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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)

Primary Purpose

Syphilis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
follow-up by telephone
follow-up via a game in a smartphone app
conventional follow-up by a health professional
Sponsored by
Hospital Moinhos de Vento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Syphilis focused on measuring Prevalence, Incidence, Men who have sex with men, Protocol

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    compliance treatment

    compliance for blood test

    demographic socio-economic and sexuality questionnaire

    Arm Description

    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

    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.

    Questionnaire applied to all patients with positive VDRL

    Outcomes

    Primary Outcome Measures

    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.
    complince of exams
    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
    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.

    Full Information

    First Posted
    January 28, 2021
    Last Updated
    February 10, 2021
    Sponsor
    Hospital Moinhos de Vento
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04753125
    Brief Title
    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
    Acronym
    SIM
    Official Title
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Moinhos de Vento

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Syphilis
    Keywords
    Prevalence, Incidence, Men who have sex with men, Protocol

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    10000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    compliance treatment
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    compliance for blood test
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    demographic socio-economic and sexuality questionnaire
    Arm Type
    Placebo Comparator
    Arm Description
    Questionnaire applied to all patients with positive VDRL
    Intervention Type
    Behavioral
    Intervention Name(s)
    follow-up by telephone
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    follow-up via a game in a smartphone app
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    conventional follow-up by a health professional
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    complince of treatment
    Description
    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)
    Title
    complince of exams
    Description
    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 Outcome Measure Information:
    Title
    identify behavioral risk factors for non-adherence to treatment
    Description
    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)

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    All adults aged 18 years and older
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eliana Marcia Ros Wendland, MD
    Phone
    55(51)99046384
    Email
    elianawend@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    VANESSA M DE OLIVEIRA, MD
    Phone
    55(51) 9925-13723
    Email
    Vanessa.martins@hmv.org.br

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    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

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