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Trial record 2 of 1593 for:    PARTNER trial

Syphilis Treatment of Partners Trial (STOP)

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ClinicalTrials.gov Identifier: NCT02262390
Recruitment Status : Unknown
Verified October 2014 by Infectious Diseases Institute, Makerere University.
Recruitment status was:  Not yet recruiting
First Posted : October 13, 2014
Last Update Posted : October 13, 2014
Sponsor:
Collaborator:
Infectious Diseases Institute, Uganda
Information provided by (Responsible Party):
Infectious Diseases Institute, Makerere University

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.

Condition or disease Intervention/treatment Phase
Syphilis Infection Procedure: Partner Notification Reminders Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1752 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Comparison of Different Partner Notification Strategies After Antenatal Syphilis Screening
Study Start Date : November 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syphilis

Arm Intervention/treatment
Active Comparator: Standard of Care
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

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.

Active Comparator: SMS reminders and notification slip for partner screening
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

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.

Active Comparator: Phone call reminders and notification slip for partner scree
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

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.




Primary Outcome Measures :
  1. Proportion of male partners who present at clinic and receive syphilis testing [ Time Frame: 2 years ]
    Proportion of male partners who present at clinic and receive syphilis testing


Secondary Outcome Measures :
  1. Male partners tested (standard vs. intervention in 3 arm randomization) [ Time Frame: 2 years ]
    Male partners tested (standard vs. intervention in 3 arm randomization)

  2. Proportion of male partners who test positive for syphilis when they report to the clinic after notification. [ Time Frame: 2 years ]
    Proportion of male partners who test positive for syphilis when they report to the clinic after notification.

  3. Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups. [ Time Frame: 2 years ]
    Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.

  4. Factors associated with partners reporting/not reporting after notification. [ Time Frame: 2 years ]
    Factors associated with partners reporting/not reporting after notification.

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

  6. Mother reported birth outcomes (by standard vs. intervention arm) [ Time Frame: 2 years ]
    Mother reported birth outcomes (by standard vs. intervention arm)



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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262390


Contacts
Contact: Rosalind Parkes-Ratanshi, PhD +256312307000 ext 237 rratanshi@idi.co.ug
Contact: Joshua K Mbazira, CO +256312307000 ext 310 jmbazira@idi.co.ug

Locations
Uganda
Infectious Diseases Institute Not yet recruiting
Kampala, Uganda, 256
Contact: Rosalind Parkes-Ratanshi, PhD    +256312307000 ext 237    rratanshi@idi.co.ug   
Contact: Allen M Mukhwana, MBA    +256312307000 ext 242    amukhwana@idi.co.ug   
Sub-Investigator: Edith Nakku-Joloba, PhD         
Sponsors and Collaborators
Makerere University
Infectious Diseases Institute, Uganda
Investigators
Study Chair: Yuka C Manabe, MD Johns Hopkins University

Responsible Party: Infectious Diseases Institute, Head of Prevention Care & Treatment, IDI, Makerere University
ClinicalTrials.gov Identifier: NCT02262390     History of Changes
Other Study ID Numbers: ST/0109/14
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 13, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Syphilis
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female