Spokeswoman: Not Enough Transgenders to Include in NIH-Funded HIV Study

By Barbara Hollingsworth | November 3, 2016 | 1:32pm EDT
Transgender actress Alexis Arquette, 47, died of cardiac arrest and an underlying HIV infection on Sept. 11. 2016. (AP photo)

(CNSNews.com) -- A clinical trial funded by the National Institutes of Health (NIH) is currently recruiting participants in Atlanta, Baltimore, Birmingham and Boston to test various interventions designed to “maintain viral suppression among HIV-infected men who have sex with men (MSM)”.

But transgenders need not apply, even though the Centers for Disease Control and Prevention (CDC) estimates that 28 percent of all transgender women have HIV, because there are not enough of them "to make any conclusions," a spokeswoman for the clinical trial said.

According to ClinicalTrials.gov, only individuals who meet the study’s “Inclusion Criteria” are eligible to participate in the study.

Participants must be a “biological male (currently and at birth)” over the age of 16 who has had “anal intercourse with another man within the last 6 months.”

“Exclusion Criteria” include those who are “unable or unwilling to provide consent”; “transgender women”; and anyone who has “active or previous participation in an HIV vaccine trial”.

CNSNews.com asked Theresa Gamble, a spokeswoman for Family Health International and contact for the study, why transgenders were excluded from the clinical trial.

“When we were designing this study (HPTN 078), we considered including transgender women, as we know what great risk they have for HIV acquisition,” Gamble replied. “However, when they are not specifically targeted in a study, their numbers are often too small to make any conclusions. 

“Therefore, our network, the HIV Prevention Trials Network (HPTN), is developing studies that will include only transgender women in order to make more rigorously sound recommendations for this population.”  

Researchers conductng the clinical trial will determine each MSM participant’s HIV status and viral load at the initial screening, and then monitor them for the next 24 months for “self-reported sexual risk behavior of unprotected anal intercourse” and their adherence to an antiretroviral regimen.

Participants’ viral load will be assessed again at the end of the two-year study to determine which interventions work best to slow down transmission of the virus.

“Developing and validating strategies to enhance the engagement of men who have sex with men living with HIV in care and treatment is essential for controlling the HIV epidemic in this critical population in the United States,” National Institute for Allergies and Infectious Diseases director Anthony Fauci said in a news release.

About 1.2 million Americans have HIV, but 1 in 8 do not know they are infected, according to CDC statistics. Two-thirds (67 percent) of new HIV cases are transmitted by male-to-male sexual contact.

“The U.S. National HIV/AIDS Strategy calls for 90 percent of people living with HIV to be diagnosed, 90 percent of those diagnosed to be on antiretroviral treatment, and 90 percent of those in treatment to be virally suppressed by 2020,” according to NIH.

“The new model predicts that meeting these ‘90-90-90’ targets would require 75 percent of all HIV-infected MSM to be virally suppressed by 2020 and would lead to a 50 percent reduction in HIV incidence.”

NIH noted that MSM make up only 2 percent of the U.S. population, but accounted for 67 percent of newly diagnosed HIV infections in 2014.

 “MSM in the United States are disproportionately affected by HIV/AIDS, and rates of viral suppression among MSM are quite low,” according to NIH.

In 2013, just 57 percent of MSM who had been diagnosed with HIV for at least one year were receiving “continuous HIV medical care” to suppress the virus, the agency noted. The percentage was even lower in Baltimore, where “according to data from 2013, only 37 percent of these men were virally suppressed.”

A new mathematical model shows that “achieving moderate reduction of new HIV infections among men who have sex with men will depend on significantly increasing the percentage of HIV-infected MSM whose viral load is suppressed to undetectable levels,” the federal agency said.

According to CDC, 6,995 people died from HIV and AIDS in 2013, making it the 8th leading cause of death for Americans between the ages of 25 and 34.

Related: CDC: High Rate of HIV Among Transgender Women

Related: Obama Proclamation: Gay, Bisexual, Transgender Women at ‘High Risk for HIV’

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