Overview

Comprehensive HIV Prevention Package for MSM in Port Elizabeth

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
Treatments:
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Tenofovir
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