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