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

NCT02454816 | Completed DMC

• 1 other identifier: HIV2.0
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Syphilis; HIV

Outcome Measures

Primary Outcomes (1)

• Number of participants in syphilis testing with SRDT compared to DRDT post intervention

  4 months

Secondary Outcomes (5)

• Differences in Number of participants with uptake of HIV testing between Arm A and Arm B.

  4 months

• Number of participants with syphilis treatment between Arm A and Arm B

  4 months

• Number of participants with uptake of syphilis treatment between Arm A and Arm B

  4 months

• Number of participants with acceptability and feasibility of dual RDTand health care workers.

  4 months

• Determine the workload and cost implications of the introduction of dual RDTs in antenatal services through a time/motion/cost exercise.

  4 months

Study Arms (2)

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

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

Device: Dual HIV/syphilis RDT

Interventions

Single HIV RDT and single syphilis RDT DEVICE

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

Single HIV RDT and single syphilis RDT

Dual HIV/syphilis RDT DEVICE

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

Dual HIV/syphilis RDT

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women who have already been enrolled in this study
• Women \< 14 years of age
• Women unable to provide informed consent

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead

Study Sites (1)

Hospital Carlos Holmes Trujillo

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (1)

• 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.

  PMID: 28495681 DERIVED

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A cluster randomised controlled trial will be conducted in 12 health facilities (4 hospitals and 8 health centres) in Bogota and Cali, Colombia.

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: April 1, 2015
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

CO (1)