HIV Clinical Trial
Official title:
Assessment of Factors Surrounding Fistula Formation and Successful Repair at Bwaila Hospital, Lilongwe
The objective of this proposal is to create a database for obstetric fistula patients at Bwaila Hospital containing their demographics, obstetric history, fistula history, physical exam findings, intraoperative and postoperative results. Data collection will be prospective starting in 2011 upon institutional review board (IRB) approval to last a minimum of five years and will have a retrospective component tracing back to January 2010. Primary goals of data analysis will be to determine the risk factors for fistula formation, risk factors for poor surgical outcomes and long-term incontinence, social and economic impact of fistula repair, and the ability of various physical exam findings to predict likelihood of successful repair. It is expected that findings will lead to improved surgical management of obstetric fistulas both locally and internationally.
This is a prospective and retrospective chart review of a cohort of women aged 12 years and
above who present to Bwaila Hospital with obstetric fistulas. Variables from existing subject
records tracing back to January 2010 will be input into the REDCap database and analyzed.
Prospective data collection will begin alongside obstetric fistula repairs upon IRB approval
and will last for a minimum of 5 years.
A few variables were selected from the database for sample size determination:
1. HIV prevalence In order to assess a statistically significant difference in HIV
prevalence amongst fistula patients and the general population, with a projected
prevalence of 25% in fistula patients and 15% in the general population based on prior
studies, approximately 416 fistula patients would need to be enrolled in the study.
2. Risk factors for failure of repair-Goh classification Type 4 In order to assess a
statistically significant difference in failure of repair for fistula patients
classified based on the Goh classification as Type4 (approximately 30% failure rate
based on prior studies) and all other fistula patients (15% failure rate reported for
uncomplicated fistulas), approximately 200 patients would need to be enrolled in the
study.
It is estimated that about 200 fistula patients will be enrolled into the database every
year. The study is expected to last a minimum of 5 years, for a total enrollment of 1250
patients.
Current Procedures For more than a year, the Freedom to Fight Fistula Foundation (FFFF) has
sponsored a fistula repair program at Bwaila that has consisted of visiting fistula surgeons
coming for short periods of time to conduct repairs. Since September 2011, a full time
fistula surgeon has been on site at Bwaila hospital.
Referral to the FFFF at Bwaila occurs primarily via word-of-mouth, as currently demand highly
exceeds capacity. As of now, there is a waiting list of approximately 50 fistula patients.
Occasionally, the foundation makes visits to health centers to give educational presentations
on obstetric fistulas, and distributes flyers advertising its services in the local
community. Once the presence of a regular surgeon is established, and the waiting list is
diminished, the foundation anticipates increasing its advertising through newspaper and
radio, and by making regular visits to community events and district health centers.
Bwaila Hospital is a hospital located in Lilongwe designated for women. It provides basic,
regular obstetric and gynecologic services.
Data Collection and Bwaila Hospital
Retrospective Arm A chart review of existing subject records tracing back to January 2010
will be conducted, and input in the REDCap database to the extent that it is available and
complete.
Prospective Arm Nurses will obtain informed consent from all patients admitted to Bwaila
Hospital for obstetric fistula evaluation to participate in the research study.
They will then interview the patients with a clinical history form. The information collected
with the form will be relevant to the care of the patient, and is part of routine care for
obstetric fistula patients.
The form includes demographic data, sexual history, obstetric history, and medical history,
and a depression screening and diagnostic tool.
After the interview the patient will receive standard of care with their obstetrics doctor
for their fistulas (this is not part of the study): assessed for the presence of an obstetric
fistula; discuss possible repair; have repair; recuperate; discharged; return for follow-up
visits at one month and three months to assess how the patient is doing.
At these visits patient will have 5 minute study interviews discussing their ability to
control their urination, and also how well they are getting by in their community, both
financially and socially.
Additional data will be extracted directly from the patient chart as a secondary chart review
for the study, and will include a review of physical exam findings, preoperative findings,
intraoperative findings, postoperative results and follow-up findings at the one-month and
three-month review dates.
This data will be transferred from the patient charts to REDCap. All information collected
will be de-identified.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06162897 -
Case Management Dyad
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT02528773 -
Efficacy of ART to Interrupt HIV Transmission Networks
|
||
Active, not recruiting |
NCT05454839 -
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
|
||
Recruiting |
NCT05322629 -
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
|
N/A | |
Completed |
NCT02579135 -
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
|
N/A | |
Active, not recruiting |
NCT01790373 -
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
|
N/A | |
Not yet recruiting |
NCT06044792 -
The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
|
||
Completed |
NCT04039217 -
Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM
|
Phase 4 | |
Active, not recruiting |
NCT04519970 -
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
|
N/A | |
Completed |
NCT04124536 -
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
|
N/A | |
Recruiting |
NCT05599581 -
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT02758093 -
Speed of Processing Training in Adults With HIV
|
N/A | |
Completed |
NCT02500446 -
Dolutegravir Impact on Residual Replication
|
Phase 4 | |
Completed |
NCT03805451 -
Life Steps for PrEP for Youth
|
N/A | |
Active, not recruiting |
NCT03902431 -
Translating the ABCS Into HIV Care
|
N/A | |
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 |