Improving Access to Control of Diseases for Women

Study Overview
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Brief Summary
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The aim of this study is to evaluate the feasibility and acceptability of the model of delivering CHW-driven home-based comprehensive NCD control services aimed to prevent premature deaths from cardio-vascular diseases, stroke and breast, cervix and oral cancers in the hard-to-reach women.

Detailed Description
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Specific objectives of this study are the evaluation of: The social, cultural and behavioral factors that impact the uptake of the NCD control services among rural women using the Rapid Assessment, Response and Evaluation (RARE) approach; The feasibility and acceptability of the strategy to deliver the following NCD control services to the rural women at their homes by the trained CHWs: Counselling of the tobacco habitués to give up the practice Early detection of hypertension and diabetes to ensure prompt and regular treatment Creating breast awareness and ensuring access to prompt diagnosis and treatment of the women with symptoms suggestive of breast cancer Screening for cervical cancer by self-collected HPV test and ensuring prompt treatment of screen detected precancers and cancers Screening of the habitual tobacco/alcohol users for oral cancer by OVE and ensuring prompt treatment of screen detected precancers and cancers

Official Title
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Improving Access to Control of Diseases for Women

Conditions
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Cardio-vascular Disease, Stroke Cancer, Breast Cancer, Oral Cancer, Cervical Cancer

Intervention / Treatment
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* Diagnostic Test: Evaluation of social, cultural and behavioral factors
* Diagnostic Test: Evaluation of the feasibility and acceptability of delivery of early detections services


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 30 to 60 years residing in the villages of the Gogunda block in the district of Udaipur in Rajasthan, India, will be eligible to participate. Exclusion Criteria: Women suffering from debilitating illnesses, pregnant women and women refusing to participate will be excluded.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: 35,000 households in 228 villages, among which women between 30 to 60 years residing in the villages of the block are eligible to participate
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Evaluation of social, cultural and behavioral factors|Evaluation of the social, cultural and behavioral factors that impact the uptake of the NCD prevention and control services among women, using the RARE methodology|
|Diagnostic Test: Evaluation of the feasibility and acceptability of delivery of early detections services|Evaluation of the feasibility and acceptability of delivery of the NCD early detections services by the trained community health workers at home settings|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcomes of the questionnaire survey 1/5 | proportion of the participants who know about the adverse effect of smoking, chewing tobacco and consuming alcohol on health in general and NCDs in particular | 1 year | 
| Outcomes of the questionnaire survey 2/5 | proportion of the participants who know about the common NCDs including cancers and their early symptoms | 1 year | 
| Outcomes of the questionnaire survey 3/5 | proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised | 1 year | 
| Outcomes of the questionnaire survey 4/5 | proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised | 1 year | 
| Outcomes of the questionnaire survey 5/5 | proportion of the participants with a diagnosis of cancer who adhere to the treatment advised | 1 year | 
| NCD Screening study 1/11 | screen positivity - proportion of the screened participants detected to have high blood pressure | 1 year | 
| NCD Screening study 2/11 | screen positivity - proportion of the screened participants detected to have high BMI | 1 year | 
| NCD Screening study 3/11 | screen positivity - proportion of the screened participants detected to have abnormal HPV detection test | 1 year | 
| NCD Screening study 4/11 | screen positivity - proportion of the screened participants detected to have abnormal oral examination test | 1 year | 
| NCD Screening study 5/11 | screen positivity - proportion of the screened participants detected to have abnormal visual examination test | 1 year | 
| NCD Screening study 6/11 | compliance to further assessment - proportion of screen positive participants undergoing further assessment at the primary health center or at the hospital | 1 year | 
| NCD Screening study 7/11 | positive predictive values of further assessment - proportion of participants with confirmed diagnosis of hypertension among those assessed for high BP | 1 year | 
| NCD Screening study 8/11 | positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar | 1 year | 
| NCD Screening study 9/11 | positive predictive values of further assessment - proportion of participants with confirmed cervical neoplasias on colposcopy and/or biopsy among those assessed for positive HPV test | 1 year | 
| NCD Screening study 10/11 | positive predictive values of further assessment - proportion of participants with confirmed oral premalignant and malignant lesions on examination and/or biopsy among those assessed for positive oral examination | 1 year | 
| NCD Screening study 11/11 | positive predictive values of further assessment - proportion of participants with confirmed visual premalignant and malignant lesions on examination and/or biopsy among those assessed for positive visual examination | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis | effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardio-vascular disease, stroke cancer, breast cancer, oral cancer, cervical cancer