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

Stress, Psychological Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02739178
• Other study ID #: 6580 Norman
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2018

Study information

• Verified date: April 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1275
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

Other:
• 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.

Locations

Country	Name	City	State
India	NEERMAN	Mumbai

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month follow-up
Secondary	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.	12 month follow-up
Secondary	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.	12 month follow-up
Secondary	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.	12 month follow-up
Secondary	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.	12 month follow-up
Secondary	Hair cortisol	Hair cortisol will be assessed in a sub-sample of women in both intervention and comparison communities.	12 month follow-up
Secondary	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?	12 month follow-up