Men's Acceptability of Long-acting HIV prevention methods in South Africa

项目概要/摘要 长效（LA）暴露前预防（PrEP）为现有的艾滋病毒预防提供了一种有希望的替代方案 方法.研究评估终端用户对新型运载制剂的接受程度和实际体验 然而，尽管这些产品适合男性使用， 无论男女本研究旨在评估新型LA-PrEP的可接受性和偏好 关键终端用户中的递送制剂使用情况： 南非男子尽早参与产品开发是衡量和 解决产品可接受性问题，促进男性对新战略的所有权，从而提高潜力 提高艾滋病毒预防的有效性和影响力，扩大男性对艾滋病毒预防的参与。 通过植入或注射提供的LA-PrEP解决了用户对简单性、谨慎性和更长时间的偏好 给药持续时间。目前，有几种PrEP植入物处于临床前开发阶段， 在早期人类阶段试验中的制剂。生物医学战略有两个核心组成部分： 药物成分和递送机制;两者都有助于可接受性， 成功使用产品。评估LA-PrEP递送形式安慰剂使用可接受性的研究 在最终用户中提供的洞察力可能适用于许多正在开发的产品。的 避孕字段提供了大量关于LA分娩的潜在可接受性和使用的信息 在撒哈拉以南非洲（SSA）的妇女。然而，在知识方面存在差距， 植入和注射给药平台在男性中的可接受性，特别是在SSA中。 我们建议进行一项为期4年的研究，比较研究安慰剂植入物的可接受性和偏好， 使用交叉设计的混合方法在异性恋男性和男男性行为者中进行的注射剂研究， 南非约翰内斯堡和开普敦。我们假设男性会发现植入物的使用是可以接受的， 递送形式，并且不低于肌内注射的可接受性。首先，我们将进行定性分析， 与男性（n=40）进行研究，以评估知识和经验，并为我们的信息和材料提供信息 目标2和3的工作。随后，我们将进行一项临床交叉试验，其中男性（n=200）将服用安慰剂 植入6个月，并以随机顺序每两个月注射三次。对这些的偏好 然后将测量这些LA方法、口服PrEP和避孕套的递送形式和产品属性 使用离散选择实验调查。

PROJECT SUMMARY/ABSTRACT Long-acting (LA) pre-exposure prophylaxis (PrEP) offers a promising alternative to existing HIV prevention methods. Research to assess end-user acceptability and actual experiences of novel delivery formulations has neglected, however, to include male perspectives, despite these products being appropriate for use by both men and women. This research aims to assess acceptability of and preferences for novel LA-PrEP delivery formulation use among key end users: heterosexual men and men who have sex with men (MSM) in South Africa. Early involvement of men in product development is an important opportunity to measure and address product acceptability and foster male ownership of novel strategies, thereby enhancing potential effectiveness and impact, and broadening male engagement in HIV prevention. LA-PrEP delivered by implant or injection addresses user preferences for simplicity, discretion, and longer dose duration. Currently, there are several PrEP implants in preclinical development and a few injectable formulations in early human phase trials. Biomedical strategies have two core components: the active pharmaceutical ingredient and the delivery mechanism; both of which contribute to acceptability and successful use of products. Research to assess acceptability of placebo use of LA-PrEP delivery forms among end users provides insight that may apply to the many products under development. The contraceptive field provides substantial information about potential acceptability and use of LA delivery methods among women in sub-Saharan Africa (SSA). However, there is a gap in knowledge regarding acceptability of implant and injectable dosing platforms among men, particularly in SSA. We propose a 4-year study to comparatively examine acceptability and preferences of placebo implants and injectables using a crossover-designed mixed methods study among heterosexual men and MSM in Johannesburg and Cape Town, South Africa. We hypothesize that men will find implant use acceptable as a delivery form and no less acceptable than intramuscular injections. First, we will do formative qualitative research with men (n=40) to assess knowledge and experiences and inform messages and materials for our Aim 2 and 3 work. Subsequently, we will conduct a clinical crossover in which men (n=200) will wear placebo implants for 6 months and have three bimonthly injections in a randomized sequence. Preferences for these delivery forms and product attributes of these LA methods, oral PrEP, and condoms will then be measured using a discrete choice experiment survey.