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

May 2, 2025 updated by: HIV Prevention Trials Network

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

HIV-uninfected BMSM at risk for HIV infection in three U.S. cities. Enrollment will include those aged 18 and over with efforts at each site to attempt to recruit an equal number of BMSM under age 25 and 25 and over.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Observational
Observational study
Other: Observational
HPTN 073 is an observational study in MSM in the United States

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Initiation of PrEP
Time Frame: 30 months
Documented in either study CRFs or ACASI
30 months
Adherence to PrEP
Time Frame: 30 months
Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration
30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 30 months
Graded via DAIDS Toxicity Grading System determined by review of reported adverse events (clinical and laboratory)
30 months
STIs
Time Frame: 30 months
Rectal and urine GC/CT, and NAAT for syphilis and chlamydia
30 months
Changes in sexual risk-taking behavior
Time Frame: 30 months
Measured by ACASI assessments
30 months
Initiate or decline PrEP
Time Frame: 30 months
Refusal rates will be measured by ACASI assessments
30 months
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
30 months
Participant perception of care and referral plan
Time Frame: 30 months
Assessed via interviewer-administered questionnaire
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HIV Prevention Trials Network

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HPTN 073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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