Bloodborne HIV: Don't Get Stuck!

If a hospital or clinic infects you or your child with HIV, you’d probably call it a disaster. Health care bureaucrats and managers call it an “adverse event.”  How often do patients get HIV from health care in Africa? The World Health Organization (WHO) has estimated it happens 50,000-100,000 times each year.  Other estimates are higher.

That’s a lot of “adverse events.” In more than 25 years, no international agency, no donor health aid program, and no African government has done the right thing to stop them.

When a department of health finds one or several unexplained HIV infections in patients that can be traced to a suspected hospital or clinic, the recommended “textbook” response is to investigate — to invite others who attended the same facility to come for tests to see how many, if any, others are infected. By finding others infected in the same outbreak, an investigation can pin-point the errors that did the damage. This alerts health care workers to fix things they didn’t know were problems, and warns patients to demand safe care. In this way, investigations save lives.

Consider the response to “adverse events” in other countries. For example, although the US health care system is not the best or safest in the world by a long shot, US state and federal governments have been doing the right thing in response to unexplained infections of hepatitis B and C virus. In health care settings, these viruses transmit just like HIV – from patient-to-patient through blood-to-blood contact when doctors and nurses reuse instruments without sterilization.

In 10 years from 1998 through 2008, the US Centers for Disease Control (CDC) recorded 33 investigations of hepatitis B and/or C transmission through health care in clinics, nursing homes, etc. Each investigation tested from 4 to >12,000 patients. The 33 investigations found a total of 448 hepatitis B and C infections from health care (average of 13 infections per outbreak). During the next 3 years, 2008-11, 32 investigations (including 3 from the previous list plus 29 new ones) invited a total of more than 90,000 patients to come for tests and identified a total of 217 infections (average of 7 per outbreak).

Did these investigations scare people to stay away from health care? Maybe some people got scared. But the real impact goes the other way: The fact that government is alert to investigate unexplained infections assures the public that someone is watching.

Consider the alternative – what happens when there are no investigations? Not investigating unexplained infections is like smelling smoke, ignoring it, and letting the house burn down. Or yelling at your dog to be quiet when she barks at night – and waking up to find your motorcycle missing.

Aside from a few HIV infections traced to blood transfusions, there have been no investigations of any of the thousands of recognized HIV “adverse events” in Africa. During 1991-93, for example, a WHO study in Rwanda, Tanzania, Uganda, and Zambia identified 61 children aged 6-60 months who were HIV-positive with HIV-negative mothers. There is no report of any investigation in any of the four countries to find the source of these unexplained infections. Incredibly, the WHO study team concluded “The risk of nosocomial [hospital-acquired]…HIV infection appears low among these populations.”

Ideally, foreign experts and agencies would be at the forefront to help with investigations. That has not happened.

Lack of interest on the part of international agencies and donors leaves African governments with the task. Which government will take the lead to begin to investigate unexplained HIV infections? Investigations are not expensive in monetary terms – but they may ruffle feathers. Someone has to push — to persuade health care bureaucrats to recognize and investigate HIV “adverse events.”

This was written together with Joseph Sonnabend [go to or return to first circumcision page]

In 2010 there was a great deal of outraged comment about the US government’s award of $823,000 to an HIV related project in Africa. Specifically, the taxpayer dollars were to be used to teach uncircumcised African men how to wash their genitals after having sex. The grant states; “If we find that men are able to practice consistent washing practices after sex, we will plan to test whether this might protect men from becoming HIV infected in a later study.”

The reasoning behind the project was based on the assumption that the reported protective effect of male circumcision was due to improved genital hygiene. This is in the project description:

“The protective effect of male circumcision on HIV acquisition may be due to improved genital hygiene. We propose to evaluate the feasibility of a post-coital genital hygiene study among men unwilling to be circumcised in Orange Farm, South Africa. Men in high prevalence settings could potentially benefit from improved genital hygiene if this intervention proved to be efficacious in reducing HIV acquisition risk” Genital hygiene was to be improved by asking men to wash their penis after sex.

Widespread criticism of such a use of public funds might have missed the main problem. As it turns out, not washing immediately after sex may actually have a significant protective effective for men at risk from heterosexual intercourse – including both circumcised and uncircumcised men

This was noted in two randomized studies of male circumcision to prevent HIV infection in the Rakai region of Uganda in 2003-2007. Although the effect of washing on HIV acquisition received some media attention at the time its relevance to HIV prevention remained generally unnoticed. It apparently also remained unnoticed or considered to be of no consequence to the applicants as well as the funders of the $823,000 grant noted above.

Combining results from these two trials, Tobian and colleagues in an article in AIDS in 2009 report information on risks for 105 HIV seroconversions in 6,396 initially HIV-negative men observed during 9,604 person years (PY) of follow-up. Half the men were circumcised for the trial and half remained uncircumcised.

