Syphilis Treatment of Partners Trial

Syphilis Infection Clinical Trial

— STOP  

Official title:

Comparison of Different Partner Notification Strategies After Antenatal Syphilis Screening

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02262390
• Other study ID #: ST/0109/14
• Status: Not yet recruiting
• Phase: N/A
• First received: October 8, 2014
• Last updated: October 10, 2014
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2014
• Source: Makerere University
• Contact: Rosalind Parkes-Ratanshi, PhD
• Phone: +256312307000
• Email: rratanshi[@]idi.co.ug
• Is FDA regulated: No
• Health authority: Uganda: Infectious Diseases Institute
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1752
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Syphilis
• Syphilis Infection

Intervention

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.

Locations

Country	Name	City	State
Uganda	Infectious Diseases Institute	Kampala

Sponsors (2)

Lead Sponsor	Collaborator
Makerere University	Infectious Diseases Institute, Uganda

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Male partners tested (standard vs. intervention in 3 arm randomization)	Male partners tested (standard vs. intervention in 3 arm randomization)	2 years	No
Secondary	Proportion of male partners who test positive for syphilis when they report to the clinic after notification.	Proportion of male partners who test positive for syphilis when they report to the clinic after notification.	2 years	No
Secondary	Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.	Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.	2 years	No
Secondary	Factors associated with partners reporting/not reporting after notification.	Factors associated with partners reporting/not reporting after notification.	2 years	No
Secondary	Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)	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	No
Secondary	Mother reported birth outcomes (by standard vs. intervention arm)	Mother reported birth outcomes (by standard vs. intervention arm)	2 years	No