Establishing communication challenges and preferences among clinical trial participants in an under-resourced setting to improve adherence to study visits and participant retention

Background Ensuring protocol visit compliance and maintaining high participant retention remain critical elements of clinical trials. In the HVTN 702 HIV vaccine trial, Setshaba Research Centre in Soshanguve, Tshwane, South Africa, experienced challenges in communicating with participants to remind them about their study visits. In order to improve participants adhering to their study visits, and study retention, we aimed to identify challenges in mobile communication, and to establish preferences in communication methods and interest in receiving study information via cellphones. Methods We conducted a paper-based survey among HVTN 702 HIV vaccine trial participants at Setshaba Research Centre. The survey comprised of dichotomous and scale questions and was completed voluntarily and anonymously. The questions included those on their primary form of communication (calling, SMS and WhatsApp), the best time of day for the site to communicate with them, whether they were interested in receiving regular general study information updates via their cellular phone, how often they changed their cellular phones and/or network, whether they experienced any challenges with their cellular phones and what these challenges were, if any. All participants scheduled to visit the clinic from February to May 2019 were invited to participate. Thus, 90 of 380 (24%) participants enrolled by May 2019 were surveyed. Results The majority (68%) of participants were 26−35 years old and almost three-quarters (73%) were female. Almost all participants (99%) had a personal cellphone. Half of the participants experienced some challenge related to cellphones, these being poor network signal at home (12%), battery running flat frequently (11%), sharing their phone (9%), lack of data (9%), challenges with use of applications (6%) and their cellphones being unreliable (3%). Annually, 20% of participants made a single or multiple network changes. Communication preferences were calls by site staff (80%), SMS (16%) and WhatsApp (3%). Most preferred to be contacted in the morning (49%) or afternoon (31%). Site contact was rated as ‘very helpful’ (87%), and 97% were interested in receiving regular general study information updates via their cellphone. Conclusion Despite participants owning cellphones, there are still technical challenges, for example, network signals, battery-charging and applications. The majority of participants preferred being called rather than communicating by text messages or WhatsApp. Future studies need to include addressing participant challenges in maintaining contact and training of participants on use of cellphone applications to optimise communication. Noting the preferred time of day for participants to be called might improve the likelihood of making contact with them. The willingness to receive updates will aid in keeping participant interest high and enhance retention.

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Background morbidity in HIV vaccine trial participants from various geographic regions as assessed by unsolicited adverse events

Human Vaccines & Immunotherapeutics ◽

10.4161/hv.19454 ◽

2012 ◽

Vol 8 (5) ◽

pp. 630-638 ◽

Cited By ~ 4

Author(s):

Claudia Schmidt ◽

Carol Smith ◽

Burc Barin ◽

Arash Bakhtyari ◽

Pierre-Alexandre Bart ◽

...

Keyword(s):

Adverse Events ◽

Vaccine Trial ◽

Hiv Vaccine ◽

Geographic Regions ◽

Trial Participants

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Monitoring HIV vaccine trial participants for primary infection: studies in the SIV/macaque model

AIDS ◽

10.1097/qad.0b013e32832b43d9 ◽

2009 ◽

Vol 23 (12) ◽

pp. 1453-1460 ◽

Cited By ~ 13

Author(s):

James B Whitney ◽

Corinne Luedemann ◽

Saran Bao ◽

Ayako Miura ◽

Srinivas S Rao ◽

...

Keyword(s):

Primary Infection ◽

Vaccine Trial ◽

Hiv Vaccine ◽

Macaque Model ◽

Trial Participants

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A qualitative study on experiences of HIV vaccine trial participants in a phase I/II double-blinded, randomized placebo-controlled clinical trial in Tanzania: Lessons for COVID-19 vaccine testing

Journal of Public Health and Epidemiology ◽

10.5897/jphe2021.1338 ◽

2021 ◽

Vol 13 (3) ◽

pp. 210-217

Author(s):

S. Sanga Erica ◽

Van Wyk Brian ◽

L. Maboko Leonard ◽

Shamu Simukai

Keyword(s):

Clinical Trial ◽

Qualitative Study ◽

Phase I ◽

Vaccine Trial ◽

Hiv Vaccine ◽

Controlled Clinical Trial ◽

Double Blinded ◽

Vaccine Testing ◽

Trial Participants

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A Qualitative Study on Experiences of HIV Vaccine Trial Participants in a Phase I/II Double Blinded, Randomized Placebo Controlled Clinical Trial in Tanzania: Lessons for COVID-19 Vaccine Testing

10.21203/rs.3.rs-142571/v1 ◽

2021 ◽

Author(s):

Erica Sanga ◽

Brian Van Wyk ◽

Leonard Maboko ◽

Simukai Shamu

Keyword(s):

