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

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

Interventions

DEVICE

Single HIV RDT and single syphilis RDT

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

Dual HIV/syphilis RDT

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

Sponsors & Collaborators

• Universidad Nacional de Colombia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2014-10-31

Completion

2015-04-30

Countries

• Colombia

Study Locations