According to the grant abstract, men who have sex with men or MSM “are the only CDC-defined risk group in the US in which new HIV infections have been increasing steadily since the 1990s.”
“This study focuses on HIV-uninfected men and transgender women who have sex with men, with special emphasis on ethnic minority individuals, who have more than one sexual partner and never or seldom use condoms,” the grant said.
“Statistics about HIV among male-to-female transgender women (TGW) are often unavailable but it is known that HIV prevalence in this population is high, and the 2011 Institute of Medicine Consensus Report called for much needed research among transgender populations,” the grant said.
“Alternatives to condom use are needed for individuals who cannot or will not use condoms,” it said.
Researchers will study one such alternative to condom use: rapid HIV home tests (HT).
The study “seeks to demonstrate that these individuals will have fewer occasions of risky sex if they use a rapid HIV home test (HT) to determine if their sexual partners are infected with HIV (although the test does not detect very recent infections).
It also seeks to show that “having easy access to HT, including an affordable price, is crucial so that people can use it to test potential sexual partners; this is important because this procedure may become a brand new approach to HIV-prevention, leading to fewer new infections and a decrease in healthcare costs,” the grant said.
“This 5-year randomized controlled trial will target mainly, but not exclusively, ethnic minority men and TGW who have sex with men, are HIV-uninfected and non-monogamous, never or seldom use condoms, and have a history of serodiscordant UAI,” the grant said.
Serodiscordant UAI is when one partner is infected with HIV and the other is not.
On July 3, 2012, the Food and Drug Administration approved the OraQuick in-home HIV test that does not require sending in a sample to a lab for analysis. The kit involves swabbing the upper and lower gums for an oral fluid sample with the test device and placing the sample in a tube with a developing solution. After a 20-40 minute waiting period, one line means the sample has tested negative for HIV, and two lines indicate it tested positive for HIV.
Follow-up confirmatory testing is needed for those who receive a positive result. Also, a false negative result is possible for those who were exposed to the HIV virus in the past three months.
“The test is not reliable at detecting HIV infection until at least three months after infection,” the FDA said on its website. It also advised that people “should not interpret a negative test to indicate that engaging in high risk behavior is safe.”
Researchers will recruit and pre-screen about 600 people in New York City and San Juan, Puerto Rico – two cities with high HIV prevalence. Only 300 participants, however, are expected to be eligible to enroll in the trial after screening at the first visit, due to the “stringent eligibility criteria.”
Participants will then be “randomized” and assigned to one of two groups. “Group A participants will receive an HT intervention orientating them to effective ways of using HT to screen sexual partners and will be supplied with HT kits to use with sexual partners over 6 months.”
“Group B participants will receive neither the HT intervention nor supply of kits, and we will monitor whether they avail themselves of HT kits through purchase or other means,” the grant said. “Both groups will receive risk-reduction counseling.”
“All participants’ behavior will be monitored for 6 months through daily brief SMS reports,” it said.
CNSNews.com contacted the project leader, Alex Carballo-Dieguez, and asked: “Will your study include an explanation that a negative result does not mean that the ‘individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months,’ as indicated by the FDA on its website page about the OraQuick In-home HIV test?
“Will it address the risk one takes when engaging in unprotected sex even after a negative result from such a test and the false sense of security the negative result may give?” CNSNews.com asked.
“You mentioned that Group A and B participants will receive risk-reduction counseling. Will that counseling include the FDA's warning that even getting a negative result using at-home HIV tests does not guarantee that the person is not infected with HIV, especially if that person was infected in the past 3 months?” CNSNews.com added.
Carballo-Deiguez responded by referring CNSNews.com to a study similar to the one in question.
“It will probably respond to many of your questions,” Carballo-Deiguez wrote. “As you will see, we only recruit people who seldom or never use condoms and who have multiple partners. We not only extensively explain the window period and the limitations of the test but we even test the participants understanding of this window period. If they don’t understand it, they are not eligible to participate in the study.”
A paper on the aforementioned study published in 2012, titled, “Use of a Rapid HIV Home Test Prevents HIV Exposure in a High Risk Sample of Men Who Have Sex With Men,” explained the “window period.”
“A caveat is that OraQuick is an antibody test; therefore, an HIV-infected individual may appear uninfected until anti-bodies are generated. The window period of antibody tests lasts 25 days on average and in some cases as long as 8 weeks,” the paper said. “Thus, despite the high sensitivity and specificity of OraQuick, using it to screen sexual partners still would not completely eliminate risk.”
The project and budget start date is listed as July 1, 2014 and is expected to end on June 30, 2019. The budget end date is listed as June 30, 2015.