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| ID | Type | Description | Link |
|---|---|---|---|
| R00HD086232 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Makerere University | OTHER |
| Mama, LLC | UNKNOWN |
| Mulago Hospital, Uganda |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-component reintegration intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-component reintegration intervention | Behavioral | The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Planned Intervention Sessions That Were Delivered | Number of planned intervention session over the total number of planned interention sessions | 6 weeks |
| 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. | Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants. | 6 weeks |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison El Ayadi, ScD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mulago Specialized Women's and Children's Hospital | Kampala | Uganda |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Planned Intervention Sessions That Were Delivered | Number of planned intervention session over the total number of planned interention sessions | Posted | Median | Inter-Quartile Range | percentage of planned sessions | 6 weeks |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Multi-component reintegration intervention: The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison El Ayadi, Associate Professor | University of California San Francisco | 415-476-5877 | alison.elayadi@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 15, 2021 | Mar 24, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
The intervention incorporates 15 health education sessions, 6 psychosocial counseling sessions, 15 physiotherapy sessions, and an economic investment.
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Number of participants reporting to be "satisfied" or "very satisfied" about their experience participating in the health education component of the intervention on a five-point Likert scale at six weeks over the total number of participants. |
| 6 weeks |
| 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. | 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. | 6 weeks |
| 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. | 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. | 6 weeks |
| 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 | 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 | 6 weeks |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | 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. | Number of participants reporting to be "satisfied" or "very satisfied" about their overall experience participating in the intervention on a five-point Likert scale at six weeks over the total number of participants. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | scores on a scale | Baseline and 6 months |
|
|
|
| Secondary | 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 | Number of participants reporting to be "satisfied" or "very satisfied" about their experience participating in the health education component of the intervention on a five-point Likert scale at six weeks over the total number of participants. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | 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 | 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 | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |