Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study

Gafos, Mitzy; Brodnicki, Elizabeth; Desai, Monica; McCormack, Sheena; Nutland, Will; Wayal, Sonali; White, Ellen; Wood, Gemma; Barber, Tristan; Bell, Gill; Clarke, Amanda; Dolling, David; Dunn, David; Fox, Julie; Haddow, Lewis; Lacey, Charles; Nardone, Anthony; Quinn, Killian; Rae, Caroline; Reeves, Iain; Rayment, Michael; White, David; Apea, Vanessa; Ayap, Wilbert; Dewsnap, Claire; Collaço‐Moraes, Yolanda; Schembri, Gabriel; Sowunmi, Yinka; Horne, Rob

doi:10.1371/journal.pone.0175596

Cited by 7 publications

(9 citation statements)

References 25 publications

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“…PrEP rollout in Kenya was implemented in the context of global randomized clinical trials that provided evidence on the efficacy of PrEP for HIV serodiscordant couples, MSM, persons who inject drugs (PWID) and heterosexual individuals [5][6][7][8]24,25 . The Partners Scale Up, LVCT Health-led IPCP, and the Jilinde scale up project were designed to continue generating evidence on PrEP uptake by serodiscordant couples, MSM, FSW, and young women to inform the national program.…”

Section: Research and Implementation Science Sub-committeementioning

confidence: 99%

Pre-exposure prophylaxis rollout in a national public sector program: the Kenyan case study

Masyuko

Mukui

Njathi³

et al. 2018

Sex. Health

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Background While advances have been made in HIV prevention and treatment, new HIV infections continue to occur. The introduction of pre-exposure prophylaxis (PrEP) as an additional HIV prevention option for those at high risk of HIV may change the landscape of the HIV epidemic, especially in sub-Saharan Africa, which bears the greatest HIV burden. Methods: This paper details Kenya’s experience of PrEP rollout as a national public sector program. The process of a national rollout of PrEP guidance, partnerships, challenges, lessons learnt and progress related to national scale up of PrEP in Kenya, as of 2018, is described. National rollout of PrEP was strongly lead by the government, and work was executed through a multidisciplinary, multi-organisation dedicated team. This required reviewing available evidence, providing guidance to health providers, integration into existing logistic and health information systems, robust communication and community engagement. Mapping of the response showed that subnational levels had existing infrastructure but required targeted resources to catalyse PrEP provision. Rollout scenarios were developed and adopted, with prioritisation of 19 counties focusing on high incidence area and high potential PrEP users to maximise impact and minimise costs. Results: PrEP is now offered in over 900 facilities countrywide. There are currently over 14000 PrEP users 1 year after launching PrEP.Conclusions: Kenya becomes the first African country to rollout PrEP as a national program, in the public sector. This case study will provide guidance for low- and middle-income countries planning the rollout of PrEP in response to both generalised and concentrated epidemics.

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Section: Research and Implementation Science Sub-committeementioning

confidence: 99%

Pre-exposure prophylaxis rollout in a national public sector program: the Kenyan case study

Masyuko

Mukui

Njathi³

et al. 2018

Sex. Health

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“…As such, there were unanswered questions about the potential for risk compensation when people were using PrEP knowing it was efficacious against HIV acquisition. In order to support PrEP availability in England, the PrEP e-group, formed in 2011 of community members, healthcare providers, policy makers and researchers, recommended a randomised open label wait-listed trial design [ 10 ]. By randomising participants to an immediate start of PrEP or a deferred start of PrEP after 12 months, the trial design allowed for a robust assessment of differences in sexual behaviour and STIs between PrEP and non-PrEP users.…”

Section: Introductionmentioning

confidence: 99%

The Context of Sexual Risk Behaviour Among Men Who Have Sex with Men Seeking PrEP, and the Impact of PrEP on Sexual Behaviour

