Patient-centred peer support intervention to promote the detection, reporting and management of adverse drug reactions among people living with HIV in Uganda

Not Applicable

Completed

• Conditions: Pharmacovigilance among people living with HIV; Infections and Infestations; Human immunodeficiency virus [HIV] disease

• Registration Number: ISRCTN75989485
• Lead Sponsor: Makerere University

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35589351/ (added 23/05/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-02
• Study Completion: 2022-06-30
• Last Update Posted: 16 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

PLHIV:
1. Accessible PLHIV aged 15 years and older
2. Receiving antiretroviral therapy at the study sites
3. Own a mobile phone (smartphone or basic feature phone)
4. Provide written/thumb-printed informed consent

Community health workers and expert clients recognized and seconded by the study sites or patient safety groups, who own mobile phones

Exclusion Criteria

1. PLHIV who will have received antiretroviral therapy for less than 6 months
2. Community health workers and expert clients who are unable to commit at least 4 months to the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 04/04/2022:<br><br> 1. Attrition rate measured by number of study participants who remain in the study until the end of follow-up at 4 months<br> 2. Number of ADR reports submitted to NPC by PLHIV as measured by questionnaire and data abstraction from the national pharmacovigilance database at baseline and 4 months<br><br> _____<br><br> Previous primary outcome measure:<br><br> Attrition rate recorded as the number of study participants who remain in the study until the end of follow-up at 4 months<br>