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

NCT04753125 | Unknown DMC

• 1 other identifier: 0000001
• Study Type: interventional
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Syphilis

Keywords

Prevalence; Incidence; Men who have sex with men; Protocol

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• identify behavioral risk factors for non-adherence to treatment

  upt to 12 months (July 2023)

Study Arms (3)

compliance treatment

ACTIVE COMPARATOR

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; Behavioral: follow-up via a game in a smartphone app; Behavioral: conventional follow-up by a health professional

compliance for blood test

ACTIVE COMPARATOR

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; Behavioral: follow-up via a game in a smartphone app; Behavioral: conventional follow-up by a health professional

demographic socio-economic and sexuality questionnaire

PLACEBO COMPARATOR

Questionnaire applied to all patients with positive VDRL

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

Interventions

follow-up by telephone BEHAVIORAL

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

compliance for blood test; compliance treatment; demographic socio-economic and sexuality questionnaire

follow-up via a game in a smartphone app BEHAVIORAL

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

compliance for blood test; compliance treatment; demographic socio-economic and sexuality questionnaire

conventional follow-up by a health professional BEHAVIORAL

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

compliance for blood test; compliance treatment; demographic socio-economic and sexuality questionnaire

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: All adults aged 18 years and older
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead

MeSH Terms

Conditions

Syphilis; Homosexuality

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases; Sexuality; Sexual Behavior; Behavior

Central Study 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Eliana Marcia Ross Wendland

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 15, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: July 1, 2023
• Last Updated: February 15, 2021

Record last verified: 2021-02