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 (SIM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Syphilis
• Intervention / Treatment: Behavioral: follow-up by telephone; Behavioral: follow-up via a game in a smartphone app; Behavioral: conventional follow-up by a health professional

• Study Type: Interventional
• Enrollment (Anticipated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eliana Marcia Ros Wendland, MD; Phone Number: 55(51)99046384; Email: elianawend@gmail.com
• Study Contact Backup: Name: VANESSA M DE OLIVEIRA, MD; Phone Number: 55(51) 9925-13723; Email: Vanessa.martins@hmv.org.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Prevalence; Men who have sex with men; Incidence; Protocol
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Spirochaetales Infections; Treponemal Infections; Sexually Transmitted Diseases; Syphilis
• Other Study ID Numbers: 0000001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No