These 105 HIV seroconversions represent 1.09 infections per 100 PY.

Among the questions that trial participants were asked in attempting to define risks for HIV infection was whether or not they washed their genitals after sex.

Among men who did so there were 1.35 infections per 100PY compared to only 0.38 infections per 100PY among men who did not wash their genitals. The adjusted relative risk for washing vs. not washing was 3.04 (95% confidence interval: 1.11-8.33; P = 0.031).

The authors make the following comment in their discussion,

“The finding that HIV incidence was increased with washing genitals after sexual intercourse is counterintuitive, but supports previous finding that washing the penis within 10 min of sexual intercourse increases the risk of HIV acquisition among uncircumcised men. The increased HIV acquisition with penile washing may be due to the removal of acidic vaginal secretions or the addition of water with a neutral pH may assist HIV survival and infectivity”.

The “previous finding” referred to is an earlier report by Makumbi and colleagues in 2007, who interviewed 2552 uncircumcised men enrolled in the control arm of a randomized trial of circumcision for HIV prevention in the Rakai region of Uganda (these men are included in the data reported by Tobian and colleagues in 2009). Some of the information reported by Makumbi and colleagues is shown in the last four slides in this presentation prepared by i-Base, UK.

This is one of the slides showing that there were 2.32 HIV infections per 100PY among men who washed their penis within 3 minutes of intercourse, but only 0.39 infections per 100PY among men who waited for 10 minutes or longer before washing.

If we were to express the efficacy of delayed washing in the same way that the results of PrEP trials were reported, that is as relative risk reductions, this would mean that not washing immediately, but waiting for at least 10 minutes after intercourse before washing can reduce the risk of infection by 83%. Compare this to the 44% efficacy of Truvada in the iPrEx trial, the 39 % efficacy of tenofovir gel in reducing the risk of infection in women in the Caprisa 004 trial, and the 38-66% efficacy reported for circumcision over 24 months.

Genital washing after sex may be quite common in parts of Africa. A study in Nairobi in 2004 found that a majority of men washed their genitals after sex. Here is a link to a table in the report; 60% of men reported always washing their genitals after sex.

We have had evidence that this practice may contribute to the risk of HIV infection in men since 2007. We have to wonder if the many questions this raises have been addressed, or even considered.

Could the practice of immediate post-coital genital washing contribute to the risk of sexual transmission of HIV to men?

Are there regional variations in this practice, and could this be related to HIV prevalence to some extent?

Should there be a debate on the evidence by experts, with recommendations for further research – such as adding questions to on-going or proposed studies, laboratory testing of HIV viability in semen and vaginal fluids at body temperature or conducting a trial to nail down the risk of immediate washing, or in other words, the protective effect of delayed washing?

If immediate washing increases the risk of infection does this not raise the question of the extent to which infection occurs after withdrawal?

Considering how innocuous the intervention is do we have sufficient evidence now to advise African men at risk of HIV through heterosexual contact not to clean their penis for at least 10 minutes after sex? Should a dry cloth without water or soap be used?

The study teams for these trials have more information on post-coital penis cleaning that they have not reported. We know that for uncircumcised men, wiping was safer than washing, and waiting at least 10 minutes to clean significantly reduced risk for HIV (see the last several slides in this reference. But we don’t have similar details for circumcised men. What information has been collected but not reported?

We have evidence that a common practice, at least in certain regions can substantially increase the risk of HIV infection in men through heterosexual intercourse. Considerable attention has been given to newer prevention methods in the past few years, notably pre – exposure prophylaxis and male circumcision, but almost none to the simplest of procedures that may be even more effective in preventing the sexual transmission of HIV.

Many other questions and concerns will no doubt arise as more people look at the evidence, and figure out what to do about it. Lives are at stake. Scientific competence and integrity are also at stake – researchers have overlooked and/or incompletely reported information that could save lives.

[go to first injections page] [Note: Stephen F. Minkin (sfminkin@yahoo.com) submitted the following as a guest blog.]

The CDC [US Centers for Disease Control and Prevention] first reported on four large outbreaks of hepatitis B and hepatitis C at outpatient medical facilities between 2000 and 2002. Two outbreaks occurred in a private physician’s offices in New York, one at an Oklahoma pain remediation center, and one at a hematology/oncology clinic in Nebraska. A total of 247 patients were known to have been infected at these facilities.

In addition, unsafe practices were uncovered at a phlebotomy center in California in 2001, where needles for drawing blood were reused. As a result, 15,000 people had to be tested for HIV, hepatitis B, and hepatitis C.

Two more recent outbreaks discovered in Nevada and New York garnered considerable media attention. In November 2007, reports surfaced that a New York anesthesiologist reused syringes when withdrawing medicine from multi-dose vials. In the process he potentially exposed thousands of patients to blood-borne viruses. On December 14, 2007 the New York Department of Health contacted approximately 8,500 patients exposed by this practice and urged them to be tested for Hepatitis and HIV.

