The Sukhshanti Study: Effect of a Sanitation Intervention on Women's Health
Primary Purpose
Stress, Psychological
Status
Terminated
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
GSF Intervention
Sponsored by
About this trial
This is an interventional other trial for Stress, Psychological
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
Sites / Locations
- NEERMAN
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
GSF Sanitation intervention
Comparator
Arm Description
This arm will receive the GSF sanitation intervention, a community-level sanitation intervention
This arm will receive the GSF intervention in 2017 or later.
Outcomes
Primary Outcome Measures
Sanitation-Related Psychosocial Stress Scale (SRPS)
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 Outcome Measures
Perceived Stress Scale (PSS10)
A measure for non-specific perceived stress. The PSS10 is the short form of the PSS and consist of 10 items rated on a 5-point Likert scale (0 to 4). Scores are calculated by reverse scoring items with positive wording and summing across all items for a final score of 0 to 40. The PSS10 is not a diagnostic scale.
Kessler Psychological Distress Scale (K10)
The K10 provides a measure of non-specific psychological distress and consists of 10 items rated on a 5-point Likert scale (1 to 5). Scores are calculated by summing response across each item.
The WHO5 Well-Being Index (WHO-5)
The WHO5 consist of 5 items rated on a 6-point Likert scale (0 to 5) related to subjective well-being, vitality, and mood.
Self-reported urogenital infections
Urogenital infections, a health outcome linked to both menstrual hygiene management practices and sanitation access (Das et al., 2015) will be identified through self-report of any one of the following four symptoms: abnormal vaginal discharge (unusual texture / color and/or more abundant discharge than normal), burning or itching of the genitalia, burning or itching when urinating, or having genital sores.
Hair cortisol
Hair cortisol will be assessed in a sub-sample of women in both intervention and comparison communities.
Sleep duration
Sleep duration will be assessed through a variety of self-report methods. The investigators will adapt questions from the Pittsburgh Sleep Quality Index that assess sleep duration over the past month: 1. During this past month, how many hours of actual sleep did the participant usually get at night? (Herring et al., 2013). The investigators will also ask the following questions: 1. To the best of the participant's knowledge, what time did the participant go to bed last night? 2. To the best of the participant's knowledge, what time did the participant wake up this morning?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02739178
Brief Title
The Sukhshanti Study: Effect of a Sanitation Intervention on Women's Health
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Administratively inactivated by IRB due to no response for Continuing Review
Study Start Date
April 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1275 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSF Sanitation intervention
Arm Type
Experimental
Arm Description
This arm will receive the GSF sanitation intervention, a community-level sanitation intervention
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
This arm will receive the GSF intervention in 2017 or later.
Intervention Type
Other
Intervention Name(s)
GSF Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sanitation-Related Psychosocial Stress Scale (SRPS)
Description
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.
Time Frame
12 month follow-up
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS10)
Description
A measure for non-specific perceived stress. The PSS10 is the short form of the PSS and consist of 10 items rated on a 5-point Likert scale (0 to 4). Scores are calculated by reverse scoring items with positive wording and summing across all items for a final score of 0 to 40. The PSS10 is not a diagnostic scale.
Time Frame
12 month follow-up
Title
Kessler Psychological Distress Scale (K10)
Description
The K10 provides a measure of non-specific psychological distress and consists of 10 items rated on a 5-point Likert scale (1 to 5). Scores are calculated by summing response across each item.
Time Frame
12 month follow-up
Title
The WHO5 Well-Being Index (WHO-5)
Description
The WHO5 consist of 5 items rated on a 6-point Likert scale (0 to 5) related to subjective well-being, vitality, and mood.
Time Frame
12 month follow-up
Title
Self-reported urogenital infections
Description
Urogenital infections, a health outcome linked to both menstrual hygiene management practices and sanitation access (Das et al., 2015) will be identified through self-report of any one of the following four symptoms: abnormal vaginal discharge (unusual texture / color and/or more abundant discharge than normal), burning or itching of the genitalia, burning or itching when urinating, or having genital sores.
Time Frame
12 month follow-up
Title
Hair cortisol
Description
Hair cortisol will be assessed in a sub-sample of women in both intervention and comparison communities.
Time Frame
12 month follow-up
Title
Sleep duration
Description
Sleep duration will be assessed through a variety of self-report methods. The investigators will adapt questions from the Pittsburgh Sleep Quality Index that assess sleep duration over the past month: 1. During this past month, how many hours of actual sleep did the participant usually get at night? (Herring et al., 2013). The investigators will also ask the following questions: 1. To the best of the participant's knowledge, what time did the participant go to bed last night? 2. To the best of the participant's knowledge, what time did the participant wake up this morning?
Time Frame
12 month follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Cumming, Mr.
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kathleen O'Reilly, PhD
Organizational Affiliation
Texas A&M University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seema Kulkarni
Organizational Affiliation
Society for the Promotion of Participatory Ecosystem Management (SOPPECOM)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robert Dreibelbis, PhD
Organizational Affiliation
University of Oklahoma
Official's Role
Principal Investigator
Facility Information:
Facility Name
NEERMAN
City
Mumbai
ZIP/Postal Code
400 022
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available after completion of the study.
Learn more about this trial
The Sukhshanti Study: Effect of a Sanitation Intervention on Women's Health
We'll reach out to this number within 24 hrs