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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. 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.

  1. First posted17 May 2017
  2. Study start1 May 2013
  3. Primary completion30 Sep 2013
  4. Study completion30 Sep 2013

Resources

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)
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

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.

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