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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01808352
• Other study ID #: HPTN 073
• Status: Completed
• Phase: Phase 4
• First received: March 5, 2013
• Last updated: January 20, 2016
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2014
• Source: HIV Prevention Trials Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• FTC/TDF
All participants will be offered once daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) combined with C4.

Locations

Country	Name	City	State
United States	UNC CRS	Chapel Hill	North Carolina
United States	UCLA Vine Street Clinic	Los Angeles	California
United States	George Washington University CRS	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
HIV Prevention Trials Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initiation of PrEP	Documented in either study CRFs or ACASI	30 months	No
Primary	Adherence to PrEP	Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration	30 months	No
Secondary	Adverse events	Graded via DAIDS Toxicity Grading System determined by review of reported adverse events (clinical and laboratory)	30 months	No
Secondary	STIs	Rectal and urine GC/CT, and NAAT for syphilis and chlamydia	30 months	No
Secondary	Changes in sexual risk-taking behavior	Measured by ACASI assessments	30 months	No
Secondary	Initiate or decline PrEP	Refusal rates will be measured by ACASI assessments	30 months	No
Secondary	Incident HIV-seroconversions/characteristics	HIV RNA and genotyping will be performed at the NL on samples confirmed to be HIV infected	30 months	No
Secondary	Participant perception of care and referral plan	Assessed via interviewer-administered questionnaire	30 months	No