Decision making for invasive and non-invasive optional procedures within an acute HIV research cohort in Bangkok

Sinéad Isaacson; Kristine Kuczynski; Nuchanart Ormsby; Holly L Peay; Stuart Rennie; R Jean Cadigan; Eugène Kroon; Nittaya Phanuphak; Jintanat Ananworanich; Thidarat Jupimai; Peeriya Prueksakaew; Gail E Henderson

doi:10.1016/j.conctc.2022.101054

Decision making for invasive and non-invasive optional procedures within an acute HIV research cohort in Bangkok

Contemp Clin Trials Commun. 2022 Dec 23:31:101054. doi: 10.1016/j.conctc.2022.101054. eCollection 2023 Feb.

Authors

Affiliations

¹ Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
² Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
³ RTI International, Research Triangle Park, Durham, NC, USA.
⁴ Center for Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁵ SEARCH, Institute of HIV Research and Innovation, Bangkok, Thailand.
⁶ Department of Global Health, Amsterdam University Medical Centers, University of Amsterdam, And Amsterdam Institute for Global Health and Development, Amsterdam, Netherlands.
⁷ Center of Excellence in Pediatric Infectious Diseases and Vaccines Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Abstract

Clinical research regularly includes required, nontherapeutic procedures to answer research questions. Optional procedures usually offer minimal or no personal benefit and may involve harms and burdens. Members from the Bangkok SEARCH010/RV254 HIV research cohort of individuals acutely HIV-infected are recruited to six optional procedures varying in invasiveness: leukapheresis, genital secretions collection, lumbar puncture, brain MRI/MRS/DTI, colon biopsy, and lymph node biopsy. We surveyed cohort members about their first recruitment for each procedure to examine factors associated with decision making and attitudes about compensation. 406 members (68%) completed the survey. Reported procedure participation ranged from 71% (MRI) to 27% (lymph node biopsy). Respondents underwent 0-6 procedure types (median 3). Ordinal regression indicated that lower perceived HIV impact and HIV remission trial participation were associated with more procedures completed. Reports of decision difficulty varied, and feeling pressured by research staff was low overall. Notably, those who declined procedures and those who underwent more invasive procedures reported greater decision difficulty and perceived pressure. Most respondents felt compensation amounts were appropriate, although opinions differed by procedure, and for some procedures, between people who agreed and declined. There is limited literature regarding consent to and attitudes about optional research procedures. Researchers must consider how to best support voluntary decisions for procedures with little personal benefit, particularly in lower-income or marginalized populations. In this longitudinal research cohort, perceived pressure to participate may be a concern, although our finding of variation in participation rates corresponding to invasiveness is reassuring. Data from different research contexts would provide important comparators.

Keywords: Clinical research ethics; Decision-making; HIV research; Optional procedures; Research biopsies; Research cohorts.