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

Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence Among Black Men Who Have Sex With Men (BMSM) in Three U.S. Cities

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

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Drug: FTC/TDF

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 Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Vine Street Clinic
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • George Washington University CRS
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • UNC CRS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initiation of PrEP	Documented in either study CRFs or ACASI	30 months
Adherence to PrEP	Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Graded via DAIDS Toxicity Grading System determined by review of reported adverse events (clinical and laboratory)	30 months
STIs	Rectal and urine GC/CT, and NAAT for syphilis and chlamydia	30 months
Changes in sexual risk-taking behavior	Measured by ACASI assessments	30 months
Initiate or decline PrEP	Refusal rates will be measured by ACASI assessments	30 months
Incident HIV-seroconversions/characteristics	HIV RNA and genotyping will be performed at the NL on samples confirmed to be HIV infected	30 months
Participant perception of care and referral plan	Assessed via interviewer-administered questionnaire	30 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 5, 2013
• First Submitted That Met QC Criteria: March 7, 2013
• First Posted (Estimate): March 11, 2013

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: March 1, 2014

More Information

Terms related to this study

• 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
• Other Study ID Numbers: HPTN 073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No