Syphilis
Conditions
Keywords
Prevalence, Incidence, Men who have sex with men, Protocol
Brief 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. 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.
Interventions
BEHAVIORALfollow-up by telephone
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
BEHAVIORALfollow-up via a game in a smartphone app
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
BEHAVIORALconventional follow-up by a health professional
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
Sponsors
Hospital Moinhos de Vento
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complince of treatment | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| identify behavioral risk factors for non-adherence to treatment | upt to 12 months (July 2023) | 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. |
Contacts
Primary ContactEliana Marcia Ros Wendland, MD
Backup ContactVANESSA M DE OLIVEIRA, MD
Outcome results
None listed