Syphilis InfectionSTOPNCT02262390
Syphilis Treatment of Partners Trial
A study testing Partner Notification Reminders in people with Syphilis Infection, run by Makerere University at 1 site in Uganda.
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]. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Syphilis Infection
- What is being tested?
- Partner Notification Reminders
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,752 participants
- Where
- 1 siteUganda
- Study dates
- Nov 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Uganda1 site
Infectious Diseases Institute
Kampala, Kampala, 256
Rosalind Parkes-Ratanshi, PhD, +256312307000 ext. 237, rratanshi@idi.co.ug
Allen M Mukhwana, MBA, +256312307000 ext. 242, amukhwana@idi.co.ug
About this study
Official title: Comparison of Different Partner Notification Strategies After Antenatal Syphilis Screening
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.
Read the 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:
- Proportion of male partners who present at clinic and receive syphilis testing
Secondary:
- Male partners tested (standard vs. intervention in 3 arm randomization)
- Proportion of male partners who test positive for syphilis when they report to the clinic after notification.
- Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.
- Factors associated with partners reporting/not reporting after notification.
- Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)
- 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.
- Conditions
- Syphilis Infection
- Being tested
- Partner Notification Reminders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partner Notification RemindersProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Procedure: Partner Notification Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of male partners who present at clinic and receive syphilis testing
Proportion of male partners who present at clinic and receive syphilis testing
Measured: 2 years
Secondary outcomes (6)
Male partners tested (standard vs. intervention in 3 arm randomization)
Male partners tested (standard vs. intervention in 3 arm randomization)
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Factors associated with partners reporting/not reporting after notification.
Factors associated with partners reporting/not reporting after notification.
Measured: 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)
Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)
Measured: 2 years
Mother reported birth outcomes (by standard vs. intervention arm)
Mother reported birth outcomes (by standard vs. intervention arm)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Syphilis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Institute, Uganda
- Responsible party
- Principal investigator, Infectious Diseases Institute, Makerere University
- Investigators
- Yuka C Manabe, MD, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262390
- Sponsor's protocol ID
- ST/0109/14
- Acronym
- STOP
- Status last verified
- Oct 2014
- First submitted
- 8 Oct 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30727950
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Partner Notification Strategies After Antenatal Syphilis Screening
- ClinicalTrials.gov ID
- NCT02262390
- Acronym / sponsor ID
- STOP / ST/0109/14
- Conditions
- Syphilis Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,752 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Infectious Diseases Institute, Uganda
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Proportion of male partners who present at clinic and receive syphilis testing
Secondary:
- Male partners tested (standard vs. intervention in 3 arm randomization)
- Proportion of male partners who test positive for syphilis when they report to the clinic after notification.
- Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.
- Factors associated with partners reporting/not reporting after notification.
- Syphilis infected pregnant women re-tested in 3rd trimester with a 4-fold dilutional titer decrease in RPR (by standard vs. intervention arm)
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Partner Notification RemindersPartner 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). |
| SMS reminders and notification slip for partner screening | Active comparator | Procedure: Partner Notification RemindersParticipants 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. |
| Phone call reminders and notification slip for partner scree | Active comparator | Procedure: Partner Notification RemindersParticipants 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Any subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partner Notification RemindersFor 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. | Procedure or surgery | Phone call reminders and notification slip for partner scree, SMS reminders and notification slip for partner screening, Standard of Care |
Primary outcome
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
6 secondary outcomes
Male partners tested (standard vs. intervention in 3 arm randomization)
Time frame: 2 years
Proportion of male partners who test positive for syphilis when they report to the clinic after notification.
Time frame: 2 years
Proportion of syphilis positive male (tested by syphilis POCT) partners who undergo treatment among the three groups.
Time frame: 2 years
Factors associated with partners reporting/not reporting after notification.
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)
Time frame: 2 years
Mother reported birth outcomes (by standard vs. intervention arm)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Derived from this study: PubMed 30727950Nakku-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuka C Manabe, MD study chair
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partner Notification Reminders in people with Syphilis Infection, run by Makerere University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosalind Parkes-Ratanshi, PhD (+256312307000 ext. 237, rratanshi@idi.co.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of male partners who present at clinic and receive syphilis testing (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2014.