Conducting an ongoing HIV clinical trial during the COVID-19 pandemic in Uganda: a qualitative study of research team and participants' experiences and lessons learnt

Patience A Muwanguzi, Paul Kutyabami, Charles Peter Osingada, Esther M Nasuuna, Freddy Eric Kitutu, Tom Denis Ngabirano, Joyce Nankumbi, Richard Muhindo, Lydia Kabiri, Mariam Namutebi, Racheal Nabunya, Noah Kiwanuka, Nelson Sewankambo, Patience A Muwanguzi, Paul Kutyabami, Charles Peter Osingada, Esther M Nasuuna, Freddy Eric Kitutu, Tom Denis Ngabirano, Joyce Nankumbi, Richard Muhindo, Lydia Kabiri, Mariam Namutebi, Racheal Nabunya, Noah Kiwanuka, Nelson Sewankambo

Abstract

Objective: To explore the experiences and lessons learnt by the study team and participants of the Workplace-based HIV self-testing among Men trial during the COVID-19 pandemic in Uganda.

Design: An explorative qualitative study comprising two virtual focus group discussions (FGDs) with 12 trial team members and 32 in-depth participant interviews (N=44). Data were collected via telephone calls for in-depth interviews or Zoom for FGDs and manually analysed by inductive content analysis.

Setting: Fourteen private security companies in two Uganda districts.

Participants: Members of the clinical trial study team, and men working in private security companies who undertook workplace-based HIV testing.

Results: The key themes for participants experiences were: 'challenges in accessing HIV treatment and care, and prevention services', 'misinformation' and 'difficulty participating in research activities'. The effects on HIV treatment and prevention resulted from; repercussions of the COVID-19 restrictions, participants fear of coinfection and negative experiences at health facilities. The difficulty in participating in research activities arose from: fear of infection with COVID-19 for the participants who tested HIV negative, transport difficulties, limited post-test psychosocial support and lack of support to initiate pre-exposure prophylaxis. The key study team reflections focused on the management of the clinical trial, effects of the local regulations and government policies and the need to adhere to ethical principles of research.

Conclusions: Findings highlight the need to organise different forms of HIV support for persons living with HIV during a pandemic. Additionally, the national research regulators and ethics committees or review boards are strongly urged to develop policies and guidelines for the continuity of research and clinical trials in the event of future shocks. Furthermore, this study calls on the appropriate government agencies to ensure public and researchers' preparedness through continuing education and support.

Trial registration number: Clinicaltrials.gov NCT04164433; Pre-results.

Keywords: COVID-19; HIV & AIDS; qualitative research.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Coding tree for the participants experiences of participating in an ongoing HIV clinical trial during a pandemic. *(PrEP Pre-exposure prophylaxis)
Figure 2
Figure 2
Coding tree for the clinical trial study team of managing an ongoing HIV clinical trial during a pandemic.

