Status:
UNKNOWN
Syphilis Treatment of Partners Trial
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Infectious Diseases Institute, Uganda
Conditions:
Syphilis Infection
Eligibility:
All Genders
14+ years
Phase:
NA
Brief 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 outcome...
Detailed Description
Title: Comparison of Different Partner Notification Strategies after Antenatal Syphilis Screening Short Title: Syphilis Treatment of Partners (STOP) Trial Objectives: Primary For pregnant women who te...
Eligibility Criteria
Inclusion
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate:
- Pregnant women
- Treponemal antibody rapid positive test
- Age\> 14 years
- Written informed consent
- Known sexual partner
- Access to cell phone and willing and able to use and receive SMS or phone calls In the Uganda guidelines (section 9.3 Mature and Emancipated Minors), "mature minors are individuals 14-17 years of age who have drug or alcohol dependency or a sexually transmitted infection; Mature minors may independently provide informed consent to participate in research if in the view of the IRC the research is not objectionable to parents or guardian (established by the IRC with evidence from the community); and b) The research protocol include clear justification for targeting mature and emancipated." This protocol will recruit pregnant women with a sexually transmitted infection in an intervention with minimal risk and with the potential to prevent future reinfection.
Exclusion
- Any subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
- Illiterate and unable to read a text message
- Inability to use a mobile phone
- Patients with confirmed neuro syphilis treated with IV Benzyl penicillin
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
1752 Patients enrolled
Trial Details
Trial ID
NCT02262390
Start Date
November 1 2014
End Date
December 1 2016
Last Update
October 13 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Infectious Diseases Institute
Kampala, Kampala, Uganda, 256