Comprehensive HIV Prevention Package for MSM in Southern Africa: Pilot Study (Sibanye Health Project)

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
• 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