West Africa Self-Sampling HPV Based Cervical Cancer Control Program (WA-SS-HCCP) for WLWHA: Barriers, challenges, and needs

项目概要/摘要 在全球范围内，每年70%的新艾滋病毒感染发生在撒哈拉以南非洲（SSA），那里有74%的人 艾滋病毒/艾滋病感染者，其中50%以上是妇女。此外，宫颈癌的发病率最高， 癌症（CC）发病率和相关死亡也发生在SSA，其中约60%的CC病例发生在SSA。 感染艾滋病毒/艾滋病的妇女（WLWHA）。人乳头瘤病毒（HPV），CC的主要原因，是最 在SSA中常见的性传播感染和几乎所有世界范围内发展CC的WLWHA都是共同的， 感染了HPV。通过接种HPV疫苗和进行宫颈筛查以早期发现， 治疗在高收入国家，这些战略已导致CC急剧下降;然而， 低收入和中等收入国家的妇女基本上仍然无法获得这些服务。基于自采样的HPV （SS-HPV）检测已被证明是一种具有成本效益和可行的方法，以确定妇女感染 高危HPV病毒株（hr-HPV），需要更先进的诊断测试和治疗。但是，SS- HPV检测尚未在大多数中低收入国家广泛实施，包括撒哈拉以南非洲，尽管艾滋病毒流行率很高。 利用我们在马里长达十年、广泛且成功的培训合作伙伴关系和研究合作 和尼日利亚，我们建议实施一种新的西非自我采样HPV为基础的宫颈癌 控制程序（WA-SS-HCCP）。该项目利用现有的优势和资源，包括 与社区卫生工作者建立关系的艾滋病毒护理系统， WLWHA可提供HPV和CC教育/咨询和SS标本采集指导，快速 将样本运送到医院实验室，将个性化的检测结果直接交付给妇女， 并为感染hr-HPV的妇女转诊到诊所接受进一步诊断和治疗提供便利。这项研究将 对障碍、挑战和需求进行深入评估，以适应、实施和 评估WA-SS-HCCP的有效性和成功性。具体目标是：（1）评估障碍， 需要在马里和尼日利亚的WLWHA中根据具体情况调整WA-SS-HCCP，使用定性风险 评估和观察方法;（2）使用学习协作方法（例如， 每月的网络研讨会，快速周期的小型变革测试）和实施框架（例如，培训 CHW的能力、跨设置的数据协调、实施仪表板），以优化WA-SS- 所有四个地点的HCCP;以及（3）对有效性进行双重评估（例如，% WLWHA完全 筛选和%变化）和实施（例如，覆盖范围、采用率、实施保真度，以及 （维护或可持续性），并制定一个“WA-SS-HCCP扩展工具包”，以广泛传播 “检测到治疗”方案，可扩大到艾滋病毒感染妇女和整个低收入国家。

PROJECT SUMMARY/ABSTRACT Worldwide, 70% of new HIV infections every year occur in Sub-Saharan Africa (SSA), home to 74% of people living with HIV/AIDS (PLWHA), of whom over 50% are women. Furthermore, the highest rates of cervical cancer (CC) incidence and related death also occur in SSA, where approximately 60% of all CC cases are in women living with HIV/AIDS (WLWHA). Human Papillomavirus (HPV), amajor cause of CC, is the most common sexually transmitted infection in SSA and nearly all WLWHA worldwide who develop CC are co- infected with HPV. CC is largely preventable by HPV vaccination and cervical screening for early detection and treatment. In high income countries (HICs), these strategies have led to a steep decline in CC; however they remain largely inaccessible to women in low- and middle-income countries (LMICs). Self-sampling-based HPV (SS-HPV) tests have been shown to be a cost-effective and feasible approach to identifying women infected with high-risk HPV strains (hr-HPV) who need more advanced diagnostic tests and treatment. However, SS- HPV testing has not been widely implemented in most LMICs, including SSA despite high HIV prevalence. Leveraging our decade-long, extensive, and successful training partnership and research collaborations in Mali and Nigeria, we propose to implement a novel West African Self-Sampling HPV-Based Cervical Cancer Control Program (WA-SS-HCCP). The project capitalizes on existing strengths and resources including the HIV systems of care with Community Health Workers (CHWs) who have established relationships with WLWHA and can provide HPV and CC education/counseling and SS specimen collection guidance, rapid transportation of specimens to hospital laboratories, personalized delivery of test results directly to the women, and facilitation of clinic referrals for women with hr-HPV for advanced diagnostics and treatment. The study will conduct in-depth assessment of barriers, challenges, and needs to contextually adapt, implement, and evaluate the effectiveness and success of WA-SS-HCCP. The specific aims are to (1) Assess barriers and needs for contextual adaptations of WA-SS-HCCP among WLWHA in Mali and Nigeria, using qualitative risk assessment and observation methods; (2) Contextually adapt, using a learning collaborative approach (e.g., monthly webinars, rapid-cycle small tests of change) and an implementation framework (e.g., training to competency of CHWs, data coordination across settings, implementation dashboard) to optimize the WA-SS- HCCP across all four sites; and (3) Conduct a dual evaluation of the effectiveness (e.g., % WLWHA fully screened and % change in) and implementation (e.g., reach, adoption, implementation fidelity, and maintenance or sustainability) and develop a “WA-SS-HCCP Scale-Up Toolkit” for wide dissemination of this “detect-to-treat” program that can be expanded to HIV- women and across LMICs.