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

• Register: ISRCTN
• Last refreshed on: 14 June 2021
• Main ID: ISRCTN75989485
• Date of registration: 02/06/2021
• Prospective Registration: No
• Primary sponsor: Makerere University
• Public title: Patient-centred peer support intervention to promote the detection, reporting and management of adverse drug reactions among people living with HIV in Uganda
• Scientific title: Development and implementation of a patient-centred peer support intervention to promote the detection, reporting and management of adverse drug reactions among people living with HIV in Uganda
• Date of first enrolment: 15/05/2021
• Target sample size: 660
• Recruitment status: Ongoing
• URL: http://isrctn.com/ISRCTN75989485
• Study type: Interventional
• Study design: Quasi-experimental design with pre-post and there-there comparisons (Treatment)
• Phase: Not Applicable

Countries of recruitment

Uganda

Contacts

• Name: Ronald Kiguba

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Pharmacovigilance among people living with HIV
Infections and Infestations
Human immunodeficiency virus [HIV] disease

Intervention(s)

PLHIV in the intervention group will be assigned to peers to support their antiretroviral therapy (ART) for 4-6 months. Peer supporters will constitute a mixed group of community health workers (CHWs) and expert clients. The peer supporter will be a layperson whom a PLHIV can identify with and rely on to improve his/her healthcare-seeking behaviour. This layperson will be a PLHIV with more experience in the use of ART than the targeted PLHIV; or a recognized CHW.

The assignment of PLHIV to peer supporters will not be random; it will depend on the available number and calibre of peer supporters. Each peer supporter will be assigned five (5) PLHIVs from his/her community with the target of having weekly (minimum fortnightly) face-to-face and phone call interactions between the peer -supporter and each assigned PLHIV. Thus, a peer -supporter will be expected to interact with one PLHIV per day and five PLHIV in 5 days each week. Peer supporters will use one-on-one in-person support blended with mobile phone-based interaction to encourage each assigned PLHIV to recognize and report suspected adverse drug reactions (ADRs) to the peer supporter, health care professional (HCP) or National Pharmacovigilance Centre (NPC). The peer supporter will also administer a short weekly questionnaire to each assigned PLHIV regarding ADR experience in the past 1 week.

Primary Outcome(s)

Attrition rate recorded as the number of study participants who remain in the study until the end of follow-up at 4 months

Secondary Outcome(s)

1. Acceptability of the peer support intervention measured using questionnaires and qualitative interviews at 4 months post-intervention
2. Barriers/facilitators of the peer support intervention measured using a questionnaire during the intervention and qualitative interviews at 4 months post-intervention
3. Number of ADRs reported by PLHIV using a questionnaire at baseline and 4 months
4. Rate of ADR-reporting by PLHIV measured using a questionnaire at baseline and 4 months
5. Time to ADR-reporting by PLHIV measured using a questionnaire from baseline
6. Health-related quality of life measured using a questionnaire at baseline and 4 months
7. Management of ADRs recorded using a questionnaire during the 4 months
8. Health seeking behaviour measured using a questionnaire at baseline and 4 months
9. Positive and negative affect measured using a questionnaire at baseline and 4 months

Secondary ID(s)

MAKSHSREC-2020-64

Nil known

Source(s) of Monetary Support

World Health Organization

Ethics review

Status:
Approval date:
Contact:

Approved 09/01/2021, Makerere University School of Health Sciences Research & Ethics Committee (PO Box 7072, Kampala, Uganda; [phone]; [e-mail], [e-mail]), ref: MAKSHSREC-2020-64

Results

• Date Completed: 05/11/2021