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Completed

NCT Number: NCT03604939

Improving Access to Control of Diseases for Women

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.

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Key information

Conditions

Cardio-vascular Disease Breast Cancer Breast Diseases Breast Neoplasms Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Oral Cancer Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Stroke Cancer Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GBH Cancer Memorial Hospital

Udaipur, Rajasthan, 313001, India

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Evaluation of social, cultural and behavioral factors

Diagnostic Test

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

Evaluation of the feasibility and acceptability of delivery of early detections services

Diagnostic Test

Evaluation of the feasibility and acceptability of delivery of the NCD early detections services by the trained community health workers at home settings

Primary outcomes

  1. Outcomes of the questionnaire survey 1/5

    Time frame: 1 year

    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

  2. Outcomes of the questionnaire survey 2/5

    Time frame: 1 year

    proportion of the participants who know about the common NCDs including cancers and their early symptoms

  3. Outcomes of the questionnaire survey 3/5

    Time frame: 1 year

    proportion of the participants with a diagnosis of hypertension who adhere to the treatment advised

  4. Outcomes of the questionnaire survey 4/5

    Time frame: 1 year

    proportion of the participants with a diagnosis of diabetes who adhere to the treatment advised

  5. Outcomes of the questionnaire survey 5/5

    Time frame: 1 year

    proportion of the participants with a diagnosis of cancer who adhere to the treatment advised

  6. NCD Screening study 1/11

    Time frame: 1 year

    screen positivity - proportion of the screened participants detected to have high blood pressure

  7. NCD Screening study 2/11

    Time frame: 1 year

    screen positivity - proportion of the screened participants detected to have high BMI

  8. NCD Screening study 3/11

    Time frame: 1 year

    screen positivity - proportion of the screened participants detected to have abnormal HPV detection test

  9. NCD Screening study 4/11

    Time frame: 1 year

    screen positivity - proportion of the screened participants detected to have abnormal oral examination test

  10. NCD Screening study 5/11

    Time frame: 1 year

    screen positivity - proportion of the screened participants detected to have abnormal visual examination test

  11. NCD Screening study 6/11

    Time frame: 1 year

    compliance to further assessment - proportion of screen positive participants undergoing further assessment at the primary health center or at the hospital

  12. NCD Screening study 7/11

    Time frame: 1 year

    positive predictive values of further assessment - proportion of participants with confirmed diagnosis of hypertension among those assessed for high BP

  13. NCD Screening study 8/11

    Time frame: 1 year

    positive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar

  14. NCD Screening study 9/11

    Time frame: 1 year

    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

  15. NCD Screening study 10/11

    Time frame: 1 year

    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

  16. NCD Screening study 11/11

    Time frame: 1 year

    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

Secondary outcomes

  1. effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis

    Time frame: 1 year

    effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

  • GBH Cancer Memorial Hospital Udaipur, India

Registry information

Acronym: IMPACD

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 30, 2018
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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