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HIV Home Testing: More Problem Than Solution

By Jeannie Wraight

May 29, 2012

This article was cross-posted from

Take a moment and think back to when you tested positive for HIV. What was your initial reaction? What went through your head? For most of us it was sheer panic. "What now?" is usually one of the first questions that comes to mind.

If you're not HIV positive, think of a time where you were tested for HIV and sweated it out while waiting for the results. Some of us thought we'd kill ourselves rather than live with HIV/AIDS, believing our lives would be over.

Many people go on drinking binges, drug runs and/or get extremely depressed after finding out we have HIV. Now think about what it would have been like to receive the diagnosis at home, without support to assure us that a positive result didn't mean the end of our lives.

This will be the case for many if the FDA approves OraSure's OraQuick In-Home HIV Test. The Blood Products Advisory Committee (BPAC) has already recommended the FDA do just that. The FDA usually follows the recommendations of its committees.

The whole idea behind an at-home HIV test is to give people access and options to HIV testing for those who don't want to go to a test center. But we already have that option and have since 1996 with the Home Access HIV test. The Home Access HIV test requires a drop of blood to be sent to a lab. The results are given over the phone by a trained professional. This test maintains a 98.98% accuracy rate and provides people who don't want to be tested at a clinic or HIV test site an option, but also provides mandatory counseling to access the results.

When talking about HIV home test kits, it's important to remember that we're not just talking about its appropriateness in the United States. Governments all over the world historically base their decisions on what should be approved and what shouldn't, on the FDA's decisions. Other governments will and are following the FDA's lead on HIV home tests. Uganda has already said they will also approve the OraQuick HIV home tests based on the BPAC's recommendation.

This scares the hell out of me. The possibilities for abuse in countries like Uganda are endless. We put up the news every day on my website and debate whether or not to put up some of the stories we find from Uganda and other African and Asian countries as many are just too horrible. This is a country where people are still killed for being HIV positive. It's not uncommon for people with HIV to be ostracized, beat and/or thrown out of their homes and villages. Women are often not treated with respect and are abused physically and mentally. Some men blame their HIV infection on their wives, even though the husbands are usually the ones who have been unfaithful. Is it so ridiculous to believe that people will be forced to take an HIV test against their will if it's readily available? The only saving grace in this situation is that the test may be too expensive for many.

We can say that the FDA has to do what's right for citizens of the United States and any backlash in other countries if they follow the FDA are unfortunate but a consequence we can't control. I say bullshit! People with HIV are people with HIV -- no matter where they live. It is those that don't have the advantages we have in the U.S. that we should be protecting and advocating for the most! They must be considered in the decision to support or fight the OraQuick HIV home test.

When you're tested, you have someone there to put things in perspective. With the lack of HIV education out there, this really is essential. Alone many people not familiar with HIV will think:

  1. I'm going to die
  2. I can never have sex again
  3. Everyone I know will abandon me and I'll be all alone.

When you're tested for HIV in a clinic or testing center, you have a trained professional to assure you that HIV is not a death sentence and there are medications that can keep you healthy. They can make it clear that there are ways to have safe sex and sex isn't something you have to give up. A pre and post test counselor will explain that there's a huge support system of people living with HIV. There's also help with telling family and friends. They explain that you don't have to tell anyone you're not comfortable telling, except your partner. A counselor will also help a person who just tested positive to recognize what the next steps are, including a confirmatory test and an appointment at an HIV clinic.

Pre and post test counseling is mandatory not optional, for reasons. One of which is to give hope during a moment of despair. We all know there's the possibility that some people will take their life after an HIV diagnosis. Mandatory pre and post test counseling helps make suicide less probable by providing a clear perspective.

OraSure's answer to the counseling issue is an optional 24/7 hotline. Really, it's just not good enough. Who knows if people will even read the package insert with the hotline info. Even if they do read the insert, most people who will take the test at home will do so because they don't want to interact with someone else during the process.

Then of course we have the accuracy issue. The OraSure rapid HIV home test would produce one false negative result for every 13 true positive tests. The test would produce one false positive result for every 3,750 true negative tests. People who test negative will believe they are negative and may not feel the need to use protection.

