A Successful National and Multipartner Approach to Increase Immunization Coverage: The Democratic Republic of Congo Mashako Plan 2018-2020.

BACKGROUND: The immunization system in the Democratic Republic of the Congo faces many challenges, including persistent large-scale outbreaks of polio, measles, and yellow fever; a large number of unvaccinated children for all antigens; minimal and delayed funding; and poor use of immunization data at all levels. In response, the Expanded Programme on Immunization within the Ministry of Health (MOH) collaborated with global partners to develop a revitalization strategy for the routine immunization (RI) system called the Mashako Plan. MASHAKO PLAN DESIGN AND DEVELOPMENT: The Mashako Plan aimed to increase full immunization coverage in children aged 12-23 months by 15 percentage points overall in 9 of 26 provinces within 18 months of implementation. In 2018, we conducted a diagnostic review and identified gaps in coordination, service delivery, vaccine availability, real-time monitoring, and evaluation as key areas for intervention to improve the RI system. Five interventions were then implemented in the 9 identified provinces. DISCUSSION: According to the 2020 vaccine coverage survey, full immunization coverage increased to 56.4%, and Penta3/DTP3 increased to 71.1% across the Mashako Plan provinces; the initial objective of the plan was reached and additional improvements in key service delivery indicators had been achieved. Increases in immunization sessions held per month, national stock of pentavalent vaccine, and supervision visits conducted demonstrate that simple, measurable changes at all levels can quickly improve immunization systems. Despite short-term improvements in all indicators tracked, challenges remain in vaccine availability, regular funding of immunization activities, systematic provision of immunization services, and ensuring long-term sustainability. CONCLUSIONS: Strong commitment of MOH staff combined with partner involvement enabled the improvement of the entire system. A simple set of interventions and indicators focused the energy of managers on discrete actions to improve outcomes. Further exploration of the results is necessary to determine the long-term impact and generate all-level engagement for sustainable success in all provinces.

Comparison of adverse pregnancy and birth outcomes using archival medical records before and during the first wave of the COVID-19 pandemic in Kinshasa, Democratic Republic of Congo: a facility-based, retrospective cohort study.

BACKGROUND: Little research has been conducted on the impact of the coronavirus disease 2019 (COVID-19) pandemic on either birth outcomes or the ability of archival medical records to accurately capture these outcomes. Our study objective is thus to compare the prevalence of preterm birth, stillbirth, low birth weight (LBW), small for gestational age (SGA), congenital microcephaly, and neonatal bloodstream infection (NBSI) before and during the first wave of the COVID-19 pandemic in Kinshasa, Democratic Republic of Congo (DRC). METHODS: We conducted a facility-based retrospective cohort study in which identified cases of birth outcomes were tabulated at initial screening and subcategorized according to level of diagnostic certainty using Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) definitions. Documentation of any birth complications, delivery type, and maternal vaccination history were also evaluated. The prevalence of each birth outcome was compared in the pre-COVID-19 (i.e., July 2019 to February 2020) and intra-COVID-19 (i.e., March to August 2020) periods via two-sample z-test for equality of proportions. RESULTS: In total, 14,300 birth records were abstracted. Adverse birth outcomes were identified among 22.0% and 14.3% of pregnancies in the pre-COVID-19 and intra-COVID-19 periods, respectively. For stillbirth, LBW, SGA, microcephaly, and NBSI, prevalence estimates were similar across study periods. However, the prevalence of preterm birth in the intra-COVID-19 period was significantly lower than that reported during the pre-COVID-19 period (8.6% vs. 11.5%, p < 0.0001). Furthermore, the level of diagnostic certainty declined slightly across all outcomes investigated from the pre-COVID-19 to the intra-COVID-19 period. Nonetheless, diagnostic certainty was especially low for certain outcomes (i.e., stillbirth and NBSI) regardless of period; still, other outcomes, such as preterm birth and LBW, had moderate to high levels of diagnostic certainty. Results were mostly consistent when the analysis was focused on the facilities designated for COVID-19 care. CONCLUSION: This study succeeded in providing prevalence estimates for key adverse birth outcomes using GAIA criteria during the COVID-19 pandemic in Kinshasa, DRC. Furthermore, our study adds crucial real-world data to the literature surrounding the impact of the COVID-19 pandemic on maternal and neonatal services and outcomes in Africa.

Adherence to face mask use during the COVID-19 pandemic among women seeking antenatal care in Kinshasa, Democratic Republic of Congo: a facility-based cross-sectional study.

