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

南非男性对长效艾滋病毒预防方法的接受度

• 批准号: 9925625
• 负责人: Elizabeth Trask Montgomery
• 金额: $ 71.75万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-14 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9925625
• 关键词: AIDS prevention; Address; Adherence; Africa South of the Sahara; Attitude; Clinical; Clinical Research; Complement; Comprehension; Contraceptive Agents; Cross-Over Studies; Crossover Design; Data; Development; Dose; Effectiveness; Formulation; Fostering; Foundations; Future; HIV; Heterosexuals; Human; Implant; Influentials; Injectable; Injections; Institutes; International; Intervention; Interview; Intramuscular Injections; Knowledge; Measures; Methods; Oral; Ownership; Pharmacologic Substance; Phase; Placebos; Prevention; Public Health; Qualitative Research; Randomized; Regimen; Reproductive Health; Research; Role; South Africa; Surveys; Symptoms; Universities; Wit; Woman; Work; aged; behavioral study; comparative; condoms; experience; experimental study; insight; male; men; men who have sex with men; multidisciplinary; neglect; novel; novel strategies; pre-exposure prophylaxis; preclinical development; preference; product development; satisfaction; success; transmission process; uptake; young man

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.

项目摘要/摘要 长效（LA）暴露前预防（PREP）为现有的HIV预防提供了有希望的替代品 方法。评估最终用户可接受性和新型交付配方的实际经验的研究 然而，尽管这些产品适合使用 男人和女人。这项研究旨在评估新型LA-PREP的可接受性和偏好 关键最终用户的交付配方使用：与男性发生性关系的异性恋男人（MSM） 南非。男性早期参与产品开发是衡量和的重要机会 解决产品可接受性并培养男性对新型策略的所有权，从而提高潜力 有效性和影响，并扩大男性在预防艾滋病毒预防方面的参与。 通过植入物或注射提供的LA-PREP为简单，酌处权和更长的时间介绍用户偏好 剂量持续时间。目前，临床前开发中有几种准备植入物，有一些注射剂 在人类早期试验中的配方。生物医学策略有两个核心组成部分：主动 药物成分和递送机制；这两者都有助于可接受性和 成功使用产品。研究以评估LA-PREP输送表格的安慰剂使用的可接受性 最终用户提供的见解可能适用于正在开发的许多产品。这 避孕领域提供了有关潜在可接受性和使用LA交付的大量信息 撒哈拉以南非洲（SSA）妇女的方法。但是，关于 男性，特别是在SSA中的植入物和可注射剂量平台的可接受性。 我们提出了一项为期4年的研究，以相对检查安慰剂植入物的可接受性和偏好和偏好 在异性恋男性和MSM中使用交叉设计的混合方法研究的注射剂 约翰内斯堡和南非开普敦。我们假设男人会发现植入物用作可以接受的植入物 递送形式，不亚于肌肉内注射。首先，我们将进行形成性的定性 与男性的研究（n = 40）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工作。随后，我们将进行临床跨界 植入6个月，在随机序列中进行三次两次注射。对这些的偏好 然后将测量这些LA方法，口服准备和避孕套的递送表格和产品属性 使用离散选择实验调查。