Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT),The Lancet Global Health

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Point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation for the early detection and treatment of cervical pre-cancer in women in Papua New Guinea: a prospective, single-arm intervention trial (HPV-STAT)
The Lancet Global Health ( IF 34.3 ) Pub Date : 2022-07-22 , DOI: 10.1016/s2214-109x(22)00271-6
Andrew J B Vallely ₁ , Marion Saville ₂ , Steven G Badman ₃ , Josephine Gabuzzi ₄ , John Bolnga ₄ , Glen D L Mola ₅ , Joseph Kuk ₆ , Malts Wai ₆ , Gloria Munnull ₇ , Suzanne M Garland ₈ , Julia M L Brotherton ₉ , Angela Kelly-Hanku ₁ , Christopher Morgan ₁₀ , Pamela J Toliman ₁₁ , Zure Kombati ₁₂ , Grace Kariwiga ₁₃ , Delly Babona ₁₄ , Grace Tan ₂ , Kate T Simms ₁₅ , Alyssa M Cornall ₁₆ , Sepehr N Tabrizi ₁₆ , Handan Wand ₃ , Rebecca Guy ₃ , Karen Canfell ₁₇ , John M Kaldor ₃

Affiliation

Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; Kirby Institute for Infection and Immunity in Society, UNSW Sydney, Kensington, NSW, Australia.
VCS Foundation, Melbourne, VIC, Australia.
Kirby Institute for Infection and Immunity in Society, UNSW Sydney, Kensington, NSW, Australia.
Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; Department of Obstetrics and Gynaecology, Modilon General Hospital, Madang, Papua New Guinea.
School of Medicine and Health Sciences, University of Papua New Guinea, Port Moresby, Papua New Guinea.
Department of Obstetrics and Gynaecology, Mt Hagen Provincial Hospital, Mount Hagen, Papua New Guinea.
Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea; Department of Obstetrics and Gynaecology, Mt Hagen Provincial Hospital, Mount Hagen, Papua New Guinea.
Centre for Women's Infectious Diseases Research, Royal Women's Hospital, Melbourne, VIC, Australia; Infection and Immunity, Murdoch Children's Research Institute, Parkville, VIC, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, VIC, Australia.
VCS Foundation, Melbourne, VIC, Australia; School of Population and Global Health, University of Melbourne, VIC, Australia.
Jhpiego, Johns Hopkins University Affiliate, Baltimore, MD, USA; Macfarlane Burnet Institute for Medical Research and Public Health, Melbourne, VIC, Australia.
Papua New Guinea Institute of Medical Research, Goroka, Papua New Guinea.
Department of Pathology, Mt Hagen Provincial Hospital, Mount Hagen, Papua New Guinea.
Department of Obstetrics and Gynaecology, Alotau Provincial Hospital, Alotau, Papua New Guinea.
Department of Obstetrics and Gynaecology, St Mary's Vunapope Rural Hospital, Kokopo, Papua New Guinea.
Daffodil Centre, The University of Sydney-Cancer Council New South Wales, Sydney, NSW, Australia.
Centre for Women's Infectious Diseases Research, Royal Women's Hospital, Melbourne, VIC, Australia.
Prince of Wales Clinical School, UNSW Sydney, Kensington, NSW, Australia; Daffodil Centre, The University of Sydney-Cancer Council New South Wales, Sydney, NSW, Australia.

Background

WHO recommends human papillomavirus (HPV) testing and same-day treatment for cervical screening in low-income and middle-income countries (LMICs); however, few published data exist on the validity of the strategy. We aimed to evaluate the clinical performance, treatment completion rates, adverse events profile, and acceptability of a fully integrated strategy, comprising point-of-care HPV DNA testing of self-collected specimens and same-day thermal ablation, for screening of cervical cancer in women in Papua New Guinea.

Methods

HPV-STAT was a large-scale, prospective, single-arm intervention trial conducted at two clinical sites in Papua New Guinea. Cervical screening clinics with an on-site consultant gynaecologist were selected in consultation with national and provincial health authorities, church health services, and local stakeholders. Eligible participants were women aged 30–59 years attending cervical screening services at the two clinics, who were willing to comply with study procedures and able to provide written informed consent. Women self-collected vaginal specimens for point-of-care GeneXpert testing (Cepheid, Sunnyvale, CA, USA) for oncogenic HPV types. Women testing positive for HPV underwent pelvic examination followed by same-day thermal ablation or referral for gynaecology review. All HPV-positive women and a 15% random sample of HPV-negative women provided a clinician-collected cervical specimen for liquid-based cytology. The primary outcome was clinical performance (ie, sensitivity, specificity, positive predictive value [PPV], and negative predictive value [NPV]) of the strategy for the detection of high-grade squamous intraepithelial lesion (HSIL) or worse. This trial is registered with ISRCTN, ISRCTN13476702.

