Two-way risk communication mobile application versus traditional methods of adverse drug reaction reporting in Uganda: a randomized controlled trial

Phase 4

Recruiting

• Conditions: HIV/AIDS; Tuberculosis

• Registration Number: PACTR202009822379650
• Lead Sponsor: Makerere University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-09
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3820

Inclusion Criteria

All health facilities where antiretroviral therapy is prescribed and dispensed to people living with HIV and at least one healthcare professional owns a smartphone.

Exclusion Criteria

Health facilities where none of the healthcare professionals owns a smartphone.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of healthcare professional-reported adverse drug reactions per 100,000 person-months of treated-PLHIV per study arm

Secondary Outcome Measures

Name	Time	Method
umber of app-ADR-reports per 1,000 app-downloads per completed-month of follow-up;Completeness score of ADR-report;Causality of ADR;Seriousness of ADR