Human Immunodeficiency Virus Clinical Trial
Official title:
Cervical Cancer Screening Among HIV-infected Women in Western Kenya: Evaluation of the Safety, Acceptability, and Efficacy of an Alternative Ablation Method for Treatment of Precancerous Lesions
Verified date | December 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety, acceptability, and efficacy of Thermocoagulation for treatment of precancerous lesions among HIV-positive women in a screen-and-treat program in Western Kenya.
Status | Completed |
Enrollment | 379 |
Est. completion date | November 30, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Age 25-65 years. 2. Enrolled in HIV care at FACES-supported clinics in Kisumu County. 3. Able to understand a written informed consent document, and willing to sign it. 4. Speaks a language that the consent form and data collection instruments are written in. Exclusion Criteria: 1. Has a history of cervical cancer. 2. Has received any treatment for cervical precancer after screening positive for precancer. 3. Has evidence of cervical infection. 4. Pregnant women are excluded from this study. |
Country | Name | City | State |
---|---|---|---|
Kenya | Kenya Medical Research Institute | Kisumu |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Fogarty International Center of the National Institute of Health, National Institutes of Health (NIH) |
Kenya,
Mungo C, Osongo CO, Ambaka J, Randa MA, Omoto J, Cohen CR, Huchko M. Safety and Acceptability of Thermal Ablation for Treatment of Human Papillomavirus Among Women Living With HIV in Western Kenya. JCO Glob Oncol. 2020 Jul;6:1024-1033. doi: 10.1200/GO.20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months | The proportion of participants with no evidence of cervical dysplasia at 12-months follow-up, defined as biopsy-con?rmed CIN1 result or normal ?ndings, 12-months following treatment. | 12 months | |
Primary | Proportion of Participants With Persistent HPV at 12-month Follow-up | The proportion of persistence of HPV at follow-up will be reported defined as treatment failure with persistent biopsy-confirmed CIN2/3. | 12 months | |
Secondary | Frequency of Pain Score Category | A 4-point Visual Analog Scale (VAS) for pain assessment was used to evaluate pain immediately after treatment. The pain VAS was comprised of verbal descriptors, one for each symptom extreme. The pain VAS is self-completed by the respondent. The respondent is asked to select the point that represents their pain intensity. The "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). | Day of Treatment, approximately 1 day | |
Secondary | Percentage of Participants Reporting Treatment-related Adverse Events (AE) | The percentage of participants reporting grade 2 and higher AEs, and severe adverse events (SAEs) during the 4-week follow-up will be reported by event. | Up to 6 weeks following treatment | |
Secondary | Frequency of Positive Participant Satisfaction Responses | Participant satisfaction with thermocoagulation will be evaluated by determining the proportion of participants indicating a response of 'yes' to the question "Do you feel satisfied with the treatment you received?" with an alternative response of 'no' at the 4-6 week follow-up visit. | Up to 6 weeks following treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03516318 -
Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria
|
N/A | |
Completed |
NCT04653194 -
Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'
|
Phase 3 | |
Completed |
NCT01792570 -
DRV/r + RPV QD: Efficacy and Toxicity Reduction
|
Phase 3 | |
Active, not recruiting |
NCT04826562 -
Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)
|
Phase 4 | |
Completed |
NCT02919306 -
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
|
Phase 1/Phase 2 | |
Completed |
NCT02812329 -
Intervention to Encourage HIV Testing and Counseling Among Adolescents
|
Phase 1 | |
Completed |
NCT02516930 -
A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China
|
N/A | |
Completed |
NCT02651376 -
Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients
|
Phase 1/Phase 2 | |
Recruiting |
NCT02392884 -
HIV Medication Adherence in Underserved Populations
|
N/A | |
Completed |
NCT01944371 -
Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT01778374 -
Mater-Bronx Rapid HIV Testing Project.
|
N/A | |
Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
Completed |
NCT01076179 -
Kaletra in Combination With Antiretroviral Agents
|
N/A | |
Completed |
NCT01490346 -
Tissue Drug Levels of HIV Medications
|
N/A | |
Completed |
NCT01460433 -
Problems With Immune Recovery in the Gut Tissue
|
N/A | |
Completed |
NCT00317460 -
Buprenorphine and Integrated HIV Care
|
Phase 4 | |
Terminated |
NCT04240210 -
Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)
|
Phase 4 | |
Active, not recruiting |
NCT04704336 -
Integration of Hypertension Management Into HIV Care in Nigeria
|
N/A | |
Completed |
NCT03254277 -
3BNC117-LS First-in-Human Phase 1 Study
|
Phase 1 | |
Terminated |
NCT01692236 -
Brain Imaging for HIV-Associated Thinking and Mood Disorders
|