在肯尼亚私人药店评估 HIV 自我检测的表现：一项横断面研究。
Measuring the performance of HIV self-testing at private pharmacies in Kenya: a cross-sectional study.
机构信息
Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.
出版信息
J Int AIDS Soc. 2023 Oct;26(10):e26177. doi: 10.1002/jia2.26177.
INTRODUCTION
HIV self-testing (HIVST) has the potential to support daily oral pre-exposure prophylaxis (PrEP) delivery in private pharmacies, but many national guidelines have not approved HIVST for PrEP dispensing. In Kenya, pharmacy providers are permitted to deliver HIVST, but often do not have the required certification to deliver rapid diagnostic testing (RDT). We estimated the performance of provider-delivered HIVST compared to RDT, the standard of care for PrEP delivery, at private pharmacies in Kenya to inform decisions on the use of HIVST for PrEP scale-up.
METHODS
At 20 pharmacies in Kisumu County, we trained pharmacy providers (pharmacists and pharmaceutical technologists) on blood-based HIVST use and client assistance (if requested). We recruited pharmacy clients purchasing sexual and reproductive health-related products (e.g. condoms) and enrolled those ≥18 years with self-reported behaviours associated with HIV risk. Enrolled clients received HIVST with associated provider counselling, followed by RDT by a certified HIV testing services (HTS) counsellor. Pharmacy providers and clients independently interpreted HIVST results prior to RDT (results interpreted only by the HTS counsellor). We calculated the sensitivity and specificity of pharmacy provider-delivered HIVST compared to HTS counsellor-administered RDT.
RESULTS
Between March and June 2022, we screened 1691 clients and enrolled 1500; 64% (954/1500) were female and the median age was 26 years (IQR 22-31). We additionally enrolled 40 providers; 42% (17/40) were pharmacy owners and their median years of experience was 6 (IQR 4-10). The majority (79%, 1190/1500) of clients requested provider assistance with HIVST and providers spent a median of 20 minutes (IQR 15-43) with each HIVST client. The sensitivity of provider-delivered HIVST at the pharmacy was high when interpreted by providers (98.5%, 95% CI 97.8%, 99.1%) and clients (98.8%, 95% CI 98.0%, 99.3%), as was the specificity of HIVST in this setting (provider-interpretation: 96.9%, 95% CI 89.2%, 99.6%; client-interpretation: 93.8%, 95% CI 84.8%, 98.3%).
CONCLUSIONS
When compared to the national HIV testing algorithm, provider-delivered blood-based HIVST at private pharmacies in Kenya performed well. These findings suggest that blood-based HIVST may be a useful tool to support PrEP initiation and continuation at private pharmacies and potentially other community-based delivery settings.
简介
HIV 自我检测（HIVST）有可能支持在私人药店提供每日口服暴露前预防（PrEP），但许多国家的指南尚未批准 HIVST 用于 PrEP 配药。在肯尼亚，药店供应商被允许提供 HIVST，但通常没有提供快速诊断检测（RDT）所需的认证。我们评估了在肯尼亚私人药店由供应商提供的 HIVST 与 PrEP 交付的标准护理（即 RDT）相比的性能，以告知关于将 HIVST 用于 PrEP 扩大规模的决策。
方法
在基苏木县的 20 家药店中，我们对药店供应商（药剂师和药学技术员）进行了有关血液 HIVST 使用和客户协助（如果需要）的培训。我们招募了购买性健康和生殖健康相关产品（例如避孕套）的药店客户，并招募了自我报告有 HIV 风险相关行为的年龄在 18 岁及以上的客户。入组的客户接受了 HIVST 检测，同时接受了供应商咨询，随后由经过认证的 HIV 检测服务（HTS）顾问进行了 RDT。在接受 RDT 之前，药店供应商和客户均独立对 HIVST 结果进行了解读（仅由 HTS 顾问对结果进行解读）。我们计算了与 HTS 顾问管理的 RDT 相比，由药店供应商提供的 HIVST 的灵敏度和特异性。
结果
2022 年 3 月至 6 月期间，我们对 1691 名客户进行了筛查，并入组了 1500 名客户；其中 64%（954/1500）为女性，中位年龄为 26 岁（IQR 22-31）。我们还额外招募了 40 名供应商；其中 42%（17/40）为药店老板，他们的中位从业年限为 6 年（IQR 4-10）。大多数（79%，1190/1500）客户请求供应商协助进行 HIVST，供应商为每位 HIVST 客户提供的服务时间中位数为 20 分钟（IQR 15-43）。当由供应商和客户解读时，HIVST 的检测效果非常好（供应商解读：98.5%，95%CI 97.8%，99.1%；客户解读：98.8%，95%CI 98.0%，99.3%），在这种情况下 HIVST 的特异性也很高（供应商解读：96.9%，95%CI 89.2%，99.6%；客户解读：93.8%，95%CI 84.8%，98.3%）。
结论
与国家 HIV 检测算法相比，肯尼亚私人药店由供应商提供的血液 HIVST 表现良好。这些发现表明，血液 HIVST 可能是支持在私人药店和潜在的其他社区提供环境中启动和继续 PrEP 的有用工具。
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