HPTN 073

Pre-Exposure Prophylaxis (PrEP) Initiation and Adherence among Black Men who have Sex with Men (BMSM) in Three U.S. Cities


 

HPTN 073

NEW Report Available!

Identifying Research Gaps for Black Men Who Have Sex with Men: A Way Forward
- HIV Preventions Trials Network Black Caucus Scientific Report 2014

 

 

HPTN 073 Webinar

Twitter Chat 3

A very successful webinar! Over 200 participants joined to learn more about HPTN 073. Thank you to all who joined.

If you were unable to attend the webinar, a video is available. View video here

What Is HPTN 073?

 

StoryCorps Conversation with Darrell Wheeler and Russell Brewer

See a complete list and links to all of the HPTN StoryCorps conversations.


Protocol Status: Closed to Accrual

Study Summary

Study PurposeTo assess the initiation, acceptability, safety, and feasibility of PrEP for Black men who have sex with men (BMSM) in three U.S. cities utilizing client-centered care coordination (C4) models.

Study Design: An open label demonstration study with PrEP + C4 model. A subset of participants will also be recruited to participate in qualitative interviews about facilitators and barriers regarding PrEP.

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.

Study Size: A total of 225 participants with 75 participants at each of three sites.

Study Duration: 30 months including closeout activities. Recruitment is anticipated to take place over a 12-month period. Each participant will be followed for a total of 12 months. Six additional months are included for data clean-up and closeout.

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

Primary Objectives: • To assess the initiation and correlates of daily PrEP use by sociodemographics, including age, education, and risk practices • To assess PrEP adherence via self-report (ACASI) and antiretroviral drug detection

Secondary Objectives: - To describe side effects, toxicities, risk compensation, and STIs among participants who initiate PrEP - To describe patterns and attributes of PrEP initiation and adherence among participants (e.g., C4, substance use, sociocultural factors and incarceration) - To measure changes in sexual risk taking behavior among study participants - To describe reasons BMSM choose to initiate or decline PrEP - To describe the number of HIV seroconversions, and to analyze viral characteristics (e.g., drug resistance) and the host response to infection in participants who become HIV-infected while on PrEP. - To characterize the participant perception of care and referral plans


 

Protocol Team Member: Alena Pechonkina get info

Protocol Team Member: Anthony Mwatha get info

Protocol Team Member: Beryl Koblin get info

Protocol Team Member: Cheryl J. Marcus get info

Protocol Team Member: Christopher Chauncey Watson get info

Protocol Team Member: Craig Hendrix get info

Protocol Team Member: David Borasky get info

Protocol Team Member: Estelle Piwowar-Manning get info

Protocol Team Member: Gregory Victorianne get info

Protocol Team Member: James Rooney get info

Protocol Team Member: John K. Williams get info

Protocol Team Member: Jonathan Lucas get info

Protocol Team Member: Katie Shin get info

Protocol Team Member: Keith Rawlings get info

Protocol Team Member: Kenneth H. Mayer get info

Protocol Team Member: Leo Wilton get info

Protocol Team Member: Lisa Hightow-Weidman get info

Protocol Team Member: Lynda Marie Emel get info

Protocol Team Member: Manya Magnus get info

Protocol Team Member: Rebecca Guzman get info

Protocol Team Member: Ron Stall get info

Protocol Team Member: Rotrease Regan get info

Protocol Team Member: Stephaun E. Wallace get info

Protocol Team Member: Steven Shoptaw get info

Protocol Team Member: Steven Wakefield get info

Protocol Team Member: Vanessa Elharrar get info

Protocol Team Member: William Clarke get info

Protocol Team Member: Ying Q. Chen get info

Protocol Co-Chair: LaRon Nelson get info

Protocol Co-Chair: Sheldon Fields get info

Protocol Chair: Darrell Wheeler get info

CORE Protocol Specialist: Phaedrea Watkins get info

CORE Protocol Specialist: Scott Rose get info

Site Target
Enrollment
Cumulative
Enrollment
Implementation
Status
More
Info

Chapel Hill CRS

3201

Chapel Hill, United States

75 BMSM (across UNC and Wake County sites)

75

Enrollment Closed

get more

UCLA Vine Street CRS

31607

Los Angeles, United States

75 BMSM

76

Enrollment Closed

get more

Wake County Health and Human Services CRS

30076

Raleigh, United States

75 BMSM (acrross UNC and Wake County sites)

 

Enrollment Closed

get more

George Washington Univ. CRS

31608

Washington, United States

75 BMSM

75

Enrollment Closed

get more