Contextualizing willingness to participate: recommendations for engagement, recruitment & enrolment of Kenyan MSM in future HIV prevention trials

Abstract

BackgroundThe HIV epidemic among men who have sex with men (MSM) continues to expand globally. The addition of an efficacious, prophylactic vaccine to combination prevention offers immense hope, particularly in low- and middle- income countries which bear the greatest global impact. However, in these settings, there is a paucity of vaccine preparedness studies that specifically pertain to MSM. Our study is the first vaccine preparedness study among MSM and female sex workers (FSWs) in Kenya. In this paper, we explore willingness of Kenyan MSM to participate in HIV vaccine efficacy trials. In addition to individual and socio-cultural motivators and barriers that influence willingness to participate (WTP), we explore the associations or linkages that participants draw between their experiences with or knowledge of medical research both generally and within the context of HIV/AIDS, their perceptions of a future HIV vaccine and their willingness to participate in HIV vaccine trials.MethodsUsing a social network-based approach, we employed snowball sampling to recruit MSM into the study from Kisumu, Mombasa, and Nairobi. A field team consisting of seven community researchers conducted in-depth interviews with a total of 70 study participants. A coding scheme for transcribed and translated data was developed and the data was then analysed thematically.ResultsMost participants felt that an HIV vaccine would bring a number of benefits to self, as well as to MSM communities, including quelling personal fears related to HIV acquisition and reducing/eliminating stigma and discrimination shouldered by their community. Willingness to participate in HIV vaccine efficacy trials was highly motivated by various forms of altruism. Specific researcher responsibilities centred on safe-guarding the rights and well-being of participants were also found to govern WTP, as were reflections on the acceptability of a future preventive HIV vaccine.ConclusionStrategies for engagement of communities and recruitment of trial volunteers for HIV vaccine efficacy trials should not only be grounded in and informed by investigations into individual and socio-cultural factors that impact WTP, but also by explorations of participants’ existing experiences with or knowledge of medical research as well as attitudes and acceptance towards a future HIV vaccine.

The willingness to participate in biomedical research involving human beings in low‐ and middle‐income countries: a systematic review

“…The gaining of knowledge through research participation was mentioned 16 times overall, ranked in the top three reasons four times, and was given as the top reason in one paper to participate . Knowledge was ranked fifth in Sub‐Saharan Africa and Eastern Europe, in HIV research, by male and patient participants and for hypothetical studies.…”

“…Additional reasons for participation mentioned were: ability to withdraw , advice from physician , community involvement , cultural acceptability , creating a feeling of community , low pressure decision , need for treatment , research involving a non‐invasive procedure , peer enrolment , low perception of risk , result availability , guarantee of confidentiality , being unaware of voluntariness of participation , research outcome, and finally seeing research participation as motivation to avoid risky behaviour .…”

“…The gaining of knowledge through research participation was mentioned 16 times overall, [25,27,41,44,54,59,60,62,67,73,76,81,82,[86][87][88] ranked in the top three reasons four times, [44,59,67,88] and was given as the top reason in one paper to participate [44]. Knowledge was ranked fifth in Sub-Saharan Africa and Eastern Europe, in [20,32,36,69,78], and ranked sixth overall.…”

“…Additional reasons for participation mentioned were: ability to withdraw [91], advice from physician [20,27,77,85], community involvement [34,[61][62][63]66], cultural acceptability [63,91], creating a feeling of community [44], low pressure decision [75], need for treatment [77], research involving a non-invasive procedure [46,81], peer enrolment [33,44,84], low perception of risk [54,70], result availability [20], guarantee of confidentiality [23,33,34,62], being unaware of voluntariness of participation [46], research outcome, [60,62,66,84] and finally seeing research participation as motivation to avoid risky behaviour [59]. The most important reasons for non-participation were safety concerns, inconvenience, stigmatisation, lack of social support, confidentiality concerns, physical pain, efficacy concerns and distrust.…”

Stakeholder engagement to informHIVclinical trials: a systematic review of the evidence

“…In contrast, fewer studies conducted stakeholder engagement in middle‐ (30 studies; 27.8%) 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100 and low‐income (nine studies; 8.3%) 101, 102, 103, 104, 105, 106, 107, 108, 109 countries. The location of stakeholder engagement could not be discerned in six studies (5.6%) 110, 111, 112, 113, 114, 115, and fifteen studies (13.9%) 16, 24, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128 conducted stakeholder engagement in multiple countries at different income levels.…”