SyphilisNCT02454816
Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in Colombia
A study testing Single HIV RDT and single syphilis RDT and Dual HIV/syphilis RDT in people with Syphilis and HIV, run by Universidad Nacional de Colombia at 1 site in Colombia.
Trial summary
Global and regional initiatives have been launched for the dual elimination of mother-to-child transmission (MTCT) of HIV and syphilis. As one of the important components in the initiatives, early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Single HIV RDT and single syphilis RDT and Dual HIV/syphilis RDT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteColombia
- Study dates
- May 2014to Apr 2015
- Phase
- Interventional
- 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 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women attending first ANC visit at the study sites, or women not previously tested in this pregnancy
- Women aged 14 years old or above
- Any woman who has tested positive for HIV and/or syphilis in the past (will be permitted to enrol)
- Women providing a written informed consent
Who cannot join
- Women who have already been enrolled in this study
- Women < 14 years of age
- Women unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Carlos Holmes Trujillo
Cali, Valle del Cauca Department
About this study
Official title: Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in COLOMBIA
Global and regional initiatives have been launched for the dual elimination of mother-to-child transmission (MTCT) of HIV and syphilis. As one of the important components in the initiatives, early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. In order to improve the number of women tested and treated, innovative strategies are needed.
Serologic tests are the diagnostic tests of choice for HIV and syphilis. There are two types of serological tests (treponemal and non-treponemal tests) for diagnosis of syphilis. These generally require venous blood for screening of symptomatic and asymptomatic patients. In addition, these tests are technically demanding, and require laboratory equipment which is not widely available in most resource-limited settings.
Read more
Recently, Rapid diagnostic tests (RDTs) that can be used at point-of-care for simultaneously detecting antibodies to HIV and syphilis (dual HIV \& syphilis treponemalRDTs) using serum/plasma, venous whole blood, or finger-stick whole blood have been developed and are now commercially available.
In low-resource settings, a combination of two or three rapid diagnostic tests (RDTs), in which one screening test with a second test to confirm initial positive results or two RDTs in parallel with a third test as a tiebreaker for discordant samples, can be used to diagnose HIV on finger-stick blood. To date, there are few data on the implications of using these RDTs in the antenatal clinic settings, although they have been evaluated in laboratory-based studies and shown encouraging sensitivities and specificities as compared with reference laboratory tests.
The objective of this research is to assess the uptake of syphilis testing after the introduction of dual HIV/syphilis rapid testing as compared to single rapid syphilis testing in antenatal clinics in Colombia.
The secondary objectives of the study are: To determine the uptake of treatment of syphilis after the intervention, To determine the uptake of HIV testing in ANC attendees after the intervention, To explore the acceptability of dual HIV/syphilis RDTs by ANC attendees and health workers, To assess the organizational and socio-cultural advantages and barriers to introduction with a aim of sustainable adoption of dual HIV/syphilis RDTs in antenatal services, To determine the workload and cost implications of introduction of dual HIV/syphilis RDTs in antenatal services
Read the detailed description
Methods:
Desing: Cluster randomized trial including and quantitative component, a qualitative component (in-deep interviews)and a time and cost estimation component in the antenatal care setting.
Population: Primary health facilities (n=12) in Bogotá and Cali, Colombia. Eligibility criteria: Inclusion Criteria: Pregnant women attending first ANC visit at the study sites, or women not previously tested in this pregnancy,Women aged 14 years old or above, Any woman who has tested positive for HIV and/or syphilis in the past (will be permitted to enrol), Women providing a written informed consent.Exclusion Criteria: Women who have already been enrolled in this study, Women < 14 years of age, Women unable to provide informed consent.
Test to be evaluated: Each of the 12 institutions participating in the trial were assigned in a random way to rapid single test for HIV and Syphilis or dual rapid test HIV/syphilis. The brand of the rapid test selected for the study, passed throw a process of selection by the National Health Institute in Colombia, in order to choose the best test according to desirable performance and operational characteristics. The brand Standard Diagnostics the Bioline was donated to do the rapid test in the present study with pregnant women.
Analysis:
- CONSORT diagram for the cluster randomized trial will be shown.
- Primary analysis will be based on intention-to-treat principle, with no facility excluded from analysis after the random assignment.
- Baseline characteristics of clusters (facilities) and of the women enrolled in each arm will be provided.
