Clinical trial NCT02449733: Comprehensive HIV Prevention Package for MSM in Port Elizabeth
Official title: Comprehensive HIV Prevention Package for MSM in Port Elizabeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: voluntary counseling and testing (VCT)
couples voluntary counseling and testing (CVCT)
pre-exposure prophylaxis (PrEP)
homosexuality
male
South Africa
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-05-20
Enrollment: 101
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Retention in the cohort
timeFrame: 12 months
measure: Use of PrEP
timeFrame: 6 months
measure: Incident HIV infection
timeFrame: 12 months
Secondary outcomes:
measure: Condom use
timeFrame: 3 months
measure: Lubricant use
timeFrame: 3 months
measure: VCT and CVCT uptake
timeFrame: 12 months
measure: Serodiscordant unprotected anal intercourse (UAI)
timeFrame: 3 months
measure: Acceptability of PEP
timeFrame: 12 months
measure: MSM-specific provider training
timeFrame: 12 months
Other outcomes:
Locations:
city: Port Elizabeth
country: South Africa
facility: Human Sciences Research Council
Study officials:
affiliation: Rollins School of Public Health
name: Patrick S Sulivan, DVM, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rollins School of Public Health
name: A.D. McNaghten, PhD, MHSA
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Stefan Baral, MD, MPH, CCFP
role: PRINCIPAL_INVESTIGATOR
affiliation: Human Sciences Research Council
name: Nancy Phaswanamafuya, PhD
role: PRINCIPAL_INVESTIGATOR
References: