Advancing long-acting and extended delivery HIV prevention and treatment regimens through behavioural science: NIH workshop directions

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The first long-acting injectable drug regimen for HIV antiretroviral therapy (ART) has received regulatory approval in the United States (USA) and Canada [1,2]. A monthly intervaginal ring for HIV prevention has gained the recommendation of the WHO and a positive opinion from the European Medicines Agency (EMA) [3,4]. Recent efficacy findings for long-acting injectable HIV preexposure prophylaxis (PrEP) in the HIV Prevention Trials Network (HPTN) 083 and 084 trials hold enormous potential to reshape the HIV prevention landscape [5,6]. These important advances reflect a broad set of long-acting and extended delivery (LAED) regimens in the development for HIV treatment and prevention [7,8]. Additional LAED products in the HIV research pipeline include monthly oral regimens, extended-release implants, parenterally administered antibodies and multidose vaccine regimens. Although LAED regimens address a fundamental behavioural challenge by reducing the burden of daily pill adherence, retention in care remains critical for achieving clinical outcomes. Many existing barriers to equitable healthcare access, engagement and implementation will persist. Behavioural and social science can optimize the development, use and impact of LAED regimens. We see three key gaps that behavioural and social science research (BSSR) can address to strengthen future use of LAED regimens for HIV treatment and prevention: expand scientific understanding of end-user needs, desires and contexts to improve LAED product development; develop tools and approaches to support LAED regimen choice, use and care retention; and advance innovative healthcare delivery models to maximize equitable and efficient access to LAED HIV prevention and treatment regimens for improved impact (Table 1). These directions emerged from our independent assessment of presentations and discussions at a US National Institutes of Health (NIH) workshop examining behavioural aspects of LAED regimens for HIV prevention and treatment, which was attended by over 100 subject matter experts providing diverse expertise across clinical, behavioural, social and implementation sciences and community engagement [9]. Table 1 - Behavioural and Social Science Research priorities on long-acting and extended delivery regimens for HIV treatment and prevention. BSSR priority Overarching goal Related BSSR topics/methods Further scientific understanding of end-user needs, desires, and contexts through BSSR to improve LAED product development and testing. Advance novel LAED regimens that are desirable to end-users to optimize their future use. Qualitative methods (interviews, focus groups, ethnographic research)Discrete choice surveys with intended end-usersMixed-methods research with clinical trial participantsPlacebo trials or prototyping studiesCommunity engagement research Develop tools and approaches to support LAED regimen choice, use and care retention through BSSR. Support the safe and effective use of proven LAED regimens. Create decision tools to support person-centred, shared decision-making regarding LAED product initiation and discontinuationSupport oral medication adherence during any induction or discontinuation taper period required for LAED regimensAdvance care retention interventions to facilitate continuous/sustained use of LAED regimensUnderstand and address intersectional stigma as a fundamental barrier to care engagement and retention Advance innovative healthcare delivery models through BSSR to maximize equitable and efficient access to LAED regimens Maximize the reach and impact of LAED regimens for HIV treatment and prevention. Understanding provider and care factorsAdvance provider and workforce trainingInform development of innovative healthcare delivery models, including injection clinics, pharmacy-based care, community-based care and telemedicineGeolocation and time-motion analyses on care deliveryIntegrated care approachesDifferentiated care approachesAttending to cost and cost-effectiveness Expand scientific understanding of end-user needs, desires, and contexts to improve long-acting and extended delivery product development and testing BSSR improves understanding of end-user needs, desires and context-specific challenges and should be undertaken prior to development of novel LAED products and strategies, as well as during early and late-stage clinical trials. Early and iterative incorporation of user perspectives ensures that new LAED regimens are ‘gain creators’ or ‘pain relievers’ for both end-users/consumers and their providers. Human-centred design and consumer research approaches seek to understand the needs and desires of people for whom products will be designed [10,11]. Populations studied should reflect the sex, age and other diversity of the populations who will use the products. Qualitative BSSR methods including interviews, focus groups and ethnography are useful for understanding the interests of intended end-users. Focus groups with USA MSM revealed preferences for long-acting PrEP formulations that simplified their lives, and this view generated interest in biodegradable PrEP implants that do not require surgical removal [12]. Other important elicitation approaches include discrete choice experiments that ask respondents to rate contrasting options for hypothetical products, or ‘placebo trials’ that test use of inert product facsimiles [13–15]. BSSR also informs thoughtful design and conduct of LAED clinical trials [16–18]. Mixed methods BSSR (quantitative surveys and qualitative research) and community-based participatory research provide approaches for engaging community input to optimize clinical trial questions, design, recruitment and participation [19]. Systematic stakeholder consultation and development of culture and context-specific multimedia tools to support community engagement in clinical trials represent best practices. BSSR can help refine products that have advanced into clinical trials. Mixed methods BSSR research can identify reasons for differential product use across different clinical trial participants [20]. BSSR conducted with individuals not enrolled or poorly retained in LAED clinical trials provides understanding of individual and contextual factors that impact their product-related views or experience. HIV prevention and treatment product developers must ask, ‘How might we further improve this product and/or its delivery for you?’, at every stage of development and testing. Develop tools and approaches to support long-acting and extended delivery regimen choice, use and care retention Findings from BSSR have been important for optimizing the use and impact of novel healthcare regimens. For example, the benefits of highly efficacious oral HIV ART and PrEP prevention regimens have been constrained by suboptimal patient engagement and retention in care [21,22], requiring the development of associated BSSR-based interventions to improve care retention [23,24]. BSSR has been critical for understanding and addressing challenges to uptake and completion of HPV vaccine regimens, as well [25]. HIV-related LAED regimens that enter the marketplace will similarly require BSSR for best use. Decision tools are needed to clarify patient preferences around available regimens and to maximize patient satisfaction with regimen choice [26]. Decision tools have been helpful in the contraceptive field [27] and will facilitate LAED regimen selection and adoption for HIV treatment and prevention without coercion. Robust tools informed by decision science will attend to both deliberative reasoning and intuitive and emotional processes that guide decisions [28,29]. Decision tools could inform choices about LAED regimen discontinuation as well as initiation, as product preferences may shift over time. Oral regimens may precede and follow LAED regimens, and BSSR-informed strategies are needed to support their use. Current LAED regimens for HIV treatment or prevention require an oral i

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