ClinicalTrials.gg
CompletedNCT03156751Updated May 17, 2017

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

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

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,205
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Syphilis Infection
  • Diagnoses Disease

Keywords

  • Syphilis screening
  • antenatal care
  • prenatal diagnosis
  • rapid diagnosis test
  • Burkina Faso
  • feasibility
03

In context

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,205 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testFeasibility of introducing onsite test for syphilis in the package of antenatal care at rural primary health care in Burkina Faso

    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.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No — The individual participant data could be obtained if requested by other researchers to the principal investigator.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2013 to primary completion in Sep 2013, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2017
First posted
May 17, 2017
StartActual
May 1, 2013
Primary completionActual
Sep 30, 2013
CompletionActual
Sep 30, 2013
Last update
May 17, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03156751
Lead sponsor
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborators
World Health Organization, African Population and Health Research Center
Responsible party
Sponsor
First posted
May 17, 2017
Start date
May 1, 2013
Primary completion
Sep 30, 2013
Completion
Sep 30, 2013
Last update
May 17, 2017

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion