Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT02474303
Eligibility Criteria:
Inclusion Criteria:
* • Completion of the written informed consent process prior to undergoing any screening evaluations
* ≥ 18 years and older
* Active sex work (Paid sex within the past six months)
* In general good health, confirmed by medical history and physical examination
* Has laboratory evidence of absence of HIV infection, defined as a negative 4th generation HIV ELISA test prior to enrollment
* Serum creatinine less than or equal to the upper limit of normal (ULN) and calculated creatinine clearance of at least 70 mL/minute by Cockcroft-Gault formula
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5 times ULN
* Hemoglobin greater than 8.5 g/dL
* Does not report intention to relocate out of the study area during the course of the study
* If able to become pregnant, self-reported use of an effective method of contraception at enrollment, and intending to use an effective method during the follow-up period
* Without signs or symptoms of acute HIV infection (acute retroviral syndrome)
Exclusion Criteria:
* • HIV-1 and HIV-2 screening tests are reactive
* Is enrolled in any other clinical product trial
* Serious and active medical condition
* Proteinuria 2+ or greater at screening
* Glucosuria 2+ or greater at screening
* Use of disallowed medications (\*See note below)
* Presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent
* Intoxicated or under the influence of alcohol or other drugs at the time of screening
* Pregnant females and females who are breast-feeding
* Any other reason or condition that in the opinion of the investigator would interfere with participation, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02474303
Study Brief:
Protocol Section:
NCT02474303