Findings

Between June 5, 2018, and Jan 6, 2020, we recruited 4285 women, 3638 (84·9%) of whom tested negative for HPV and 647 (15·1%) tested positive for one or more oncogenic HPV type. Sensitivity of the algorithm to detect HSIL or worse was 85·4% (95% CI 81·0–89·6), with specificity 89·6% (88·6–90·6), PPV 35·2% (31·6–39·0), and NPV 98·9% (98·6–99·2). Among HPV-positive women, 602 (93·0%) received same-day thermal ablation and 42 (6·5%) were referred for gynaecology review, 37 (88·1%) of whom attended. Acceptability was high among both HPV-positive and HPV-negative women. Among the 329 HPV-positive women who attended a 3-month follow-up visit, 51 (15·5%) reported mild adverse symptoms that resolved in all cases by the follow-up visit. There were no serious adverse events.

Interpretation

We conducted the first real-world evaluation of a fully integrated point-of-care HPV self-collect, test, and treat strategy for same-day cervical screening in a LMIC and found it to be effective, acceptable, and safe when implemented at scale in primary health-care facilities in Papua New Guinea. Our findings support the introduction and scale-up of HPV screening and treatment for the control and elimination of cervical cancer in LMICs, as recommended by WHO.

Funding

Australian National Health and Medical Research Council.

中文翻译：

巴布亚新几内亚妇女宫颈癌前病变早期检测和治疗的自我收集样本的床旁 HPV DNA 检测和当天热消融：一项前瞻性、单臂干预试验 (HPV-STAT)

背景

世卫组织建议在低收入和中等收入国家 (LMIC) 进行人乳头瘤病毒 (HPV) 检测和宫颈筛查当日治疗；然而，关于该策略的有效性的已发表数据很少。我们旨在评估临床表现、治疗完成率、不良事件概况和完全整合策略的可接受性，包括自我收集标本的即时 HPV DNA 检测和当天热消融，用于筛查宫颈癌在巴布亚新几内亚的妇女中。

方法

HPV-STAT 是在巴布亚新几内亚的两个临床地点进行的大规模、前瞻性、单臂干预试验。在与国家和省级卫生当局、教会卫生服务机构和当地利益相关者协商后，选择了配备现场咨询妇科医生的宫颈筛查诊所。符合条件的参与者是在两家诊所接受宫颈筛查服务的 30-59 岁女性，她们愿意遵守研究程序并能够提供书面知情同意书。女性自行收集阴道样本用于即时检测 GeneXpert（Cepheid，Sunnyvale，CA，USA），用于检测致癌 HPV 类型。对 HPV 检测呈阳性的女性进行了盆腔检查，然后在同一天进行热消融或转诊进行妇科检查。所有 HPV 阳性女性和 15% 的 HPV 阴性女性随机样本提供了临床医生收集的宫颈标本进行液基细胞学检查。主要结果是检测高级别鳞状上皮内病变 (HSIL) 或更差的策略的临床表现（即敏感性、特异性、阳性预测值 [PPV] 和阴性预测值 [NPV]）。该试验已在 ISRCTN 注册，ISRCTN13476702。

发现

在 2018 年 6 月 5 日至 2020 年 1 月 6 日期间，我们招募了 4285 名女性，其中 3638 名 (84·9%) 的 HPV 检测为阴性，647 名 (15·1%) 的一种或多种致癌 HPV 类型检测为阳性。该算法检测 HSIL 或更差的灵敏度为 85·4% (95% CI 81·0–89·6)，特异性为 89·6% (88·6–90·6)，PPV 35·2% (31 ·6–39·0)，NPV 98·9% (98·6–99·2)。在 HPV 阳性女性中，602 人（93·0%）接受了当天的热消融治疗，42 人（6·5%）被转诊至妇科复查，其中 37 人（88·1%）就诊。HPV 阳性和 HPV 阴性女性的可接受性都很高。在参加 3 个月随访的 329 名 HPV 阳性女性中，51 名 (15·5%) 报告了轻微的不良症状，这些症状在所有病例中均在随访中得到缓解。没有严重的不良事件。