Evaluation of the practicability and virological performance of finger-stick whole-blood HIV self-testing in French-speaking sub-Saharan Africa

BackgroundOpportunities for HIV testing could be enhanced by offering HIV self-testing (HIVST) in populations that fear stigma and discrimination when accessing conventional HIV counselling and testing in health care facilities. Field experience with HIVST has not yet been reported in French-speaking African countries.MethodsThe practicability of HIVST was assessed using the prototype the Exacto® Test HIV (Biosynex, Strasbourg, France) self-test in 322 adults living in Kisangani and Bunia, Democratic Republic of the Congo, according to World Health Organization’s recommendations. Simplified and easy-to-read leaflet was translated in French, Lingala and Swahili.ResultsForty-nine percent of participants read the instructions for use in French, while 17.1% and 33.9% read the instructions in Lingala and Swahili, respectively. The instructions for use were correctly understood in 79.5% of cases. The majority (98.4%) correctly performed the HIV self-test; however, 20.8% asked for oral assistance. Most of the participants (95.3%) found that performing the self-test was easy, while 4.7% found it difficult. Overall, the results were correctly interpreted in 90.2% of cases. Among the positive, negative, and invalid self-tests, misinterpretation occurred in 6.5%, 11.2%, and 16.0% of cases, respectively (P® Test HIV self-test showed 100.0% (95% CI; 98.8–100.0) sensitivity and 99.2% (95% CI; 97.5–99.8) specificity.ConclusionsOur field observations demonstrate: (i) the need to adapt the instructions for use to the Congolese general public, including adding educational pictograms as well as instructions for use in the local vernacular language(s); (ii) frequent difficulties understanding the instructions for use in addition to frequent misinterpretation of test results; and (iii) the generally good practicability of the HIV self-test despite some limitations. Supervised use of HIVST is recommended among poorly-educated people.背景：对于畏惧在医疗机构接受常规艾滋病咨询检测时遭遇耻辱与歧视的人群而言，推广艾滋病自我检测（HIV self-testing, HIVST）可有效拓展艾滋病检测的覆盖途径。目前法语非洲国家尚未有艾滋病自我检测的现场应用经验报道。方法：本研究参照世界卫生组织（World Health Organization, WHO）的推荐方案，在刚果民主共和国基桑加尼与布尼亚两地招募322名成年受试者，采用Exacto® HIV检测试剂盒（法国斯特拉斯堡Biosynex公司研发）的原型产品，评估艾滋病自我检测的实用性。配套的简易易懂使用说明书被翻译成法语、林加拉语（Lingala）与斯瓦希里语（Swahili）。结果：49.0%的受试者使用法语阅读使用说明书，17.1%与33.9%的受试者分别使用林加拉语与斯瓦希里语阅读。79.5%的受试者能够正确理解使用说明。绝大多数（98.4%）受试者可正确完成艾滋病自我检测，但20.8%的受试者需要口头协助。多数受试者（95.3%）认为自我检测操作简便，仅4.7%认为操作存在困难。整体而言，90.2%的受试者能够正确解读检测结果。在阳性、阴性与无效自检结果中，结果解读错误率分别为6.5%、11.2%与16.0%（P < 0.001）；此外，Exacto® HIV自检试剂盒的灵敏度为100.0%（95%置信区间（Confidence Interval, CI）：98.8–100.0），特异度为99.2%（95%置信区间（Confidence Interval, CI）：97.5–99.8）。结论：本研究的现场观察结果表明：（1）需针对刚果普通民众优化使用说明书，例如添加教学性图示，并提供当地本土语言版本的使用指导；（2）部分受试者存在使用说明理解困难与检测结果解读错误的问题；（3）尽管存在一定局限，艾滋病自我检测整体实用性良好。建议受教育程度较低的人群在监督下开展艾滋病自我检测。