Fistula Reintegration Pilot

Study Overview
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Brief Summary
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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.

Official Title
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Comprehensive Reintegration Assistance for Women With Obstetric Fistula

Conditions
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Female Genital Fistula, Urinary Incontinence

Intervention / Treatment
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* Behavioral: Multi-component reintegration intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing surgery for female genital fistula Age 18 or above, or emancipated minor per Ugandan law Exclusion Criteria: No further criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-component reintegration intervention<br>There is one arm for the feasibility and acceptability study - all intervention participants will receive the intervention: health education, psychosocial counseling, physiotherapy, and economic investment. | Behavioral: Multi-component reintegration intervention<br>* The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of planned intervention sessions that were delivered | Number of participants who received each planned intervention session over the total number of participants enrolled. | 6 weeks | 
| Proportion of participants indicating satisfied or very satisfied with the intervention. | Number of participants reporting to be satisfied or very satisfied about their overall experience with each intervention module on a five-point Likert scale at six weeks over the total number of participants completing each module. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in reintegration score | Mean change in reintegration score from pre-intervention (baseline) to post (6 months) on the post-fistula repair reintegration instrument (range 0-100, higher indicating better) | Baseline and 6 months | 
| Change in quality of life | Mean change in quality of life score from pre-intervention (baseline) to post (6 months) on the World Health Organization Quality of Life Abbreviated Form measure (range 0-100, higher indicating better) | Baseline and 6 months |