Will everyone who takes the test take the time to fully read the box and package insert to determine whether they are in the 'window period' before a positive result shows up? Again, more people who will believe it is safe for them to have unprotected sex.

What's to stop an employer from demanding an HIV test under the guise of it being a drug test. Or someone testing another person's DNA. A quick swab of the mouth isn't hard to get from someone who's asleep.

If you agree that the OraQuick In-Home HIV Test should not be approved by the FDA, please visit and like our page on Facebook -- Stop the FDA Approval of the Do-It-Yourself Home HIV Test Kit. A petition to the FDA and a letter to the Ugandan government will be posted shortly. Please check for other updates and help us stop this test from being approved by the FDA.

Testing and diagnosis of a life-threatening illness should be done by a trained professional!!!

Send Jeannie an email.

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See Also
Quiz: Are You at Risk for HIV?
10 Common Fears About HIV Transmission
More on Home HIV Testing

Reader Comments:

Comment by: Jeannie Wraight (Bronx, New York) Tue., Jun. 26, 2012 at 12:28 pm UTC
John, my apologies, you are right. I didn't realize you were referring to a comment on another persons article and I actually forgot I had mentioned that anywhere. I understand your prior statement now and why you said that. The sentence read "Those who supported this in the FDA..." was supposed to read "Those who supported this BEFORE the FDA..." My bad, I stand corrected.
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Comment by: John (Columbus, Ohio) Tue., Jun. 19, 2012 at 9:26 am UTC
I am on the opposite end of the spectrum concerning this test form the author. Over the counter sales of this product is long overdue. This same author on another website has actually accused the FDA members that supported orasure HIV ovc as recieving money from Orasure. Jeannie, can you prove any of that? As far as I'm concerned you have no evidence or facts to back up anything you have written. This test will do far more good then harm. Please stop trying to scare everyone.

[Moderator's note: This comment was edited to remove text that was against our comment policy.]
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Comment by: Jeannie Wraight (Bronx, New York) Mon., Jun. 25, 2012 at 3:54 pm UTC
I've written one blog shared here and on and one article on HIV Haven about this issue:

The article contains quotes from one person for (Tom Donahoe) and one against Colin Robinson-Vokoun)the test. It cited test accuracy data and briefly mentioned community concerns regarding the lack of pre and post test counseling and fear of abuse of this test. No where in either article/blog did I mention or accuse any member of the FDA BPAC of receiving money from OraSure.

You are likely talking about a random post on Facebook where I may have referred to an article on Rueters that said "The panel heard overwhelmingly supportive public testimony from more than two-dozen witnesses including HIV activists, black community representatives and public health experts, some of whom received money and other assistance from OraSure". - which a choose not to include in the article or blog.

I do believe that the hearing was unfairly packed with OraSure supporters and that there was little advanced knowledge on the part of the HIV community or general public that this hearing was about to take place. I also personally am concerned by a statement on FB the day before the hearing that "This is going to be approved, it is already a done deal" by someone on the forefront of this fight who out of respect for this person who I believe is otherwise a good activist, I will not name. I also have never mentioned this publicly before on FB,, HIV Haven or anywhere else.

Although I'm not 100% sure, I believe by your comment, tone and wording, you may be the same person who also attacked other people on a FB thread for their opinions on this test. FB, blogs and the comment section here exist to provide people the opportunity to express their opinions just as I have. Some of the comments here against the test were from conversations I had and I welcome all sides to every issue. There is no reason to be insulting.
Comment by: John (Ohio) Tue., Jun. 26, 2012 at 10:16 am UTC
I am sorry if you were insulted by my posting. That was not my intention. I was referring to a comment you left on the website. I have made no other postings except here.

Comment by: C. T. Robinson-Vokoun (Holland, Pennsylvania) Fri., Jun. 8, 2012 at 12:06 am UTC
A post that is near and dear to the hearts of all of us caught my eye on Facebook just moments ago, 11:15 pm, Thursday June 7, 2012.

It was a link to a discussion on "The pros and cons of Home HIV Tests."

In clicking on this link I received a message that read, "This link has been reported as abusive by Facebook users."

Seriously people?

And I am seeing nothing less here on this site,

A discussion on the pros and cons of the in-home, do-it-yourself OraSure test has become "abusive." Have some of stooped so low that they had to come down to being abusive toward one another over this?

