Secondary Cervical Cancer Prevention of Vulnerable Women with HPV and HIV Co-infection in India

印度 HPV 和 HIV 合并感染的弱势女性的二级宫颈癌预防

• 批准号: 10761950
• 负责人: CATHERINE L CARPENTER
• 金额: $ 61.03万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10761950
• 关键词: Appointment; CD4 Lymphocyte Count; CD4 Positive T Lymphocytes; Cancer Prevention Trial; Caring; Cell Count; Cells; Cervical; Cervical Cancer Screening; Cervical Intraepithelial Neoplasia; Cervix Uteri; Chronic; Clinical; Collaborations; Communities; Community Health Aides; Coupled; Data; Development; Diagnosis; Dietary Intervention; Education; Emotional; Focus Groups; Food Supplements; Fortified Food; Goals; HIV; HIV/AIDS; HPV-High Risk; Health; Health Promotion; High Risk Woman; Human Papillomavirus; Human papilloma virus infection; Immune; Immune response; Immunologics; Impairment; Incidence; India; Intervention; Iron; Lesion; Link; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Malnutrition; Measures; Mediating; Mental Depression; Mental Health; Modeling; Nurses; Nutritional; Nutritional Support; Odds Ratio; Outcome; Participant; Play; Policy Developments; Proliferating; Proteins; Psychosocial Assessment and Care; Randomized; Recovery; Research; Risk; Risk Factors; Risk Reduction; Role; Rural; Secondary Prevention; Serum Albumin; Services; Social support; Testing; Thinness; Training; Viral; Viral Load result; Vitamin A; Vitamin D; Woman; Women' s Health; acceptability and feasibility; antiretroviral therapy; care seeking; cervical cancer prevention; co-infection; depressive symptoms; design; dietary supplements; efficacy evaluation; follow-up; food insecurity; future implementation; high risk; immune activation; implementation science; implementation trial; improved; indexing; internalized stigma; intervention effect; nutrition; nutrition education; premalignant; prevent; preventable death; primary outcome; programs; psychologic; psychosocial; randomized, clinical trials; scale up; screening; secondary outcome; skills; social stigma; standard of care; success; treatment adherence; treatment as usual; treatment center; tumorigenesis; two-arm study

ABSTRACT In India, cervical cancer (CC) remains one of the most common malignancies among women, with about 100,000 women diagnosed annually. HIV promotes the progression of precancerous lesions. Among women living with HIV/AIDS, a lack of Human Papilloma Virus (HPV) screening, coupled with high levels of depressive symptoms and stigma, along with malnutrition, negatively impact the activation and proliferation of immune cells, further promoting development of precancerous lesions in the cervix. Programs for women living with HIV (WLH) that include HPV screening and psychosocial and nutritional support are almost non-existent, and the gap is critical in hopes of reducing high CC incidence rates. In our recently completed R01 study of 600 WLH in rural India, we assessed the impact of our “ASHA-Nutrition” intervention, co-delivered by our community health workers (ASHA), and led by nurses, in providing emotional support, skill-building, nutrition education, and/or protein-enriched food supplements. Our findings revealed that the nurse-led ASHA support plus protein supplements and nutritional education showed a significant association with improved CD4+ T cell counts and increased lean mass at 18 months as well as improved depression, social support and stigma. CC screening of 598 of these WLH revealed 13% had abnormal cervical lesions and 4 (1%) had squamous CC. Further, our preliminary data suggest that nutritional supplements may be associated with a 40% reduction in the risk of abnormal cervical lesions. Our stellar team plans to build upon our prior successful model to refine our newly developed nurse-led, ASHA co-delivered, nutrition-enhanced, ASHA-Health HPV intervention, adapted to the needs of a high-risk sub-population of women co-infected with HPV and HIV (W-Co-V), and randomized by village clusters among women treated in antiretroviral treatment (ART) centers in underserved Karnataka, India. With a major focus on secondary prevention of CC, we hope to mitigate the link between high-risk human papillomavirus (HR-HPV) persistence (measured as 2 positive tests for the same HR-HPV type, separated by 12 -18 months), risk of CC, as well as improved health of W-Co-V. We will conduct a parallel-group cluster randomized clinical trial, assessing the efficacy of our refined comprehensive, ASHA-Health HPV intervention, as it relates to CC prevention, ongoing engagement in the HIV treatment cascade, and managing nutritional health among 420 high-risk co-infected women, as compared with an enhanced Standard of Care (SOC+). Our Primary outcome is HR-HPV persistence. Secondary outcomes will be the improvement in: 1) HIV indices (HIV viral load and CD4+ T cells); 2) Nutritional indices (serum albumin levels, Vitamin A, Vitamin D, and Iron); 3) Mental health (depression and HPV/HIV internalized stigma); and 4) Engagement in care (HPV/HIV appointment keeping and ART adherence); all measures will be assessed at baseline, and at 6-, 12-, and 18- month follow-ups. The ASHA-Health HPV Intervention builds on a highly successful multifaceted US-Indo collaboration of over 10 years, has a high potential for scale-up in India, and engages HPV co-infected WLH in reducing the risk of CC as well as improving their health. The success of this intervention can lead to policy development and future implementation science trials in the prevention of CC among co-infected Indian women.

