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

项目摘要/摘要 长效(LA)暴露前预防(PrEP)为现有的HIV预防提供了一种有前途的替代方案 方法：研究方法。评估终端用户可接受性和新递送配方的实际体验的研究 然而，忽略了包括男性观点，尽管这些产品适合于 男人和女人都是。本研究旨在评估新的LA-PrEP的可接受性和偏好 分娩配方在主要最终用户中的使用：异性恋男子和男男性行为者(MSM) 南非。男性早期参与产品开发是衡量和 解决产品可接受性问题，培养男性对新战略的所有权，从而提高潜力 有效性和影响力，并扩大男性对艾滋病毒预防的参与。 通过植入或注射方式提供的La-PrEP满足了用户对简单性、自主性和更长时间的偏好 剂量持续时间。目前，有几种PrEP植入物处于临床前开发阶段，还有几种可注射 早期人体阶段试验中的配方。生物医学战略有两个核心组成部分：主动 药物成分和给药机制；这两者都有助于接受性和 成功使用产品。评估安慰剂使用LA-PrEP给药形式的可接受性的研究 在终端用户中提供了可能适用于许多正在开发的产品的见解。这个 避孕领域提供了有关LA交付的潜在可接受性和使用的大量信息 方法对撒哈拉以南非洲(SSA)的妇女进行调查。然而，关于以下方面的知识存在差距 男性对植入物和注射给药平台的接受度，特别是在SSA中。 我们建议进行一项为期4年的研究，以比较研究安慰剂植入物和安慰剂植入物的可接受性和偏好。 使用交叉设计混合方法的注射剂在异性恋男性和男男性接触者中的研究 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 给药方式，并不比肌肉注射更容易接受。首先，我们将做形成性的定性 与男性(n=40)进行研究，以评估知识和经验，并为我们的 目标2和目标3奏效。随后，我们将进行临床交叉试验，其中200名男性将佩戴安慰剂。 植入6个月，按随机顺序每两个月注射三次。这些产品的首选项 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.