Lessons for Patient Education Around Long-Acting Injectable PrEP: Findings from a Mixed-Method Study of Phase II Trial Participants
- 226 Downloads
This study aimed to identify patients’ physical and psychosocial experiences of an investigational long-acting injectable PrEP product to aid in the development of patient and provider education materials. Twenty-eight participants of a Phase 2 safety, tolerability, and acceptability study of long-acting integrase inhibitor cabotegravir (CAB-LA) were interviewed on their physical and psychosocial experiences of the injections. Five themes emerged through a framework analysis on these interview transcripts: (1) injection-related pain is highly variable across individuals; (2) pain is more impactful after the injections than during; (3) patient anxiety is critical, but does not determine the experience of injections and decreases over time; (4) intimacy and awkwardness of gluteal injections impacts patients’ experiences; (5) patient education and care strategies can mitigate the above factors. These findings can inform further sociobehavioral research within Phase 3 efficacy trials of CAB-LA, as well as patient education and provider guidance for future injectable PrEP products.
KeywordsPrEP Long-acting injectable HIV MSM Patient education Providers
El propósito de este estudio fue a identificar las experiencias físicas y psicosociales de los pacientes de un producto inyectable de PrEP de acción prolongada para ayudar en el desarrollo de materiales de educación de pacientes y proveedores. Veintiocho participantes de un estudio de seguridad, tolerabilidad y aceptabilidad de la Fase 2 del inhibidor de la integrasa de acción prolongada, cabotegravir (CAB-LA), fueron entrevistados sobre sus experiencias físicas y psicosociales de las inyecciones. Cinco temas emergieron en los análisis de las transcripciones de las entrevistas: (1) el dolor de la inyección es muy variable entre individuos; (2) el dolor es más impactante después de las inyecciones que durante; (3) la ansiedad del paciente es crítico, pero no determina la experiencia de las inyecciones y disminuye con tiempo; (4) la intimidad y la incomodidad de las inyecciones glúteas repercute en las experiencias de los pacientes; (5) la educación del paciente y las estrategias de cuido pueden mitigar los factores anteriores. Estas recomendaciones pueden informar a más investigación socio-conductual dentro de los ensayos de eficacia de la Fase 3 de CAB-LA, así como la educación del paciente y la orientación del proveedor para futuros productos inyectables de PrEP.
SG and KM are supported by R01MH106380 (Golub, PI), which provided the funding for this study. We gratefully acknowledge the advice and guidance of Dr. Susannah Allison and Dr. Michael Stirratt. KM was additionally supported by grant #UL1TR001866 from the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program. DD, IF, BK, ML, MM, MS, and HT received funding from PPD Development for the conduct of GSK201120 (ECLAIR study). DD and IF are additionally supported by Penn Center for AIDS Research (P30 AI 045008). KM and SG conceived of the study design. KM and KR developed data collection instruments and implemented the study. DD, IF, BK, ML, MM, MS, and HT treated participants and facilitated access to study participants. DM gave input into the study design and gave overall access to the ECLAIR participants. KM, SG, AB, and YW contributed to data analysis. KM and SG drafted the manuscript. All authors reviewed and approved the final manuscript.
This study was funded by R01MH106380 (Golub, PI).
Compliance with Ethical Standards
Conflicts of interest
Kathrine Meyers has received grant support from GlaxoSmithKline. Kristina Rodriguez declares that she has no conflict of interest. Atrina Brill declares that she has no conflict of interest. Yumeng Wu declares that she has no conflict of interest. Melissa La Mar declares that she has no conflict of interest. Debora Dunbar has received salary support from GlaxoSmithKline. Beryl Koblin received a research grant from GlaxoSmithKline for the ECLAIR study. David Margolis is a fulltime employee and shareholder of ViiV Healthcare, who sponsored the ECLAIR Study. Magdalena Sobieszczyk received a research grant to the institution from GlaxoSmithKline for the ECLAIR study. Hong Van Tieu received a research grant from GlaxoSmithKline for the ECLAIR study and has received a research grant from Merck. Ian Frank has received research grants from ViiV/GlaxoSmithKline and is a member of an advisory board for Gilead Sciences. Martin Markowitz receives grant support from Gilead Sciences, GlaxoSmithKline, ViiV and Merck Laboratories, is a paid consultant to Merck and ViiV and receives honoraria for speaking from Gilead Sciences. Sarit Golub received free study drug from Gilead Sciences for a PrEP demonstration project (R01AA02267).
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
It was obtained from all individual participants included in the study.
- 3.McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet (London, England). 2016;387(10013):53–60.CrossRefGoogle Scholar
- 7.Grossman H, Anderson P, Grant R, Gandhi M, Mohri H, Markowitz M, editors. Newly Acquired HIV-1 Infection with Multi-Drug Resistant (MDR) HIV-1 in a Patient on TDF/FTC-based PrEP. HIV Research for Prevention (HIVR4P), October 2016, Chicago. Abstract OA03.06LB.Google Scholar
- 9.Hoornenborg E, de Bree G. Acute Infection with a Wild-type HIV-1 Virus in PrEP User with High TDF Levels. CROI, February 2017, Seattle. Abstract 953.. 2017.Google Scholar
- 13.Meyers K, Wu E, Qian H, Huang X, H W. High degree of interest in long-acting injectable pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in two Chinese cities. 142nd APHA Annual Meeting and Exposition, November 2014, New Orleans. Abstract 305569.Google Scholar
- 17.Ross J, Stover J. Use of modern contraception increases when more methods become available: analysis of evidence from 1982–2009. Glob Health. 2013;1(2):203–12.Google Scholar
- 18.Cohen SE, Vittinghoff E, Bacon O, Doblecki-Lewis S, Postle BS, Feaster DJ, et al. High interest in preexposure prophylaxis among men who have sex with men at risk for HIV infection: baseline data from the US PrEP demonstration project. J Acquir Immune Defic Syndr. 2015;68(4):439–48.CrossRefPubMedPubMedCentralGoogle Scholar
- 21.Markowitz M, Frank I, Robert M. Grant, Kenneth H. Mayer, Richard Elion, Deborah Goldstein, et al. ECLAIR: a randomised phase IIA safety and pharmacokinetic study of cabotegravir long-acting injection 800 mg every 12 weeks in HIV-uninfected men. Lancet HIV. 2017 May 22.Google Scholar
- 22.Dedoose. Dedoose qualitative software 2011 [August 2013]. http://www.dedoose.com/.
- 24.Srivastava A, Thomson S. Framework analysis: a qualitiative methodology for applied policy research Journal of Administration and Governance. 2009;4(2).Google Scholar
- 25.Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men. (2016). https://clinicaltrials.gov/ct2/show/NCT02720094?term=HPTN083&rank=1 (Identification No. NCT02720094).
- 26.HPTN 084: A phase 3 double blind safety and efficacy study of long-acting injectable cabotegravir compared to daily oral TDF/FTC for pre-exposure prophylaxis in HIV-uninfected women. https://www.hptn.org/research/studies/hptn084. Accessed 15 June 2017.