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:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT02449733
Eligibility Criteria:
Inclusion Criteria:
* Male sex at birth
* Anal sex with another man in the past 12 months
* 18 years of age or older
* Resident of the study city, Port Elizabeth
* Able to complete study instruments, with or without assistance, in English, Xhosa or Afrikaans
* Willing to provide contact information
* Has a phone
Exclusion Criteria:
* Not male sex at birth
* No self-reported anal sex with a man in the past 12 months
* Less than 18 years of age
* Not a resident of the study city
* Plans to move from the study city within the year after enrollment
* Not able to complete study instructions, with or without assistance, in English, Xhosa or Afrikaans
* Not willing to provide contact information
* Does not have a phone
Additional Inclusion and Exclusion Criteria for participants on PrEP:
PrEP Inclusion Criteria:
* Identified as high-risk for HIV by the provider by meeting one or more of the criteria below:
* Have multiple partners
* Engage in transactional sex, including sex workers
* Use or abuse drugs
* Drink alcohol heavily
* Had more than 1 episode of a STI in the last year
* Is the HIV-negative partner in a discordant relationship, especially if the HIV-positive partner is not on antiretroviral therapy (ART)
* Is in a non-monogamous concordant relationship with a HIV-negative partner
* Is unable or unwilling to achieve consistent use of male condoms
* No contra-indications to Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)
* Calculated creatinine clearance of at least 60 mL/min
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2 x upper limit of normal (ULN)
* Hepatitis B surface antigen (HBsAg) negative
* Motivated to follow PrEP prescribing guidelines
* Willing to adhere to daily oral dosing
* Willing to attend PrEP maintenance visits every 3 months
PrEP Exclusion Criteria:
* HIV positive
* Signs or symptoms suggestive of acute HIV infection
* Have baseline creatinine clearance \<60 ml/min
* Are unwilling to follow PrEP prescribing guidelines
* Are unwilling to attend PrEP maintenance visits every 3 months
* Are known to have hypertensives or diabetes
* Are hepatitis B susceptible (test HBsAg and HBsAb negative) and refuse to take a hepatitis B vaccine series
* Any contraindication to taking FTC/TDF
* Proteinuria 2+ or greater at screening
* Glucosuria 2+ or greater at screening
* Use of antiretroviral (ARV) therapy (e.g., for PEP or PrEP) in the 90 days prior to study entry
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02449733
Study Brief:
Protocol Section:
NCT02449733