Improving Access to Control of Diseases for Women

NCT ID: NCT03604939

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-07-01

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

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

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

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GBH Cancer Memorial Hospital Udaipur, India

UNKNOWN

Sponsor Role: collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GBH Cancer Memorial Hospital

Udaipur, Rajasthan, India

Countries

India

References

Mahajan M, Naik N, Jain K, Patira N, Prasad S, Mogri S, Muwonge R, Lucas E, Faruq F, Sankaranarayanan R, Iyer S, Basu P. Study of Knowledge, Attitudes, and Practices Toward Risk Factors and Early Detection of Noncommunicable Diseases Among Rural Women in India. J Glob Oncol. 2019 Apr;5:1-10. doi: 10.1200/JGO.18.00181.

Reference Type: BACKGROUND

PMID: 30998427 (View on PubMed)

Basu P, Mahajan M, Patira N, Prasad S, Mogri S, Muwonge R, Lucas E, Sankaranarayanan R, Iyer S, Naik N, Jain K. A pilot study to evaluate home-based screening for the common non-communicable diseases by a dedicated cadre of community health workers in a rural setting in India. BMC Public Health. 2019 Jan 3;19(1):14. doi: 10.1186/s12889-018-6350-4.

Reference Type: BACKGROUND

PMID: 30606132 (View on PubMed)

Other Identifiers

DCA/SCR/2016/01

Identifier Type: -

Identifier Source: org_study_id