Recruitment and ethical considerations in HIV cure trials requiring treatment interruption

Arnold, Michael P.; Evans, David; Vergel, Nelson

doi:10.1016/s2055-6640(20)31148-1

Cited by 41 publications

(24 citation statements)

References 37 publications

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“…Where participants indicted they were willing to participate in a HIV cure trial, a series of questions was asked of them relating to possible social and personal benefits. These questions were adapted, with permission, from Arnold and colleagues’ US-based survey of people living with HIV ( 61 ).…”

Section: Materials and Equipmentmentioning

confidence: 99%

HIV Futures 8: Protocol for a Repeated Cross-sectional and Longitudinal Survey of People Living with HIV in Australia

Power

Brown

Lyons

et al. 2017

Front. Public Health

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IntroductionMore than 27,000 Australians currently live with HIV. Most of these people have access to quality clinical care and antiretroviral treatment (ART) and can expect good general health. However, HIV-related stigma is a problem and many people living with HIV experience poorer than average mental health. Issues of aging are also of increasing concern. This paper describes the methods and sample for the HIV Futures 8 study, a national survey of people living with HIV in Australia that aimed to identify factors that support health and well-being among this population. HIV Futures 8 forms part of a series of cross-sectional surveys (The “HIV Futures” studies) that have been repeated periodically since 1997. In the most recent survey, participants were able to opt into a prospective longitudinal study.Materials and equipmentHIV Futures 8 was open to people aged over 17 who were living with HIV. Data were collected in 2015/2016 using a self-complete survey that contained approximately 250 items related to physical and mental health, use of ART, HIV exposure and testing, financial security, social connectedness, relationships, life satisfaction, resilience, stigma, use of health and support services, and health literacy. To enable comparison of cross-sectional data over time, questionnaire items were consistent with those used in previous HIV Futures surveys. In HIV Futures 8, participants were invited to volunteer coded information that will allow longitudinal follow-up when participants complete subsequent HIV Futures surveys. The survey was advertised through the networks of HIV organizations, on social media and through HIV clinics and services. HIV Futures 8 was completed by 895 participants. This represents approximately 3.8% of the total number of people living with diagnosed HIV in Australia in 2014.Expected impact of the study on public healthFindings from HIV Futures 8 will contribute important insights into the complexity of factors that support physical and mental well-being among people living with HIV. The findings will also assist HIV services to align with broader public health goals related to increasing ART use and improving quality of life among people living with HIV.

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Section: Materials and Equipmentmentioning

confidence: 99%

HIV Futures 8: Protocol for a Repeated Cross-sectional and Longitudinal Survey of People Living with HIV in Australia

Power

Brown

Lyons

et al. 2017

Front. Public Health

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“…Although previous research has shown high acceptance of HIV cure research in people living with HIV (PLHIV), 8 , 9 , 10 there are to date only limited reports regarding the experience of participants in such trials.…”

Section: Introductionmentioning

confidence: 99%

Motivations, barriers and experiences of participants in an HIV reservoir trial

Scheerder

Bilsen

Dullaers

et al. 2021

Journal of Virus Eradication

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Objectives We aimed to investigate the motives, barriers and experiences of HIV-STAR study participants. The HIV-STAR study was an analytical HIV treatment interruption trial (ATI) aiming to evaluate the origin of viral rebound, conducted in Ghent, Belgium. Methods A mixed-method study was performed among 11 participants of the HIV-STAR study. Two self-administered questionnaires with 32 and 23 items, respectively, assessed motives, barriers and experiences of the research participants. In-depth interviews were conducted to further explore and understand topics that had emerged from these surveys. Results Motives of ATI study participants were primarily related to the improvement of their own health perspectives and to their contribution to find an HIV cure. Barriers for ATI participation mostly related to practical issues, such as difficulty in planning study visits. Ten out of 11 participants reported a very high overall satisfaction and were willing to participate in another ATI. This satisfaction was predominantly linked to clear communication and guidance. Invasive sampling during the ATI was less of a burden than anticipated by participants. However, most participants underestimated the emotional impact of HIV treatment interruption, which was associated with feelings of uncertainty and loss of control. Risk of HIV transmission because of viral rebound was also mentioned as burdensome during this phase. Conclusions Involvement in an ATI was positively evaluated by HIV-STAR participants. Contributing to HIV cure research outweighed the burden of study participation for most participants. The latter aspects were attenuated by mutual decision making and the experience of empathy from the research team. Still, issues regarding privacy and the psychosocial impact of treatment interruption, including sexuality and HIV transmissibility, should be addressed in a better way.

