Secondary Cervical Cancer Prevention of Vulnerable Women with HPV and HIV Co-infection in India
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- National Institutes of Health, National Cancer Institute
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- HR-HPV persistence or 2 positive tests for the same HR-HPV type, separated by 12 to 18 months.
概览
简要总结
Using qualitative research methods, we plan to first refine a nurse-led, ASHA co-
delivered, nutrition-enhanced ASHA-Health HPV intervention, adapted for high-risk
group of women co-infected with HIV and HPV, and then conduct a parallel-group
cluster randomized control trial, assessing the efficacy of our ASHA-Health HPV
intervention, as compared with an enhanced Standard of Care (SOC+) (usual care +
3 sessions [wellness, basic nutrition and HPV/HIV health promotion]) among 420
high-risk co-infected women to prevent cervical cancer while remaining engaged in
the HIV treatment cascade, and managing nutritional health. Our Primary outcome is
HR-HPV persistence (2 positive tests for the same HR-HPV type separated by 6 or
12 months). Secondary outcomes will be improvement in: 1) HIV outcomes (HIV
viral load and CD4 count; 2) Nutritional indices (serum albumin, Vitamin A and
Vitamin D - for immune support; and Iron); 3) Mental health (depression, HIV
internalized stigma, and HPV/HIV stigma fears); and 4) Engagement in care
(HPV/HIV appointment keeping and ART adherence) at 6, 12, and 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 WLH, 25 to 50 years of age per HIV-based guidelines 2 receiving ART for over two months to ensure medication stabilization, validated by an ART card given to all ART patients 3 screened as HPV positive with self sample vaginal collection 4 assessed to have oncogenic HPV and 5 assessed to be VIA negative for cervical lesions, performed by our trained Auxiliary Nurse Midwife (ANM).
排除标准
- •1 pregnant or lactating women due to hormonal and dietary guideline differences 2 women below 25 years and 3 women determined to be VIA positive as they will be immediately referred to our Gynecology specialist.
结局指标
主要结局
HR-HPV persistence or 2 positive tests for the same HR-HPV type, separated by 12 to 18 months.
时间窗: 12, 18 months
次要结局
- 1 HIV outcomes HIV(viral load and CD4 count 2 Nutritional indices serum albumin, Vitamin A and)
研究者
Veena A Satyanarayana
National Institute of Mental Health and Neuro Sciences