Syphilis Treatment of Partners Trial

NCT02262390 | Unknown

• 1 other identifier: ST/0109/14
• Study Type: interventional
• Target: 1,752
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Proportion of male partners who present at clinic and receive syphilis testing

  Proportion of male partners who present at clinic and receive syphilis testing

  2 years

Secondary Outcomes (6)

• Male partners tested (standard vs. intervention in 3 arm randomization)

  2 years

• Proportion of male partners who test positive for syphilis when they report to the clinic after notification.

  2 years

• Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.

  2 years

• Factors associated with partners reporting/not reporting after notification.

  2 years

• Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)

  2 years

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

Partner notification slip is given to the pregnant female participant on the day she receives her syphilis test results to give to their sexual partner encouraging them to come to the STI clinic and be screened for syphilis. The partner notification slip will have a code number, but no identifiable features (no names).

Procedure: Partner Notification Reminders

SMS reminders and notification slip for partner screening

ACTIVE COMPARATOR

Participants will receive weekly SMS reminders to encourage their partners to attend the STI clinic for syphilis testing for up to 8 weeks after initial positive syphilis test for the participant. The participant ID number will be written on both the notification paper which partners should bring in with them and on the SMS reminders.

Procedure: Partner Notification Reminders

Phone call reminders and notification slip for partner scree

ACTIVE COMPARATOR

Participants will receive weekly phone call reminders to encourage their partners to attend the STI clinic for syphilis testing for up to 8 weeks after initial positive syphilis test for the participant. The participant ID number will be written on both the notification paper which partners should bring in with them and be given to the participant when the nurse calls.

Procedure: Partner Notification Reminders

Interventions

Partner Notification Reminders PROCEDURE

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.

Phone call reminders and notification slip for partner scree; SMS reminders and notification slip for partner screening; Standard of Care

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Illiterate and unable to read a text message
• Inability to use a mobile phone
• Patients with confirmed neuro syphilis treated with IV Benzyl penicillin

Sponsors & Collaborators

• Makerere University: lead
• Infectious Diseases Institute, Uganda: collaborator

Study Sites (1)

Infectious Diseases Institute

Kampala, Kampala, 256, Uganda

Location

Related Publications (1)

• Nakku-Joloba E, Kiguli J, Kayemba CN, Twimukye A, Mbazira JK, Parkes-Ratanshi R, Birungi M, Kyenkya J, Byamugisha J, Gaydos C, Manabe YC. Perspectives on male partner notification and treatment for syphilis among antenatal women and their partners in Kampala and Wakiso districts, Uganda. BMC Infect Dis. 2019 Feb 6;19(1):124. doi: 10.1186/s12879-019-3695-y.

  PMID: 30727950 DERIVED

Study Officials

• Yuka C Manabe, MD

  Johns Hopkins University

  STUDY CHAIR

Central Study Contacts

Rosalind Parkes-Ratanshi, PhD

CONTACT

+256312307000; rratanshi@idi.co.ug

Joshua K Mbazira, CO

CONTACT

+256312307000; jmbazira@idi.co.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Prevention Care & Treatment, IDI

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

UG (1)