- For qualitative variables frequencies and percentages will be reported. For quantitative normally distributed variables, the number of subjects, means and standard errors will be provided, while medians, interquartile range, minima and maxima will be reported for skewed non-normal quantitative variables.
- Because of the clustered nature of outcomes due to randomization to interventions based on clusters (facilities), the Generalized Estimating Equations (GEE) modelling, with binomial distribution and logit link, will be used to estimate the risk difference (RD) and odds ratio (OR) of Syphilis testing, Syphilis treatment and HIV testing uptake, with 95% Confidence Interval, adjusted for clustering, between interventions arms A and B. This model will adjust for any important baseline factors, including whether any testing in Syphilis or HIV was ever done previously.
- Intra-cluster correlations (ICC) for overall, as well as ICCs stratified for important baseline factors of interest, will be estimated.
- Two-sided tests and 5% significance levels will be used, and 95% confidence intervals for all relevant parameters. SAS statistical packages will be used for the statistical analyses.
Expected results: The results of the study will be used in the design of strategies of policies/national o local guidelines or even screening antenatal programs for HIV and syphilis, the development of the best practice to the adoption of the rapid test for HIV and Syphilis. The information collected will be used to share the experience and the lessons learned to other countries in order to development guidelines of global, regional and national policies to implement in order to impact the transmission of maternal-child HIV and syphilis.
- Being tested
- Single HIV RDT and single syphilis RDT, Dual HIV/syphilis RDT
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single HIV RDT and single syphilis RDTDevice
It is a diagnostic intervention, at the cluster level This arm includes a single (separate) rapid test for HIV and Syphilis. In this case pregnant women enrolled are sampled with two drops of blood (one for each cassette). Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling
Dual HIV/syphilis RDTDevice
It is a diagnostic intervention, at the cluster level. This arm includes a dual rapid test for HIV and syphilis, which means that in the same cassette will be available the information about the results for both conditions. In this case pregnant women enrolled are sampled with one drop for the cassette, which is enough to get both of the results. Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling
| Study group | Role | What they receive |
|---|---|---|
| Single HIV RDT and single syphilis RDT | Experimental | It is a diagnostic intervention, at the cluster level This arm includes a single (separate) rapid test for HIV and Syphilis. In this case pregnant women enrolled are sampled with two drops of blood (one for each cassette). Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling Receives: Device: Single HIV RDT and single syphilis RDT |
| Dual HIV/syphilis RDT | Active comparator | It is a diagnostic intervention, at the cluster level. This arm includes a dual rapid test for HIV and syphilis, which means that in the same cassette will be available the information about the results for both conditions. In this case pregnant women enrolled are sampled with one drop for the cassette, which is enough to get both of the results. Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling Receives: Device: Dual HIV/syphilis RDT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in syphilis testing with SRDT compared to DRDT post intervention
Measured: 4 months
Secondary outcomes (5)
Differences in Number of participants with uptake of HIV testing between Arm A and Arm B.
Measured: 4 months
Number of participants with syphilis treatment between Arm A and Arm B
Measured: 4 months
Number of participants with uptake of syphilis treatment between Arm A and Arm B
Measured: 4 months
Number of participants with acceptability and feasibility of dual RDTand health care workers.
Measured: 4 months
Determine the workload and cost implications of the introduction of dual RDTs in antenatal services through a time/motion/cost exercise.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2014
- Study completionApr 2015
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 SyphilisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A cluster randomised controlled trial will be conducted in 12 health facilities (4 hospitals and 8 health centres) in Bogota and Cali, Colombia.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Colombia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454816
- Sponsor's protocol ID
- HIV2.0
- Status last verified
- May 2021
- First submitted
- 12 May 2015
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Obure CD, Gaitan-Duarte H, Losada Saenz R, Gonzalez L, Angel-Muller E, Laverty M, Perez F. A comparative analysis of costs of single and dual rapid HIV and syphilis diagnostics: results from a randomised controlled trial in Colombia. Sex Transm Infect. 2017 Nov;93(7):482-486. doi: 10.1136/sextrans-2016-052961. Epub 2017 May 11.
PubMed 28495681
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in COLOMBIA
- ClinicalTrials.gov ID
- NCT02454816
- Acronym / sponsor ID
- HIV2.0
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Nacional de ColombiaUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 May 2015 (estimated)
- 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.
Global and regional initiatives have been launched for the dual elimination of mother-to-child transmission (MTCT) of HIV and syphilis. As one of the important components in the initiatives, early detection and timely intervention of pregnant women infected with HIV and/or syphilis is critical. In order to improve the number of women tested and treated, innovative strategies are needed.
Serologic tests are the diagnostic tests of choice for HIV and syphilis. There are two types of serological tests (treponemal and non-treponemal tests) for diagnosis of syphilis. These generally require venous blood for screening of symptomatic and asymptomatic patients. In addition, these tests are technically demanding, and require laboratory equipment which is not widely available in most resource-limited settings.
Recently, Rapid diagnostic tests (RDTs) that can be used at point-of-care for simultaneously detecting antibodies to HIV and syphilis (dual HIV \& syphilis treponemalRDTs) using serum/plasma, venous whole blood, or finger-stick whole blood have been developed and are now commercially available.
In low-resource settings, a combination of two or three rapid diagnostic tests (RDTs), in which one screening test with a second test to confirm initial positive results or two RDTs in parallel with a third test as a tiebreaker for discordant samples, can be used to diagnose HIV on finger-stick blood. To date, there are few data on the implications of using these RDTs in the antenatal clinic settings, although they have been evaluated in laboratory-based studies and shown encouraging sensitivities and specificities as compared with reference laboratory tests.
The objective of this research is to assess the uptake of syphilis testing after the introduction of dual HIV/syphilis rapid testing as compared to single rapid syphilis testing in antenatal clinics in Colombia.
The secondary objectives of the study are: To determine the uptake of treatment of syphilis after the intervention, To determine the uptake of HIV testing in ANC attendees after the intervention, To explore the acceptability of dual HIV/syphilis RDTs by ANC attendees and health workers, To assess the organizational and socio-cultural advantages and barriers to introduction with a aim of sustainable adoption of dual HIV/syphilis RDTs in antenatal services, To determine the workload and cost implications of introduction of dual HIV/syphilis RDTs in antenatal services
Detailed description
Methods:
Desing: Cluster randomized trial including and quantitative component, a qualitative component (in-deep interviews)and a time and cost estimation component in the antenatal care setting.
Population: Primary health facilities (n=12) in Bogotá and Cali, Colombia. Eligibility criteria: Inclusion Criteria: Pregnant women attending first ANC visit at the study sites, or women not previously tested in this pregnancy,Women aged 14 years old or above, Any woman who has tested positive for HIV and/or syphilis in the past (will be permitted to enrol), Women providing a written informed consent.Exclusion Criteria: Women who have already been enrolled in this study, Women < 14 years of age, Women unable to provide informed consent.
Test to be evaluated: Each of the 12 institutions participating in the trial were assigned in a random way to rapid single test for HIV and Syphilis or dual rapid test HIV/syphilis. The brand of the rapid test selected for the study, passed throw a process of selection by the National Health Institute in Colombia, in order to choose the best test according to desirable performance and operational characteristics. The brand Standard Diagnostics the Bioline was donated to do the rapid test in the present study with pregnant women.
Analysis:
- CONSORT diagram for the cluster randomized trial will be shown.
- Primary analysis will be based on intention-to-treat principle, with no facility excluded from analysis after the random assignment.
- Baseline characteristics of clusters (facilities) and of the women enrolled in each arm will be provided.
- For qualitative variables frequencies and percentages will be reported. For quantitative normally distributed variables, the number of subjects, means and standard errors will be provided, while medians, interquartile range, minima and maxima will be reported for skewed non-normal quantitative variables.
- Because of the clustered nature of outcomes due to randomization to interventions based on clusters (facilities), the Generalized Estimating Equations (GEE) modelling, with binomial distribution and logit link, will be used to estimate the risk difference (RD) and odds ratio (OR) of Syphilis testing, Syphilis treatment and HIV testing uptake, with 95% Confidence Interval, adjusted for clustering, between interventions arms A and B. This model will adjust for any important baseline factors, including whether any testing in Syphilis or HIV was ever done previously.
- Intra-cluster correlations (ICC) for overall, as well as ICCs stratified for important baseline factors of interest, will be estimated.
- Two-sided tests and 5% significance levels will be used, and 95% confidence intervals for all relevant parameters. SAS statistical packages will be used for the statistical analyses.
