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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: FTC/TDF | Phase 4 |
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 |
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.
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Drug: FTC/TDF
All participants will be offered once daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) combined with C4.
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- Initiation of PrEP [ Time Frame: 30 months ]Documented in either study CRFs or ACASI
- Adherence to PrEP [ Time Frame: 30 months ]Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration
- Adverse events [ Time Frame: 30 months ]Graded via DAIDS Toxicity Grading System determined by review of reported adverse events (clinical and laboratory)
- STIs [ Time Frame: 30 months ]Rectal and urine GC/CT, and NAAT for syphilis and chlamydia
- Changes in sexual risk-taking behavior [ Time Frame: 30 months ]Measured by ACASI assessments
- Initiate or decline PrEP [ Time Frame: 30 months ]Refusal rates will be measured by ACASI assessments
- 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
- Participant perception of care and referral plan [ Time Frame: 30 months ]Assessed via interviewer-administered questionnaire

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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
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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

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
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 |
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 |
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 |