抽象的 在印度，宫颈癌（CC）仍然是女性中最常见的恶性肿瘤之一，约有100,000人 妇女每年被诊断出。艾滋病毒促进癌前病变的进展。与生活在一起的妇女 艾滋病毒/艾滋病，缺乏人类乳头瘤病毒（HPV）筛查，再加上高水平的抑郁症状和 污名以及营养不良，对免疫细胞的激活和增殖产生负面影响，进一步促进 子宫颈中癌性病变的发展。包括HPV在内的艾滋病毒（WLH）的妇女计划 筛查，社会心理和营养支持几乎不存在，差距对于减少的希望至关重要 高CC事件率。在我们最近在印度农村对600 WLH的R01研究中，我们评估了我们的影响 由我们的社区卫生工作者（ASHA）共同交付的“ Asha-Nutrition”干预措施，由护士领导，提供 情绪支持，技能建设，营养教育和/或富含蛋白质的食物补充剂。我们的发现揭示了 由护士领导的ASHA支持以及蛋白质补充剂和营养教育表明了重要的关联 随着CD4+ T细胞计数的改善，在18个月时增加瘦肉质量以及抑郁症，社交 支持和污名。其中598个WLH的CC筛查显示，有13％的宫颈病变异常，4（1％）患有 鳞状CC。此外，我们的初步数据表明营养补品可能与40％有关 降低宫颈病变异常的风险。我们出色的团队计划以我们先前的成功模型来建立完善 我们新开发的护士领导的ASHA共同交付，营养增强的Asha-Health HPV干预，适应于 与HPV和HIV（W-CO-V）共同感染的妇女的高风险亚人口的需求，并由村 在印度卡纳塔克邦欠佳的抗逆转录病毒治疗（ART）中心接受治疗的妇女中。与专业 专注于CC的二级预防，我们希望减轻高风险人乳头瘤病毒（HR-HPV）之间的联系 持久性（以相同的HR -HPV类型为2个阳性测试，分别为12 -18个月），CC的风险也 随着W-CO-V的健康状况提高。我们将进行平行组集群随机临床试验，评估 我们精致的全面，ASHA健康HPV干预与CC预防有关 HIV治疗级联以及420名高危女性的营养健康 增强的护理标准（SOC+）。我们的主要结果是HR-HPV持久性。次要结果将是 改进：1）HIV指数（HIV病毒载荷和CD4+ T细胞）； 2）营养指数（血清白蛋白水平，维生素A， 维生素D和铁）； 3）心理健康（抑郁症和HPV/HIV内部污名）； 4）参与护理 （HPV/HIV任命保存和艺术依从性）；所有措施将在基线以及6，12-和18-的评估中进行评估。 一个月随访。 ASHA-HEALTH HPV干预措施建立在非常成功的多方面的US-INDO合作基础上 超过10年的印度有很高的扩展潜力，并参与HPV共同感染的WLH降低了CC的风险 以及改善他们的健康。这种干预的成功可以导致政策制定和未来 在共同感染的印度妇女中预防CC的实施科学试验。