Do it Yourself Swabs

I was approached by a med-tech start-up company regarding their self-collection device for at-home screening “to prevent cervical cancer and Pelvic Inflammatory Disease (PID)”.  The Eve Kit’s promo video and Indiegogo funding campaign explains the device and their motivation for designing it.

Violeta Cobo, Territory Manager, said that “HerSwab™ (the device that collects the sample) has been approved for self-collection of cervico-vaginal samples” by Health Canada.  The device is to be launched in late 2016.

The promo video raised a number of questions for me.

The device was registered with Health Canada for “safety, efficacy and intended use”, but as I explained to Jessica Ching, co-founder and CEO, the term “approved” is open to interpretation.

But that was only a quibble.

How exactly did they intend to test for cancer, HPV and “STIs which could cause PID”?  Was the device a Pap test?  An HPV DNA test?  A swab for chlamydia and gonorrhea?

Ms. Ching explained that the device is not a Pap test.  It can sample for either HPV or gonorrhea and chlamydia depending on which test the woman prefers.  To detect HPV, the device collects the sample from the upper vaginal canal.  The lab uses PCR amplification to test for high-risk strains of HPV.

However, because Pap tests use cytology when they sample from the cervix, I expressed some concern in case the self-sample result was inaccurate.  A meta-analysis concluded that self-sampling and physician sampling were equivalent; but studies are ongoing.

Regarding the self-sample for chlamydia and gonorrhea a small study (189 women) found their swab for “easy, comfortable” and “suitable for diagnosis”.

As to what happens after diagnosis, Ms. Cobo responded:

“When a patient gets a positive result, she gets referred to one of the doctors we are going to work with. The doctor will follow up with her and prescribe treatment or refer to a screening visit (in case of HPV) if needed.  She could also grant us permission to share the results with her family doctor if she has one.”

However, when I asked about the availability of those doctors, Ms. Ching admitted that to date there were very few with whom they have been able to partner.  The ideal, she added, would be to eventually offer follow-up across the country; however, one of the rationales for the product is precisely the dearth of health care providers.

Do women want to do it for themselves?

The promotional material for the $85.00 kit argues that women find testing “awkward” and that they may not have time to see a health professional.  They also see at-home privacy as a plus.

I asked Ms. Ching about research they had done into whether and why women would prefer at-home testing.  They did focus groups with 20 women and spoke with 50 others from whom they gathered anecdotal information.  She also mentioned focus groups conducted by the Dalla Lana School of Public Health and St. Michael’s hospital and commented, “Our informal findings did mirror the findings of other published studies”.  A CMAJ commentary asks whether the time for self-testing in Canada has come.

The CMAJ commentary poses the question from a public health point of view about women at risk in Canada who might truly benefit.

In Australia, self-testing will be available in 2017 – to targeted women.  For me, this is the real public health issue.  In Australia,

“Women who don’t normally get pap smears – including indigenous women, victims of sexual abuse and those who avoid the test for cultural or religious reasons – have the highest rates of cervical cancer.  These are the women who, from 2017, will be able to collect their own tissue samples in world-first changes to the country’s screening program”.

Targeted self-testing strikes me as an improvement on the selling points of awkwardness, privacy and time constraints.

In Canada as in Australia, the women who get cervical cancer are not screened regularly and/or do not have follow-up and treatment for abnormal Pap tests.  They are poor, marginalized and Indigenous.  The Canadian government’s response has been expensive vaccinations for girls (and in some provinces, boys) against HPV.  Women’s health advocates would prefer to see better access to screening and follow-up through Pap registries; and improved access to health care, especially in remote areas.  According to the CMAJ commentary, some pilot testing of self-sampling has already taken place for these high-risk women.

The value of health professionals

 As someone who worked in a sexual health clinic as a counsellor for three decades, I have one more issue.

When a woman came in for testing, I explained the Pap test, what it was for and how it was done.  In fact, I often accompanied her to the examining room to translate (Spanish, French and occasionally very inadequate Portuguese) and in some cases, to hold her hand, especially when there had been past sexual trauma.

Counsellors use an intake sheet which covers not just medical, but also sexual history.  We find out if the woman has a history of sexual abuse, if she has been having unprotected sexual activity, if it was vaginal, anal or oral, if she understands the difference between the Pap test and STI testing.  We find out which STI she should be tested for depending on her risk factors.  We tell her about contact tracing in case we find a reportable STI.  We explain that HPV is very common and that only certain types may lead to cervical cancer unless the abnormal cells are treated.

