Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753125
Status:
UNKNOWN
Last Update Posted:
2021-02-15
First Post:
2021-01-28
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
Sponsor:
Hospital Moinhos de Vento
Organization:
Hospital Moinhos de Vento
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIM
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 10000 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None