OBJECTIVES: To describe face mask use among pregnant women seeking antenatal care (ANC) in Kinshasa, Democratic Republic of Congo and to identify factors associated with masking adherence in this population. DESIGN: Facility-based cross-sectional study nested within a prospective cohort study. SETTING: Random sample of 10 health facilities, including 5 primary health centers and 5 secondary facilities or hospitals. PARTICIPANTS: A total of 934 pregnant women aged 18 years or above with a gestational age of at least 32 weeks were consecutively surveyed from 17 August 2020 to 31 January 2021. PRIMARY AND SECONDARY OUTCOME MEASURES: We estimated the proportions of pregnant women wearing a face mask and masking correctly (ie, over the mouth and nose), and assessed their knowledge regarding the COVID-19 pandemic. Multivariable logistic regression was employed to identify factors associated with overall and correct face mask use. RESULTS: Overall, 309 (33.1%) women wore a mask during the interview after their antenatal appointments, but only 33 (10.7%) wore a mask correctly. The odds of masking and correct mask use were significantly higher among women who had their ANC visit in a facility that provided COVID-19 care. Additionally, women who experienced COVID-19-like symptoms in the past 6 months had higher odds of wearing a mask correctly compared with those reporting no recent symptoms. Although 908 (97.2%) women were aware of the COVID-19 pandemic, only 611 (67.3%) thought that COVID-19 was circulating locally in Kinshasa. CONCLUSION: Overall and correct face mask adherence levels were low among pregnant women attending ANC in Kinshasa. Our study highlights the need for improving adherence to correct face mask use in order to help control the spread of COVID-19 within Kinshasa alongside other control measures, like vaccination.

Hesitancy to receive the novel coronavirus vaccine and potential influences on vaccination among a cohort of healthcare workers in the Democratic Republic of the Congo.

Hesitancy to receive the COVID-19 vaccine among healthcare workers (HCWs) in low-resource settings, such as the Democratic Republic of the Congo (DRC), is a major global health challenge. This study identifies changes in willingness to receive vaccination among 588 HCWs in the DRC and reported influences on COVID-19 vaccination intentions. Up to 25 repeated measures were collected from participants between August 2020 to August 2021. Among the overall cohort, between August 2020 and mid-March 2021, the proportion of HCWs in each period of data collection reporting COVID-19 vaccine hesitancy ranged from 8.6% (95% CI: 5.97, 11.24) to 24.3% (95% CI: 20.12, 28.55). By early April 2021, the proportion reporting hesitancy more than doubled (52.0%; 95% CI: 46.22, 57.83). While hesitancy in the cohort began to decline by late-June 2021, 22.6% (95% CI: 18.05, 27.18) respondents indicated hesitancy in late-August 2021 which remains greater than the proportion of hesitancy at any time prior to early-March 2021. Patterns in reported influences on COVID-19 vaccination were varied with the proportion reporting some influences (e.g., no serious side effects, country of vaccine production) remaining stable throughout the year and other factors (e.g., recommendation of Ministry of Health, ease of vaccination) falling in popularity among respondents. Agreement that the national vaccination schedule should be followed apart from the COVID-19 vaccine remained high among respondents throughout the study period. This study shows that, among a cohort of HCWs in the DRC who have likely been influenced by regional, national, and global factors, COVID-19 vaccine hesitancy has fluctuated during the pandemic and should not be treated as a static factor. Additional research to determine which factors most influence HCWs' willingness to receive the COVID-19 vaccine offers opportunities to reduce vaccine hesitancy among this important population through tailored public health messaging.

Assessing the feasibility of passive surveillance for maternal immunization safety utilizing archival medical records in Kinshasa, Democratic Republic of the Congo.

