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

Not Applicable

• Conditions: Syphilis
• Interventions: Behavioral: follow-up by telephone; Behavioral: follow-up via a game in a smartphone app; Behavioral: conventional follow-up by a health professional

• Registration Number: NCT04753125
• Lead Sponsor: Hospital Moinhos de Vento

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-28
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-15
• Last Update Posted: 2021-02-15
• Study Start: 2021-04
• Primary Completion: 2022-12
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• All adults aged 18 years and older with sorologic test positive for syphilis

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
compliance for blood test	follow-up by telephone	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	conventional follow-up by a health professional	Questionnaire applied to all patients with positive VDRL
compliance treatment	follow-up by telephone	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 treatment	follow-up via a game in a smartphone app	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	conventional follow-up by a health professional	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	follow-up by telephone	Questionnaire applied to all patients with positive VDRL
compliance treatment	conventional follow-up by a health professional	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	follow-up via a game in a smartphone app	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	follow-up via a game in a smartphone app	Questionnaire applied to all patients with positive VDRL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.