Qualitative research on community experiences in large HIV research trials: what have we learned?

Abstract

IntroductionVery few pragmatic and community‐level effectiveness trials integrate the use of qualitative research over all stages of the trial, to inform trial design, implementation optimization, results interpretation and post‐trial policy recommendations. This is despite the growing demand for mixed methods research from funding agencies and awareness of the vital importance of qualitative and mixed methods research for understanding trial successes and challenges.DiscussionWe offer examples from work we have been involved in to illustrate how qualitative research conducted within trials can reveal vital contextual factors that influence implementation and outcomes, can enable an informed adaptation of trials as they are being conducted and can lead to the formulation of theory regarding the social and behavioural pathways of intervention, while also enabling community engagement in trial design and implementation. These examples are based on published findings from qualitative studies embedded within two ongoing large‐scale studies demonstrating the population‐level impacts of universal HIV testing and treatment strategies in southern and eastern Africa, and a qualitative study conducted alongside a clinical trial testing the adaptation, acceptability and experience of short‐cycle therapy in children and adolescents living with HIV.ConclusionsWe advocate for the integration of qualitative with clinical and survey research methods in pragmatic clinical and community‐level trials and implementation studies, and for increasing visibility of qualitative and mixed methods research in medical journals. Qualitative research from trials ideally should be published along with clinical outcome data, either integrated into the “main” trial papers or published concurrently in the same journal issue. Integration of qualitative research within trials can help not only to understand the why behind success or failure of interventions in different contexts, but also inform the adaptation of interventions that can facilitate their success, and lead to new alternative strategies and to policy changes that may be vital for achieving public health goals, including the end of AIDS.

Understanding implementation barriers in the national scale-up of differentiated ART delivery in Uganda

“…We found that stable patients enrolled in community models feared a detachment from health facilities and felt that they would not receive comprehensive care and treatment in the event of opportunistic infections such as tuberculosis if they remained in community-based models owing to their being categorized as 'stable'. Previous studies have highlighted the psycho-social satisfaction patients derive from engaging with health workers on a regular basis [33]. Adjetey and colleagues [17] in a study in Ghana report that patients preferred facility-based HIV services to community-based care even after the government there had invested considerably in the latter models.…”

Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions

“…Along similar lines, a fundamental change in the publishing bias of medical journals which favours brief quantitative articles is needed to bring method-neutral and transdisciplinary approaches to public health evaluation research [71]. In 2016, the current bias towards publishing quantitative articles led to an open letter to the British Medical Journal calling for it to “move beyond a ‘quantitative strong, qualitative weak’ stance” and to stop “rejecting qualitative research on the grounds of low priority” [72] (page 2).…”

Understanding implementation barriers in the national scale-up of Differentiated ART delivery in Uganda

“…We found that stable patients enrolled in community models feared a detachment from health facilities and felt that they would not receive comprehensive care and treatment in the event of opportunistic infections such as tuberculosis if they remained in community-based models owing to their being categorized as 'stable'. Previous studies have highlighted the psycho-social satisfaction patients derive from engaging with health workers on a regular basis [33]. Adjetey and colleagues [18] in a study in Ghana report that patients preferred facility-based HIV services to community-based care even after the government there had invested considerably in the latter models.…”