By: Eric Brus*—
Last month, a demonstration study was launched to determine whether black gay and bisexual men would benefit from the use of drugs to prevent HIV infection. Generally referred to as pre-exposure prophylaxis, or PrEP for short, the preventive medicine is Truvada, a once-daily pill that contains the two antiretroviral drugs tenofovir and emtricitabine. The U.S. Food and Drug Administration approved the use of Truvada for PrEP in 2012, but research is ongoing to determine how the drug might best be used, and its acceptability, safety, and effectiveness in different risk groups.
The study, dubbed HPTN 073, which is being administered by the HIV Prevention Trials Network, will enroll a total of 225 uninfected Black MSM in three US cities: Chapel Hill, North Carolina; Los Angeles, California; and Washington, D.C.
“Considering Black MSM make up nearly 30% of all new infections in the US, it is imperative that we explore prevention strategies that might help Black men better protect themselves and their communities,” study researcher Dr. Sheldon Fields noted at the study launch. The men who enroll in the study must be at least 18 years old. Since HIV infection rates are highest among Black MSM between the ages of 18 and 25, researchers will try to recruit a substantial number of participants from this age group. [pullquote]The men who enroll in the study must be at least 18 years old. Since HIV infection rates are highest among Black MSM between the ages of 18 and 25, researchers will try to recruit a substantial number of participants from this age group. [/pullquote]
All participants in the study will be offered daily Truvada plus client-centered care coordination, which consists of an individualized plan of care and support that may include referrals to health care and mental health services or to other organizations that can help participants with other needs they may have, such as services for housing assistance, domestic violence, or drug or alcohol use counseling. All participants will also receive HIV and sexually transmitted infection (STI) risk reduction counseling and an HIV/STI test at each study visit. They will also be provided with, and encouraged to use, condoms.
It is important to note that the participants do not have to agree to take Truvada to be in the trial. They may decide to start taking or stop taking Truvada at any time. The study will address the following research questions:
- Will Black MSM initiate PrEP? Why or why not?
- Will Black MSM use PrEP daily as prescribed? If not, how often?
- Is it safe for Black MSM to use PrEP?
- Will the sexual practices of the participants change if they decide to start PrEP?
- Will local healthcare facilities find it acceptable to administer client-centered care coordination along with PrEP to Black MSM?
For the participants who take Truvada and later become infected with HIV, the researchers will also evaluate their blood levels of Truvada and whether they have drug-resistant virus.
“This is an exciting study that will provide us with critical information about whether Black men will accept PrEP,” according to study researcher Dr. Darrell Wheeler. “It will also help us better understand under what conditions they are willing to accept taking PrEP and how healthcare providers and researchers might be able to better support their efforts to achieve optimal health outcomes.” [pullquote]It is important to note that the participants do not have to agree to take Truvada to be in the trial. They may decide to start taking or stop taking Truvada at any time.[/pullquote]
HPTN has developed a number of educational materials about the trial, including a fact sheet, slide deck, and 90-minute webinar, all of which are available at their website. The slide deck provides a detailed overview of the study, together with contextual information about the U.S. HIV/AIDS epidemic, the epidemic’s impact on Blacks, MSM, and Black MSM in particular, PrEP’s potential role in HIV prevention, and the results of PrEP studies performed to date.
National Gay Men’s HIV/AIDS Awareness Day
National Gay Men’s HIV/AIDS Awareness Day (NGMHAAD) was held Friday, September 27. The National Association of People with AIDS founded NGMHAAD “to help gay men remember how much we have accomplished together in the fight against HIV/AIDS, remember the quarter-million lovers and brothers we have lost, and renew our commitment to ending what is now an endable epidemic.” For more information about HIV/AIDS among gay, bisexual, and other men who have sex with men, see the following annotated list of online resources.
National Gay Men’s HIV/AIDS Awareness Day. The U.S. Centers for Disease Control (CDC) web page for the day, with links to fact sheets, reports, and other materials.
Also from the CDC:
- HIV/AIDS among Gay, Bisexual, and Other Men Who Have Sex with Men (MSM). Also available in Spanish.