These conversations are critical in helping a woman take control of her health in a way that DIY testing cannot.

Given the cost and limitations, it remains to be seen what role self-testing might play in this country.

 

 

 

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Yikes. An STI Spike.

A recent story about a spike in Sexually Transmitted Infections (STIs) in Alberta piqued my interest, not so much because of the increase, but the reaction to it.  The Alberta Chief Medical Officer of Health, Dr. Karen Grimsrud, blamed “apps”: “We believe this is due to use of social media to set up sexual encounters,” she said, and added that social media tools are helping people communicate quickly to arrange anonymous sexual encounters.  While I agree with her follow-up statement – that anonymous encounters make it difficult to contact people for testing and treatment – I cannot join her in blaming a social media platform for a complex social issue.

After discussing the increase on CBC’s “The Current” , I decided to expand my thoughts.

Unprotected sexual activity

While it is true that apps make casual sexual relationships more accessible, you still have to make a decision about what’s going to happen – and how – whether you meet in a bar; or whether you meet online through a dating site or app.  Human behaviour is complicated; and human sexual behaviour is especially complicated when it comes to risk-taking.  Any sexual relationship, be it a one-time hook-up or longer term, requires clear communication.  Consent – ongoing, affirmative consent about the sexual activities that will occur should be established; and the level of safety with which both people are comfortable should be negotiated.  Should.

And yet, communication and negotiation are not always straightforward.  The result is risky behaviour.

The social determinants of health influence risk-taking.  Poverty, for example, is associated with increased risk-taking.  In my city, one can map the curve of teen pregnancy and STIs through the poorer neighbourhoods.  Internalized homophobia, current or previous abuse may also prevent a person’s ability to be assertive about safer sex because of low self-worth.

Of course, comprehensive sexual health education and the availability of sexual health clinics also play a crucial role.  Awareness and testing go hand in hand.

One, two, three testing

Why get tested?  Here are the basics.

Most STIs show no symptoms.  To be blunt, if you have had unprotected sexual activity, you need to be tested.  But you will not necessarily get an HIV test for example, unless you specifically ask for it.  That means you have to actually disclose your unsafe sexual practices.  Bacterial infections can be cured with antibiotics, but viral infections, although treatable, generally stay in the body.  The exception is Human Papillomavirus (HPV) which clears in the majority of cases.

Women may falsely believe they are protected because they have regular Pap tests.  But they are unaware that the Pap only looks for unusual cells on the cervix: it does not test for STIs.

Men may avoid testing because they are afraid they will be swabbed for Chlamydia and gonorrhea; clinics generally do a urine test.

There is no test for  (HPV) or a screening test for herpes.  You have to show your bump or sore to a doctor.  You may not even notice a sore on, around or inside the genitals, especially if it goes away.

Some people want testing so they can stop using barrier protection for vaginal or anal sex.  One of the reasons for an increase in chlamydia among young heterosexuals is that he drops the condom before testing once she starts using the Pill.

After testing, a couple can negotiate the sexual activities they are willing to have without protection.  If someone has a history of cold sores, for example (caused by herpes simplex virus – 1), they should tell their partner before offering unprotected oral sex.  (In the absence of a sore, one can still transmit HSV-1.)

Public Health initiatives

After the first Alberta STI spike in 2013, they came up with sexgerms.com .  “Plenty of syph” received a lot of attention, much of it negative.  The site has since been revised.  But it still refers, as do most educational materials, to “sex” rather than higher and lower risk sexual activities.  Moreover, the assumption is that “sex” means penis in vagina intercourse.  Skin-to-skin contact in the “boxer short area” is enough to spread HPV and HSV -1 and -2.

Since we’re not going to plastic wrap our entire bodies, there is always some risk involved.

But health authorities are not always realistic.  Dr. James Talbot, former Chief MOH of Alberta interviewed during the 2015 STI spike called for:

  • no unprotected sex
  • abstinence
  • mutual monogamy
  • condoms

This is not a risk reduction strategy.

There is no point encouraging unrealistic, unattainable goals.  In 30 years of clinic work, I can count a handful of people who used condoms for oral sex, most of whom were sex workers.  So when I talked with men who had sex with men, I explained that if they were having multiple oral sex partners and not using condoms, they needed to be tested more frequently for syphilis, which could be treated and cured.  This is a concrete way to prevent HIV transmission.

