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Clinical Trials/NCT02739178
NCT02739178
Terminated
Not Applicable

The Sukhshanti Study: a Controlled Before-and-after Mixed Methods Study of the Effect of a Sanitation Intervention on Women's Health in Bihar, India

University of Oklahoma1 site in 1 country1,275 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Psychological
Sponsor
University of Oklahoma
Enrollment
1275
Locations
1
Primary Endpoint
Sanitation-Related Psychosocial Stress Scale (SRPS)
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

The study will measure the impact of sanitation access on women and girl's social and emotional health, behaviors, and quality of life in rural India before and after a sanitation intervention compared to a comparison group that will receive the same intervention at a later date.

Detailed Description

This mixed-methods, quasi-experimental study will evaluate the extent to which the Global Sanitation Fund (GSF) sanitation program in Bihar, India improves health and well-being among women and girls. Our study consists of a controlled before-and-after (CBA) study with an embedded ethnography. Specific objectives are: * Measure the effect of the GSF intervention on sanitation-related psychosocial stress (SRPS), generalized psychosocial stress (PSS), perceived quality of life, hair cortisol, and urogenital health among women between the ages of 14 and 65. * Measure changes in sanitation adoption (e.g.: sanitation access and exclusive use) among individuals / households receiving the GSF intervention. * Document individual and community experiences with sanitation, intervention participation, and latrine coverage through ethnographic methods.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
May 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • between 14 years to 65 years old
  • live in geographic area receiving GSF sanitation intervention in 2016
  • live in geographic areas matched to intervention communities

Exclusion Criteria

  • less than 25 years old and not reached menarche
  • greater than 25 years old and never married
  • refusal to participate

Outcomes

Primary Outcomes

Sanitation-Related Psychosocial Stress Scale (SRPS)

Time Frame: 12 month follow-up

The SRPS consist of 25 yes/no questions on experiences related to sanitation within the past thirty days of the date the SRPS is completed.This SRPS Scale specifically includes questions related to defecation, menstrual hygiene management, and post-defecation cleaning - the three behaviors that have the greatest contribution to sanitation-related psychosocial stress among women in India.

Secondary Outcomes

  • Kessler Psychological Distress Scale (K10)(12 month follow-up)
  • The WHO5 Well-Being Index (WHO-5)(12 month follow-up)
  • Self-reported urogenital infections(12 month follow-up)
  • Perceived Stress Scale (PSS10)(12 month follow-up)
  • Hair cortisol(12 month follow-up)
  • Sleep duration(12 month follow-up)

Study Sites (1)

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