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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Syphilis

Intervention / Treatment
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* Behavioral: follow-up by telephone
* Behavioral: follow-up via a game in a smartphone app
* Behavioral: conventional follow-up by a health professional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adults aged 18 years and older with sorologic test positive for syphilis Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: compliance treatment<br>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 | Behavioral: follow-up by telephone<br>* 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<br>Behavioral: follow-up via a game in a smartphone app<br>* 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<br>Behavioral: conventional follow-up by a health professional<br>* 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<br>|
| Active Comparator: compliance for blood test<br>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. | Behavioral: follow-up by telephone<br>* 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<br>Behavioral: follow-up via a game in a smartphone app<br>* 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<br>Behavioral: conventional follow-up by a health professional<br>* 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<br>|
| Placebo Comparator: demographic socio-economic and sexuality questionnaire<br>Questionnaire applied to all patients with positive VDRL | Behavioral: follow-up by telephone<br>* 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<br>Behavioral: follow-up via a game in a smartphone app<br>* 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<br>Behavioral: conventional follow-up by a health professional<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 12 months (July 2023) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | upt to 12 months (July 2023) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevalence, Incidence, Men who have sex with men, Protocol