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

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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202009822379650

Enrollment

3820

Registered

2020-09-15

Start date

2020-07-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Tuberculosis

Interventions

Intervention arm

Control arm

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Number of healthcare professional-reported adverse drug reactions per 100,000 person-months of treated-PLHIV per study arm	—

Secondary

Measure	Time frame
Number 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	—

Countries

Uganda

Contacts

Public ContactVictoria Nambasa

Pharmacovigilance Manager National Drug Authority

vnambasa@nda.or.ug00256772834126

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026