Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in Colombia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 May 2021
• Main ID: NCT02454816
• Date of registration: 12/05/2015
• Prospective Registration: No
• Primary sponsor: Universidad Nacional de Colombia
• Public title: Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in Colombia
• Scientific title: Introduction Study of Dual HIV & Syphilis Rapid Diagnostic Tests in Antenatal Clinics in COLOMBIA
• Date of first enrolment: May 2014
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02454816
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Colombia

Key inclusion & exclusion 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



Age minimum: 14 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Syphilis

HIV

Intervention(s)

Device: Dual HIV/syphilis RDT

Device: Single HIV RDT and single syphilis RDT

Primary Outcome(s)

Number of participants in syphilis testing with SRDT compared to DRDT post intervention [Time Frame: 4 months]

Secondary Outcome(s)

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]

Number of participants with syphilis treatment between Arm A and Arm B [Time Frame: 4 months]

Differences in Number of participants with uptake of HIV testing 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]

Secondary ID(s)

HIV2.0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors