Abstract
BackgroundClinical trials remain the cornerstone of improving outcomes for HIV-infected individuals with cryptococcal meningitis. Community engagement aims at involving participants and their advocates as partners in research rather than merely trial subjects. Community engagement can help to build trust in communities where these trials are conducted and ensure lasting mutually beneficial relationships between researchers and the community. Similarly, different studies have reported the positive effects of social support on patient’s outcomes. We aimed to describe our approach to community engagement in Uganda while highlighting the benefits of community engagement and social support in clinical trials managing patients co-infected with HIV and cryptococcal meningitis.MethodsWe carried out community engagement using home visits, health talks, posters, music and drama. In addition, social support was given through study staff individually contributing to provide funds for participants’ food, wheel chairs, imaging studies, adult diapers, and other extra investigations or drugs that were not covered by the study budget or protocol. The benefits of this community engagement and social support were assessed during two multi-site, randomized cryptococcal meningitis clinical trials in Uganda.ResultsWe screened 1739 HIV-infected adults and enrolled 934 with cryptococcal meningitis into the COAT and ASTRO-CM trials during the period October 2010 to July 2017. Lumbar puncture refusal rates decreased from 31% in 2010 to less than 1% in 2017. In our opinion, community engagement and social support played an important role in improving: drug adherence, acceptance of lumbar punctures, data completeness, rate of screening/referrals, reduction of missed visits, and loss to follow-up.ConclusionsCommunity engagement and social support are important aspects of clinical research and should be incorporated into clinical trial design and conduct.Trial registrationClinicalTrials.gov number, NCT01075152 and NCT01802385.
Highlights
Clinical trials remain the cornerstone of improving outcomes for human immunodeficiency virus (HIV)-infected individuals with cryptococcal meningitis
In this study we aimed to highlight the benefits of community engagement and social support in two clinical studies managing patients co-infected with HIV and cryptococcal meningitis
Lumbar puncture refusal rates decreased from 31% in 2010 to less than 1% in 2017
Summary
Clinical trials remain the cornerstone of improving outcomes for HIV-infected individuals with cryptococcal meningitis. We aimed to describe our approach to community engagement in Uganda while highlighting the benefits of community engagement and social support in clinical trials managing patients co-infected with HIV and cryptococcal meningitis. Uganda is found in sub-Saharan Africa (SSA) where the prevalence of human immunodeficiency virus (HIV) and HIV-related opportunist infections is high [1, 2]. Cryptococcal meningitis accounts for 15–25% of all HIV-related deaths [4,5,6,7]. Clinical trials provide a platform for improving outcomes for HIV-infected individuals with cryptococcal meningitis [10,11,12,13,14]
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