In the development of pharmacotherapies for substance use disorders, willingness to participate in randomized controlled trials (RCTs) among people who use drugs (PWUD) is influenced by numerous social and structural factors. Considering the criminalization and stigma experienced by PWUD and range of experiences in healthcare and research, PWUD may vary in their trust of health providers, health research physicians, or medical research processes. We therefore examine associations between trust in these three domains and willingness to participate in a hypothetical RCT for a novel pharmacotherapy for stimulant use among PWUD.
Methods
Data were derived from a cross-sectional questionnaire administered to participants using crack and/or cocaine from three cohort studies of PWUD in Vancouver (N = 229).
Results
A majority of participants were “definitely” or “probably” willing to participate in an RCT. In multivariable ordinal regression, trust in research physicians was positively associated with willingness to participate, while trust in primary care providers or medical research processes were not significantly associated.
Conclusions
This data suggests trust in research physicians plays a role in RCT decision-making among PWUD, while trust in healthcare providers and research processes appears less relevant. These findings highlight opportunities for supporting RCT recruitment by building trust in research physicians.
BothwellLE, GreeneJA, PodolskySH, JonesDS. Assessing the gold standard-lessons from the history of RCTs. N Engl J Med. 2016;374(22):2175–2181.
2.
RossS, GrantA, CounsellC, GillespieW, RussellI, PrescottR.Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol. 1999;52(12):1143–1156.
3.
VolkmannER, ClaiborneD, CurrierJS. Determinants of participation in HIV clinical trials: the importance of patients’ trust in their provider. HIV Clin Trials. 2009;10(2):104–109.
4.
RobinerWN, YozwiakJA, BearmanDL, StrandTD, StrasburgKR.Barriers to clinical research participation in a diabetes randomized clinical trial. Soc Sci Med. 2009;68(6):1069–1074.
5.
TownsendA, CoxSM.Accessing health services through the back door: a qualitative interview study investigating reasons why people participate in health research in Canada. BMC Med Ethics. 2013;14(1):40.
6.
TrauthJM, JewellIK, RicciE, MusaD, SiminoffL.Public attitudes regarding willingness to participate in medical research studies. J Health Soc Policy. 2000;12(2):23–43.
7.
SellarsB, GarzaMA, FryerCS, ThomasSB.Utilization of health care services and willingness to participate in future medical research: the role of race and social support. J Natl Med Assoc. 2010;102(9):776–786.
8.
GuilleminM, BarnardE, AllenA, . Do research participants trust researchers or their institution?J Empir Res Hum Res Ethics. 2018;13(3):285–294.
9.
SmirnoffM, WiletsI, RaginDF, . A paradigm for understanding trust and mistrust in medical research: The Community VOICES study. AJOB Empir Bioeth. 2018;9(1):39–47.
10.
BonevskiB, RandellM, PaulC, . Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC Med Res Methodol. 2014;14(1):42
11.
BraunsteinJB, SherberNS, SchulmanSP, DingEL, PoweNR.Race, medical researcher distrust, perceived harm, and willingness to participate in cardiovascular prevention trials. Medicine. 2008;87(1):1–9.
12.
PaquetteCE, SyvertsenJL, PolliniRA.Stigma at every turn: health services experiences among people who inject drugs. Int J Drug Policy. 2018;57:104–110.
13.
CockroftJD, AdamsSM, BonnetK, MatlockD, McMillanJ, SchlundtD. “A scarlet letter”: stigma and other factors affecting trust in the health care system for women seeking substance abuse treatment in a community setting. Subst Abus. 2019;40(2):170–177.
14.
FisherCB, OranskyM, MahadevanM, SingerM, MirhejG.Marginalized populations and drug addiction research: realism, mistrust, and misconception. IRB Ethics Hum Res. 2008;30(3):1–9.
15.
BellK, SalmonA.What women who use drugs have to say about ethical research: findings of an exploratory qualitative study. J Empir Res Hum Res Ethics. 2011;6(4):84–98.
16.
TreloarC, ByronP, McCannP, MaherL. “Fitness for duty”: social, organisational and structural influences on the design and conduct of candidate hepatitis C vaccine trials involving people who inject drugs. Vaccine. 2010;28(32):5228–5236.
17.
WelchMJ, LallyR, MillerJE, . The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clin Trials. 2015;12(5):503–510.
18.
AbadieR, GoldenbergS, Welch-LazoritzM, FisherCB.Establishing trust in HIV/HCV research among people who inject drugs (PWID): insights from empirical research. PLoS One. 2018;13(12):e0208410–15.
19.
NealeJ, TompkinsCNE, McDonaldR, StrangJ.Improving recruitment to pharmacological trials for illicit opioid use: findings from a qualitative focus group study. Addiction. 2018;113(6):1066–1076.
20.
HallMA, DuganE, ZhengB, MishraAK.Trust in physicians and medical institutions: what is it, can it be measured, and does it matter?Milbank Q. 2001;79(4):613–639.
21.
SafranDG, KosinskiM, TarlovAR, . The Primary Care Assessment Survey: tests of data quality and measurement performance. Med Care. 1998;36(5):728–739.
22.
HallMA, CamachoF, LawlorJS, DepuyV, SugarmanJ, WeinfurtK.Measuring trust in medical researchers. Med Care. 2006;44(11):1048–1053.
23.
SherberNS, PoweNR, BraunsteinJB.Personal physicians as study investigators: impact on patients’ willingness to participate in clinical trials. Contemp Clin Trials. 2009;30(3):227–232.
24.
BarataPC, GucciardiE, AhmadF, StewartDE.Cross-cultural perspectives on research participation and informed consent. Soc Sci Med. 2006;62(2):479–490.
25.
McDonaldM, TownsendA, CoxSM, PatersonND, LafrenièreD.Trust in health research relationships: accounts of human subjects. J Empir Res Hum Res Ethics. 2008;3(4):35–47.
26.
Corbie-SmithG, ThomasSB, GeorgeDMM.St.Distrust, Race, and Research. Arch Intern Med. 2002;162(21):2458.
27.
FarmerDF, JacksonSA, CamachoF, HallMA.Attitudes of African American and low socioeconomic status white women toward medical research. J Health Care Poor Underserved. 2007;18(1):85–99.
28.
SlomkaJ, RatliffE, McCurdyS, TimpsonS, WilliamsML.Decisions to participate in research: views of underserved minority drug users with or at risk for HIV. AIDS Care. 2008;20(10):1224–1232.
29.
SvenssonK, RamírezOF, PeresF, BarnettM, ClaudioL.Socioeconomic determinants associated with willingness to participate in medical research among a diverse population. Contemp Clin Trials. 2012;33(6):1197–1205.
30.
Haynes-MaslowL, GodleyP, DimartinoL, . African American women's perceptions of cancer clinical trials. Cancer Med. 2014;3(5):1430–1439.
31.
ParkJN, WhiteB, BatesA, EnriquezJ, LiaoL, MaherL.Motivators and barriers influencing willingness to participate in candidate HCV vaccine trials: perspectives of people who inject drugs. Drug Alcohol Depend. 2012;123(1–3):35–40.
32.
Oviedo-JoekesE, NosykB, MarshDC, . Scientific and political challenges in North America's first randomized controlled trial of heroin-assisted treatment for severe heroin addiction: rationale and design of the NAOMI study. Clin Trials. 2009;6(3):261–271.
33.
AlsanM, WanamakerM.Tuskegee and the health of black men. Q J Econ. 2018;133(1):407–455.
FischerB, KuganesanS, GallassiA, Malcher-LopesR, van den BrinkW, WoodE.Addressing the stimulant treatment gap: a call to investigate the therapeutic benefits potential of cannabinoids for crack-cocaine use. Int J Drug Policy. 2015;26(12):1177–1182.
36.
BrincksAM, Shiu-YeeK, MetschLR, . Physician mistrust, medical system mistrust, and perceived discrimination: associations with HIV care engagement and viral load. AIDS Behav. 2019;23(10):2859–2869.
37.
UhlmannS, MilloyMJ, AhamadK, . Factors associated with willingness to participate in a pharmacologic addiction treatment clinical trial among people who use drugs. Am J Addict. 2015;24(4):368–373.
38.
HalpernSD, MetzgerDS, BerlinJA, UbelPA.Who will enroll? Predicting participation in a Phase II AIDS Vaccine Trial. J Acquir Immune Defic Syndr. 2001;27:281–288.
