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.

摘要 在印度，宫颈癌（CC）仍然是女性最常见的恶性肿瘤之一，约有10万人 每年诊断的女性HIV促进癌前病变的进展。在女性中， 艾滋病毒/艾滋病，缺乏人乳头瘤病毒（HPV）筛查，加上高水平的抑郁症状， 污名，沿着营养不良，对免疫细胞的激活和增殖产生负面影响，进一步促进 宫颈癌前病变的发展。针对女性艾滋病毒感染者（WLH）的计划，包括HPV 筛查以及心理和营养支持几乎不存在，差距至关重要，希望减少 高CC发病率。在我们最近完成的对印度农村600名WLH的R 01研究中，我们评估了 “ASHA-营养”干预，由我们的社区卫生工作者（阿莎）共同提供，并由护士领导， 情感支持、技能培养、营养教育和/或富含蛋白质的食物补充剂。我们的发现表明 护士主导的阿莎支持加上蛋白质补充剂和营养教育显示出显着的关联 在18个月时，CD 4 + T细胞计数和瘦体重增加，以及抑郁、社交 支持和耻辱。其中598例WLH的CC筛查显示13%有异常宫颈病变，4例（1%） 鳞状CC。此外，我们的初步数据表明，营养补充剂可能与40%的 降低异常宫颈病变的风险。我们的明星团队计划在我们之前成功的模型的基础上， 我们新开发的护士主导，阿莎共同提供，营养增强，ASHA健康HPV干预，适应于 同时感染HPV和HIV（W-Co-V）的高危妇女亚群的需求，并按村庄随机分组 在印度服务水平低下的卡纳塔克邦，在抗逆转录病毒治疗（ART）中心接受治疗的妇女中，专业 重点关注CC的二级预防，我们希望减轻高危型人乳头瘤病毒（HR-HPV） 持续性（测量为相同HR-HPV类型的2次阳性检测，间隔12 - 18个月），CC的风险，以及 我们将进行一项平行分组的随机临床试验，评估 我们完善的全面的ASHA健康HPV干预措施，因为它涉及CC预防， 艾滋病毒治疗级联，并管理420名高风险合并感染妇女的营养健康， 加强护理标准（SOC+）。我们的主要结果是HR-HPV持续性。次要结局将是 改善：1）HIV指数（HIV病毒载量和CD 4 + 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/艾滋病毒内化的耻辱）;以及4）参与护理 (HPV/HIV预约保持和ART依从性）;将在基线以及6、12和18岁时评估所有指标， 月随访。ASHA-健康HPV干预建立在非常成功的多方面美国-印度合作的基础上 超过10年，在印度具有很大的扩大潜力，并使HPV共感染的WLH参与降低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的制定和未来 实施科学试验，在共同感染的印度妇女中预防CC。