Clinical trial NCT02739178: 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
Overall status: TERMINATED
Phase: NA
Conditions: Stress, Psychological
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 1275
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Sanitation-Related Psychosocial Stress Scale (SRPS)
timeFrame: 12 month follow-up
Secondary outcomes:
measure: Perceived Stress Scale (PSS10)
timeFrame: 12 month follow-up
measure: Kessler Psychological Distress Scale (K10)
timeFrame: 12 month follow-up
measure: The WHO5 Well-Being Index (WHO-5)
timeFrame: 12 month follow-up
measure: Self-reported urogenital infections
timeFrame: 12 month follow-up
measure: Hair cortisol
timeFrame: 12 month follow-up
measure: Sleep duration
timeFrame: 12 month follow-up
Other outcomes:
Locations:
city: Mumbai
country: India
facility: NEERMAN
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Oliver Cumming, Mr.
role: STUDY_DIRECTOR
affiliation: Texas A&M University
name: Kathleen O'Reilly, PhD
role: STUDY_DIRECTOR
affiliation: Society for the Promotion of Participatory Ecosystem Management (SOPPECOM)
name: Seema Kulkarni
role: STUDY_DIRECTOR
affiliation: University of Oklahoma
name: Robert Dreibelbis, PhD
role: PRINCIPAL_INVESTIGATOR
References: