在乌干达，艾滋病毒感染的妇女接受宫颈癌筛查服务的利用率仅为46.7%，仅有9%的妇女坚持每年进行宫颈癌筛查。一些研究已经评估了社区或家庭基于人乳头瘤病毒（HPV）自采阴道拭子的可行性，但尚未研究过基于诊所的HPV自采阴道拭子。因此，我们建议进行一项研究，以确定乌干达农村艾滋病毒诊所接受治疗的艾滋病毒感染妇女中，基于诊所与基于家庭的HPV DNA自取样的疗效。我们相信，一项随机、单盲试验可以实现这一目标，因此我们选择它来指导研究。该研究将纳入来自农村HIV诊所的382名参与者，按1:1的比例随机分配到基于诊所和基于家庭的HPV自行取样中，以适当地确定两组之间HPV自行取样的接受率之间的差异。乌干达H3 Africa综合生物库实验室将用作HPV DNA提取、分型和测序的参考实验室。在基线，将使用修改的泊松回归模型来衡量与HPV的患病率和两组基线上的接受率相关的因素。对于随机选取的75名自行采集HPV样本的妇女，将进行乙酸检视下的视觉检查（VIA），作为宫颈癌筛查的金标准，以评估宫颈上皮内瘤变的分级情况，在0个月和6个月时进行。接受疗程为自行采集的HPV样本的妇女。使用意向治疗分析可以确定接受率的差异。通过将每个变量在两组之间的差异总结为标准化平均差异（即均值差异除以汇总标准差），来确定各个变量在两组之间的差异。预测参与者在两组中进行HPV自采样的持续时间的因素，将使用修正风险比模型和Cox比例风险回归进行分析。在双变量级别上，将计算每个独立变量与时间之间的关联性，以及持续进行HPV自取样的时间。在结果展示上，将使用粗疫情比和其95%的置信区间，并将p值<0.05视为双变量级别的显著性。使用马尔科夫模型进行递增成本-效果分析（CEA），来确定基于诊所的HPV自采样的成本。我们相信，对疾病分层筛查方法的研究可以为目前诊断宫颈癌的方法的优点和局限性提供了解，以及这些方法如何最终在乌干达的HIV诊所和其他发展中国家得到实施的方式。预计该研究结果将指导HPV自采样方法的逐步指南的制定。

In Uganda, the uptake of cervical cancer (CC) screening services is low, at 46.7%, among HIV-infected women, and only 9% of these women adhere to annual CC screening. Some studies have evaluated the possibility of community or home-based human papillomavirus (HPV) self-collected vaginal swabs, but not clinic-based HPV self-collected vaginal swabs. Therefore, we propose a study to determine the efficacy of clinic-based versus home-based HPV DNA self-sampling among HIV-infected women attending a rural HIV clinic in Uganda. We believe that a randomized, single-blinded trial would achieve this objective, and so we have chosen it to guide the study. Including a total of 382 participants from a rural HIV clinic, randomized into a ratio of 1:1 for clinic- and home-based HPV self-sampling, would allow us to appropriately ascertain the difference in the uptake of HPV self-sampling between the two arms. The Integrated Biorepository of H3 Africa Uganda Laboratory would be used as a reference laboratory for the HPV DNA extraction, typing, and sequencing. At baseline, modified Poisson regression models would be used to measure factors associated with the prevalence of HPV and uptake in both arms at baseline. Visual inspection under acetic acid (VIA), as a gold-standard test for CC to grade for CIN, would be performed at 0 and 6 months among a random sample of 75 women with a self-collected HPV sample. The difference in uptake could be determined using the intention-to-treat analysis. The difference in the groups by each variable would be summarized as the standardized mean difference (i.e., the mean difference divided by the pooled standard deviation). The predictors of the time for which participants would continue with HPV self-sampling in both arms, recovery, and Cox proportional hazards regression would be used. At the bivariate level, the associations between each independent variable and time, with the time of continuing HPV self-sampling, would be computed. Crude hazard ratios and their 95% confidence interval would be used in the presentation of the results, with p-values < 0.05 considered significant at the bivariate level. Incremental cost-effectiveness analysis (CEA) using a Markov model would be used to determine the cost of clinic-based HPV self-sampling. We believe that screening approaches to disease stratification could provide an insight into the merits and limitations of current approaches to the diagnosis of cervical cancer, and how these could eventually be implemented into HIV clinics in Uganda and other developing African countries. It is anticipated that the findings would guide the development of step-by-step guidelines for the HPV self-sampling approach.