Clinical trial NCT02367807: PrEP With TDF/FTC to Prevent HIV-1 Acquisition in Young MSM and Transgender Women of Color
Official title: Pre-Exposure Prophylaxis With TDF/FTC to Prevent HIV-1 Acquisition in Young Men and Transgender Women of Color Who Have Sex With Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: HIV prevention
PrEP
young men who have sex with men
Truvada
Lead sponsor: Philadelphia Fight
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 biological males from urban Philadelphia who identify as men who have sex with men (MSM) ages 18-30 at risk of HIV acquisition

Brief summary: This is a 48-week prospective observational study that will allow testing of the hypothesis that a program in which pre-exposure prophylaxis (PrEP) is administered to young men of color who have sex with men (yMSMc) in a community youth drop-in center in conjunction with a multifaceted behavioral intervention as well as standard HIV prevention interventions can achieve at least 70% retention, as well as a medication adherence rate significantly better than that previously reported in the literature. The proposed program evaluation can provide critical information for the enhancement and scale-up of successful PrEP programs at FIGHT and elsewhere in an effort to make PrEP available to a growing number of persons at risk of acquiring human immunodeficiency virus (HIV).

Detailed description: PrEP for HIV prevention with once daily Truvada has been shown to be extremely safe and efficacious in multiple populations when taken consistently. Young men who have sex with men of color (yMSMc) comprise the group at the highest risk of new HIV infections and the only group whose HIV infection rates continue to increase. New data suggest interrupting transmission among MSM can reduce HIV acquisition among other risk groups as well. However, accessing, linking, and retaining yMSMc in a PrEP program is both critical to successful HIV prevention and historically difficult to achieve. Philadelphia FIGHT initiated a PrEP program at the youth site, Youth Health Empowerment Project (Y-HEP), for yMSMc approximately 1.5 years ago that also gives all participants access to general primary care. Y-HEP utilizes a unique biomedical/biobehavioral approach to enhance adherence and retention of yMSMc receiving PrEP.

The purpose of this protocol is to increase access to safe and effective PrEP to yMSMc in order to reduce incident HIV infections and health disparities in HIV incidence and prevalence through the use of a combined biomedical/behavioral intervention in a community-based setting servicing high-risk youth in Philadelphia. It is hypothesized this unique, combined biomedical/behavioral HIV prevention strategy will lead to high recruitment and retention rates in this community setting. All subjects will be offered primary care services as well as a package of HIV risk reduction interventions including once daily PrEP with tenofovir and emtricitabine (TDF/FTC), condoms, risk reduction counseling, HIV testing, and sexually transmitted infection (STI) screening and treatment. A weekly support group will aim to maximize medication adherence and retention by engaging subjects in prevention, risk-reduction and behavioral counseling, education about HIV, leadership training, and social networking.

Subjects will consist of 50 HIV-negative biological males between the ages of 18 and 30 who meet eligibility criteria as defined below.

All subjects will receive Truvada as PrEP on Monday evenings on an either weekly, biweekly, or monthly basis depending on an initial assessment of their need for adherence support, with provisions to obtain medication the following day(s) at Y-HEP if they are unable to attend the Monday night session. Study subjects will be considered to have picked up their medications if they come any time during the week designated as a medication pick-up week. In addition, all subjects will receive standard HIV prevention services including condom provision, risk reduction counseling, HIV testing, STI screening and treatment, as well as basic medical care and linkage to HIV care in the event of PrEP failure. Subjects will receive a behavioral intervention consisting of youth-focused men's wellness services centered around education about HIV, adherence counseling and knowledge of PrEP efficacy on risk behavior, general health services such as smoking cessation support and nutritional counseling, job and leadership training, and sexual health and well-being promotion.

Subjects will be screened for HIV, STIs, and renal function at baseline and every three months, and will also have a rapid test for HIV on a monthly basis (Table 1). Treatment will be provided for all STIs diagnosed during this study, and non-immune subjects will be offered vaccines against hepatitis A and B. Adherence will be assessed by the percentage of medication pick-up visits attended as well as urine tenofovir levels every 2-4 weeks and plasma tenofovir levels at weeks 24 and 48. Risk behaviors will be assessed by STI rates and the adapted Risk Assessment Battery at baseline, and weeks 24 and 48. A qualitative interview will be conducted at the end of the study to assess program acceptability.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 30 years at the time of signed informed consent
* Willing and able to independently provide written informed consent
* Biological male at birth
* Tests HIV negative at time of screening using rapid HIV antibody test (HIV viral load testing is also conducted immediately prior to initiation of PrEP, but is not an inclusion criteria as screening labs may be collected weeks prior to medication initiation and we would like to confirm a negative viral load as close to medication initiation as possible for subject's safety)
* Willing to provide locator information to study staff for a 48-week period
* Current participant in I Am Men's Health PrEP program or willing to become a participant

Exclusion Criteria:

* Evidence of acute or chronic hepatitis B infection at the time of screening
* Other clinically significant acute or chronic medical condition, including severe infections requiring treatment such as tuberculosis, as determined by the study investigator
* Evidence of renal dysfunction (Creatinine Clearance \< 50 ml/min) at the time of screening; Use Cockcroft-Gault equation: GFR = (140-Age in years) x (Weight in kg) / (72 x serum creatinine)
* History of bone fractures not explained by trauma
* Grade 3 laboratory abnormality on screening tests/assessments as defined by the DAIDS grading system
* Concurrent participation in an HIV vaccine study
* Known allergy/sensitivity to the study drug or its components
* Current use of any antiretroviral agent other than Truvada for any reason
* Experiencing decompensated cirrhosis (e.g., ascites, encephalopathy, etc.)
* Any other clinical condition or prior therapy that, in the opinion of the Principal Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements

Primary outcomes:
measure: Evaluate program retention
timeFrame: 48 weeks
measure: Evaluate adherence to PrEP
timeFrame: 48 weeks
Secondary outcomes:
measure: Assess behavioral change
timeFrame: 48 weeks
measure: Measure program acceptability and feasibility
timeFrame: 48 weeks
measure: Measure the success rate in linking to care participants who seroconvert to HIV positive status while receiving PrEP
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia FIGHT
state: Pennsylvania
Study officials:
affiliation: Philadelphia Fight
name: Helen C Koenig, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: