Clinical trial NCT04748653: Fistula Reintegration Pilot
Official title: Comprehensive Reintegration Assistance for Women With Obstetric Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Genital Fistula
Urinary Incontinence
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Makerere University
name: Mama, LLC
name: Mulago Hospital, Uganda
First posted: 2021-02-10
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study to test the feasibility and acceptability of a multi-component facility-based intervention designed to be provided adjunct to genital fistula surgery incorporating: health education, psychosocial counseling, physiotherapy, and economic investment. We will include a total of 30 women in the study, and follow them for 6-months using a mixed-methods strategy for feasibility and acceptability assessment.


Eligibility criteria: Inclusion Criteria:

* Undergoing surgery for female genital fistula
* Age 18 or above, or emancipated minor per Ugandan law

Exclusion Criteria:

* No further criteria

Primary outcomes:
measure: Percentage of Planned Intervention Sessions That Were Delivered
timeFrame: 6 weeks
measure: Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Overall Experience With the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Reintegration Score
timeFrame: Baseline and 6 months
measure: Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Health Education Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
timeFrame: 6 weeks
measure: Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience Participating in the Psychosocial Counseling Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Participants.
timeFrame: 6 weeks
measure: Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Physiotherapy Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants.
timeFrame: 6 weeks
measure: Number of Participants Reporting to be "Satisfied" or "Very Satisfied" About Their Experience With the Economic Empowerment Component of the Intervention on a Five-point Likert Scale at Six Weeks Over the Total Number of Intervention Participants
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago Specialized Women's and Children's Hospital
Study officials:
affiliation: University of California, San Francisco
name: Alison El Ayadi, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: