Background Women living with human immunodeficiency virus (WLWH), especially those living in low- and middle-income countries (LMIC), are at increased risk of cervical cancer. The optimal cervical-cancer screening strategy for WLWH has not been determined. We therefore conducted a pilot study of screening methods in WLWH living in Limbe, Cameroon. Methods Five-hundred sixty-six WLWH, aged 25–59 years, were enrolled. After self-collecting a cervicovaginal specimen, they underwent a pelvic exam, during which a provider also collected a cervical specimen and visual inspection after acetic acid (VIA) was performed. Both self- and provider-collected specimens were tested for high-risk HPV by the Xpert HPV Test (Cepheid, Sunnyvale, CA, USA), with the residual of the latter used for liquid-based cytology. Women testing HPV positive on either specimen and/or VIA positive were referred to colposcopy and biopsies. However, because of poor attendence for follow-up colposcopy for the screen positives due to civil strife and technical issues with biopsies, high-grade cytology and/or clinical diagnosis of cancer was used as the primary high-grade cervical abnormality endpoint. Clinical performances for high-grade cervical abnormality of HPV testing and VIA for screening WLWH, and the most carcinogenic HPV genotypes and/or VIA to triage high-risk HPV-positive WLWH, were evaluated. Results Four-hundred eighty-seven (86.0%) WLWH had results for HPV testing on both specimen, VIA, and cytology and were included in the analysis. Forty-nine (10.1%) had a high-grade cervical abnormality. HPV testing on provider- and self-collected specimens was more sensitive than VIA (95.9 and 91.8% vs. 43.8%, respectively, p < 0.01 for both comparisons) for identifying women with high-grade cervical abnormalities. HPV testing on provider- and self-collected specimens was less specific than VIA (57.5 and 51.6% vs. 89.7%, respectively, p < 0.01 for both comparisons) for identifying women with high-grade cervical abnormalities; HPV testing on provider-collected specimens was more specific than on self-collected specimens ( p < 0.01). Among HPV-positive women, HPV16/18/45 detection or VIA positivity had a sensitivity and positive predictive value of 73.5 and 29.0%, respectively, for provider-collected specimens and 68.8 and 22.9%, respectively, for self-collected specimens for high-grade cervical abnormalities. Conclusions HPV testing was more sensitive but less specific than VIA for detection of high-grade cervical abnormality in WLWH. Improved triage methods for HPV-positive WLWH are needed. Trial registration NCT04401670 (clinicaltrials.gov); retrospectively registered on May 26, 2020

中文翻译：

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喀麦隆 HIV 感染妇女高级别宫颈异常筛查试验的比较

背景 感染人类免疫缺陷病毒 (WLWH) 的女性，尤其是生活在低收入和中等收入国家 (LMIC) 的女性，患宫颈癌的风险增加。WLWH 的最佳宫颈癌筛查策略尚未确定。因此，我们对居住在喀麦隆林贝的 WLWH 的筛查方法进行了初步研究。方法 入组 566 名 WLWH，年龄 25 ～ 59 岁。在自行收集宫颈阴道标本后，他们接受了盆腔检查，在此期间，提供者还收集了宫颈标本，并在进行醋酸 (VIA) 后进行了目视检查。通过 Xpert HPV Test (Cepheid, Sunnyvale, CA, USA) 对自我和提供者收集的样本进行高危 HPV 检测，后者的残留物用于液基细胞学检查。在样本中检测出 HPV 阳性和/或 VIA 阳性的女性被转诊进行阴道镜检查和活检。然而，由于内乱和活检技术问题导致筛查阳性的后续阴道镜检查出勤率低，高级别细胞学和/或癌症的临床诊断被用作主要的高级别宫颈异常终点。评估了 HPV 检测和 VIA 筛查 WLWH 的高级别宫颈异常的临床表现，以及最致癌的 HPV 基因型和/或 VIA 对高危 HPV 阳性 WLWH 进行分类的临床表现。结果 487 名 (86.0%) WLWH 的样本、VIA 和细胞学均获得了 HPV 检测结果，并被纳入分析。49 人 (10.1%) 有严重的宫颈异常。对提供者和自行收集的样本进行 HPV 检测比 VIA 更敏感（分别为 95.9% 和 91.8% 对 43.8%，两个比较的 p < 0.01），以识别具有高度宫颈异常的女性。对提供者和自行收集的样本进行 HPV 检测的特异性低于 VIA（分别为 57.5% 和 51.6% 对 89.7%，两个比较的 p < 0.01）在识别患有高度宫颈异常的女性方面；对提供者收集的样本进行 HPV 检测比对自我收集的样本进行更具体的检测（p < 0.01）。在 HPV 阳性女性中，HPV16/18/45 检测或 VIA 阳性对于提供者收集的样本的敏感性和阳性预测值分别为 73.5% 和 29.0%，对于自我收集的高危样本的敏感性和阳性预测值分别为 68.8% 和 22.9%。级宫颈异常。结论 HPV 检测在检测 WLWH 中高级别宫颈异常方面比 VIA 更敏感，但特异性较低。需要改进 HPV 阳性 WLWH 的分类方法。试验注册NCT04401670（clinicaltrials.gov）；2020 年 5 月 26 日追溯登记