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

NCT02739178 | Terminated

• 1 other identifier: 6580 Norman
• Study Type: interventional
• Target: 1,275
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Perceived Stress Scale (PSS10)

  12 month follow-up

• 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

• Hair cortisol

  12 month follow-up

Study Arms (2)

GSF Sanitation intervention

EXPERIMENTAL

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

Other: GSF Intervention

Comparator

NO INTERVENTION

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

Interventions

GSF Intervention 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.

GSF Sanitation intervention

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

NEERMAN

Mumbai, 400 022, India

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Oliver Cumming, Mr.

  London School of Hygiene and Tropical Medicine

  STUDY DIRECTOR

• Kathleen O'Reilly, PhD

  Texas A&M University

  STUDY DIRECTOR

• Seema Kulkarni

  Society for the Promotion of Participatory Ecosystem Management (SOPPECOM)

  STUDY DIRECTOR

• Robert Dreibelbis, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: April 15, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)