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Syphilis Treatment of Partners Trial

NCT02262390 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1752

Last updated 2014-10-13

No results posted yet for this study

Summary

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.

Conditions

  • Syphilis Infection

Interventions

PROCEDURE

Partner Notification Reminders

For all 3 arms, the following will be done: * All participants will have an antenatal clinic visit every 4 weeks until delivery. * All notification slips will be duplicate; one given to the mother and one held in the clinic. The study ID number will be documented on the slip. On partner return the slips will be matched and used to link mothers with male returning partners. * Partner participant test result will be linked to the patient using the participant ID number in the lab. Partners will be tested using a rapid treponemal antibody test.

Sponsors & Collaborators

  • Infectious Diseases Institute, Uganda

    collaborator OTHER

  • Makerere University

    lead OTHER

Principal Investigators

  • Yuka C Manabe, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02262390 on ClinicalTrials.gov