Comprehensive HIV Prevention Package for MSM in Port Elizabeth
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Details and patient eligibility
About
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.
Full description
The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral and community-level HIV prevention interventions and services for men who have sex with men (MSM) in Africa. Experience implementing the prevention interventions and preliminary data collected regarding the acceptability of the HIV prevention package will be used to develop a proposal to design a larger efficacy trial to test the combination HIV prevention package for MSM.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
101 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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