On February 29, 2008 health officials in Las Vegas closed the Endoscopy Center of Southern Nevada after six patients were diagnosed with hepatitis C.  The outbreak was traced to nurse anesthetists reusing syringes to draw up medicine from single use vials for multiple patients.

According to the CDC,

A clean needle and syringe were used to draw medication from a single-use vial of propofol, a short acting intravenous anesthetic agent.  The medicine was injected directly through an intravenous catheter into the patient’s arm.  If a patient required more sedation, the needle was removed from the syringe and replaced with a new needle; the new needle and old syringe was used to draw more medication.

This was a “common practice” at this center for at least 4 years. As a result 40,000 patients were potentially exposed to this risk of hepatitis and HIV infections.

The CDC suggests two possible ways the syringes could have been contaminated.

Backflow from the patient’s intravenous catheter or from needle removal might have contaminated the syringe with HCV (hepatitis C) and subsequently contaminated the vial. Medication remaining in the vial was used to sedate the next patient.

Investigators concluded that each of these outbreaks resulted from “unsafe injection practices primarily the reuse of syringes and needles or contamination of multiple-dose vials leading to patient to patient transmission” (page 901 in this link).

The changing of needles while reusing the syringe is very, very risky and is not a WHO recommended practice (page 35 in this link).

The 2002 Oklahoma outbreak was traced back to a nurse anesthetist supervised by an anesthesiologist at a hospital outpatient clinic. In response the American Association of Nurse Anesthetists (AANA) mailed copies of the AANA Infection Control Guidelines to its members. 

The organization also hired a research firm to conduct a random telephone survey of Certified Registered Nurse Anesthetists (CRNAs) and anesthesiologists “to learn more about practices and attitudes on needle and syringe reuse.”  A spokesperson termed the finding as “eye opening.”

Among the different categories of health professionals surveyed, 3 percent of anesthesiologists who responded indicated they reuse needles and/or syringes on multiple patients. CRNAs, other physicians, nurses and oral surgeons reported reuse at 1 percent or less.

Extrapolating the survey findings – 3 percent of anesthesiologists plus 1 per cent of CRNAs – equated in 2002 to approximately 1,000 anesthesia professionals who might have been exposing more than a million patients to the risks of contaminated needles and syringes.

They were forced to revisit the problem of the reuse because of the events in New York and Nevada. On March 6, 2008, Dr. Wanda Wilson, the AANA President, commented on the sad state of affairs.

It is astounding that in this day and age there are still nurse anesthetists, anesthesiologists and other health professionals who still risk using needles and syringes on more than one patient, or know of such activities and don’t report them. Published standards and guidelines dictate that single-use and disposal of these products is the best way to ensure patient safety. Patient safety is our primary focus – not cost savings, time savings, or any other factor

If the hepatitis C outbreaks in New York and Nevada demonstrated anything, it was that such incidents occur regardless of a provider’s degree, credentials, or title.  For any group to suggest otherwise is to put its collective head in the sand—it is irresponsible, negligent, and a sure invitation for yet another Nevada or New York situation to occur.

A 1990 study by Canadian researchers experimentally examined the risk of cross infection related to the multiple use of disposable syringes connected to IV tubing during anesthesia.  The authors were motivated because  “the practice of reusing disposable plastic syringes for several patients is still prevalent in North American operating rooms despite warnings about possible hazards.”

In some operating rooms, the usual practice is to reuse disposable syringes while changing needles.  This practice is based on the assumption, that since only needles enter the injection site, it is the only part that can be contaminated.  A high proportion of reused syringes were contaminated even if only the needle had contact with blood.  The probable mechanism of contamination is by aspiration into the syringe of blood remaining in the needle because of the negative pressure generated while removing the needle.

In view of these finding the authors emphasized that “changing needles alone is a useless procedure to prevent contamination.”

CDC PUBLIC HEALTH SYRINGE ADVISORY

[go to or return to first circumcision page]

Last week, while looking for something else, I ran across a report that has big implications for HIV/AIDS prevention in Africa: Almost five years ago, a trial of circumcision to protect men in Rakai, Uganda, reported that intact (uncircumcised) men who waited at least 10 minutes after sex before cleaning their penis were at less risk to get HIV than men who had been circumcised: intact men who waited to clean got HIV at the rate of 0.39% per year compared to 0.66% per year for circumcised men. Although the study team reported these results to an international AIDS conference in 2007, and several newspapers wrote about it at the time, the report has dropped out of view. That is a big mistake.

Why is this report important? Here are three reasons.

