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

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 buil...

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Autores principales: Kwizera, Richard, Sadiq, Alisat, Ndyetukira, Jane Frances, Nalintya, Elizabeth, Williams, Darlisha, Rhein, Joshua, Boulware, David R., Meya, David B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7441728/
https://www.ncbi.nlm.nih.gov/pubmed/32843994
http://dx.doi.org/10.1186/s40900-020-00228-z
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author Kwizera, Richard
Sadiq, Alisat
Ndyetukira, Jane Frances
Nalintya, Elizabeth
Williams, Darlisha
Rhein, Joshua
Boulware, David R.
Meya, David B.
author_facet Kwizera, Richard
Sadiq, Alisat
Ndyetukira, Jane Frances
Nalintya, Elizabeth
Williams, Darlisha
Rhein, Joshua
Boulware, David R.
Meya, David B.
author_sort Kwizera, Richard
collection PubMed
description 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.
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spelling pubmed-74417282020-08-24 Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting Kwizera, Richard Sadiq, Alisat Ndyetukira, Jane Frances Nalintya, Elizabeth Williams, Darlisha Rhein, Joshua Boulware, David R. Meya, David B. Res Involv Engagem Commentary 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. BioMed Central 2020-08-20 /pmc/articles/PMC7441728/ /pubmed/32843994 http://dx.doi.org/10.1186/s40900-020-00228-z Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Kwizera, Richard
Sadiq, Alisat
Ndyetukira, Jane Frances
Nalintya, Elizabeth
Williams, Darlisha
Rhein, Joshua
Boulware, David R.
Meya, David B.
Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting
title Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting
title_full Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting
title_fullStr Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting
title_full_unstemmed Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting
title_short Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting
title_sort impact of community engagement and social support on the outcomes of hiv-related meningitis clinical trials in a resource-limited setting
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7441728/
https://www.ncbi.nlm.nih.gov/pubmed/32843994
http://dx.doi.org/10.1186/s40900-020-00228-z
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