SyphilisSIMNCT04753125
Interventions for Enhancing Adherence to Syphilis Treatment and Follow-up: Study Protocol for the Health Information and Monitoring of Sexually Transmitted Infections (SIM) Randomized Controlled Trial
A study testing follow-up by telephone, follow-up via a game in a smartphone app and conventional follow-up by a health professional in people with Syphilis, run by Hospital Moinhos de Vento.
Trial summary
The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Syphilis
- What is being tested?
- follow-up by telephone, follow-up via a game in a smartphone app and conventional follow-up by a health professional
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Jul 2023
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults aged 18 years and older with sorologic test positive for syphilis
Who cannot join
- Participants who did not return after three contact attempts will be excluded from the study,
- pregnant women
- participants who are not able to provide contact information
- participants who are illiterate
- participants those who underwent syphilis treatment within the previous three months.
Trial locations and contacts
No sites are listed yet.
About this study
The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance. The recruitment of participants will be done by invitation, and tests will be performed in a mobile unit in locations accessible to large populations. The goal is to perform 10,000 quick tests, with results confirmed by venereal disease research laboratory (VDRL) tests. Patients with a confirmed diagnosis according to VDRL test results will be randomized in one of three monitoring arms: follow-up by telephone, follow-up via a game in a smartphone app, or conventional follow-up by a health professional. All analyses will follow the intention-to-treat principle.
- Conditions
- Syphilis
- Being tested
- follow-up by telephone, follow-up via a game in a smartphone app, conventional follow-up by a health professional
- Keywords
- Prevalence, Incidence, Men who have sex with men, Protocol
- Medical subject headings
- Syphilis, Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-up by telephoneBehavioural
The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance
follow-up via a game in a smartphone appBehavioural
The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance
conventional follow-up by a health professionalBehavioural
The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance
| Study group | Role | What they receive |
|---|---|---|
| compliance treatment | Active comparator | controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance for 3, 6. 9 and 12 months Receives: Behavioral: follow-up by telephone; Behavioral: follow-up via a game in a smartphone app; Behavioral: conventional follow-up by a health professional |
| compliance for blood test | Active comparator | controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance, follow-up via a game in a smartphone app through an interactive game with stimuli to pass the phase as the treatment was completed and blood tests were performed in 3,6,9 and 12 months. Receives: Behavioral: follow-up by telephone; Behavioral: follow-up via a game in a smartphone app; Behavioral: conventional follow-up by a health professional |
| demographic socio-economic and sexuality questionnaire | Placebo comparator | Questionnaire applied to all patients with positive VDRL Receives: Behavioral: follow-up by telephone; Behavioral: follow-up via a game in a smartphone app; Behavioral: conventional follow-up by a health professional |
What is being measured
The primary outcome is the main question the study is designed to answer.
complince of treatment
3 doses of penicillin g benzathine 3,000,000 UI. The injections are given in the gluteal region once a week from the first dose.
Measured: ut to 12 months (July 2023)
complince of exams
Performing the VDRL blood test that should be done at 3, 6, 9 and 12 months after treatment with penicillin.
Measured: up to 12 months (July 2023)
Secondary outcomes (1)
identify behavioral risk factors for non-adherence to treatment
Identification of risk factors for non-adherence to treatment that will be carried out using a questionnaire applied to study participants with social, racial, sexual, economic and demographic issues.
Measured: upt to 12 months (July 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study startApr 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Martins de Oliveira, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753125
- Sponsor's protocol ID
- 0000001
- Acronym
- SIM
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2021
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions for Enhancing Adherence to Syphilis Treatment and Follow-up: Study Protocol for the Health Information and Monitoring of Sexually Transmitted Infections (SIM) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04753125
- Acronym / sponsor ID
- SIM / 0000001
- Conditions
- Syphilis
- Keywords
- Prevalence, Incidence, Men who have sex with men, Protocol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 15 Feb 2021 (actual)
- 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.
The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance. The recruitment of participants will be done by invitation, and tests will be performed in a mobile unit in locations accessible to large populations. The goal is to perform 10,000 quick tests, with results confirmed by venereal disease research laboratory (VDRL) tests. Patients with a confirmed diagnosis according to VDRL test results will be randomized in one of three monitoring arms: follow-up by telephone, follow-up via a game in a smartphone app, or conventional follow-up by a health professional. All analyses will follow the intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| compliance treatment | Active comparator | Behavioral: follow-up by telephone, Behavioral: follow-up via a game in a smartphone app, Behavioral: conventional follow-up by a health professionalcontrolled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance for 3, 6. 9 and 12 months |
| compliance for blood test | Active comparator | Behavioral: follow-up by telephone, Behavioral: follow-up via a game in a smartphone app, Behavioral: conventional follow-up by a health professionalcontrolled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance, follow-up via a game in a smartphone app through an interactive game with stimuli to pass the phase as the treatment was completed and blood tests were performed in 3,6,9 and 12 months. |
| demographic socio-economic and sexuality questionnaire | Placebo comparator | Behavioral: follow-up by telephone, Behavioral: follow-up via a game in a smartphone app, Behavioral: conventional follow-up by a health professionalQuestionnaire applied to all patients with positive VDRL |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults aged 18 years and older with sorologic test positive for syphilis
Key exclusion criteria (5 listed)
- Participants who did not return after three contact attempts will be excluded from the study,
- pregnant women
- participants who are not able to provide contact information
- participants who are illiterate
- participants those who underwent syphilis treatment within the previous three months.
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 |
|---|---|---|
| follow-up by telephoneThe SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance | Behavioural | compliance for blood test, compliance treatment, demographic socio-economic and sexuality questionnaire |
| follow-up via a game in a smartphone appThe SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance | Behavioural | compliance for blood test, compliance treatment, demographic socio-economic and sexuality questionnaire |
| conventional follow-up by a health professionalThe SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance | Behavioural | compliance for blood test, compliance treatment, demographic socio-economic and sexuality questionnaire |
Primary outcome
complince of treatment
Time frame: ut to 12 months (July 2023)
3 doses of penicillin g benzathine 3,000,000 UI. The injections are given in the gluteal region once a week from the first dose.
complince of exams
Time frame: up to 12 months (July 2023)
Performing the VDRL blood test that should be done at 3, 6, 9 and 12 months after treatment with penicillin.
1 secondary outcome
identify behavioral risk factors for non-adherence to treatment
Time frame: upt to 12 months (July 2023)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing follow-up by telephone, follow-up via a game in a smartphone app and conventional follow-up by a health professional in people with Syphilis, run by Hospital Moinhos de Vento.
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 1 inclusion and 5 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 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Eliana Marcia Ros Wendland, MD (55(51)99046384, elianawend@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complince of treatment (time frame: ut to 12 months (July 2023)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2021.