Older folks get frisky, too

The Current discussion  touched on seniors and safer sex.  The statistics for seniors are becoming alarming.  Statistics show increases in incidents of syphilis, chlamydia and gonorrhea in adults 45-64.  Alex McKay of SIECCAN mentioned an ongoing study of middle aged Canadians, indicating that condom use for this group is “staggeringly low”.

Older people may be even less able to communicate about STIs than teenagers or young adults.  Heterosexuals may have used condoms in the old days for pregnancy protection, rather than out of concern for STIs.  They may (erroneously) assume that a new sexual partner was monogamous during their former long-term relationship.  They may also be learning the dating game the “hard” way.  A 2010 study discovered that men who use erectile dysfunction drugs such as Viagra have higher rates of STIs in the year before and after use of these drugs.

Older women whose vaginas may have lost elasticity and the ability to lubricate may be at higher risk for STIs including HIV.  Potential abrasions during vaginal intercourse may allow the entrance of viruses and bacteria.  Prolonged vaginal intercourse with a Viagra inspired partner may not help either.

 True prevention

Rather than app bashing or unrealistic expectations, let’s just apply good old public health policy.

Here is my short wish list to prevent STIs:

  • ensure comprehensive sexual health education across the country
  • eliminate poverty, sexism, sexual abuse, homophobia and transphobia
  • adopt harm reduction as a national strategy
  • establish sexual health clinics from sea to sea to sea

That’s not a lot to ask, is it?

 

Chickens coming home to roost

If you have a cervix, read this.

In 2013, I wrote a blog on new provincial and federal cervical screening guidelines (https://springtalkssex.wordpress.com/2015/01/08/confused-about-pap-tests-july-2-2013/) partly because women’s health advocates were worried that these updated policies were putting women at risk in order to save money.  There was no risk, in my opinion, in delaying the initial Pap or from the longer interlude between screening tests.  But there certainly was a risk: not informing women of the difference between cervical screening and Sexually Transmitted Infection (STI) testing.

Because most Human Papilloma Virus (HPV) infections resolve on their own, research indicated that earlier and annual testing did not decrease sickness or death from cervical cancer.  Even high-risk HPV infections that cause cellular changes on the cervix tend to resolve on their own without treatment.  Cervical cancer develops when there is persistent infection with a high-risk type of HPV in the presence of co-factors like a suppressed immune system.  Pap testing (and/or HPV testing) indicate when treatment is necessary to prevent its development.

When Cancer Care Ontario (CCO) published fact sheets to inform the public about the new guidelines, I contacted them to point out that they also needed to provide information about the importance of STI testing.  It was obvious to me at the time that there would be repercussions.

I had been selling the annual Pap as part of sexual health education classes for years.  Suddenly, young women (including trans men with a cervix) were being told they didn’t have to start till they were 21 (Ontario) or 25 (federally); and they didn’t need to have a Pap every year.  So, of course, many stopped having internal exams until they were told they had to.

Young women, in my experience, especially those whose annual Pap test coincided with – and in some cases were dependent on – their birth control pill renewal, had no idea what was going on during their internal exam.  Despite the efforts of sexual health educators in the classroom to distinguish between the Pap test (checking for abnormal cells on the cervix) and STI screening (swabbing the cervix and inside of the vagina) when they arrived at clinic for their exam, counsellors had to take the time to explain it again. It is not clear if Physical Education teachers and family physicians today consider it important to educate about this important difference.

So what’s the big deal?

The importance of the distinction becomes clear when we look at the statistics.  According to the lead researcher of a recently published article on this issue (see below), over the past 10 years, chlamydia and gonorrhea rates in Canadians rose by 72 and 53 per cent, respectively, especially for chlamydia.  The highest number of cases of chlamydia are diagnosed in young people between the ages of 15 – 24.  The increase in diagnoses was in part due to Public Health Units encouraging an increase in testing in the early 2000s.  The urine (NAAT) test (v-e-e-ry appealing to men) also brought in more young people for testing.  One of the suspected behavioural reasons for the increased number of cases was less condom use among older adolescents and young adults who made the switch from condoms to hormonal contraception without being tested first.

Untreated chlamydia, which is commonly asymptomatic, can do serious damage to the Fallopian tubes.  Moreover, untreated STIs which provoke an increase in white blood cells at the site of the infection, make it easier for HIV to enter the bloodstream.

