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Developing standards of care for HIV prevention research in developing countries-a case study of 10 research centers in Eastern and Southern Africa

机译:为发展中国家的艾滋病毒预防研究制定护理标准-以东部和南部非洲的10个研究中心为例

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Standards of care provided to volunteers in HIV prevention research in developing countries are evolving. Inconsistency in standards, particularly within a research network highlights the need to balance volunteers' health and wellness with the efficient conduct of research. Ten research centers (RC's) in East and Southern Africa affiliated with the International AIDS Vaccine Initiative (IAVI) were studied using a mixed methods approach to understand variations, similarities and gaps in services provided, recipients of services, referral systems, and barriers to referral uptake. These data were then used to develop expected standards across the 10 RCs. Findings indicated that RCs consistently provided HIV risk reduction and family planning (FP) counseling, male condoms, management of sexually transmitted infections, CD-4 counts, and general medical care to volunteers and non-research volunteers. Services that were less consistently provided on-site included: female condoms, adult male circumcision (AMC), antiretroviral therapy (ART) and post-exposure prophylaxis (PEP) in case of rape. The FP options provided on-site varied, with few providing implants, intrauterine devices, tubal ligation, and vasectomy. Most RCs had established referral systems for ART, AMC, PEP, and FP, but few had referral points for psychosocial services. Few RCs had comprehensive guidelines on referrals other than those related to adverse events. Findings indicate that the greatest challenges for referral uptake were transportation and health care costs, poor quality and inconsistency of services at some referral points. Few RCs covered the cost of referrals for non-study related adverse events. A collaborative process between IAVI and the RCs was undertaken to reach consensus on expected standards of care. A set of required and recommended services to be provided on-site or by referral was developed. In developing such standards, we tried to balance scientific priorities, equity, contextual realities, community expectations, and cost-effectiveness.
机译:在发展中国家,为艾滋病毒预防研究提供给志愿者的护理标准正在不断发展。标准之间的不一致,特别是在研究网络内部,不一致突出了需要在志愿者的健康和健康与有效研究之间取得平衡。使用混合方法研究了东部和南部非洲十个与国际艾滋病疫苗倡议(IAVI)相关的研究中心(RC),以了解所提供服务的差异,相似性和差距,服务的接受者,推荐系统以及推荐的障碍摄取。然后将这些数据用于制定10个RC的预期标准。调查结果表明,RC一直为志愿者和非研究志愿者提供降低HIV风险和计划生育(FP)咨询,男性避孕套,性传播感染管理,CD-4计数以及一般医疗服务。现场提供的服务较不稳定,包括:女用避孕套,成年男性包皮环切术(AMC),抗逆转录病毒疗法(ART)和强奸后的暴露后预防(PEP)。现场提供的FP选项多种多样,很少提供植入物,子宫内装置,输卵管结扎和输精管切除术。大多数RC建立了ART,AMC,PEP和FP的转诊系统,但很少有心理社会服务的转诊点。除了与不良事件有关的推荐之外,很少有RC拥有关于转诊的综合指南。调查结果表明,转介的最大挑战是交通和医疗保健成本,质量差以及某些转介点的服务不一致。很少有RC承担因非研究相关不良事件而转诊的费用。在IAVI和RC之间进行了合作,以就预期的护理标准达成共识。已开发了一套现场或通过转介提供的必需和推荐服务。在制定此类标准时,我们试图平衡科学优先级,公平性,背景现实性,社区期望和成本效益。

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