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 名女性患有宫颈癌。 每年诊断出艾滋病毒的女性都会促进癌症前期病变的进展。 艾滋病毒/艾滋病、缺乏人乳头瘤病毒 (HPV) 筛查、加上严重的抑郁症状和 耻辱以及营养不良会对免疫细胞的激活和增殖产生负面影响，进一步促进 针对感染艾滋病毒 (WLH) 的女性开展的宫颈癌前病变计划，其中包括 HPV。 筛查以及社会心理和营养支持几乎不存在，这一差距对于减少 在我们最近完成的针对印度农村 600 WLH 的 R01 研究中，我们评估了我们的影响。 “ASHA-营养”干预措施，由我们的社区卫生工作者 (ASHA) 共同实施，并由护士领导，旨在提供 我们的研究结果表明，情感支持、技能培养、营养教育和/或富含蛋白质的食品补充剂。 护士主导的 ASHA 支持加上蛋白质补充剂和营养教育显示出显着的关联 18 个月时 CD4+ T 细胞计数有所改善，瘦体重有所增加，抑郁症、社交能力也有所改善 对其中 598 名 WLH 进行的支持和耻辱筛查显示，13% 患有异常宫颈病变，4 名 (1%) 患有宫颈病变。 此外，我们的初步数据表明，营养补充剂可能与 40% 相关。 降低异常宫颈病变的风险我们的一流团队计划在我们之前的成功模型的基础上进行改进。 我们新开发的由护士主导、ASHA 共同实施、营养强化的 ASHA-Health HPV 干预措施，适应了 合并感染 HPV 和 HIV (W-Co-V) 的女性高风险亚群的需求，并按村庄随机分组 印度卡纳塔克邦服务水平低下的抗逆转录病毒治疗 (ART) 中心接受治疗的女性群体。 重点关注CC的二级预防，我们希望减轻高危人乳头瘤病毒（HR-HPV）之间的联系 持续性（以相同 HR-HPV 类型的 2 次阳性检测来衡量，间隔 12 -18 个月）、CC 风险以及 随着 W-Co-V 健康状况的改善，我们将进行一项平行组群随机临床试验，评估其疗效。 我们完善的综合 ASHA-Health HPV 干预措施，因为它与 CC 预防相关，持续参与 与 420 名高危合并感染女性相比，艾滋病毒治疗级联和营养健康管理 增强护理标准 (SOC+) 我们的主要结果是 HR-HPV 持续性。 改善：1) HIV 指数（HIV 病毒载量和 CD4+ T 细胞）；2) 营养指数（血清白蛋白水平、维生素 A、 3) 心理健康（抑郁症和 HPV/HIV 内在耻辱）；以及 4) 参与护理 （HPV/HIV 预约和 ART 依从性）；所有措施将在基线、6 岁、12 岁和 18 岁时进行评估 ASHA-Health HPV 干预措施建立在美国与印度高度成功的多方面合作之上。 超过 10 年，在印度具有很大的推广潜力，并利用 HPV 合并感染的 WLH 来降低 CC 风险 以及改善他们的健康状况，这种干预措施的成功可以促进政策的制定和未来。 在印度女性合并感染者中实施预防 CC 的科学试验。