Syphilis InfectionNCT03156751
Feasibility of Introducing an Onsite Test for Syphilis in the Package of Antenatal Care in Burkina Faso
An observational study of Syphilis Infection and Diagnoses Disease, run by Institut de Recherche en Sciences de la Sante, Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Syphilis Infection, Diagnoses Disease
- What is being tested?
- Feasibility of introducing onsite test for syphilis in the package of antenatal care at rural primary health care in Burkina Faso
- How many people
- 1,205 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 30 Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women coming for antenatal care visit at selected health facilities in Kaya health district
Who may be able to join
- pregnant woman aged 18 and over at first antenatal care visit
- pregnant woman who gave consent for receiving rapid diagnosis test
Who cannot join
- 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
About this study
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
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.
- Conditions
- Syphilis Infection, Diagnoses Disease
- Being tested
- Feasibility of introducing onsite test for syphilis in the package of antenatal care at rural primary health care in Burkina Faso
- Keywords
- Syphilis screening, antenatal care, prenatal diagnosis, rapid diagnosis test, Burkina Faso, feasibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility of introducing onsite test for syphilis in the package of antenatal care at rural primary health care in Burkina FasoDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnant women who were screened for syphilis
Number of pregnant women who received rapid diagnostic test for syphilis
Measured: may 2013 to september 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 May 2013
- Primary completion30 Sep 2013
- Study completion30 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Syphilis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina Faso
- Sponsor type
- Other government
- Collaborators
- World Health Organization, African Population and Health Research Center
- Responsible party
- Sponsor
- Investigators
- Seni KOUANDA, PhD, Principal investigator, Insitut de Recherche en Science de la santéFadima YAYA BOCOUM, PhD, Study director, Insitut de Recherche en Science de la santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156751
- Sponsor's protocol ID
- IRSS003
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 17 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data could be obtained if requested by other researchers to the principal investigator.
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.
PubMed 28558812
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03156751
- Acronym / sponsor ID
- IRSS003
- Conditions
- Syphilis Infection, Diagnoses Disease
- Keywords
- Syphilis screening, antenatal care, prenatal diagnosis, rapid diagnosis test, Burkina Faso, feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,205 participants (actual)
- Lead sponsor
- Institut de Recherche en Sciences de la Sante, Burkina FasoOther government
- Collaborators
- World Health Organization, African Population and Health Research Center
- Study start
- 1 May 2013 (actual)
- Primary completion
- 30 Sep 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women coming for antenatal care visit at selected health facilities in Kaya health district
Key inclusion criteria (2 listed)
- pregnant woman aged 18 and over at first antenatal care visit
- pregnant woman who gave consent for receiving rapid diagnosis test
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feasibility of introducing onsite test for syphilis in the package of antenatal care at rural primary health care in Burkina FasoThis 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. | Diagnostic test | – |
Primary outcome
Pregnant women who were screened for syphilis
Time frame: may 2013 to september 2013
Number of pregnant women who received rapid diagnostic test for syphilis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Derived from this study: PubMed 28558812Bocoum 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.
- Individual participant dataSharing planned: No. The individual participant data could be obtained if requested by other researchers to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seni KOUANDA, PhD principal investigator
Insitut de Recherche en Science de la santé
Fadima YAYA BOCOUM, PhD study director
Insitut de Recherche en Science de la santé
Questions about this trial
What is this clinical trial studying?
An observational study of Syphilis Infection and Diagnoses Disease, run by Institut de Recherche en Sciences de la Sante, Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnant women who were screened for syphilis (time frame: may 2013 to september 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03156751, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.