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

Richard Kwizera, Alisat Sadiq, Jane Frances Ndyetukira, Elizabeth Nalintya, Darlisha Williams, Joshua Rhein, David R Boulware, David B Meya, COAT and ASTRO trial teams, David B Meya, Abdu Musubire, Henry W Nabeta, Andrew Kambugu, Yukari C Manabe, Jane Francis Ndyetukira, Cynthia Ahimbisibwe, Florence Kugonza, Alisat Sadiq, Richard Kwizera, Ali Elbireer, Robert Lukande, Andrew Akampurira, Robert Wagubi, Henry Kajumbula, Grace Najjuka, Catherine Nanteza, Mariam Namawejje, Mark Ssennono, Agnes Kiragga, Edward Mpoza, Reuben Kiggundu, Lillian Tugume, Kenneth Ssebambulidde, Paul Kirumira, Carolyne Namuju, Tony Luggya, Julian Kaboggoza, Eva Laker, Alice Namudde, Conrad Muzoora, Kabanda Taseera, Liberica Ndyatunga, Brian Memela, Busingye Noeme, Emily Ninsiima, James Mwesigye, Rhina Mushagara, David R Boulware, Melissa A Rolfes, Kathy Huppler Hullsiek, Darlisha A Williams, Radha Rajasingham, Joshua Rhein, Melanie W Lo, Kirsten Nielsen, Tracy L Bergemann, Paul R Bohjanen, James Scriven, Edward N Janoff, Nicholas Fossland, Monica Rani, Renee Carlson, Kate Birkenkamp, Elissa Butler, Tami McDonald, Anna Strain, Darin Wiesner, Maximilian von Hohenberg, Ann Vogt, Grant Botker, Nathan Bahr, Kosuke Yasukawa, Jason V Baker, Sarah Lofgren, Anna Stadelman, Ananta S Bangdiwala, Charlotte Schutz, Friedrich Thienemann, Graeme Meintjes, Yolisa Sigila, Monica Magwayi, Leya Hassanally, Tihana Bicanic, Lewis J Haddow, Richard Kwizera, Alisat Sadiq, Jane Frances Ndyetukira, Elizabeth Nalintya, Darlisha Williams, Joshua Rhein, David R Boulware, David B Meya, COAT and ASTRO trial teams, David B Meya, Abdu Musubire, Henry W Nabeta, Andrew Kambugu, Yukari C Manabe, Jane Francis Ndyetukira, Cynthia Ahimbisibwe, Florence Kugonza, Alisat Sadiq, Richard Kwizera, Ali Elbireer, Robert Lukande, Andrew Akampurira, Robert Wagubi, Henry Kajumbula, Grace Najjuka, Catherine Nanteza, Mariam Namawejje, Mark Ssennono, Agnes Kiragga, Edward Mpoza, Reuben Kiggundu, Lillian Tugume, Kenneth Ssebambulidde, Paul Kirumira, Carolyne Namuju, Tony Luggya, Julian Kaboggoza, Eva Laker, Alice Namudde, Conrad Muzoora, Kabanda Taseera, Liberica Ndyatunga, Brian Memela, Busingye Noeme, Emily Ninsiima, James Mwesigye, Rhina Mushagara, David R Boulware, Melissa A Rolfes, Kathy Huppler Hullsiek, Darlisha A Williams, Radha Rajasingham, Joshua Rhein, Melanie W Lo, Kirsten Nielsen, Tracy L Bergemann, Paul R Bohjanen, James Scriven, Edward N Janoff, Nicholas Fossland, Monica Rani, Renee Carlson, Kate Birkenkamp, Elissa Butler, Tami McDonald, Anna Strain, Darin Wiesner, Maximilian von Hohenberg, Ann Vogt, Grant Botker, Nathan Bahr, Kosuke Yasukawa, Jason V Baker, Sarah Lofgren, Anna Stadelman, Ananta S Bangdiwala, Charlotte Schutz, Friedrich Thienemann, Graeme Meintjes, Yolisa Sigila, Monica Magwayi, Leya Hassanally, Tihana Bicanic, Lewis J Haddow

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.

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

© The Author(s) 2020.

Figures

Fig. 1
Fig. 1
Poster for lumbar puncture procedure. a) English version, b) Luganda version

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Source: PubMed

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