Understanding causes of incomplete reports of adverse drug reactions associated with dolutegravir-based HIV treatment in uganda: a qualitative study

Although dolutegravir (DTG)-based HIV treatment has demonstrated superior efficacy, it has been associated with adverse drug reactions (ADRs). Robust pharmacovigilance systems that ensure that received ADRs reports are complete and accurate facilitate timely regulatory decision making. However, there is little research seeking to understand the contexts underpinning data capture of DTG- associated ADRs. We sought to understand barriers to achieving completeness of DTG-associated ADR reports in HIV clinics in Uganda.

We adopted a qualitative exploratory research design. Between August and October 2024, we conducted 36 in-depth interviews with HIV clinicians and eight focus groups with people with HIV or PWH (56 participants) in the HIV clinics of 12 purposively selected health facilities across Uganda. Data were analyzed by thematic approach.

Our study unearthed patient-based barriers to achieving completeness of data in ADR reports which include the six-monthly appointment spacing intervals for PWH which impede recall of events surrounding ADRs, difficulty by PWH in eliciting details on DTG medication (such as brand and batch numbers), non-disclosure of concurrent use of herbal medicines and the fear by PWH of being switched away from DTG-based therapy which was perceived as superior. Health workforce barriers include a novel finding of 'professional agency' whereby HIV clinicians manage DTG-associated ADRs at an individual-level, fear of inviting scrutiny post-reporting impedes the supply of complete details on ADR reports such as on dosage as well as the low awareness among mid-cadres such as nurses of the importance of providing complete ADR reports in enabling regulatory action. Health system barriers include the reported shortage of in-puts for conducting laboratory investigations of suspected ADRs and limited incentives to reporters for providing complete information on ADR reports.

Health workers perceived factors underpinning incomplete DTG-associated ADR reports in Uganda as stemming from patient-based factors (e.g. non-disclosure of concomitant use of herbal medicines), health workforce-drivers (e.g. 'professional agency' in responding to ADRs) and health system constraints (lack of incentives for reporting). The policy and programming implications for improving data quality in reporting DTG-associated ADRs in Uganda and countries with similar setting are discussed.