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

Completed · Not applicable

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT02043015

Run by

Emory University

People needed

100

Starts

2015-02-01

Expected to finish

2017-03-01

Last updated by the study team

2018-09-17

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rollins School of Public Health — Atlanta, Georgia, United States
• Johns Hopkins School of Public Health — Baltimore, Maryland, United States
• Desmond Tutu HIV Foundation — Cape Town, South Africa

Full record on ClinicalTrials.gov

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