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

Syphilis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04753125
• Other study ID #: 0000001
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: July 2023

Study information

• Verified date: February 2021
• Source: Hospital Moinhos de Vento
• Contact: Eliana Marcia Ros Wendland, MD
• Phone: 55(51)99046384
• Email: elianawend[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: July 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Syphilis

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)