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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| demographic socio-economic and sexuality questionnaire | Placebo Comparator | Questionnaire applied to all patients with positive VDRL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| follow-up by telephone | Behavioral | 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 |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
All adults aged 18 years and older
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eliana Marcia Ros Wendland, MD | Contact | 55(51)99046384 | elianawend@gmail.com | |
| VANESSA M DE OLIVEIRA, MD | Contact | 55(51) 9925-13723 | Vanessa.martins@hmv.org.br |
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| follow-up via a game in a smartphone app | Behavioral | 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 professional | Behavioral | 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 |
|
| ID | Term |
|---|---|
| D013587 | Syphilis |
| D006716 | Homosexuality |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |
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