In this day and age of HIV, I find it appalling and shameful that we face discrimination and abuse ... but this demonstrates a fact that I have sadly seen in recent years:

The greatest abuses and discriminations we face are NOT from the non-infected world around us. They are from within our own ranks!

Shame on those PLWHA's that have sunken so low in their ethics and morals ... sunken so low in caring for their fellow man and woman who also lives with this virus, that they cannot hold a civil, constructive and healthy discussion on this, or any other HIV-related issue that so desperately needs discussion!

Those of you that scream the loudest that "The stigma must end" are your own, and our cause's worst enemies.

It is YOU who are bringing this stigma upon us more strongly than the world around us is doing so.

Please, I beg of you, bring back the camaraderie and unity we once had so that constructive discussions and progress may happen!

Younger ones... Listen to those of us that have been on this path a little longer than you have. We just may have some useful and accurate advice from having been there ahead of you.

I'm not saying we'll always be right. You may, and very probably will, have new and better ways of seeing and acting upon needs within our cause. But age and experience just may still have valid and good id
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Comment by: Krista Dong (KZN, South Africa) Mon., Jun. 4, 2012 at 6:06 pm UTC
6. "Will everyone who takes the test take the time to fully read the box and package insert"
COMMENT: This would certainly be the aim, in order to ensure that self-tests are performed reliably and results interpreted accurately. However, there would be enormous benefit to introducing self-testing with strong social medical support. In South Africa, envision local language radio stations running weekly 'Radio Test Time' during which listeners can tune in and open/perform their HIV rapid test along with the DJ or on-air guest. Sensitive issues portrayed in ever popular daytime soaps, etc. Dispense with the tired billboards and make information sexy, relevant and accessible.

7. "What's to stop an employer from demanding an HIV test ..."
COMMENT: This is not uncommon in South Africa now. Disempowered employees are sent or escorted to their local clinics and made to test. Employers thing nothing of demanding the result of the clinic either in person or by phone. Many of these are well meaning and are willing to support their employee, though it completely violates any right to privacy. Another source of risk is husbands or boyfriends forcing testing on their partner or guardians on their wards/children. Because there is some risk, does not warrant eliminating the option.

8. " The possibilities for abuse in countries like Uganda are endless - - This is a country where people are still killed for being HIV positive. It's not uncommon for people with HIV to be ostracized, beat and/or thrown out of their homes and villages. - - Some men blame their HIV infection on their wives..."
COMMENT: Yes, the things you describe do happen in Africa. We feared these things when pushing patients to disclose their status at home. But these things were the exceptions and not at all the rule; fear of them occurring did not warrant discontinuation of promoting disclosure which resulted in support from family and partners 99% of the time.
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Comment by: Sam (Denver) Thu., Jun. 7, 2012 at 12:59 am UTC
Fine. You can have this d*** test In South Africa. In the US, where your employer pays your healthcare and thus has a vested interest in discrimination, where counseling is more often better than not, it's a terrible idea!

Comment by: Krista Dong (KZN, South Africa) Mon., Jun. 4, 2012 at 5:52 pm UTC
1. "The only saving grace in this situation is that the test may be too expensive for many."
COMMENT: We are developing an HIV self-test kit that will be either free or easily accessible to the poor in Africa and other RLSs"

2 "When you're tested for HIV in a clinic or testing center, you have a trained professional to assure you"
COMMENT: Too often not the case. The 'Seed Study" reported that ~80% of counseling sessions with HIV testing in South Africa are inadequate. With overworked, undertrained, under supported oft volunteer or meagerly stipended lay counselors, working in facilities that don't permit confidentiality, unfortunately patients too often do not get the sensitive and supportive care you describe.

3. "Pre and post test counseling is mandatory not optional, for reasons."
COMMENT: Studies have shown that pre-test counseling does not change outcomes, thus is not mandatory.

4. "OraSure's answer to the counseling issue is an optional 24/7 hotline. Really, it's just not good enough."
COMMENT: Why isn't that good enough? Why can't persons have the choice to have counseling or not? To request assistance with performing the test or not? This is empowerment, giving the dignity of choice.

