Identifying ethical and culturally responsive research activities to improve PrEP tele-health clinical trial participation among Black sexual minority men: Qualitative Study (Preprint)

2021 ◽  
Author(s):  
Derek T. Dangerfield II ◽  
Charleen Wylie

BACKGROUND Pre-exposure prophylaxis (PrEP) substantially reduces risk of HIV infection. Tele-health interventions could improve PrEP initiation and adherence for high incidence groups such as Black sexual minority men (BSMM). However, BSMM remain underrepresented in clinical trials and culturally responsive ways to improve PrEP tele-health trial participation among BSMM is needed. OBJECTIVE To fill this gap, this study identified ethical and culturally responsive study activities to improve PrEP tele-health clinical trials participation among BSMM. METHODS Data come from seven virtual, synchronous focus groups among 28 BSMM ages 18-34 were conducted from April to August 2020 to identify culturally responsive research activities to improve PrEP clinical trial research participation. Focus groups included a brief survey followed distributed online via Qualtrics™ followed by a virtual, synchronous focus group conducted via Zoom lasting between 50 and 75 minutes. Focus groups were stratified by age (18-24 vs 25-34) and outlined the components of an example PrEP tele-health randomized controlled trial and probed on domains of the study design- research motivations, study funding, recruitment activities, informed consent, randomization, follow-up, and end of the study activities. Participants were asked targeted questions regarding the ethics and trustworthiness of the study and ways that researchers could gain their trust in the PrEP tele-health trial along the protocol. RESULTS Focus groups resulted in 2 groups of 18-24 year olds and 5 groups of 25-35 year olds. The average age of participants was 27.2 years (SD 4.4). Ten (38.4) reported a bachelor’s degree was their highest education completed; 21% reported some graduate degree or higher. Most reported working full-time (57.1%) and being single or not in a committed relationship (75%). Most (85.7) reported using at least one drug before sex in the 6 months prior to study. Everyone reported ever hearing about PrEP and 35% were current PrEP users. Overall, focus groups yielded themes related to how researcher intentions, study funding, recruitment activities, informed consent details, randomization, and study team interactions during and after during the study impact trust and participation. CONCLUSIONS Medical/research mistrust persists among BSMM. Given the salience of medical mistrust, future studies should test the relative impact of implementing findings on research participation in a PrEP tele-health clinical trial.


2020 ◽  
Vol 7 (1) ◽  
pp. e000360
Author(s):  
Cristina Arriens ◽  
Teresa Aberle ◽  
Fredonna Carthen ◽  
Stan Kamp ◽  
Aikaterini Thanou ◽  
...  

ObjectiveAlthough SLE disproportionately affects minority racial groups, they are significantly under-represented in clinical trials in the USA. This may lead to misleading conclusions in race-based subgroup analyses. We conducted focus groups to evaluate the perceptions of diverse patients with lupus about clinical trial participation.MethodsA qualitative research design employed three 90 min focus groups led by a trained moderator and guided by the Theory of Planned Behaviour. Open-ended questions about trial participation included advantages and disadvantages (behavioural beliefs), approving and disapproving significant others (normative beliefs), and participation enhancers and barriers (control beliefs). Discussions were recorded, transcribed and analysed to identify emerging themes.ResultsPatients with SLE (n=23) aged 21–72, with increased proportion of minority groups (65%), participated. Reported advantages of trial participation included altruism and personal benefit. Disadvantages included uncertainties, disappointment, information burden, and life–health balance. Although some patients had discussed research participation with approving or disapproving family or friends, self-approval superseded external approval. Barriers included logistics and time, and facilitators included flexibility in scheduling, advance notice of studies, streamlined forms, and hope for SLE improvement.ConclusionsKnowledge about potential benefits of clinical trial participation was high. Minority patients demonstrated confidence in making their own informed decisions, but major barriers for all participants included burdensome forms, travel, childcare, and work. These suggest a major impact on minority and all recruitment from behavioural and control aspects, which should be considered in the logistics of trial design. This does not minimise the potential importance of improved access and education about clinical research.



2020 ◽  
Author(s):  
Derek Dangerfield II ◽  
Charleen Wylie ◽  
Janeane Anderson

BACKGROUND Focus groups are useful to support HIV prevention research among U.S. subpopulations such as Black gay, bisexual, and other Black sexual minority men (BSMM). Virtual synchronous focus groups provide an electronic means to obtaining qualitative data and are convenient to implement. However, the protocols for conducting virtual, synchronous focus groups in HIV prevention research among BSMM are lacking. OBJECTIVE This paper describes the protocols and acceptability of conducting virtual, synchronous focus groups in HIV prevention research among BSMM. METHODS Data come from two studies in which eight virtual, synchronous focus groups among a sample of HIV-negative BSMM in urban U.S. cities such as Baltimore, MD, Los Angeles, CA, Atlanta, GA, and Chicago, IL were conducted (n=39). Participants were recruited from a combination of active and passive recruitment strategies and focus groups were conducted via Zoom. Both studies were stratified by age and included data come from 2 groups of BSMM 18-24, 5 groups of BSMM ages 25-34 and 1 group age 35 years and older. Participants were asked to complete an electronic satisfaction survey distributed to their email through a private email link. RESULTS The age of participants ranged from 18 to 44 years (M=28.3, SD=6.0). Most reported not preferring in-person focus group participation. Regarding virtual focus group participation, 86% reported that they “strongly agreed” that they were satisfied participating in a focus group online, the remainder reported “agree.” Regarding a preference of providing written informed consent, 33% reported “strongly disagree,” 13.3% reported “disagree,” and 36.7% reported “neither agree nor disagree.” Regarding privacy, most reported “strongly agree” or “agree” that their information was safe to share with other participants in the group. Regarding the incentive, 44.8% reported strongly agreeing that they were satisfied with the incentive and 51.7% reported ‘agree.” CONCLUSIONS Conducting virtual, synchronous focus groups in HIV prevention research among BSMM is feasible. However, careful consideration and attention to safety, privacy, and culture is necessary for optimal focus group participation. Focus group facilitators must be explicitly trained to build rapport, ensure privacy, thoroughly explain study goals and safety protocols, and manage focus groups among BSMM. Conducting virtual, synchronous focus groups could be a useful modality to recruit and engage BSMM who are otherwise hard-to-reach.





2017 ◽  
Author(s):  
Aaron S. Breslow ◽  
Anthea Chan ◽  
Eric Arnold ◽  
Elizabeth Glaeser ◽  
Aysegul Yucel ◽  
...  


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