Clinical trial NCT01808352: HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)
Official title: Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence Among Black Men Who Have Sex With Men (BMSM) in Three U.S. Cities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV
Keywords: AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonisation
IND Investigational New Drug Application
IRB Institutional Review Board
IU International units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event
µg microgram
ULN upper limit of the normal range
WB Western Blot
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2013-03-11
Enrollment: 226
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-uninfected BMSM at risk for HIV infection in three U.S. cities. Enrollment will include those aged 18 and over with efforts at each site to attempt to recruit an equal number of BMSM under age 25 and 25 and over.

Brief summary: Black men who have sex with men (MSM) Pre-Exposure Prophylaxis (PrEP) Study with Client Centered Care Coordination (C4) Component.

Detailed description: An open label demonstration study with PrEP and Client Centered Care Coordination (C4) to assess the initiation, acceptability, safety, and feasibility of PrEP for Black MSM (BMSM) in three US Cities. A subset of participants will also be recruited to participate in qualitative interviews about facilitators and barriers regarding PrEP. The study will recruit HIV-uninfected BMSM at risk for HIV infection in three US Cities. Enrollment will include those aged 18 and over with an effort to recruit an equal number of BMSM under age 25 and over age 25 with a total of 225 participants (75 per site).

Eligibility criteria: Inclusion Criteria:

BMSM who meet all of the following criteria are eligible for inclusion in this study:

* 18 years of age or older
* No prior HIV diagnosis (self-report)
* Male at birth
* High risk for acquiring HIV infection including any one of the following in the previous 6 months:

  * Unprotected sex during receptive or insertive anal intercourse with a male partner
  * Any protected or unprotected:

    i. Receptive or insertive anal intercourse with more than three male sex partners ii. Exchange of money, gifts, shelter or drugs for receptive or insertive anal sex with a male partner iii. Receptive or insertive anal sex while under the influence of drugs or alcohol (i.e., high or drunk within two hours of the sex act) according to self-report"
  * STI diagnosis (i.e., syphilis, gonorrhea and chlamydia) by self-report
* Willing to provide locator information in accordance with the Study Specific Procedures (SSP) Manual
* Urine dipstick negative or trace for protein and glucose
* Hemoglobin \> 11 g/dL, absolute neutrophil count \> 750 cells/mm3, and platelet count ≥ 100,000/mm3
* Serum creatinine \< upper limit of normal (ULN) and calculated creatinine clearance of at least 60 mL/min by the Cockcroft-Gault formula where:

  o eCcr in mL/min = \[(140 - age in years) x (actual body weight in kg)\] / (72 x serum creatinine in mg/dL) Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) \< 3 times the upper limit of normal (ULN)
* Total bilirubin \< 2.5 ULN
* Hepatitis B surface antigen (HBsAg) negative

Exclusion Criteria:

BMSM who meet any of the following criteria will be excluded from this study:

* Any reactive or positive HIV test at Screening, even if subsequent testing indicates that the person is HIV-uninfected
* Transgender
* Active or chronic hepatitis B infection (as evidenced by HBsAg, HbsAb, and HbcAb testing)
* Planning to move out of the area or to travel for more than 3 months during the study follow-up period
* Unwilling to adhere to study procedures
* Current participation in any research study via self-report (however, strictly non-HIV centered observational studies are not exclusionary)
* Previous participation in an HIV vaccine study is exclusionary unless documented evidence of enrollment into a placebo arm
* Use of ARV drugs (PrEP or PEP) in the last 60 days
* Prior history of a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption (provided by self-report, or obtained from medical history or records)
* Receipt of prohibited medications: interleukin therapy, medications with significant nephrotoxic potential (including but not limited to amphotericin B, aminoglycosides, cidofovir, foscarnet and systemic chemotherapy), and medications that may inhibit or compete for elimination via active renal tubular secretion (including but not limited to probenecid) - (provided by self-report, or obtained from medical history or medical records)
* Any condition, that in the opinion of study staff, would make participation in the study unsafe, or interfere with achieving the study objective

Primary outcomes:
measure: Initiation of PrEP
timeFrame: 30 months
measure: Adherence to PrEP
timeFrame: 30 months
Secondary outcomes:
measure: Adverse events
timeFrame: 30 months
measure: STIs
timeFrame: 30 months
measure: Changes in sexual risk-taking behavior
timeFrame: 30 months
measure: Initiate or decline PrEP
timeFrame: 30 months
measure: Incident HIV-seroconversions/characteristics
timeFrame: 30 months
measure: Participant perception of care and referral plan
timeFrame: 30 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Vine Street Clinic
state: California
city: Washington
country: United States
facility: George Washington University CRS
state: District of Columbia
city: Chapel Hill
country: United States
facility: UNC CRS
state: North Carolina
Study officials:
affiliation: UCLA Vice Street Clinic
name: Steven Shoptaw, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Washington University CRS
name: Manya Magnus, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC CRS
name: Lisa Hightow-Weidman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hightow-Weidman LB, Magnus M, Beauchamp G, Hurt CB, Shoptaw S, Emel L, Piwowar-Manning E, Mayer KH, Nelson LE, Wilton L, Watkins P, Whitfield D, Fields SD, Wheeler D. Incidence and Correlates of Sexually Transmitted Infections Among Black Men Who Have Sex With Men Participating in the HIV Prevention Trials Network 073 Preexposure Prophylaxis Study. Clin Infect Dis. 2019 Oct 15;69(9):1597-1604. doi: 10.1093/cid/ciy1141.