Clinical trial NCT02262390: Syphilis Treatment of Partners Trial
Official title: Comparison of Different Partner Notification Strategies After Antenatal Syphilis Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Syphilis Infection
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Institute, Uganda
First posted: 2014-10-13
Enrollment: 1752
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 test rapid syphilis test positive; to compare the proportion of male partners who report to the clinic for syphilis testing (and treatment) when the women are given only partner notification slips (standard of care) compared to a notification slip plus a weekly automated SMS reminder OR a notification slip plus a weekly nurse phone call reminder.

Secondary

* To compare the proportion of male partners who test positive for syphilis when they report to the clinic after receiving notification in the three groups via their pregnant partners.
* To compare the proportion of male partners who undergo treatment among the three groups.
* To explore factors associated with reporting/not reporting after notification.
* To compare birth outcomes (congenital syphilis, stillbirths, neonatal deaths, preterm or low birth weight) between the three arms (self-reported by women).
* To assess time from syphilis point of care (POC) test to treatment in mothers who test syphilis positive using a rapid treponemal antibody kit.
* To compare the proportion of women who have a 4-fold decrease in RPR titer by intervention arm in each arm at post natal visit.

Study Population and sample size: • Pregnant women from 14years and above reporting to antenatal and subsequently postnatal clinics at the Infectious Disease Institute, Mulago Hospital (antenatal and STI clinics), and Kasangati Health Center IV in Kampala, Uganda who screen positive by rapid treponemal antibody test.

* Male sexual partners to these enrolled syphilis positive pregnant mothers.
* 876participants will be enrolled. Study Design: Individual patient randomized open-label clinical trial of syphilis partner notification interventions.

Study Duration: Approximately 24 months

Endpoints:

Primary:

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

Secondary:

1. 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.
3. 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.
5. 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) Subject Participants: Pregnant women testing positive for syphilis at the antenatal clinics and their partners.

Description of Study Design: This is a prospective clinical trial in which pregnant syphilis positive women (tested by rapid treponemal antibody kit) will be randomized to one of three arms to notify participants to bring their sexual partners at risk for syphilis for syphilis screening and treatment. Women will be randomized in a 1:1:1 ratio to one of the following three strategies: A) To receive a notification slip per the Ministry of Health standard B) to receive a notification slip plus an SMS reminder or C) to receive a notification slip plus standardized nurse/clinician initiated phone call.

Eligibility 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

Primary outcomes:
measure: Proportion of male partners who present at clinic and receive syphilis testing
timeFrame: 2 years
Secondary outcomes:
measure: Male partners tested (standard vs. intervention in 3 arm randomization)
timeFrame: 2 years
measure: Proportion of male partners who test positive for syphilis when they report to the clinic after notification.
timeFrame: 2 years
measure: Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.
timeFrame: 2 years
measure: Factors associated with partners reporting/not reporting after notification.
timeFrame: 2 years
measure: Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)
timeFrame: 2 years
measure: Mother reported birth outcomes (by standard vs. intervention arm)
timeFrame: 2 years
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Diseases Institute
Study officials:
affiliation: Johns Hopkins University
name: Yuka C Manabe, MD
role: STUDY_CHAIR
References:
citation: 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.