Fistula Reintegration Pilot

December 14, 2022 updated by: University of California, San Francisco

Comprehensive Reintegration Assistance for Women With Obstetric Fistula

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Uganda
      • Kampala, Uganda
        • Recruiting
        • Mulago Specialized Women's and Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No further criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multi-component reintegration intervention
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
The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of planned intervention sessions that were delivered
Time Frame: 6 weeks
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.
Time Frame: 6 weeks
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
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Mulago Hospital, Uganda
Mama, LLC

Investigators

  • Principal Investigator: Alison El Ayadi, ScD, MPH, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

February 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Estimate)

December 15, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P0527552
  • R00HD086232 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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