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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: compliance treatment 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
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
Behavioral: follow-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
Behavioral: conventional 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
|
| Active Comparator: compliance for blood test 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
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
Behavioral: follow-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
Behavioral: conventional 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
|
| Placebo Comparator: demographic socio-economic and sexuality questionnaire Questionnaire applied to all patients with positive VDRL |
Behavioral: follow-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
Behavioral: follow-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
Behavioral: conventional 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospital Moinhos de Vento
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0000001