Pharmacovigilance among people living with HIV Infections and Infestations Human immunodeficiency virus [HIV] disease
Conditions
Interventions
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)
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
Sponsors
Makerere University
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 04/04/2022: 1. Attrition rate measured by number of study participants who remain in the study until the end of follow-up at 4 months 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 _____ Previous primary outcome measure: Attrition rate recorded as the number of study participants who remain in the study until the end of follow-up at 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 12/04/2022: 1. Acceptability of the peer support intervention measured using a questionnaire 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. Fidelity to the peer support intervention measured using a questionnaire and qualitative interviews at 4 months post-intervention 4. Rate of ADR-reporting to NPC by PLHIV as measured by questionnaire and data abstraction from the national pharmacovigilance database at baseline and 4 months 5. Quality of ADR-reports by PLHIV measured by questionnaire and data abstraction from the national pharmacovigilance database at baseline and 4 months 6. Time to ADR-reporting to NPC by PLHIV since enrolment measured by questionnaire and data abstraction from the national pharmacovigilance database during the 4 months 7. Time from ADR onset to registration in the national pharmacovigilance database measured by questionnaire and data abstraction from the database during 4 months 8. Health-related quality of life measured by questionnaire at baseline and 4 months 9. Management of ADRs recorded using a questionnaire during the 4 months 10. Number of PLHIV linked to health facilities by peer supporters for ADR management as measured by questionnaire during the 4-month intervention period 11. Health-seeking behaviour measured using a questionnaire at baseline and 4 months 12. Self-efficacy to report ADRs measured by questionnaire at baseline and 4 months 13. Self-reported ART adherence measured by questionnaire at baseline and 4 months 14. Mood (positive/ negative affect) measured by questionnaire at baseli | — |
Countries
Uganda
Outcome results
None listed