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Fistula Reintegration Pilot

NCT04748653 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-22

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Multi-component reintegration intervention

The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Makerere University

    collaborator OTHER

  • Mama, LLC

    collaborator UNKNOWN

  • Mulago Hospital, Uganda

    collaborator OTHER

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Alison El Ayadi, ScD, MPH · University of California, San Francisco

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-09-14
Completion
2022-09-14

Countries

  • Uganda

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04748653 on ClinicalTrials.gov