INTRODUCTION: Since the establishment of the Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) case definitions in 2015, there has been an urgent need for field validation of pharmacovigilance feasibility in low- and middle-income countries. In this study, we assess the availability and quality of archival medical records at ten randomly selected high-traffic maternity wards in Kinshasa province, Democratic Republic of Congo (DRC). METHODS: A retrospective cohort of mother-child pairs was established from all recorded births taking place at study sites between July 1, 2019 to February 28, 2020 through digitization of medical records. Adverse birth outcomes and maternal vaccination status, where available and linkable, were defined according to GAIA. Basic demographic information on mothers and newborns was also tabulated; birth outcomes were assessed for both intra-site prevalence and a pooled prevalence. RESULTS: A total of 7,697 mother-newborn pair records were extracted, with 37% of infants screening positive as cases of adverse outcomes. Maternal vaccination information was linkable to 67% of those cases. In total, 51% of stillbirths, 98% of preterm births, 100% of low birthweight infants, 90% of small for gestational age infants, 100% of microcephalic infants, and 0% of neonatal bloodstream infections were classifiable according to GAIA standards following initial screening. Forty percent of case mothers had some indication of tetanus vaccination prior to delivery in their medical records, but only 26% of case mothers met some level of GAIA definition for maternal vaccination during the pregnancy of interest. CONCLUSIONS: Archival birth records from delivery centers can be feasibly utilized to screen for stillbirth and maternal tetanus vaccination, and to accurately classify preterm birth, low birthweight, small for gestational age, and congenital microcephaly. Assessment of other neonatal outcomes were limited by inconsistent postpartum infant follow-up and records keeping.

Intimate Partners Violence against Women during a COVID-19 Lockdown Period: Results of an Online Survey in 7 Provinces of the Democratic Republic of Congo.

Intimate Partners' Violence (IPV) is a public health problem with long-lasting mental and physical health consequences for victims and their families. As evidence has been increasing that COVID-19 lockdown measures may exacerbate IPV, our study sought to describe the magnitude of IPV in women and identify associated determinants. An online survey was conducted in the Democratic Republic of Congo (DRC) from 24 August to 8 September 2020. Of the 4160 respondents, 2002 eligible women were included in the data analysis. Their mean age was 36.3 (SD: 8.2). Most women (65.8%) were younger than 40 years old. Prevalence of any form of IPV was 11.7%. Being in the 30-39 and >50 years' age groups (OR = 0.66, CI: 0.46-0.95; p = 0.026 and OR = 0.23, CI: 0.11-048; p < 0.001, respectively), living in urban setting (OR = 0.63, CI: 0.41-0.99; p = 0.047), and belonging to the middle socioeconomic class (OR = 0.48, CI: 0.29-0.79; p = 0.003) significantly decreased the odds for experiencing IPV. Lower socioeconomic status (OR = 1.84, CI: 1.04-3.24; p = 0.035) and being pregnant (OR = 1.63, CI: 1.16-2.29; p = 0.005) or uncertain of pregnancy status (OR = 2.01, CI: 1.17-3.44; p = 0.011) significantly increased the odds for reporting IPV. Additional qualitative research is needed to identify the underlying reasons and mechanisms of IPV in order to develop and implement prevention interventions.

Adherence to COVID-19 Prevention Measures in the Democratic Republic of the Congo, Results of Two Consecutive Online Surveys.

Adherence to preventive measures is essential to reduce the risk of COVID-19 transmission. Two online surveys were conducted in the Democratic Republic of the Congo (DRC) from 23 April to 8 June 2020, and from August 24th to September 8th, respectively. A total of 3268 (round 1) and 4160 (round 2) participants were included. In both surveys, there was a moderate level of adherence to regular handwashing (85% and 77%, respectively), wearing of facemasks (41.4% and 69%, respectively), and respecting physical distancing (58% and 43.4%, respectively). The second survey found that, working in private (OR = 2.31, CI: 1.66-3.22; p < 0.001) and public organizations (OR = 1.61, CI: 1.04-2.49; p = 0.032) and being a healthcare worker (OR = 2.19, CI: 1.57-3.05; p < 0.001) significantly increased the odds for better adherence. However, a unit increase in age (OR = 0.99, CI: 0.98-0.99; p < 0.026), having attained lower education levels (OR = 0.60, CI: 0.46-0.78; p < 0.001), living in a room (OR = 0.36, CI: 0.15-0.89; p = 0.027), living in a studio (OR = 0.26, CI: 0.11-0.61; p = 0.002) and apartment (OR = 0.29, CI: 0.10-0.82; p = 0.019) significantly decreased the odds for better adherence. We recommend a multi-sectorial approach to monitor and respond to the pandemic threat. While physical distancing may be difficult in Africa, it should be possible to increase the use of facemasks.

COVID-19 Vaccine Acceptance in the Democratic Republic of Congo: A Cross-Sectional Survey.

We investigated the level of willingness for COVID-19 vaccination in the Democratic Republic of Congo (DRC). Data were collected between 24 August 2020 and 8 September 2020 through an online survey. A total of 4131 responses were included; mean age of respondents was 35 years (standard deviation: 11.5); 68.4% were females; 71% had elementary or secondary school education. One fourth (24.1%) were convinced that COVID-19 did not exist. Overall, 2310 (55.9%) indicated they were willing to be vaccinated. In a multivariable regression model, belonging to the middle and high-income category (OR = 1.85, CI: 1.46-2.35 and OR = 2.91, CI: 2.15-3.93, respectively), being tested for COVID-19 (OR = 4.71, CI: 3.62-6.12; p < 0.001), COVID-19 community vaccine acceptance (OR = 14.45, CI: 2.91-71.65; p = 0.001) and acknowledging the existence of COVID-19 (OR = 6.04, CI: 4.42-8.23; p < 0.001) were associated with an increased willingness to be vaccinated. Being a healthcare worker was associated with a decreased willingness for vaccination (OR = 0.46, CI: 0.36-0.58; p < 0.001). In conclusion, the current willingness for COVID-19 vaccination among citizens of the DRC is too low to dramatically decrease community transmission. Of great concern is the low intention of immunization among healthcare workers. A large sensitization campaign will be needed to increase COVID-19 vaccine acceptance.

Awareness of obstetric danger signs among pregnant women in the Democratic Republic of Congo: evidence from a nationwide cross-sectional study.

BACKGROUND: Poor awareness of obstetric danger signs is a major contributing factor to delays in seeking obstetric care and hence to high maternal mortality and morbidity worldwide. We conducted the current study to assess the level of agreement on receipt of counseling on obstetric danger signs between direct observations of antenatal care (ANC) consultation and women's recall in the exit interview. We also identified factors associated with pregnant women's awareness of obstetric danger signs during pregnancy in the Democratic Republic of Congo (DRC) METHODS: We used data from the 2017-2018 DRC Service Provision Assessment survey. Agreement between the observation and woman's recall was measured using Cohen's kappa statistic and percent agreement. Multivariable Zero-Inflated Poisson (ZIP) regression was used to identify factors associated with the number of danger signs during pregnancy the woman knew. RESULTS: On average, women were aware of 1.5 ± 1.34 danger signs in pregnancy (range: 0 to 8). Agreement between observation and woman's recall was 70.7%, with a positive agreement of 16.9% at the country level but ranging from 2.1% in Bandundu to 39.7% in Sud Kivu. Using multivariable ZIP analysis, the number of obstetric danger signs the women mentioned was significantly higher in multigravida women (Adj.IRR = 1.38; 95% CI: 1.23-1.55), in women attending a private facility (Adj.IRR = 1.15; 95% CI: 1.01-1.31), in women attending a subsequent ANC visit (Adj.IRR = 1.11; 95% CI: 1.01-1.21), and in women counseled on danger signs during the ANC visit (Adj.IRR = 1.19; 95% CI: 1.05-1.35). There was a regional variation in the awareness of danger signs, with the least mentioned signs in the middle and the most in the eastern provinces. CONCLUSIONS: Our findings indicated poor agreement between directly observed counseling and women's reports that counseling on obstetric danger signs occurred during the current ANC visit. We found that province of residence, provision of counseling on obstetric danger signs, facility ownership, gravidity and the number of ANC visits were predictors of the awareness of obstetric danger signs among pregnant women. These factors should be considered when developing strategies aim at improving women's awareness about obstetric danger signs in the DRC.

Factors associated with adherence to COVID-19 prevention measures in the Democratic Republic of the Congo (DRC): results of an online survey.

OBJECTIVES: We aimed to assess the level of adherence to COVID-19 preventive measures in the Democratic Republic of the Congo (DRC) and to identify factors associated with non-adherence. DESIGN: A cross-sectional population-based online survey. SETTINGS: The study was conducted in 22 provinces of the DRC. Five provinces with a satisfactory number of respondents were included in the analysis: Haut Katanga, Kasaï-Central, Kasaï-Oriental, Kinshasa and North Kivu. PARTICIPANTS: The participants were people aged ≥18 years, living in the DRC. A total of 3268 participants were included in the study analysis. INTERVENTIONS: Both convenience sampling (surveyors themselves contacted potential participants in different districts) and snowball sampling (the participants were requested to share the link of the questionnaire with their contacts) methods were used. PRIMARY AND SECONDARY OUTCOME MEASURES: We computed adherence scores using responses to 10 questions concerning COVID-19 preventive measures recommended by the WHO and the DRC Ministry of Health. We used logistic regression analysis with generalised estimating equations to identify factors of poor adherence. We also asked about the presence or absence of flu-like symptoms during the preceding 14 days, whether a COVID-19 test was done and the test result. RESULTS: Data from 3268 participants were analysed. Face masks were not used by 1789 (54.7%) participants. Non-adherence to physical distancing was reported by 1364 (41.7%) participants. 501 (15.3%) participants did not observe regular handwashing. Five variables were associated with poor adherence: lower education level, living with other people at home, being jobless/students, living with a partner and not being a healthcare worker. CONCLUSION: Despite compulsory restrictions imposed by the government, only about half of the respondents adhered to COVID-19 preventive measures in the DRC. Disparities across the provinces are remarkable. There is an urgent need to further explore the reasons for these disparities and factors associated with non-adherence.

