The Sukhshanti Study: Effect of a Sanitation Intervention on Women's Health

NCT ID: NCT02739178

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Stress, Psychological

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GSF Sanitation intervention

This arm will receive the GSF sanitation intervention, a community-level sanitation intervention

Group Type EXPERIMENTAL

GSF Intervention

Intervention Type OTHER

Intervention utilizes community-based demand generation matched with supply side improvements to improve access and use of sanitation facilities in rural communities. This is complimented with multi-stakeholder engagement to promote cooperation and coordination with national, state, and local stakeholders.

Comparator

This arm will receive the GSF intervention in 2017 or later.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GSF Intervention

Intervention utilizes community-based demand generation matched with supply side improvements to improve access and use of sanitation facilities in rural communities. This is complimented with multi-stakeholder engagement to promote cooperation and coordination with national, state, and local stakeholders.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Cumming, Mr.

Role: STUDY_DIRECTOR

London School of Hygiene and Tropical Medicine

Kathleen O'Reilly, PhD

Role: STUDY_DIRECTOR

Texas A&M University

Seema Kulkarni

Role: STUDY_DIRECTOR

Society for the Promotion of Participatory Ecosystem Management (SOPPECOM)

Robert Dreibelbis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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NEERMAN

Mumbai, , India

Site Status

Countries

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India

Other Identifiers

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6580 Norman

Identifier Type: -

Identifier Source: org_study_id

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