HPTN 073

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

Study Documents - Study Details - Key Study Personnel - Study Sites Publications

What is HPTN 073?

HPTN 073 is a demonstration study designed to see if Black men who have sex with men (BMSM) are willing to use Truvada®, a daily pill for pre-exposure prophylaxis (PrEP). HPTN 073 will gather feedback about the experience from the men who elect to use PrEP. PrEP is a new HIV prevention method in which people who are HIV-negative take an HIV treatment drug (antiretroviral – ARV) daily to reduce their risk of becoming HIV-infected.

Who participated in the study?

A total of 226 HIV-uninfected BMSM were enrolled in three U.S. cities (Washington, D.C., Los Angeles and Chapel Hill, N.C.)

What happened during the study?

Once study participants were enrolled in the study they remained involved for about one year. Participants met with members of their local study team about seven times over the course of that year. At each of these visits the study team offered participants the option to use Truvada. Participants who started PrEP received physical exams that included checking the health of their liver and kidneys, and a discussion of any concerns or side effects that may be related to the study drug. If serious side effects were reported, study participants were told to stop taking the drug.

Participants did not have to agree to take Truvada to be in this study. They may have decided to start taking or stop taking Truvada at any time. Regardless of whether or not participants utilized Truvada, everyone was offered C4 assistance (client-centered care coordination). The C4 healthcare team developed an individualized plan of care and support that may have included referrals to health care and mental health services or to other organizations that could help participants with other needs they may have had, such as services for housing assistance, domestic violence or drug or alcohol use counseling. All participants received HIV/STI risk reduction counseling and an HIV/STI test at each study visit. All participants were provided with condoms and were encouraged to use condoms every time they had sex because, while previous studies have shown that Truvada can reduce the risk of HIV infection, PrEP is not 100% effective and does not protect against other STIs (such as gonorrhea, syphilis or chlamydia)

Why was this study important?

BMSM account for 28% of all new HIV infections in the U.S., yet BMSM are underrepresented in HIV research trials. Less than 50 of the 225 MSM who participated in the iPrEx study at the two U.S. sites were BMSM. To determine the effectiveness of PrEP in this population, researchers must first understand:

* How willing BMSM are to take PrEP

* How consistently the men who do decide to take PrEP, take it as prescribed

* How the men evaluate the experience of using PrEP, and

* Is it acceptable for local health care facilities to administer client-centered care coordination (C4) along with PrEP to BMSM

Results:

Study findings, based off of participant self-report, showed high uptake of PrEP for prevention of HIV infection among BMSM in the U.S. with the use of a novel coordinated counseling and care approach resulting in findings suggestive of a lower rate of HIV infection.

A total of 209 participants (92%) completed the 12 months of follow-up. PrEP was accepted by 178 (79%) of study participants; 68% indicated they were continuing PrEP at 26 weeks. Those agreeing to take PrEP utilized a median of six C4 sessions compared to a median of four sessions by men not accepting PrEP. Among the 178 men who ever accepted PrEP in this study, five HIV infections occurred (incidence=2.9 95%CI:0.9-6.8); two of these men reported they had discontinued PrEP 50 and 272 days prior to first testing positive for HIV. Among the 48 men who never accepted PrEP, three became HIV infected (incidence=7.7 95%CI: 1.6-22.5). The study was not designed to evaluate the efficacy of FTC/TDF PrEP for HIV prevention.

 

Webinar: HPTN 073: PrEP Uptake and Use by Black Men who have Sex with Men in 3 U.S. Cities

March 1, 2016

 

What Is HPTN 073?

Study Summary
Study Documents - Study Details - Key Study Personnel - Study Sites Publications

What is HPTN 073?

HPTN 073 is a demonstration study designed to see if Black men who have sex with men (BMSM) are willing to use Truvada®, a daily pill for pre-exposure prophylaxis (PrEP). HPTN 073 will gather feedback about the experience from the men who elect to use PrEP. PrEP is a new HIV prevention method in which people who are HIV-negative take an HIV treatment drug (antiretroviral – ARV) daily to reduce their risk of becoming HIV-infected.

Who participated in the study?

A total of 226 HIV-uninfected BMSM were enrolled in three U.S. cities (Washington, D.C., Los Angeles and Chapel Hill, N.C.)

What happened during the study?

Once study participants were enrolled in the study they remained involved for about one year. Participants met with members of their local study team about seven times over the course of that year. At each of these visits the study team offered participants the option to use Truvada. Participants who started PrEP received physical exams that included checking the health of their liver and kidneys, and a discussion of any concerns or side effects that may be related to the study drug. If serious side effects were reported, study participants were told to stop taking the drug.

Participants did not have to agree to take Truvada to be in this study. They may have decided to start taking or stop taking Truvada at any time. Regardless of whether or not participants utilized Truvada, everyone was offered C4 assistance (client-centered care coordination). The C4 healthcare team developed an individualized plan of care and support that may have included referrals to health care and mental health services or to other organizations that could help participants with other needs they may have had, such as services for housing assistance, domestic violence or drug or alcohol use counseling. All participants received HIV/STI risk reduction counseling and an HIV/STI test at each study visit. All participants were provided with condoms and were encouraged to use condoms every time they had sex because, while previous studies have shown that Truvada can reduce the risk of HIV infection, PrEP is not 100% effective and does not protect against other STIs (such as gonorrhea, syphilis or chlamydia)

Why was this study important?

BMSM account for 28% of all new HIV infections in the U.S., yet BMSM are underrepresented in HIV research trials. Less than 50 of the 225 MSM who participated in the iPrEx study at the two U.S. sites were BMSM. To determine the effectiveness of PrEP in this population, researchers must first understand:

* How willing BMSM are to take PrEP

* How consistently the men who do decide to take PrEP, take it as prescribed

* How the men evaluate the experience of using PrEP, and

* Is it acceptable for local health care facilities to administer client-centered care coordination (C4) along with PrEP to BMSM

Results:

Study findings, based off of participant self-report, showed high uptake of PrEP for prevention of HIV infection among BMSM in the U.S. with the use of a novel coordinated counseling and care approach resulting in findings suggestive of a lower rate of HIV infection.

A total of 209 participants (92%) completed the 12 months of follow-up. PrEP was accepted by 178 (79%) of study participants; 68% indicated they were continuing PrEP at 26 weeks. Those agreeing to take PrEP utilized a median of six C4 sessions compared to a median of four sessions by men not accepting PrEP. Among the 178 men who ever accepted PrEP in this study, five HIV infections occurred (incidence=2.9 95%CI:0.9-6.8); two of these men reported they had discontinued PrEP 50 and 272 days prior to first testing positive for HIV. Among the 48 men who never accepted PrEP, three became HIV infected (incidence=7.7 95%CI: 1.6-22.5). The study was not designed to evaluate the efficacy of FTC/TDF PrEP for HIV prevention.

 

Webinar: HPTN 073: PrEP Uptake and Use by Black Men who have Sex with Men in 3 U.S. Cities

March 1, 2016

 

What Is HPTN 073?

Study Details

Protocol Status: Participants Off Study and Primary Analysis Completed
Study Purpose:

To 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