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

Hospital Moinhos de Vento10,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

10,000

Conditions

Syphilis

Interventions

follow-up via a game in a smartphone appBEHAVIORAL

conventional follow-up by a health professionalBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: up to 12 months (July 2023)

Secondary Outcomes

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.

Time frame: upt to 12 months (July 2023)

Central Contacts

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

Data from ClinicalTrials.gov

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