Expected results: The results of the study will be used in the design of strategies of policies/national o local guidelines or even screening antenatal programs for HIV and syphilis, the development of the best practice to the adoption of the rapid test for HIV and Syphilis. The information collected will be used to share the experience and the lessons learned to other countries in order to development guidelines of global, regional and national policies to implement in order to impact the transmission of maternal-child HIV and syphilis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster randomised controlled trial will be conducted in 12 health facilities (4 hospitals and 8 health centres) in Bogota and Cali, Colombia.
| Arm | Type | Receives |
|---|---|---|
| Single HIV RDT and single syphilis RDT | Experimental | Device: Single HIV RDT and single syphilis RDTIt is a diagnostic intervention, at the cluster level This arm includes a single (separate) rapid test for HIV and Syphilis. In this case pregnant women enrolled are sampled with two drops of blood (one for each cassette). Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling |
| Dual HIV/syphilis RDT | Active comparator | Device: Dual HIV/syphilis RDTIt is a diagnostic intervention, at the cluster level. This arm includes a dual rapid test for HIV and syphilis, which means that in the same cassette will be available the information about the results for both conditions. In this case pregnant women enrolled are sampled with one drop for the cassette, which is enough to get both of the results. Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women attending first ANC visit at the study sites, or women not previously tested in this pregnancy
- Women aged 14 years old or above
- Any woman who has tested positive for HIV and/or syphilis in the past (will be permitted to enrol)
- Women providing a written informed consent
Key exclusion criteria (3 listed)
- Women who have already been enrolled in this study
- Women < 14 years of age
- Women unable to provide informed consent
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 |
|---|---|---|
| Single HIV RDT and single syphilis RDTIt is a diagnostic intervention, at the cluster level This arm includes a single (separate) rapid test for HIV and Syphilis. In this case pregnant women enrolled are sampled with two drops of blood (one for each cassette). Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling | Device | Single HIV RDT and single syphilis RDT |
| Dual HIV/syphilis RDTIt is a diagnostic intervention, at the cluster level. This arm includes a dual rapid test for HIV and syphilis, which means that in the same cassette will be available the information about the results for both conditions. In this case pregnant women enrolled are sampled with one drop for the cassette, which is enough to get both of the results. Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling | Device | Dual HIV/syphilis RDT |
Primary outcome
Number of participants in syphilis testing with SRDT compared to DRDT post intervention
Time frame: 4 months
5 secondary outcomes
Differences in Number of participants with uptake of HIV testing between Arm A and Arm B.
Time frame: 4 months
Number of participants with syphilis treatment between Arm A and Arm B
Time frame: 4 months
Number of participants with uptake of syphilis treatment between Arm A and Arm B
Time frame: 4 months
Number of participants with acceptability and feasibility of dual RDTand health care workers.
Time frame: 4 months
Determine the workload and cost implications of the introduction of dual RDTs in antenatal services through a time/motion/cost exercise.
Time frame: 4 months
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 11 May 2021.
- Derived from this study: PubMed 28495681Obure CD, Gaitan-Duarte H, Losada Saenz R, Gonzalez L, Angel-Muller E, Laverty M, Perez F. A comparative analysis of costs of single and dual rapid HIV and syphilis diagnostics: results from a randomised controlled trial in Colombia. Sex Transm Infect. 2017 Nov;93(7):482-486. doi: 10.1136/sextrans-2016-052961. Epub 2017 May 11.
Related trials for Syphilis
Recruiting
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
HIV1 Infection, HIV 2 Infection
Active, not recruitingPhase 4
Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM
Gonorrhea Male, Chlamydia (Male)
Not yet recruitingPhase 3
Efficacy and Safety of Minocycline Add-on in Patients With Neurosyphilis
Neurosyphilis
Not yet recruiting
Pilot HIV Self-Testing And Self-collected STI Testing Strategy for Sex Worker Empowerment Study
HIV, Syphilis
RecruitingPhase 3
Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis.
Syphilis Acquired
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single HIV RDT and single syphilis RDT and Dual HIV/syphilis RDT in people with Syphilis and HIV, run by Universidad Nacional de Colombia at 1 site in Colombia.
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 4 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 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of participants in syphilis testing with SRDT compared to DRDT post intervention (time frame: 4 months). 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 NCT02454816, 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 11 May 2021.