Gafos

Horne

Nutland³

et al. 2018

AIDS Behav

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There are still important gaps in our understanding of how people will incorporate PrEP into their existing HIV prevention strategies. In this paper, we explore how PrEP use impacted existing sexual risk behaviours and risk reduction strategies using qualitative data from the PROUD study. From February 2014 to January 2016, we conducted 41 in-depth interviews with gay, bisexual and other men who have sex with men (GBMSM) enrolled in the PROUD PrEP study at sexual health clinics in England. The interviews were conducted in English and were audio-recorded. The recordings were transcribed, coded and analysed using framework analysis. In the interviews, we explored participants’ sexual behaviour before joining the study and among those using or who had used PrEP, changes to sexual behaviour after starting PrEP. Participants described the risk behaviour and management strategies before using PrEP, which included irregular condom use, sero-sorting, and strategic positioning. Participants described their sexual risk taking before initiating PrEP in the context of the sexualised use of drugs, geographical spaces linked with higher risk sexual norms, and digitised sexual networking, as well as problematic psychological factors that exacerbated risk taking. The findings highlight that in the main, individuals who were already having frequent condomless sex, added PrEP to the existing range of risk management strategies, influencing the boundaries of the ‘rules’ for some but not all. While approximately half the participants reduced other risk reduction strategies after starting PrEP, the other half did not alter their behaviours. PrEP provided an additional HIV prevention option to a cohort of GBMSM at high risk of HIV due to inconsistent use of other prevention options. In summary, PrEP provides a critical and necessary additional HIV prevention option that individuals can add to existing strategies in order to enhance protection, at least from HIV. As a daily pill, PrEP offers protection in the context of the sex cultures associated with sexualised drug use, digitised sexual applications and shifting social norms around sexual fulfilment and risk taking. PrEP can offer short or longer-term options for individuals as their sexual desires change over their life course offering protection from HIV during periods of heightened risk. PrEP should not be perceived or positioned in opposition to the existing HIV prevention toolkit, but rather as additive and as a tool that can and is having a substantial impact on HIV.

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“…Qualitative reports may also neglect underlying contexts or describe only limited areas of variation (for example, between individuals rather than over time) (e.g. Crawley et al, 2013;Gafos et al, 2017). Given the ethical importance of acceptability and its ambiguity, further work to clarify this concept may support more nuanced investigation of participant perceptions to inform responsive trial design.…”

Section: A N U S C R I P Tmentioning

confidence: 99%

“…Some assessments of trial acceptability incorporate elements of this approach. For example, research on an HIV trial asked participants whether they were glad to have joined the study, intended to remain in the study, and whether they were interested in joining future trials (Gafos et al, 2017). This approach avoids the potentially misleading use of participation as a proxy for acceptability, and elucidates different degrees of acceptance.…”

Section: Misunderstanding May Reflect the Content And Communication Omentioning

confidence: 99%

Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?

Gooding

Phiri

Peterson

et al. 2018

Social Science & Medicine

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Ethics guidelines emphasise that research should be acceptable to the people invited to take part. However, acceptability is subjective and dependent on context, complicating its assessment and use as an ethical standard. This paper examines the concept of acceptability in relation to parents' perspectives on a paediatric vaccine trial in Malawi. We examined decisions on participation and experiences of the trial through interviews with parents in 41 households invited to enrol their children and participant observation of trial processes. Fieldwork took place in Chikwawa, Southern Malawi from February-October 2016. Parents were not neatly split between those who saw the trial as acceptable and those who did not; instead there were mixed and changing feelings among parents who enrolled their children, and among those who withdrew or did not take part. Some parents agreed to participate but had concerns about the trial, while others expressed satisfaction with the trial but still did not take part. These experiences indicate substantial variation in the nature of acceptance. We describe these variations in relation to six dimensions of acceptability: how acceptable the trial is, what aspects are acceptable, changes over time, circumstances affecting acceptability, variations between people, and reasons for participation or non-participation. The findings illustrate the difficulty of determining whether a trial is sufficiently acceptable to potential participants. We suggest that clarifying definitions of acceptability and examining how acceptability varies in degree, between trial components, over time, and between people and contexts may help researchers generate more nuanced descriptions of acceptability that support responsive and ethical trial design.

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Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study

Cited by 7 publications

References 25 publications

Pre-exposure prophylaxis rollout in a national public sector program: the Kenyan case study

Pre-exposure prophylaxis rollout in a national public sector program: the Kenyan case study

The Context of Sexual Risk Behaviour Among Men Who Have Sex with Men Seeking PrEP, and the Impact of PrEP on Sexual Behaviour

Six dimensions of research trial acceptability: how much, what, when, in what circumstances, to whom and why?

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