Syphilis Treatment of Partners Trial — STOP  

Syphilis Infection Clinical Trial

Official title: Comparison of Different Partner Notification Strategies After Antenatal Syphilis Screening

Status Not yet recruiting

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.

Clinical Trial 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. ;

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

• NCT number: NCT02262390
• Study type: Interventional
• Source: Makerere University
• Contact: Rosalind Parkes-Ratanshi, PhD
• Phone: +256312307000
• Email: rratanshi@idi.co.ug
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2014
• Completion date: December 2016