This is a single arm study on the safety, feasibility, and acceptability of adjuvant, self-administered, intravaginal 5-Fluorouracil (5-FU) following treatment for high-grade cervical precancer (CIN2/3) among women living with human immunodeficiency virus (HIV).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Participants will self-administer 2 g of 5% 5-FU intravaginally using an applicator, one night per week (every other week), on weeks 1, 3, 5, 7, 9, 11, 13, 15, for a total of 8 applications.
Lumumba Sub-County Hospital KEMRI- Research Care Training Program (RCTP) Building
Kisumu, Kenya
Safety of intravaginal 5-FU
Safety will be evaluated as type, frequency, and severity of Adverse Events (AE)s. AEs will be evaluated according to the National Institute of Health (NIH) Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event Grading Tables. The DAIDS grading table provides an AE severity grading scale ranging from grades 1 to 5. Grade 1 indicates a mild event, Grade 2 indicates a moderate event, Grade 3 indicates a severe event, Grade 4 indicates a potentially life-threatening event and Grade 5 indicates death.
Time frame: Up to 5 months
Tolerability of intravaginal 5-FU
Tolerability will be evaluated by assessing the number of participants experiencing specified adverse events (SAEs), defined as a Grade 3 or 4 toxicity that is possibly, probably, or definitely related to the study agent.
Time frame: Up to 5 months
Adherence of intravaginal 5-FU
Adherence will be evaluated by assessing the number of participants who are confirmed to use 75% or more of the 5-FU applications.
Time frame: Up to 5 months
Acceptability of intravaginal 5-FU
Responses to an acceptability questionnaire will be summarized, including means and standard deviation for responses to questions graded on a Likert scale (from 0 to 4), and proportions and 95% confidence intervals for yes/no questions.
Time frame: Up to 20 weeks
Uptake of intravaginal 5-FU
The proportion of eligible screened participants who agree to participate in the trial and applied intravaginal 5-FU as the study defined.
Time frame: Up to 20 weeks
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