- HIV/AIDS and Young Men Who Have Sex with Men
- HIV/AIDS Surveillance in Men Who Have Sex with Men (MSM)
- Trends in HIV/AIDS Diagnoses Among Men Who Have Sex with Men – 33 States, 2001-2006
- Syphilis & MSM
From the UCSF Center for AIDS Prevention Studies:
- What Are Men Who Have Sex with Men HIV Prevention Needs? Also available in Spanish.
- What Are the HIV Prevention Needs of Young Men Who Have Sex with Men? Also available in Spanish.
- How Do Sexual Networks Affect HIV/STD Prevention? Also available in Spanish.
Additional Resources
Gay Men and HIV/AIDS. Web page on thebody.com site with links to many articles and resources.
HIV Transmission and Prevention in Gay Men and Other Men Who Have Sex with Men: Related Resources. Page from the HIV InSite with links to many articles, reports, and other information.
Men of Color Who Have Sex with Men and HIV/AIDS in the United States. Fact sheet from the U.S. Health Resources and Services Administration.
The Global HIV Epidemics Among Men Who Have Sex with Men. This 2011 report from the World Bank provides a summary of HIV/AIDS among MSM in different countries, as well as prevention interventions that respond to designed to reduce HIV transmission among MSM.
HIV Prevention for Men Who Have Sex with Men. Issue brief from the American Foundation for AIDS Research.
Selected Recent Articles about HIV and Hepatitis in Gay, Bisexual, and Other Men Who Have Sex with Men
PrEP Did Not Increase Sexual Risks in Study of Gay Men. (aidsmeds)
Insufficient HIV Testing May Make Gay Relationships Risky. (aidsmeds)
High Rates of Anal HPV Infection Among Young Gay Men. (aidsmap)
Strong Support for Vaccinating Young Gay Men for HPV. (aidsmeds)
Vaccinations for Meningitis Appear to Protect NYC Gays. (aidsmeds)
Rectal STIs Raise Risk of HIV Infection Among Gay Men. (aidsmeds)
Vaccination Could Prevent Infection with Anal Cancer-Associated HPV Strains in Older Gay Men. (aidsmap)
Gays in Care Identify HIV Earlier, Treat It at Higher Rates. (aidsmeds)
Age Gaps, Small Sexual Networks Drive HIV in Gay Black Men. (aidsmeds)
Herpes Linked to HIV in Semen of Gay Men on ARVs. (aidsmeds)
More Drugs, More Alcohol Often Means More Risky Sex for HIV-Negative Gay Men. (aidsmap)
Gay Men Have Fewer Sex Partners; Condom Use Unchanged. (aidsmeds)
Hep C Transmission Among Gay Men Dates Back Decades; HIV a Major Risk Factor. (aidsmeds)
PrEP Doesn’t Lead to Increases in Risky Sex Among Gay Men. (aidsmap)
Treating Everyone Diagnosed Would Not End HIV in US Gay Men, Los Angeles-Based Model Finds. (aidsmap)
Another Study Finds Gay Black Men at Higher HIV Risk Despite Fewer Partners. (aidsmeds)
Bisexual HIV+ US Men Differ in Key Ways from HIV+ Heterosexuals and Gays. (natap)
Gay Men More Aware of HIV Status, Black Men Remain “Over-burdened.” (hivandhepatitis)
Young Gay Men’s PrEP Study Shows Feasibility and Challenges. (aidmeds)
CROI Plenary: Without Focus on MSM Epidemic, “An AIDS-Free Generation Is Not Going to Be Achievable.” (Science Speaks blog)
New Evidence Suggests Hepatitis C Transmits Sexually Among HIV-Positive Gay Men. (aidsmeds)
Spoiled Identity: Gay Men, HIV, and Stigma. (Positively Aware)
Very High Rates of HIV Infection Among Gay/Bisexual Male Youths in the United States. (aidsmap)
Bacterial Meningitis Outbreak Among HIV Positive Gay Men in New York. (hivandhepatitis)
Progression of Anal Neoplasia is Common Among Gay Men with HIV. (hivandhepatitis)
Hepatitis B Rates Higher Than Expected Among Gay Men, Vaccinated Children. (hivandhepatitis)
*Eric Brus is the Director of HIV Health Promotion of AIDS Action Committee. This report is produced by the Health Library of the AIDS Action Committee in collaboration with the New England AIDS Education and Training Center Minority AIDS Initiative Project. The full version is available online.
