Clinical trial NCT03156751: Feasibility of Introducing an Onsite Test for Syphilis in the Package of Antenatal Care in Burkina Faso
Official title: Feasibility of Introducing an Onsite Test for Syphilis in the Package of Antenatal Care at the Rural Primary Health Care Level in Burkina Faso
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Syphilis Infection
Diagnoses Disease
Keywords: Syphilis screening
antenatal care
prenatal diagnosis
rapid diagnosis test
Burkina Faso
feasibility
Lead sponsor: Institut de Recherche en Sciences de la Sante, Burkina Faso
Sponsor class: OTHER_GOV
Collaborators: name: World Health Organization
name: African Population and Health Research Center
First posted: 2017-05-17
Enrollment: 1205
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women coming for antenatal care visit at selected health facilities in Kaya health district

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pregnant women who were screened for syphilis
timeFrame: may 2013 to september 2013
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Insitut de Recherche en Science de la santé
name: Seni KOUANDA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Insitut de Recherche en Science de la santé
name: Fadima YAYA BOCOUM, PhD
role: STUDY_DIRECTOR
References:
citation: 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.