This very brief news release about a University of Waterloo study looks at a medicated vaginal implant designed to diminish the T-cell immune response to HIV infection. It’s based on previous observations which suggest that women who may be naturally resistant to HIV infection show low baseline T-cell activation in the vaginal wall. This so-called “immune quiescent” state can be achieved with the medication hydrochloroquine (HCQ) embedded in the implant which, in turn, is embedded in the vagina not unlike an IUD device.
Although the news release does a nice job of describing how the implant works as a medication delivery system, as well how the medicine affects T-cells and subsequently risk for HIV transmission, it falls short in several important ways.
First, even though the language repeatedly implies the approach could “prevent women from getting HIV infection,” it fails to mention the study is in rabbits and can make no claims of efficacy in humans.
Also, claims of efficacy, reliability, and affordability are not backed up with any data whatsoever from the study. There’s also no discussion of potential harms, or just how much more time or research is needed before this implant could be tested in humans.
Over 36 million people around the world were living with HIV in 2016. Most of these people live in the developing world where anti-HIV medications and condoms may be hard to get.
So the idea of a women-oriented strategy to prevent the spread of HIV in an affordable and effective way holds strong appeal; especially if it could work as a stand-alone option, or even if it was used as an adjunct with current strategies.
This study is very preliminary, based entirely on an animal model, and quite clearly in a very developmental stage. That’s key information that needs to be shared clearly and up high in the release. Otherwise, the news release runs the risk of being misleading, and instilling false hope in people who need reliable information in the face of a global public health threat.
The lead author is quoted as stating the implant could prevent HIV infection “more reliably and cheaply,” but the cost is not provided in the release.
The cost may well be unknown since the treatment is experimental and in development. However, the published research states that the active ingredient — hydroxychloroquine, or HCQ — “is an inexpensive drug.” Perhaps that price could have been included.
And cost is relevant since the vast majority of HIV infections occur in the developing world where cost could have a major influence on compliance with prevention measures.
As stated in the news release:
The tool, a vaginal implant, decreases the number of cells that the virus can target in a woman’s genital tract
Two problems here. First, the emphasis on woman’s is ours because the research was done in rabbits. (The fact that this research used an animal model was not mentioned until the penultimate sentence.)
Second, we’re given no data whatsoever to understand just how beneficial or significant the results really are.
However, we did appreciate the inclusion of this quote from the lead researcher:
What we don’t know yet is if this can be a stand-alone option for preventing HIV transmission or if it might be used in conjunction with other prevention strategies. We aim to answer these questions with future research.
Given that the news release opens with
“Scientists at the University of Waterloo have developed a new tool to protect women [emphasis added] from HIV infection”
it might lead some interested women to ask about side effects.
The question of harms is never addressed. That’s a huge oversight given that the device is implanted and there are many risks associated with such procedures: pain, bleeding, infection, the device becoming dislodged, follow-up surgeries to remove the implant.
No potential risks are mentioned.
In addition, if the device is not effective in comparison to existing preventive strategies then there’s a potential harm in relying on the device and acquiring HIV.
This is a major weakness of the news release.
Claims of efficacy, reliability, and affordability are made in the release with absolutely no supporting data from the study.
Many readers might be familiar with the commonly quoted statistic that condoms — when used properly and consistently — are well over 90% effective in preventing HIV transmission. They would naturally want to know if this implant can approach that efficacy and be accomplished affordably and without side effects. But the news release does not include this.
If such information can not be gleaned from the study — either because it wasn’t measured or because of the limitations of applying results from animal studies to humans — then we encourage news release authors to follow up with the researchers and ask for clarity.
No disease mongering. Prevention of HIV transmission is a global public health priority.
The release does not mention funding sources.
The published study does not include any disclosures of financial conflicts of interest by the authors.
The news release briefly mentions “conventional methods of HIV prevention, such as condoms or anti-HIV drugs.”
Given the preliminary nature of this experimental device it’s unlikely the authors can conclude how effective this vaginal implant is in comparison to these well-studied, conventional approaches. But mentioning how effective condoms and anti-HIV medications are might have been helpful context.
It’s not made clear enough that this vaginal implant is experimental, in development, and has never been tested on humans and that it could be years — if ever — before the device is available.
Although the release does not claim novelty specifically, it does mention the past failure of a related attempted preventative (nonoxynol-9).
The researchers do emphasize in the published paper that this study is the first of its kind to use a vaginal implant to deliver HCQ to reduce the response of T-lymphocytes in the vagina.
Furthermore, they point out this is a uniquely women-oriented strategy against HIV infection (versus a male-dominated one such as condoms).
Alluding to potential impacts on women or people four times in the first few paragraphs, but not mentioning the research utilized an animal model until the penultimate paragraph, is quite misleading and unjustified.
We’d suggest changing the headline to: “University of Waterloo develops a new way to fight HIV transmission in rabbit study.”