Qualitative Study ◽

Vaccine Trial ◽

Hiv Vaccine ◽

Vaccine Uptake ◽

Sub Saharan Africa ◽

Trial Participation ◽

People Living With Hiv ◽

Major Public Health Problem ◽

Ongoing Research ◽

Trial Participants

Abstract Background: HIV remains a major public health problem in Sub-Saharan Africa. More than half (54.5%) of all people living with HIV live in Eastern and Southern Africa where 700,000 new infections were reported in 2019. There is no HIV vaccine or cure available yet despite ongoing research to develop one. Uptake of vaccines, when these become available, is critical for its successful introduction in the global society. It is imperative to describe the knowledge, expectations, perceptions and experiences of the vaccines trial participants, as these may be indicative of future vaccine uptake, and may give lessons for COVID-19 vaccine development. Methods: A phenomenological qualitative study was conducted to describe the experiences of volunteers who participated in the first HIV vaccine trial in Mbeya, Tanzania. A purposive sample of 20 of the 60 trial participants was interviewed. Interviews were audio-recorded, transcribed, translated, and subjected to thematic-content analysis.Results: The study showed that trial participation was driven by positive expectations related to health and the realization of the need for an effective vaccine to combat HIV. However fear, concerns and worries about the safety of the trial vaccine were the frequently reported challenges to participation. Not only participants but also the significant others and community play an important role in the trial participation.Conclusions: The success of a trial depends on direct and indirect participation in trials. Future trials, COVID-19 vaccine trials included, must promote positive expectations for trial participation and address fears and concerns related to vaccine safety.

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Human Immunodeficiency Virus (HIV) Vaccine Trials: a Novel Assay for Differential Diagnosis of HIV Infections in the Face of Vaccine-Generated Antibodies

Journal of Virology ◽

10.1128/jvi.80.5.2092-2099.2006 ◽

2006 ◽

Vol 80 (5) ◽

pp. 2092-2099 ◽

Cited By ~ 23

Author(s):

Surender Khurana ◽

James Needham ◽

Bonnie Mathieson ◽

Isaac R. Rodriguez-Chavez ◽

Andrew T. Catanzaro ◽

...

Keyword(s):

Human Immunodeficiency Virus ◽

Vaccine Trial ◽

Hiv Infections ◽

Hiv Vaccine ◽

Health Concern ◽

Hiv Vaccines ◽

Hiv Vaccine Trials ◽

Vaccine Trials ◽

Immunodeficiency Virus ◽

Trial Participants

ABSTRACT All current human immunodeficiency virus (HIV) vaccine candidates contain multiple viral components and elicit antibodies that react positively in licensed HIV diagnostic tests, which contain similar viral products. Thus, vaccine trial participants could be falsely diagnosed as infected with HIV. Additionally, uninfected, seropositive vaccinees may encounter long-term social and economic harms. Moreover, this also interferes with early detection of true HIV infections during preventive HIV vaccine trials. An HIV-seropositive test result among uninfected vaccine trial participants is a major public health concern for volunteers who want to participate in future HIV vaccine trials. Based on the increased number of HIV vaccines being tested globally, it is essential to differentiate vaccine- from virus-induced antibodies. Using a whole-HIV-genome phage display library, we identified conserved sequences in Env-gp41 and Gag-p6 which are recognized soon after infection, do not contain protective epitopes, and are not part of most current HIV vaccines. We established a new HIV serodetection assay based on these peptides. To date, this assay, termed HIV-SELECTEST, demonstrates >99% specificity and sensitivity. Importantly, in testing of plasma samples from multiple HIV vaccine trials, uninfected trial participants scored negative, while all intercurrent infections were detected within 1 to 3 months of HIV infection. The new HIV-SELECTEST is a simple but robust diagnostic tool for easy implementation in HIV vaccine trials and blood banks worldwide.

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Performance of a Redesigned HIV Selectest Enzyme-Linked Immunosorbent Assay Optimized To Minimize Vaccine-Induced Seropositivity in HIV Vaccine Trial Participants

Clinical and Vaccine Immunology ◽

10.1128/cvi.00748-13 ◽

2014 ◽

Vol 21 (3) ◽

pp. 391-398 ◽

Cited By ~ 7

Author(s):

Oksana Penezina ◽

Neil X. Krueger ◽

Isaac R. Rodriguez-Chavez ◽

Michael P. Busch ◽

John Hural ◽

...

Keyword(s):

Vaccine Trial ◽

Hiv Vaccine ◽

Enzyme Linked Immunosorbent Assay ◽

Lower Sensitivity ◽

Hiv Vaccines ◽

Vaccine Antigens ◽

True Infection ◽

Laboratory Tool ◽

Trial Participants ◽

Hiv 1

ABSTRACTVaccine-induced seropositivity (VISP) or seroreactivity (VISR), defined as the reaction of antibodies elicited by HIV vaccines with antigens used in HIV diagnostic immunoassays, can result in reactive assay results for vaccinated but uninfected individuals, with subsequent misclassification of their infection status. The eventual licensure of a vaccine will magnify this issue and calls for the development of mitigating solutions in advance. An immunoassay that discriminates between antibodies elicited by vaccine antigens and those elicited by infection has been developed to address this laboratory testing need. The HIV Selectest is based on consensus and clade-specific HIV peptides that are omitted in many HIV vaccine constructs. The assay was redesigned to enhance performance across worldwide clades and to simplify routine use via a standard kit format. The redesigned assay was evaluated with sera from vaccine trial participants, HIV-infected and uninfected individuals, and healthy controls. The HIV Selectest exhibited specificities of 99.5% with sera from uninfected recipients of 6 different HIV vaccines and 100% with sera from normal donors, while detecting HIV-1 infections, including intercurrent infections, with 95 to 100% sensitivity depending on the clade, with the highest sensitivities for clades A and C. HIV Selectest sensitivity decreased in very early seroconversion specimens, which possibly explains the slightly lower sensitivity observed for asymptomatic blood donors than for clinical HIV cases. Thus, the HIV Selectest provides a new laboratory tool for use in vaccine settings to distinguish the immune response to HIV vaccine antigens from that due to true infection.

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