96; 95% CI: 1.50 to 2.57) (see table, SupplementalDigital Content 7, http://links.lww.com/QAI/A992). Theoverall proportion of infants started on CTX between 6 and10 weeks of age was 56.6% (228/403) but the likelihood ofCTX initiation was no different by study arm though it wasslightly greater for infants born in facilities compared to thosedelivered outside the facilities (ARR 1.30; 95% CI: 1.03 to1.64) (Table 3 and Supplemental Digital Content 8, http://links.lww.com/QAI/A992).Intermediate CQI Indicators145 (74.7)49 (25.3)194 (100.0)138 (66.0)71 (34.0)209 (100.0)0.309108 (55.7)86 (44.3)194 (100.0)120 (56.6)89 (43.4)209 (100.0)0.88249 (25.3)145 (74.7)194 (100.0)102 (48.8)107 (51.2)209 (100.0)0.004*Adjusted for clustering.†Remaining in care refers to women who are still seen in the facility after delivery,regardless of the site of delivery. Even though 40% delivered outside facility, a largerpercentage returned to health facility for postpartum care.‡Intracluster correction for remained in care at delivery was 0.02.§Intracluster correction for retention in care at 6 months postpartum was 0.13.kExcluding miscarriages, unknown delivery status, stillbirth, and neonataldeath.Copyright 2017 Wolters Kluwer Health, Inc. All rights reserved.A full description of CQI process indicators areprovided in a linked publication.24 Four indicators ofintermediate CQI indicators and process indicators arepresented to illustrate adherence to the CQI protocol andresponses at health facilities. Before CQI-BTS implementation, the time spent by pregnant women at ANC services (allwomen attending ANC, not just those living with HIV) waslonger at intervention sites compared to control sites [median182 (range: 22–389) vs. 139 (range: 52–229), respectively].At the end of the study, time spent by pregnant women forreceiving services was less at intervention facilities than atcontrol sites [median 125 (range: 40–270) vs. 201 (range: 43–406), respectively]. Facility-specific run charts of weeklyassessments illustrate improvements at individual sites(Fig. 2).The mean difference in time spent by patients receivingANC services between baseline and end of study reduced inthe intervention arm by 54 minutes (95% CI: 267 to 240),whereas in the control arm it increased by 58 minutes (95%CI: 44 to 73). After adjusting for facility characteristics, therewas a significant difference in the change in time spent bypregnant women receiving ANC services between baselinewww.jaids.com S161Copyright Ó 2017 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.

J Acquir Immune Defic Syndr Volume 75, Supplement 2, June 1, 2017Oyeledun et alTABLE 3. Binomial Log-Linear Regression of Primary and Secondary Outcomes (N 511)Primary Outcome(N 511)Independent VariablesStudy armControlInterventionExposure to strike action/disrupted servicesWoman’s experienceFacility experienceHighest level of educationLess than secondarySecondary or higherPlace of deliveryOutside facilityIn facilitySecondary Outcomes (N 403)Retention in Care at 6Months PostpartumInfant ARV InitiationWithin 72 hInfant CTX InitiationWithin 6–10 wkDBS Collection Within6–10 wkARR95% CIARR95% CIARR95% CIARR95% CI11.080.78 to 1.4810.950.84 to 1.0711.010.78 to 1.3011.76*1.27 to 2.421.001.000.99 to 1.000.99 to 1.0011.050.93 to 1.1811.130.93 to 1.3811.96*1.50 to 2.5711.51*1.20 to 1.9111.30†1.03 to 1.6411.040.80 to 1.36Explanatory variables that were not significantly associated with the primary and secondary outcomes were not controlled for.*P , 0.001.†P , 0.05.ARR, adjusted relative risk.The CQI intervention implemented as part of the studydid not result in any significant difference in rates ofretention at 6 months postpartum among mothers livingwith HIV. However, the proportion of HIV-exposed infantsfrom whom a DBS was collected between 6 and 10 weeks ofage for infant diagnosis was 75% greater in the interventionarm, and waiting times among pregnant women attendingANC were also significantly less at intervention sites. Thesesuggest that staff at intervention facilities did engage withthe CQI process and were willing to implement at least somechanges in daily routines that led to measurable improvements in services.There are several possible explanations for the lack ofobserved effect on our primary outcome of retention-incare: the underlying theory of change may have beenincorrect; for example, the areas of service deliverytargeted for change were too indirectly related to theoutcome of interest and not likely to improve retentionin-care among women; the duration, dose, or intensity ofthe intervention was insufficient or the CQI interventionwas not satisfactorily executed25; the health system wasresistant to the intervention; factors extraneous to thehealth system overwhelmed any effects of improvedservice delivery on the decision-making processes andpractices of mothers living with HIV.26 The rates ofretention-in-care in the study population were also lowerthan what had been reported previously in Nigeria.6,7 Thisprobably reflected our more stringent study definition of“full retention” (seen at 6-month postpartum visit and atALL intermediate follow up visits) than the generalprogrammatic definition (“had a visit within 90 days before6-month postpartum visit”), differences in measurementapproach, and also possible selection bias as both studyarms received PEPFAR support.On reflection, our field teams considered that the overallintervention time for the study was not sufficient to producesignificant changes in practice among health workers andthereby impact on the attendance practices of mothers andtheir infants. We were unable to evaluate if there wasa difference in effect of the intervention among womenrecruited early in the study compared to those who wererecruited later. Health workers required time to assimilate theconcept and working of a CQI approach and to becomefamiliar and confident with using data for improvement.There had not been sufficient time to implement andinstitutionalize the CQI processes before enrolment to thestudy began. Although most of the planned CQI activitiestook place as scheduled, it was challenging to implement theCQI data review and action cycles in a matter of weeks

Continuous quality improvement (CQI) is a health systems’ intervention methodology that uses serial reviews of local facility data to test solutions to barriers for consistent high-quality service delivery.11–13 The Breakthrough Series (BTS) is a specific

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