Here come the chickens

St. Michael’s Hospital in Toronto raised the alarm about a decrease in testing in their recent study (http://www.sciencedaily.com/releases/2015/10/151015144701.htm).  The lead researcher said, “…we found that women weren’t visiting family physicians as often for Pap tests, causing a drop in STI screening as well.  Female patients were also less likely to be screened for syphilis, hepatitis C and HIV under the new guidelines…”

When I contacted Cancer Care Ontario to complain about the lack of information on the importance of ongoing STI testing, the woman I spoke to thought it would be confusing to try to explain the difference between the various types of testing.  Prior to writing this blog, I re-visited the CCO web-site looking for what I hoped would be updated literature.  There is still no mention at all of STI testing.

The takeaway for readers with a cervix is this: if you have had unprotected sexual activity, whether you have symptoms or not, see your health care provider even though it is not time for your Pap test.  They will look at your genitals; they will test you for chlamydia and gonorrhea and any blood-borne infections you may have been exposed to.

As for me, I guess it’s time to contact CCO medical directors encouraging them to read the St. Michael’s study.  I wonder if they still think it’s too much for women’s brains to handle.

Read more here:

Cancer Care Ontario information on screening: https://www.cancercare.on.ca/cms/One.aspx?portalId=1377&pageId=9550

There’s an app for that – October 2, 2013

Having worked in a sexual health clinic for so many years, I thought I had seen and heard it all, including imaginative self treatment for various bumps and secretions—following self-diagnosis. Only when these treatments repeatedly failed, would they come to the clinic, saying, “I researched it.”This usually meant they had done a Google search and landed in Wiki land. However, I applauded the do-it-yourself approach when a client told me she was using an app on her smart phone to chart her menstrual cycles (e.g., Justisse Charting App). I also approved heartily when some Public Health Units started using e-cards to inform infected partners they should get tested.

But an app for diagnosing sexually transmitted infections (STIs)? That’s where DIY may cross the line.

Wired Magazine interviewed the Swedish orthopedic surgeon who developed an app that would allow users to take pictures of suspicious spots on the skin (e.g., unusual moles) and send them for interpretation to a licensed dermatologist in Europe. One dermatologist interviewed on CBC about this technology dismissed it as highly unreliable for finding precancerous conditions. But while this may discourage some from using the app for serious dermatological problems, others have found a different use:  sending pictures of unusual spots on their genitals, specifically to diagnose STIs.

No doubt it’s important to be knowledgeable and sensitive to changes in one’s body, but also clear-eyed enough to know when to see a health-care provider. And we need to encourage people to see a professional when there is any change in the appearance of the genitals or their secretions. But when even health-care providers can be fooled by infections like syphilis, which has been called “the great pretender,” we need to question the usefulness of this method of diagnosis. The STI app claims, according to the article, to allow people to “spot syphilis, genital warts, herpes, and other sexually transmitted infections.”

This seems a rather far fetched promise. Suppose the doctor who receives the photo responds, “don’t worry; it will go away”?

STI symptoms may resolve on their own, but the infection may remain. For example, syphilis chancres, which are painless lesions, disappear as does a syphilis rash. However, this does not mean the infection is gone. Syphilis may remain latent for years, eventually attacking the body’s organs and nervous system.

A herpes sore also disappears (at least till the next time). So though one could guess that a recurring sore in the same spot might be herpes, the best way to diagnose and type its strain is by having a health-care provider take a swab, not by pointing your cell phone camera at it. It is important to determine the type of herpes infection present, because genital herpes (as indicated in earlier blogs) may be caused by unprotected oral sex by a person with a history of cold sores (HSV-1).  It is a lot less likely to pass on this type of herpes genitally than to pass on HSV-2; and it recurs less frequently. This is a clear case of a picture speaking less than a thousand words.

Moreover, diagnosing an STI is only one part of the process. Being sure the proper diagnostic tests are done, counselling and educating a person with an STI, treating them with the correct medication as well as encouraging them to tell their partner(s) are all part of the services offered by health-care providers.

A person newly diagnosed with herpes, for example, may feel shocked and stigmatized; important information about transmission may not sink in. They may need to return for further counselling. By the same token, clients who are told they have warts, caused by Human Papillomavirus (HPV), may be terrified they will get cancer which is, of course, unlikely [See my article on HPV]. The STI app surely cannot provide these important services to those feeling alarmed by what they’ve seen and photographed.

So, while there is plenty of good information and there are plenty of tools out there, let’s be rational, and inventive. The takeaway message? If there is a fire down below or anything that concerns you, get it checked out—in person.