Health facility readiness and provider knowledge as correlates of adequate diagnosis and management of pre-eclampsia in Kinshasa, Democratic Republic of Congo.

BACKGROUND: Hypertensive disorders in pregnancy are the second most common cause of maternal mortality in the Democratic Republic of Congo (DRC), accounting for 23% of maternal deaths. This study aimed to assess facility readiness, and providers' knowledge to prevent, diagnose, and treat pre-eclampsia. METHODS: A facility-based cross-sectional study was conducted in 30 primary health centres (PHCs) and 28 referral facilities (hospitals) randomly selected in Kinshasa, DRC. In each facility, all midwives and physicians involved in maternal care provision (n = 197) were included. Data on facility infrastructure and providers' knowledge about pre-eclampsia were collected using facility checklists and a knowledge questionnaire. Facility readiness score was defined as the sum of 13 health commodities needed to manage pre-eclampsia. A knowledge score was defined as the sum of 24 items about the diagnosis, management, and prevention of pre-eclampsia. The score ranges from 0 to 24, with higher values reflecting a better knowledge. The Mann-Witney U test was used to compare median readiness scores by facility type and ownership; and median knowledge scores between midwives in hospitals and in PHCs, and between physicians in hospitals and in PHCs. RESULTS: Overall, health facilities had 7 of the 13 commodities, yielding a median readiness score of 53.8%(IQR: 46.2 to 69.2%). Although all provider groups had significant knowledge gaps about pre-eclampsia, providers in hospitals demonstrated slightly more knowledge than those in PHCs. Midwives in public facilities scored higher than those in private facilities (median(IQR): 8(5 to 12) vs 7(4 to 8), p = 0.03). Of the 197 providers, 91.4% correctly diagnosed severe pre-eclampsia. However, 43.9 and 82.2% would administer magnesium sulfate and anti-hypertensive drugs to manage severe pre-eclampsia, respectively. Merely 14.2 and 7.1% of providers were aware of prophylactic use of aspirin and calcium to prevent pre-eclampsia, respectively. CONCLUSION: Our study showed poor availability of supplies to diagnose, prevent and treat pre-eclampsia in Kinshasa. While providers demonstrated good knowledge regarding the diagnosis of pre-eclampsia, they have poor knowledge regarding its prevention and management. The study highlights the need for strengthening knowledge of providers toward the prevention and management of pre-eclampsia, and enhancing the availability of supplies needed to address this disease.

Proportion of pregnant women screened for hypertensive disorders in pregnancy and its associated factors within antenatal clinics of Kinshasa, Democratic Republic of Congo.

BACKGROUND: Screening for hypertensive disorders in pregnancy (HDP) is clinically important for identifying women at high risk, and planning early preventative interventions to improve pregnancy outcomes. Several studies in developing countries show that pregnant women are seldom screened for HDP. We conducted a study in Kinshasa, DR Congo, in order to assess the proportion of pregnant women screened for HDP, and to identify factors associated with the screening. METHODS: We conducted a facility-based cross-sectional study in a random sample of 580 pregnant women attending the first antenatal visit. Data collection consisted of a review of antenatal records, observations at the antenatal care services, and interviews. A pregnant woman was considered as screened for HDP if she had received the tree following services: blood pressure measurement, urine testing for proteinuria, and HDP risk assessment. Multivariable logistic regression, with generalized estimating equations, was used to identify factors associated with the screening for HDP. RESULTS: Of the 580 pregnant women, 155 (26.7%) were screened for HDP, 555 (95.7%) had their blood pressure checked, 347(59.8%) were assessed for risk factors of HDP, and 156 (26.9%) were tested for proteinuria. After multivariable analysis, screening for HDP was significantly higher in parous women (AOR = 2.09; 95% CI, 1.11-3.99; P = 0.023), in women with a gestational age of at least 20 weeks (AOR = 5.50; 95% CI, 2.86-10.89; P = 0.002), in women attending in a private clinic (AOR = 3.49; 95% CI, 1.07-11.34; P = 0.038), or in a hospital (AOR = 3.24; 95% CI, 1.24-8.47; P = 0.017), and when no additional payment was required for proteinuria testing at the clinic (AOR = 2.39; 95% CI, 1.14-5.02; P = 0.021). CONCLUSION: Our results show that screening for HDP during the first antenatal visit in Kinshasa is not universal. The factors associated with screening included maternal as well as clinics' characteristics. More effort should be made both at maternal and clinic levels to improve the screening for HDP in Kinshasa.

