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HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)

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ClinicalTrials.gov Identifier: NCT01808352
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : January 21, 2016
Sponsor:
Information provided by (Responsible Party):
HIV Prevention Trials Network

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

Condition or disease Intervention/treatment Phase
HIV Drug: FTC/TDF Phase 4

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence Among Black Men Who Have Sex With Men (BMSM) in Three U.S. Cities
Study Start Date : August 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Daily PrEP + coordination of client centered svs
All participants will be offered once daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) combined with C4.
 Drug: FTC/TDF
All participants will be offered once daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) combined with C4.


Outcome Measures
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Primary Outcome Measures :
  1. Initiation of PrEP [ Time Frame: 30 months ]
    Documented in either study CRFs or ACASI

  2. Adherence to PrEP [ Time Frame: 30 months ]
    Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 30 months ]
    Graded via DAIDS Toxicity Grading System determined by review of reported adverse events (clinical and laboratory)

  2. STIs [ Time Frame: 30 months ]
    Rectal and urine GC/CT, and NAAT for syphilis and chlamydia

  3. Changes in sexual risk-taking behavior [ Time Frame: 30 months ]
    Measured by ACASI assessments

  4. Initiate or decline PrEP [ Time Frame: 30 months ]
    Refusal rates will be measured by ACASI assessments

  5. Incident HIV-seroconversions/characteristics [ Time Frame: 30 months ]
    HIV RNA and genotyping will be performed at the NL on samples confirmed to be HIV infected

  6. Participant perception of care and referral plan [ Time Frame: 30 months ]
    Assessed via interviewer-administered questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808352


Locations
United States, California
UCLA Vine Street Clinic
Los Angeles, California, United States, 90095
United States, District of Columbia
George Washington University CRS
Washington, District of Columbia, United States, 20007
United States, North Carolina
UNC CRS
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
HIV Prevention Trials Network
Investigators
Principal Investigator: Steven Shoptaw, PhD UCLA Vice Street Clinic
Principal Investigator: Manya Magnus, PhD, MPH George Washington University CRS
Principal Investigator: Lisa Hightow-Weidman UNC CRS
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: HIV Prevention Trials Network
ClinicalTrials.gov Identifier: NCT01808352     History of Changes
Other Study ID Numbers: HPTN 073
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: March 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by HIV Prevention Trials Network:
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

Additional relevant MeSH terms:
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents