Feasibility of Introducing an Onsite Test for Syphilis in the Package of Antenatal Care in Burkina Faso

Feasibility of Introducing an Onsite Test for Syphilis in the Package of Antenatal Care at the Rural Primary Health Care Level in Burkina Faso

This study used a pre post intervention mixed methods quasi-experimental design with a group of health facilities offering antenatal care (ANC) services (primary health centers in rural area) as the sampling units. This study was conducted in three phases, which consisted of a situational analysis using qualitative methods (Phase 1), selecting an appropriate test through evaluating 4 candidate tests and the participatory design and implementation of an intervention that included onsite training, provision of supplies and medicines, quality control and supervision (Phase 2), and an evaluation combining review of record tools, interviews, time motion study and estimating incremental costs (Phase 3). The conceptual framework draws on multilevel assessment (MLA), policy triangle framework, Medical Research Council framework for designing complex interventions and the Normalization Process Model (NPM). Methods included document review, seventy five interviews were conducted with health providers, district managers, facility managers, traditional healers, pregnant women, community health workers, and Non-Governmental Organizations (NGO) managers in phase I and fourteen in phase III, non-participant observation, time-motion study, incremental cost analysis, and sensitivity, specificity and ease of use analysis of four candidate point-of care tests. Data were collected between 2012 and 2014. Qualitative data were analyzed through thematic analysis supported by Nvivo software. Quantitative data were analyzed through descriptive statistics such as frequency, mean and median supported by SPSS. Phase I identified barriers to implementation and uptake of syphilis testing at health provider and community levels. The most important barriers at provider level included fragmentation of services, poor communication between health workers and clients, failure to prescribe syphilis test, and low awareness of syphilis burden. Cost of testing, distance to laboratory and lack of knowledge about syphilis were identified as barriers at community level. Phase II: Alere DetermineTM Syphilis was the most sensitive of the four point-of-care tests evaluated. The components of the intervention were successfully implemented in the selected health facilities. Overall, phase III showed that it is feasible and acceptable to introduce a point of care test for syphilis in antenatal care services at primary health care level using the available staff. The findings suggested that an intervention that introduces point of care test for syphilis at antenatal care services is feasible, acceptable, and of comparable costs to HIV screening in pregnancy. Nonetheless, instructions and supervision need to be clearer to achieve optimal levels of screening and quality control, and barriers identified by health workers need to be overcome. The point-of care test for syphilis is likely to be acceptable by health workers as a routine service and incorporated as a normal practice in Burkina Faso context.

Study Overview

• Status: Completed
• Conditions: Diagnoses Disease; Syphilis Infection
• Intervention / Treatment: Diagnostic test: Feasibility of introducing onsite test for syphilis in the package of antenatal care at rural primary health care in Burkina Faso

• Study Type: Observational
• Enrollment (Actual): 1205

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women coming for antenatal care visit at selected health facilities in Kaya health district

Description

Inclusion Criteria:

• pregnant woman aged 18 and over at first antenatal care visit
• pregnant woman who gave consent for receiving rapid diagnosis test

Exclusion Criteria:

• Pregnant woman aged less than 18 years
• Pregnant woman not at their first antenatal care visit
• Pregnant woman who did not give her consent for receiving rapid diagnosis test

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnant women who were screened for syphilis	Number of pregnant women who received rapid diagnostic test for syphilis	may 2013 to september 2013

Collaborators and Investigators

• Sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
• Collaborators: African Population and Health Research Center; World Health Organization
• Investigators: Principal Investigator: Seni KOUANDA, PhD, Insitut de Recherche en Science de la santé; Study Director: Fadima YAYA BOCOUM, PhD, Insitut de Recherche en Science de la santé

Publications and helpful links

General Publications

• Bocoum FY, Tarnagda G, Bationo F, Savadogo JR, Nacro S, Kouanda S, Zarowsky C. Introducing onsite antenatal syphilis screening in Burkina Faso: implementation and evaluation of a feasibility intervention tailored to a local context. BMC Health Serv Res. 2017 May 30;17(1):378. doi: 10.1186/s12913-017-2325-x.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2013
• Primary Completion (ACTUAL): September 30, 2013
• Study Completion (ACTUAL): September 30, 2013

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 16, 2017
• First Posted (ACTUAL): May 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: feasibility; Burkina Faso; prenatal diagnosis; antenatal care; Syphilis screening; rapid diagnosis test
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; Disease; Syphilis
• Other Study ID Numbers: IRSS003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The individual participant data could be obtained if requested by other researchers to the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No