N/A
Completed N=379
Thermocoagulation for Treatment of Precancerous Cervical Lesions
Human Immunodeficiency Virus Infection · HPV infection · CIN 2/3
Source: ClinicalTrials.gov NCT04191967 ↗
Enrolled (actual)
379
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months — 0.66 proportion of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With no Evidence of Cervical Dysplasia at 12-months |
0.66 | — |
| PRIMARY Proportion of Participants With Persistent HPV at 12-month Follow-up |
0.34 | — |
| SECONDARY Frequency of Pain Score Category |
15; 231; 42; 5 | — |
| SECONDARY Percentage of Participants Reporting Treatment-related Adverse Events (AE) |
4; 51.2; 19.6; 0 | — |
| SECONDARY Frequency of Positive Participant Satisfaction Responses |
292 | — |
Eligibility Criteria
Inclusion Criteria
- Age 25-65 years.
- Enrolled in HIV care at FACES-supported clinics in Kisumu County.
- Able to understand a written informed consent document, and willing to sign it.
- Speaks a language that the consent form and data collection instruments are written in.
Exclusion Criteria
- Has a history of cervical cancer.
- Has received any treatment for cervical precancer after screening positive for precancer.
- Has evidence of cervical infection.
- Pregnant women are excluded from this study.
Data sourced from ClinicalTrials.gov (NCT04191967). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.