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HIVNCT01808352

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

An observational study of HIV, run by HIV Prevention Trials Network at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Observational
How many people
226 participants
Where
3 sitesUnited States
Study dates
15 Aug 2013to 30 Sep 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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
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  • Any protected or unprotected:
  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • UNC CRS

    Chapel Hill, North Carolina, 27514

  • UCLA Vine Street Clinic

    Los Angeles, California, 90095

  • George Washington University CRS

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: 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.

Read the 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).

Conditions
HIV
Being tested
Observational
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
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

    HPTN 073 is an observational study in MSM in the United States

Study groups in NCT01808352
Study groupRoleWhat they receive
ObservationalObservational study
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Initiation of PrEP

    Documented in either study CRFs or ACASI

    Measured: 30 months

  2. Adherence to PrEP

    Adherence will be assessed via self-report (ACASI), PBMCs and plasma concentration

    Measured: 30 months

Secondary outcomes (6)

  1. Adverse events

    Graded via DAIDS Toxicity Grading System determined by review of reported adverse events (clinical and laboratory)

    Measured: 30 months

  2. STIs

    Rectal and urine GC/CT, and NAAT for syphilis and chlamydia

    Measured: 30 months

  3. Changes in sexual risk-taking behavior

    Measured by ACASI assessments

    Measured: 30 months

  4. Initiate or decline PrEP

    Refusal rates will be measured by ACASI assessments

    Measured: 30 months

  5. Incident HIV-seroconversions/characteristics

    HIV RNA and genotyping will be performed at the NL on samples confirmed to be HIV infected

    Measured: 30 months

  6. Participant perception of care and referral plan

    Assessed via interviewer-administered questionnaire

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2013 (estimated)
  2. Study start15 Aug 2013
  3. Primary completion30 Sep 2015
  4. Study completion30 Sep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01808352
Sponsor's protocol ID
HPTN 073
Status last verified
May 2025
First submitted
5 Mar 2013
Last updated
7 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30615169

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, run by HIV Prevention Trials Network at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Initiation of PrEP (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01808352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.

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