An observational study in Syphilis Infection and Diagnoses Disease, sponsored by Institut de Recherche en Sciences de la Sante, Burkina Faso. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-17.
Sponsored by Institut de Recherche en Sciences de la Sante, Burkina Faso · Observational
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.
Institut de Recherche en Sciences de la Sante, Burkina Faso is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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Pregnant women coming for antenatal care visit at selected health facilities in Kaya health district
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This study used a pre post intervention mixed methods quasi-experimental design with a group of health facilities offering ANC services. It 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(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, MRC framework for designing complex interventions and the Normalization Process Model (NPM). 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, barriers identified by health workers need to be overcome.
Pregnant women who were screened for syphilis
Number of pregnant women who received rapid diagnostic test for syphilis
Time frame: may 2013 to september 2013
No study locations are listed for this record.
Plan to share: No — The individual participant data could be obtained if requested by other researchers to the principal investigator.
Ran from May 2013 to primary completion in Sep 2013, 4 months.
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This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Institut de Recherche en Sciences de la Sante, Burkina Faso