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“…Motivations for PLHIV to enrol in HIV cure research involving ATI were mostly altruistic, with an emphasis on helping others above themselves. This has been demonstrated in multiple other surveys of PLHIV who have already participated in cure research [ 11 ], and those who are yet to enrol [ 3 – 5 , 12 , 15 ]. This is not so clearly apparent in other medical research fields, including paediatrics, where motivations include accessing unaffordable treatment and “enhanced care” [ 16 – 18 ] above altruistic reasons.…”

Section: Discussionmentioning

confidence: 76%

“…Despite great interest in ATI, understanding of ATI acceptability amongst people living with HIV (PLHIV) and their HIV healthcare providers (HHP) is limited. In previous surveys of PLHIV, acceptability of ATI has ranged from 34 to 68% [ 3 – 5 ], and small qualitative studies have explored understanding and acceptance of ATI [ 6 , 7 ]. Knowledge of healthcare provider acceptance of, or support for HIV cure-focused research is even more limited.…”

Section: Introductionmentioning

confidence: 99%

Acceptability, motivation and the prospect of cure for people living with HIV and their healthcare providers in HIV cure-focused treatment interruption studies

et al. 2020

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Background Analytical treatment interruptions (ATI) are commonly used clinical endpoints to assess interventions aimed at curing HIV or achieving antiretroviral therapy (ART)-free HIV remission. Understanding the acceptability of ATI amongst people living with HIV (PLHIV) and their HIV healthcare providers (HHP) is limited. Methods Two online surveys for PLHIV and HHP assessed awareness and acceptability of ATI, and understanding of the prospect for HIV cure in the future. Responses were collected from July 2017–January 2018. A descriptive analysis was performed and similar questions across the two surveys were compared using χ squared test. Results 442 PLHIV and 144 HHP completed the survey. 105/400 (26%) PLHIV had ever interrupted ART, 8% of which were in a clinical trial. Altruistic motivations were drivers of participation of PLHIV in cure related research. 81/135 (60%) HHP would support their patients wishing to enrol in an HIV cure-focused trial, but fewer would promote and allow such participation (25% and 31% respectively). Compared to HHP, PLHIV were more likely to believe that an HIV cure would be achievable within 10 years (55% vs. 19%, p < 0.001), had less awareness of ATI (46% vs. 62%, p < 0.001) and were less likely to have had experience of either participation or enrolment in an ATI study (5% vs. 18%, p < 0.001) Conclusion PLHIV were more optimistic about the potential for HIV cure. HHP had more direct experience with HIV cure-focused studies. Educational strategies are required for both groups to increase understanding around ATIs in HIV cure research but should be tailored specifically to each group.

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Recruitment and ethical considerations in HIV cure trials requiring treatment interruption

Cited by 41 publications

References 37 publications

HIV Futures 8: Protocol for a Repeated Cross-sectional and Longitudinal Survey of People Living with HIV in Australia

HIV Futures 8: Protocol for a Repeated Cross-sectional and Longitudinal Survey of People Living with HIV in Australia

Motivations, barriers and experiences of participants in an HIV reservoir trial

Acceptability, motivation and the prospect of cure for people living with HIV and their healthcare providers in HIV cure-focused treatment interruption studies

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