A multifaceted intervention to improve syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cluster randomised controlled trial.

BACKGROUND: Despite international recommendations, coverage of syphilis testing in pregnant women and treatment of those found seropositive remains limited in sub-Saharan Africa. We assessed whether combining the provision of supplies with a behavioural intervention was more effective than providing supplies only, to improve syphilis screening and treatment during antenatal care. METHODS: In this 18-month, cluster randomised controlled trial, we randomly assigned (1:1) 26 urban antenatal care clinics in Kinshasa, Democratic Republic of the Congo, and Lusaka, Zambia, to receive a behavioural intervention (opinion leader selection, academic detailing visits, reminders, audits and feedback, and supportive supervision) plus supplies for syphilis testing and treatment (intervention group) or to receive supplies only (control group). The primary outcomes were proportion of pregnant women who had syphilis screening out of the total who attended the clinic; and the proportion of women who had treatment with benzathine benzylpenicillin out of those who tested positive for syphilis at their first antenatal care visit. This trial is registered at ClinicalTrials.gov, number NCT02353117. FINDINGS: The 18-month study period was Feb 1, 2016, to July 14, 2017. 18 357 women were enrolled at the 13 intervention clinics and 17 679 women were enrolled at the 13 control clinics at their first antenatal care visit. Syphilis screening was done in a median of 99·9% (IQR 99·0-100·0) of women in the intervention clinics and 93·8% (85·0-98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1-14·1]; p=0·00092). Syphilis treatment at the first visit was done in a median of 100% (IQR 99·7-100·0) of seropositive women in intervention clinics and 43·2% (2·6-83·2) of seropositive women in control clinics (absolute difference 56·8% [12·8-99·0]; p=0·0028). INTERPRETATION: A behavioural intervention, together with the provision of supplies, can lead to more than 95% of women being screened and treated for syphilis. The sole provision of supplies is sufficient to reach such levels of screening coverage but is not sufficient to ensure high levels of treatment. FUNDING: Bill & Melinda Gates Foundation.

Barriers and facilitators to the implementation of antenatal syphilis screening and treatment for the prevention of congenital syphilis in the Democratic Republic of Congo and Zambia: results of qualitative formative research.

BACKGROUND: The impact of untreated syphilis during pregnancy on neonatal health remains a major public health threat worldwide. Given the high prevalence of syphilis during pregnancy in Zambia and Democratic Republic of Congo (DRC), the Preventive Congenital Syphilis Trial (PCS Trial), a cluster randomized trial, was proposed to increase same-day screening and treatment of syphilis during antenatal care visits. To design an accepted and feasible intervention, we conducted a qualitative  formative research. Our objective was to identify context-specific  barriers and facilitators to the implementation of antenatal screening and treatment during pregnancy. METHODS: Qualitative research included in-depth semi-structured interviews with clinic administrators, group interviews with health care providers, and focus groups with pregnant women in primary care clinics (PCCs) in Kinshasa (DRC) and Lusaka (Zambia). RESULTS: A total of 112 individuals participated in the interviews and focus groups. Barriers for the implementation of syphilis testing and treatment were identified at the a) system level: fragmentation of the health system, existence of ANC guidelines in conflict with proposed intervention, poor accessibility of clinics (geographical and functional), staff and product shortages at the PCCs; b) healthcare providers' level: lack of knowledge and training about evolving best practices, reservations regarding same-day screening and treatment; c) Pregnant women level: late enrollment in ANC, lack of knowledge about consequences and treatment of syphilis, and stigma. Based on these results, we developed recommendations for the design of the PCS Trial intervention. CONCLUSION: This research allowed us to identify barriers and facilitators to improve the feasibility and acceptability of a behavioral intervention. Formative research is a critical step in designing appropriate and effective interventions by closing the "know-do gap".