5. "Even if they do read the insert, most people who will take the test at home will do so because they don't want to interact with someone else during the process."
COMMENT: Our preliminary results with over 200 patients confirm that people avoid facility based testing at their local clinics bcs of the perception that quality of care is not good, won't be confidential and/or that they will know someone there. Participants uniformly liked being able to call someone anonymously to get accurate information. Additionally (and also important) was that counselors preferred delivering remote phone counseling. In high-burden settings, having to give positive test results day after day can is incredibly wearing and leads to rapid burn-out.
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Comment by: Colin R. (Holland, Pennsylvania) Sun., Jun. 3, 2012 at 10:34 pm UTC
I foresee numerous problems that will stem from an over-the-counter, do-it-yourself at home HIV test.

When I myself was diagnosed in 1993 at the National Institutes of Health, from the moment I was told of my HIV-positive status, I was forbidden to operate my own vehicle to drive myself home.

Prior to that moment of being given my HIV-positive diagnosis, I had been in the NIH for two months of research and was permitted to drive home on weekends.

However, based on their EXPERIENCE, the NIH had learned that too many people drove themselves over the first bridge they came to after getting their HIV-positive diagnosis.

The NIH is a renowned medical facility with expertise regarding numerous medical issues.

This was not merely an "educated guess" that people are very possibly in a more vulnerable and fragile state of mind... it was based on FACTUAL ACCOUNTS of people taking their own lives!

People that have been in favor of this test being approved have told me that the 800 number telephone help line printed on the box is the safeguard that's in place to help with this foreseeable problem. I'm sorry, but that's a poor and irresponsible excuse ... A person in that state of mind just might not be up to making a phone call at that moment!

As if the possibility of increased suicides isn't enough to see that this Over-the-counter, Do-it-yourself, in the privacy and solitude of your own home, HIV test is a bad idea, consider now the possible misuse if this test:

Imagine the possibility of employers, or potential employers using this test on the spot to decide if a person gets a job... or keeps the job they have.

Perhaps we will see a few more people getting tested... but at what cost? It's going to cost far more than the retail price of the test itself.
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Replies to this comment:
Comment by: Randall Thu., Jun. 7, 2012 at 12:55 am UTC
"but at what cost". So true! Too often, the mantra is "get tested", repeated again and again. The truth is, most people have no idea wtf they're supposed to do if the test is positive. Thats what the counseling is thre for. It adds vale to the test that we keep pushing. No one seems to be asking who all this testing is for exactly.

Comment by: Larry F. (Knoxville,TN) Sun., Jun. 3, 2012 at 4:02 pm UTC
As a certified HIV tester I do not support the at home test. I have serious concerns because of the stigma of this virus that people will not call the 800 number to self report and then there is the issue of denial also. On top of those is the lack of vital counseling and linkage to care that currently comes with testing now. There are still people who think HIV/AIDS is a death sentence and a positive result with at home may cause them to go into a deep depression and maybe cause suicide.
I just don't feel like a lot of these issues were thought about when discussing the approval of these home kits.
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Comment by: Ivan (Europe) Sat., Jun. 2, 2012 at 6:06 am UTC
A positive HIV test result in a clinic or in a testing center puts an individual into "viral underclass" , i.e. people with degraded human rights who will face pre-judgment, marginalization, discrimination and criminalisation, to whom societies may or may not provide medical care.

Read Sean Strub's article "Take the Test -- and Risk Arrest?"

This is today the NORM everywhere in the world - in the U.S. or outside the U.S. and this is why people are delaying going to a clinic or to a testing center for an HIV test. They simply want to have an illusion that they are citizens with full rights as long as their health does not start to deteriorate.

So dear Jeannie Wraight, get real before you start this nonsense campaign !
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Comment by: Jeannie Wraight (Bronx) Sun., Jun. 3, 2012 at 12:45 pm UTC
HIV criminalization is a huge issue but in the end has little to do with HIV home testing other then a general sense of not wanting to know and deal with your status for fear of criminalization.

No doubt there is a 'class' you are put into by some once you have tested positive. What you are saying then is people should not go for treatment either. When going for treatment and care your identity is clearly known. When being tested in a testing site or clinic you do not have to give your name. You can choose to be tested anonymously. If that is not so in every country then THAT is something we need to make happen. No doubt there is a lot of stigma around the world but this test will only lead to a further sense of isolation as many people will take the home test, take no further action until they're sick and live with only the negative aspects and self view of being a person with HIV without the support and knowledge we gain through education and our community.