References

    1. Gorbalenya AE, Baker SC, Baric RS. Severe acute respiratory syndrome-related coronavirus: the species and its viruses–a statement of the coronavirus Study Group. bioRxiv 2020;10.
    1. Coronaviridae Study Group of the International Committee on Taxonomy of Viruses . The species severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol 2020;5:536–44. 10.1038/s41564-020-0695-z
    1. WHO . WHO coronavirus disease (COVID-19) dashboard, 2020. Available: [Accessed 13 Jun 2020].
    1. Rewari BB, Mangadan-Konath N, Sharma M. Impact of COVID-19 on the global supply chain of antiretroviral drugs: a rapid survey of Indian manufacturers. WHO South East Asia J Public Health 2020;9:126–33. 10.4103/2224-3151.294306
    1. Oladele TT, Olakunde BO, Oladele EA, et al. . The impact of COVID-19 on HIV financing in Nigeria: a call for proactive measures. BMJ Glob Health 2020;5:e002718. 10.1136/bmjgh-2020-002718
    1. Jewell BL, Mudimu E, Stover J, et al. . Potential effects of disruption to HIV programmes in sub-Saharan Africa caused by COVID-19: results from multiple mathematical models. Lancet HIV 2020;7:e629–40. 10.1016/S2352-3018(20)30211-3
    1. Jiang H, Zhou Y, Tang W. Maintaining HIV care during the COVID-19 pandemic. Lancet HIV 2020;7:e308–9. 10.1016/S2352-3018(20)30105-3
    1. Guo W, Weng HL, Bai H, et al. . [Quick community survey on the impact of COVID-19 outbreak for the healthcare of people living with HIV]. Zhonghua Liu Xing Bing Xue Za Zhi 2020;41:662–6. 10.3760/cma.j.cn112338-20200314-00345
    1. Sun S, Hou J, Chen Y. Challenges to HIV care and psychological health during the COVID-19 pandemic among people living with HIV in China. AIDS Behav 2020:1–2.
    1. Lagat H, Sharma M, Kariithi E. Impact of the COVID-19 pandemic on HIV testing and assisted partner notification services, Western Kenya. AIDS Behav 2020:1–4.
    1. Linnemayr S, Jennings Mayo-Wilson L, Saya U. HIV care experiences during the COVID-19 pandemic: mixed-methods telephone interviews with clinic-enrolled HIV-infected adults in Uganda. AIDS Behav 2020.
    1. GOU . COVID-19 response info hub-Timeline 2020, 2020. Available: [Accessed 6 Sep 2020].
    1. UNCST . New research registration procedures 2020. Available: [Accessed 13 Jun 2020].
    1. Elo S, Kyngäs H. The qualitative content analysis process. J Adv Nurs 2008;62:107–15. 10.1111/j.1365-2648.2007.04569.x
    1. Mhango M, Chitungo I, Dzinamarira T. COVID-19 lockdowns: impact on facility-based HIV testing and the case for the scaling up of home-based testing services in sub-Saharan Africa. AIDS Behav 2020;1.
    1. Jewell BL, Mudimu E, Stover J, et al. . Potential effects of disruption to HIV programmes in sub-Saharan Africa caused by COVID-19: results from multiple mathematical models. Lancet HIV 2020;7:e629–40. 10.1016/S2352-3018(20)30211-3
    1. Pierre G, Uwineza A, Dzinamarira T. Attendance to HIV antiretroviral collection clinic appointments during COVID-19 lockdown. A single center study in Kigali, Rwanda. AIDS Behav 2020:1–3.
    1. Opio D, Semitala FC, Kakeeto A, et al. . Loss to follow-up and associated factors among adult people living with HIV at public health facilities in Wakiso district, Uganda: a retrospective cohort study. BMC Health Serv Res 2019;19:628. 10.1186/s12913-019-4474-6
    1. Rebeiro PF, Duda SN, Wools‐Kaloustian KK, et al. . Implications of COVID‐19 for HIV research: data sources, indicators and longitudinal analyses. J Int AIDS Soc 2020;23:e25627. 10.1002/jia2.25627
    1. Rusen ID. Challenges in tuberculosis clinical trials in the face of the COVID-19 pandemic: a sponsor’s perspective. Trop Med Infect Dis 2020;5:86. 10.3390/tropicalmed5020086
    1. Patel RH, Pella PM. COVID-19 in a patient with HIV infection. J Med Virol 2020;92:2356–7. 10.1002/jmv.26049
    1. Gobat N, Butler CC, Mollison J, et al. . What the public think about participation in medical research during an influenza pandemic: an international cross-sectional survey. Public Health 2019;177:80–94. 10.1016/j.puhe.2019.07.005
    1. Sentell T, Vamos S, Okan O. Interdisciplinary perspectives on health literacy research around the world: more important than ever in a time of COVID-19. Int J Environ Res Public Health 2020;17:3010. 10.3390/ijerph17093010
    1. Bikson M, Hanlon CA, Woods AJ, et al. . Guidelines for TMS/tES clinical services and research through the COVID-19 pandemic. Brain Stimul 2020;13:1124–49. 10.1016/j.brs.2020.05.010
    1. Shah SGS, Farrow A. A commentary on ‘World Health Organization declares global emergency: A review of the 2019 novel Coronavirus (COVID-19)’. Int J Surg 2020;76:128–9. 10.1016/j.ijsu.2020.03.001
    1. Padala PR, Jendro AM, Padala KP. Conducting clinical research during the COVID-19 pandemic: investigator and participant perspectives. JMIR Public Health Surveill 2020;6:e18887. 10.2196/18887
    1. Dunlop A, Lokuge B, Masters D, et al. . Challenges in maintaining treatment services for people who use drugs during the COVID-19 pandemic. Harm Reduct J 2020;17:26. 10.1186/s12954-020-00370-7
    1. Osseni IA. COVID-19 pandemic in sub-Saharan Africa: preparedness, response, and hidden potentials. Trop Med Health 2020;48:48. 10.1186/s41182-020-00240-9
    1. Hlongwa P. Current ethical issues in HIV/AIDS research and HIV/AIDS care. Oral Dis 2016;22:61–5. 10.1111/odi.12391
    1. Anker SD, Butler J, Khan MS, et al. . Conducting clinical trials in heart failure during (and after) the COVID-19 pandemic: an expert consensus position paper from the heart failure association (HFA) of the European Society of cardiology (ESC). Eur Heart J 2020;41:2109–17. 10.1093/eurheartj/ehaa461
    1. Block ES, Erskine L. Interviewing by telephone: specific considerations, opportunities, and challenges. Int J Qual Methods 2012;11:428–45. 10.1177/160940691201100409
    1. Bashshur R, Doarn CR, Frenk JM, et al. . Telemedicine and the COVID-19 pandemic, lessons for the future. Telemed J E Health 2020;26:571–3. 10.1089/tmj.2020.29040.rb
    1. Hau YS, Kim JK, Hur J, et al. . How about actively using telemedicine during the COVID-19 pandemic? J Med Syst 2020;44:108. 10.1007/s10916-020-01580-z
    1. Wright JH, Caudill R. Remote treatment delivery in response to the COVID-19 pandemic. Psychother Psychosom 2020;89:130–2. 10.1159/000507376

Source: PubMed

3
Tilaa