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

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

Detailed Description
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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).

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

Conditions
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HIV

Intervention / Treatment
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* Drug: FTC/TDF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Daily PrEP + coordination of client centered svs<br>All participants will be offered once daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) combined with C4. | Drug: FTC/TDF<br>* All participants will be offered once daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) combined with C4.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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