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Improving Access to Control of Diseases for Women

Improving Access to Control of Diseases for Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03604939
Acronym
IMPACD
Enrollment
1200
Registered
2018-07-30
Start date
2017-01-01
Completion date
2019-07-01
Last updated
2021-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

cardio-vascular disease, stroke cancer, breast cancer, oral cancer, cervical cancer

Brief summary

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

Specific objectives of this study are the evaluation of: 1. 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; 2. 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

Interventions

DIAGNOSTIC_TESTEvaluation 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_TESTEvaluation 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

Sponsors

GBH Cancer Memorial Hospital Udaipur, India
CollaboratorUNKNOWN
International Agency for Research on Cancer
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
NCD Screening study 11/111 yearpositive 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
Outcomes of the questionnaire survey 1/51 yearproportion of the participants who know about the adverse effect of smoking, chewing tobacco and consuming alcohol on health in general and NCDs in particular
Outcomes of the questionnaire survey 2/51 yearproportion of the participants who know about the common NCDs including cancers and their early symptoms
Outcomes of the questionnaire survey 3/51 yearproportion of the participants with a diagnosis of hypertension who adhere to the treatment advised
Outcomes of the questionnaire survey 4/51 yearproportion of the participants with a diagnosis of diabetes who adhere to the treatment advised
Outcomes of the questionnaire survey 5/51 yearproportion of the participants with a diagnosis of cancer who adhere to the treatment advised
NCD Screening study 1/111 yearscreen positivity - proportion of the screened participants detected to have high blood pressure
NCD Screening study 2/111 yearscreen positivity - proportion of the screened participants detected to have high BMI
NCD Screening study 3/111 yearscreen positivity - proportion of the screened participants detected to have abnormal HPV detection test
NCD Screening study 4/111 yearscreen positivity - proportion of the screened participants detected to have abnormal oral examination test
NCD Screening study 5/111 yearscreen positivity - proportion of the screened participants detected to have abnormal visual examination test
NCD Screening study 6/111 yearcompliance to further assessment - proportion of screen positive participants undergoing further assessment at the primary health center or at the hospital
NCD Screening study 7/111 yearpositive predictive values of further assessment - proportion of participants with confirmed diagnosis of hypertension among those assessed for high BP
NCD Screening study 8/111 yearpositive predictive values of further assessment - proportion of participants with confirmed diabetes among those assessed for high sugar
NCD Screening study 9/111 yearpositive predictive values of further assessment - proportion of participants with confirmed cervical neoplasias on colposcopy and/or biopsy among those assessed for positive HPV test
NCD Screening study 10/111 yearpositive 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

Secondary

MeasureTime frameDescription
effect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis1 yeareffect of different participant characteristics on the final diagnosis of hypertension and diabetes using multivariate analysis

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026