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.
Bibliographical noteFunding Information:
We thank institutional support from the IDI research office. We also thank the entire COAT and ASTRO study teams. We would like to acknowledge Kosuke Yasukawa for the creation of the figure. DBM and RK are currently supported through the DELTAS Africa Initiative grant # DEL-15-011 to 130 THRiVE-2, from Wellcome Trust grant # 107742/Z/15/Z and the UK government. Members of the COAT and ASTRO study team: 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, Busingye Noeme, 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, and Ananta S Bangdiwala, Charlotte Schutz, Friedrich Thienemann, Graeme Meintjes, Yolisa Sigila, Monica Magwayi, Leya Hassanally, Tihana Bicanic, Lewis J Haddow.
This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. However, COAT trial was supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID; U01AI089244, K23AI073192, T32AI055433, and K24AI096925), the Wellcome Trust (081667 and 098316, to Dr. Meintjes, and 087540, to Dr. Meya), and the Veterans Affairs Research Service (to Dr. Janoff). ASTRO-CM trial was supported by the National Institute of Neurologic Diseases and Stroke (R01NS086312), the Fogarty International Center (K01TW010268, R25TW009345), the National Institute of Allergy and Infectious Diseases (T32AI055433), UK Medical Research Council/Department for International Development/Wellcome Trust Global Clinical Trials (M007413/1), and Grand Challenges Canada (S4–0296–01).
© 2020 The Author(s).
- Clinical trials
- Community engagement
- Cryptococcal meningitis
- Patient public involvement
- Social support
- Sub-Saharan Africa