Wanting to have the illusion of being HIV negative leads to the continued spread of HIV and is not something we should strive to support.

Comment by: Scott (Indianapolis, IN) Fri., Jun. 1, 2012 at 11:50 pm UTC
I, too, have noticed many poz folks are against this test. They have the same concerns about no counseling at home will make people have unprotected sex, yada, yada. These are the same people who will jump all over a newly diagnosed person for having feelings of blame toward the person they aquired the virus, saying you were an adult, knew the consequences, and don't expect people to hold your hand now. But, with this home test, they are now little kids who need someone to hold their hand. I don't understand those conflicting views.

We know the majority of folks don't learn their status, until they are sick with some OI in the hospital. Many of those people knew they should be tested, but just could not bring themselves to ask their doc since childhood for a test. This can be especially true for people living in very small towns, where news can travel with lightning speed. And, many are afriad to be seen going into the local STD testing center. People can say home testing promotes hiding HIV and testing should not be anything to be ashamed, but that just isn't the reality yet.

So, I am in favor of any way to get people to test. I am concerned about the accuracy, and not sure why the professional oral swab test couldn't be marketed for home use. And, I'm not sure what this mandatory counseling means. No one can force you to sit and get counseling. And, that counseling is often "you'll be fine," but isn't even heard, because many don't hear a word after learning they tested poz.

I want a highly accurate home test for people to be able to use at home, before hitting the sheets. People will say just use condoms and you won't have anything to worry about, but we know even those who aren't serial barebackers trust a new boyfriend/girlfriend when they shouldn't. This could prevent many infections--those infections where someone is pressured to have bareback sex (or hormones trump thinking)before they can get tested together.
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Comment by: Jeannie Wraight (Bronx) Sun., Jun. 3, 2012 at 2:21 pm UTC
Thanks for your comment. I can assure you, there are lots of people not in support of the HIV home test, including myself, that wouldn't jump on someone newly infected for any reason.

I'm very sure that before I tested positive I would have been very much in favor of this test. It's the experience of testing positive (as well as a lot of experience in HIV as a writer, activist, patient, service provider, web site manager and living in an HIV epicenter) that makes me know that this is a bad idea. It's experiencing the thoughts and emotions from being in that situation that makes me fear for those who will take this test at home. I understand how hard it is to walk into a testing site and that this test would make it easier and faster for some to find out they have HIV. It does have it's benefits. But I truly believe when you weigh the benefits against the detriments, the conclusion that this test should not be offered at home is clear.

Not every testing experience at a site or clinic is a positive one (no pun intended). There are crappy councilors out there. Training needs to be better and the bad ones weeded out. But saying you shouldn't have to see a pre and post test councilor because you should have the option of who you want to see is like saying you shouldn't see an oncologist when you have cancer because you like your primary care physician and are comfortable with them. People are trained in certain areas for certain situations. A pre and post test councilor is just a first step but a necessary one. After that whether or not to see a councilor is up to the individual but the job of pre and post tests councilors is suppose to be to provide that necessary step of what to do next.

People not getting tested is one of many complex problems we have. But offering a 'solution' that would cause further problems just isn't the answer.

Comment by: Brad O. (Washington, DC) Wed., May. 30, 2012 at 2:54 pm UTC
Your talking points are familiar, but not at all substantiated by data or facts. Just taking your three examples of what people "will think" (not might think, but "will"), you are basing this on what evidence? Or is it just rhetoric? These kinds of fear messages also do little to bring reasonable conversation to the fore. Self-testing is just an option and most likely to be used by people who have a mindset they are looking for information, as opposed to the mobile testing vans where testing is often an afterthought on the way to the bar and, despite policies of integrity are not always up to standards. There are places where testing options truly are limited and for repeat and educated testers, this is a great option. We always have to be careful not to project our own experiences as the reason things have to be a certain way for all people.

