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Syphilis clinical trials

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NCT ID: NCT02454816 Completed - HIV Clinical Trials

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

Start date: May 2014
Phase: N/A
Study type: Interventional

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

NCT ID: NCT02447484 Completed - HIV Clinical Trials

Texting Intervention to Sustain HIV Prevention in Women in High-drug-use Contexts

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a program of regular, theory-based text messages that encourages the message recipient to continue practicing safer sex (i.e., using condoms with sex partners) is effective in maintaining positive behavior change in women who have completed a brief safer-sex training.

NCT ID: NCT02445846 Completed - HIV Clinical Trials

Dual Rapid HIV & Syphilis Tests in Zambia

Start date: May 2014
Phase: N/A
Study type: Observational

The purpose of this study is to provide evidence on the performance and operational characteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) in Zambia for their introduction into antenatal care and other settings.

NCT ID: NCT02353117 Completed - Congenital Syphilis Clinical Trials

Preventing Congenital Syphilis

PCS
Start date: January 11, 2016
Phase: N/A
Study type: Interventional

Nearly 1.5 million pregnant women are infected with syphilis each year, and it is estimated that half of them will have adverse birth outcomes. Congenital syphilis remains a major public health issue, despite the fact that maternal syphilis is easy to detect and treat. Multiple barriers impair the elimination of congenital syphilis. Syphilis is often stigmatized and of low priority, and even women attending prenatal care early are potentially facing multiple clinical barriers. The study objective is to use implementation research methods to evaluate a multifaceted intervention to increase the use of evidence-based clinical procedures to prevent congenital syphilis. The investigators will perform a facility-based, two-arm parallel cluster randomized implementation trial in the Democratic Republic of the Congo and Zambia. The intervention will be multifaceted, tailored by formative research, and include: opinion leaders, reminders, monitoring, and feedback; point-of-care rapid tests; and treatment kits to be used immediately if the rapid test is positive. Improving syphilis screening and treatment will be promoted as a key step toward improving the quality of all components of prenatal care.

NCT ID: NCT02262390 Not yet recruiting - Syphilis Infection Clinical Trials

Syphilis Treatment of Partners Trial

STOP
Start date: November 2014
Phase: N/A
Study type: Interventional

2.1 Primary Study Hypothesis In sub-Saharan Africa, between 2.5-17% of pregnant women are infected with syphilis [1]. It is estimated that 53-82% of women with untreated syphilis had adverse outcomes compared to only 10-21% of uninfected women[2]. The investigators and others have shown that syphilis screening integrated into an HIV antenatal clinic with prevention of mother to child transmission (PMTCT) is highly accepted with excellent uptake. Unfortunately, the minority of male partners come in for testing and treatment (1%-27%) which has important implications for the roll-out of rapid syphilis testing and the inability to detect reinfection with treponemal antibody test as the test will remain positive despite treatment. The investigators hypothesize that sending an SMS reminder or a telephone call reminder by a health care worker will be more effective than a standard notification slip given to women to bring male partners to antennal clinic for testing and treatment.

NCT ID: NCT02257658 Completed - Syphilis Clinical Trials

Efficacy of Doxycycline Prophylaxis to Reduce Syphilis in High-Risk, HIV-Positive MSM

DPMSM
Start date: September 2011
Phase: N/A
Study type: Interventional

This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free. The investigators will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.

NCT ID: NCT02191527 Completed - HIV Clinical Trials

Evaluating the Effectiveness of Point-of-care Diagnostic Technologies in MCH Services in Mozambique

Start date: September 2013
Phase: N/A
Study type: Interventional

The general goal of the proposed study is to evaluate the cost-effectiveness of POC technologies for diagnosis of syphilis, quantitative analysis for hemoglobin and CD4 counting performed within MCH services to improve maternal and infant health. A prospective, quasi-experimental study will be done in Cabo Delgado province, where health facilities will be randomized in an intervention or comparison arm. Outcomes on maternal and infant health will be measured.

NCT ID: NCT02122094 Completed - HIV Clinical Trials

Implementation of a Sexual Health Intervention for Young Men Who Have Sex With Men (MSM) in Two Vietnamese Cities

Start date: May 2013
Phase: N/A
Study type: Interventional

This study seeks to implement a sexual health promotion intervention for male sex workers in Hanoi and Ho Chi Minh City, Vietnam. The study hypothesis is that this intervention will increase testing, treatment and vaccination for sexually transmitted infections, including intentions of participants to engage in these services beyond the conclusion of the intervention. At the community level, the study hypothesis is that male sex workers will be more aware of sexual health care and more likely to access these services in the future.

NCT ID: NCT02059525 Completed - Syphilis Clinical Trials

Treponema Pallidum-specific Proteomic Changes in Patients With Incident Syphilis Infection

SeTPAT
Start date: July 2014
Phase:
Study type: Observational

This study is part of the Search for a Treponema pallidum Antigen Test (SeTPAT) project to study the proteomic, immunological, serological and clinical changes associated with pre- and post-treatment syphilis infection in a way that could ultimately lead to the development of a new ELISA and rapid diagnostic test of T. pallidum antigenaemia. The general aim of this prospecive observational cohort study is thus to quantify a set of target proteins with the highest diagnostic potential for the diagnosis of initial T. pallidum infection and T. pallidum persistence. A test which could directly detect the presence of T. pallidum antigens could represent a considerable advance over currently used tests in the diagnosis of initial syphilis infection, its response to therapy and in the diagnosis of syphilis reinfections. This prospective observational cohort study of HIV-positive patients with a new diagnosis of syphilis infection will be conducted at the HIV/Sexually Transmitted Infections (STI) Clinic at the Institute of Tropical Medicine, Antwerp.

NCT ID: NCT02031146 Completed - Syphilis Clinical Trials

Lumbar Puncture and Syphilis Outcome

Start date: August 2013
Phase: N/A
Study type: Interventional

Treponema pallidum, the bacterium that causes syphilis, invades the central nervous system in about 40% of patients with syphilis. This happens early after infection. Patients with neuroinvasion are at risk of developing serious neurological complications, including vision or hearing loss, stroke and dementia. Because neuroinvasion can happen without symptoms, the only way to identify it is by performing a lumbar puncture (LP) to examine cerebrospinal fluid (CSF).The overall hypothesis to be tested in this study is that a strategy of immediate LP, followed by therapy based on CSF evaluation, results in better serological and functional outcomes in patients with syphilis who are at high risk for neuroinvasion.