Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2020 Aug 20:6:49.
doi: 10.1186/s40900-020-00228-z. eCollection 2020.

Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting

Richard Kwizera  1 , Alisat Sadiq  1 , Jane Frances Ndyetukira  1 , Elizabeth Nalintya  1 , Darlisha Williams  1   2 , Joshua Rhein  1   2 , David R Boulware  2 , David B Meya  1   2   3 ; COAT and ASTRO trial teams
Collaborators, Affiliations
Editorial

Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting

Richard Kwizera et al. Res Involv Engagem. .

Abstract

Background: Clinical 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.

Methods: We 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.

Results: We 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.

Conclusions: Community engagement and social support are important aspects of clinical research and should be incorporated into clinical trial design and conduct.

Trial registration: ClinicalTrials.gov number, NCT01075152 and NCT01802385.

Keywords: Clinical trials; Community engagement; Cryptococcal meningitis; HIV; Patient public involvement; Social support; Sub-Saharan Africa.

PubMed Disclaimer

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Poster for lumbar puncture procedure. a) English version, b) Luganda version
See this image and copyright information in PMC

References

    1. Rubaihayo J, Tumwesigye NM, Konde-Lule J, Wamani H, Nakku-Joloba E, Makumbi F. Frequency and distribution patterns of opportunistic infections associated with HIV/AIDS in Uganda. BMC research notes. 2016;9(1):501. doi: 10.1186/s13104-016-2317-7. - DOI - PMC - PubMed
    1. Holmes CB, Losina E, Walensky RP, Yazdanpanah Y, Freedberg KA. Review of Human Immunodeficiency Virus Type 1-Related Opportunistic Infections in Sub-Saharan Africa. Clin Infect Dis. 2003;36(5):652–662. doi: 10.1086/367655%J. - DOI - PubMed
    1. Bigna JJR, Plottel CS. Koulla-Shiro SJIdop: challenges in initiating antiretroviral therapy for all HIV-infected people regardless of CD4 cell count. Infect Dis Pov. 2016;5(1):85. doi: 10.1186/s40249-016-0179-9. - DOI - PMC - PubMed
    1. Rajasingham R, Smith RM, Park BJ, Jarvis JN, Govender NP, Chiller TM, Denning DW, Loyse A, Boulware DR. Global burden of disease of HIV-associated cryptococcal meningitis: an updated analysis. Lancet Infect Dis. 2017;17(8):873–881. doi: 10.1016/S1473-3099(17)30243-8. - DOI - PMC - PubMed
    1. Durski KN, Kuntz KM, Yasukawa K, Virnig BA, Meya DB, Boulware DR. Cost-effective diagnostic checklists for meningitis in resource-limited settings. J Acquir Immune Deficiency Syndr (1999) 2013;63(3):e101–e108. doi: 10.1097/QAI.0b013e31828e1e56. - DOI - PMC - PubMed

Publication types

Associated data