No doubt self-testing has challenges to it but we should be working together to embrace the challenges. Overwhelmingly is report after report people want the option and can use it well. That, certainly should count for something. Given decreased funding for tests or the higher costs for alternatives (Home Access is both more costly and not rapid), empowerment is all about options. We need to do away with the authoritarian messages of "mandated" counseling that is often little more than a script and intrusive questions from nominally trained counselors. Plus, consider, self-testing will allow people to sit with the counselor of their choice - perhaps the highly trained therapist they really trust rather than the 3-day trained person in a van. So if counseling is the issue, this can help with that as well.

It's time to embrace change. AIDS,Inc. has been stuck for too long.
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Comment by: Jeannie Wraight (Bronx) Sun., Jun. 3, 2012 at 2:48 pm UTC
As far as your comment "Overwhelmingly is report after report people want the option and can use it well. That, certainly should count for something" as I said in another comment on this blog, before I tested positive I would have wanted the option to. We learn as adults that wanting something doesn't equal it being the best or right thing for us. For instance, those that are negative and 'want the option' do not take into account that when testing at a testing site, whether anonymously or confidentially that the positive results are reported (though not the names) and the amount of funding the government provides is based on that number. If those people then go for services later on and find they cannot access them because there are more people than were considered when advocating the already dwindling funds, they might reconsider there 'wanting an option' to not be as important as accessing what they now need.

AIDS Inc. is to a good part who is behind this test.OraSure is offering this test without any regard to public health or safety. If they really cared about the people using it they would have done whatever was necessary to have the more accurate clinic test approved for home use, not one that tells people they are HIV negative when they are positive and vice versa at the rate this home test does. And if you think that many of the people who commented before the FDA were not connected with or paid by OraSure then you are definitely not seeing the big picture.

I used the words "many will think" opposed to your suggested "might think" as it is basically the same thing. I did not say "all will think" but how you can dispute that "many people will think they are going to die etc." I don't understand as it is a common and commonly known reaction. Not something I made up to justify my stance. It makes me question your motives in commenting.

Comment by: Bill Wed., May. 30, 2012 at 12:52 pm UTC
Another excellent article.

I've noticed Poz people usually oppose home testing, unless they've got some political axe to grind. They know that if someone receives a positive result, it is sufficiently complex and traumatic to require the presence of a professional.

By contrast, those who are negative overwhelmingly support this test. With the exception of a few who work in healthcare or have close contact with poz people, they cheer the added anonymity, and cite the fact that this would make an otherwise awkward test more convenient.

Both sides are correct.

Let's block out legitimate fears about this test's accurracy, noise about whether current counseling is sufficient and drop the question of what the first step of "getting help" really is. These issues are time sucking quagmires. We're left with the question of who this test is supposed to serve. Is it supposed to serve the negative or the positive?

Are we testing to give negative people peace of mind, or to alert positive people of a health condition?

The mere fact that society seriously considers the former question to be the relevant concern speaks to how degraded our value is to the world once we test positive. It also speaks to how delusional people are about their own prospects for testing positive, the shame surrounding testing and people's inability to empathize with those who are infected. There is no home Leukemia, Huntingtons or Lou Gherig's test. There are home tests for and some cancers, blood sugar and cholesterol, but they are understood to detect indicative abnormalities, not diagnose. No one would want that kind of information dropped on their laps alone. No one would be ashamed to ask for these tests from a professional.

The drive to create this test, and the fact that people would actually favor it, speaks to HIV's place in society. It is something we don't talk about, we don't think will happen to us and don't care about those it happens to.
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Comment by: Jeannie Wraight (Bronx) Wed., Jun. 6, 2012 at 6:36 pm UTC
Thank-you Bill, you make an excellent point.

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Jeannie Wraight

Jeannie Wraight

Jeannie Wraight (known as Jeannie Gibbs before her marriage in April 2011!) has been an AIDS treatment activist for over 14 years. She was a longtime member of ACT UP New York and has participated in countless demonstrations and actions. She has attended over 75 HIV conferences around the world and writes for several HIV publications. Ms. Wraight has sat on many advisory boards as well as the Board of Directors of Health People, an AIDS service organization in the South Bronx, New York. She lives with her partner in the Bronx, where she works on her Web site and advocates for novel HIV therapies and nutritional supplements for people with HIV/AIDS. She is also an animal rescuer.

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