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

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the acceptability and uptake of a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in South Africa.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University

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

• 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