First, if you are intact, this report says you don’t need to get circumcised to reduce your risk to get HIV. Use a condom, of course, if your partner has or might have HIV. But if that fails, this report says you are as safe with a foreskin as you would be without one. Just don’t clean your penis for at least 10 minutes after sex, and then wipe it with a dry cloth, without water. A later report from the Uganda study team suggests waiting to clean is good for all men, both circumcised and intact: men who didn’t “wash genitals after sexual intercourse” got HIV less than 1/3^rd as fast as men who did.

Second, if you are a politician or public health official who is considering whether to go along with the largely US-promoted program to circumcise 20 million African men by 2015, you can take another close look at the evidence and options. The evidence that advocates use to promote circumcision comes from three studies (in South Africa, Kenya, and Uganda during 2002-06) that recruited thousands of intact, HIV-negative men, circumcised some and not others, and then followed and retested them to see who got HIV. All three studies reported that circumcised men got less HIV. But the study team for at least one of those trials – the trial in Uganda – has data showing that intact men who waited to clean after sex got less HIV than circumcised men.

Circumcision is expensive and dangerous and takes doctors and nurses away from other tasks. Why put scarce public resources into campaigns to circumcise millions of men if you can get the same results by advising men to use condoms, and if that fails to wait least 10 minutes after sex before wiping their penis with a dry cloth?

Third, this is another example of people reporting important evidence that contradicts well-funded misinformation about HIV risks. WHO, USAID, and other organizations pay for a lot of messages – some are true and helpful, but some are at best only partial truths. It’s important for people to speak up when they have good information about how to avoid HIV risks, even though what they say disagrees with the official “line” at the time.

Here are some examples of truth meeting official misinformation.

WHO warns UN employees they might get HIV from health care in Africa, but doesn’t warn the African public. But not everyone goes along with such misinformation. For example, Demographic and Health Surveys finds and reports HIV-positive children with HIV-negative mothers (in Mozambique, Swaziland, and Uganda) and virgin men and women with HIV. As more people speak up, Africans hear that a lot of infections come from minor blood exposures, and learn how to protect themselves.

Another example of official misinformation is WHO’s continuing promotion of Depo-provera injections for birth control without warning Africans that good evidence shows – and many experts believe – using Depo-provera increases a woman’s risk for HIV. One expert who has spoken out – eloquently and repeatedly – on this issue is Paula Donovan, a former high-ranking UNICEF official, who has had the heart and courage to challenge official misinformation.

Circumcision is another issue with a lot of well-funded misinformation, but also with many people speaking out to set the record straight (eg, see the article by Daniel Ncayiyana, editor of the South African Medical Journal, in this link). Unfortunately, crucial evidence is still unreported from the three key trials of circumcision to protect men: A lot of men in the trials got HIV despite no reported sex partners – what were their risks? None of the three study teams has reported the HIV status of any of the men’s sex partners, and only two have reported minimal information about blood exposures.

As for waiting and wiping to reduce HIV risk, here’s the record of partial and incomplete information from the 2003-06 trial of circumcision to protect men in Rakai, Uganda:

13 December 2006: The US National Institutes of Health reported that men circumcised in the trial had 48% lower HIV incidence compared to intact men, WITH NO MENTION OF POST-COITAL CLEANING.

24 Feb 2007: The Uganda study team reports selected trial data in Lancet, concluding: “Male circumcision reduced HIV incidence in men… Circumcision can be recommended for HIV prevention in men.” THE ARTICLE MAKES NO MENTION OF WAITING TO CLEAN, WHICH THE TEAM’S UNDISCLOSED DATA SHOWED TO BE MORE EFFECTIVE THAN CIRCUMCISION.

28 March 2007: WHO announces recommendations from an experts’ meeting: “Based on the evidence presented…experts attending the consultation recommended that male circumcision now be recognized as an additional important intervention to reduce the risk of heterosexually acquired HIV infection in men.” SEVERAL MEMBERS FROM THE UGANDA STUDY TEAM TOOK PART IN THE MEETING. THERE IS NO INDICATION THEY TOLD ANYONE ABOUT THEIR UNDISCLOSED EVIDENCE THAT WAITING TO CLEAN WAS MORE EFFECTIVE THAN CIRCUMCISION IN PROTECTING INTACT MEN FROM HIV.

25 July 2007: Frederick Makumbi and several other members of the Uganda study team tell an international AIDS conference: Among intact men reporting post-coital cleaning with all partners, “HIV incidence was significantly higher among those reporting cleansing within 3 minutes (2.32/100 py [person-years]), compared to those reporting a delay of more than 10 minutes (0.39/100py [person-years…).” (The best source i have found for these data is the last several slides in this link.)

So there you have it: In December 2006, the Uganda study team reported that circumcised men got less HIV than intact men. Not until 8 months later, in July 2007, did they disclose evidence that intact men who waited to clean their penises got less HIV than circumcised men. Despite their 2007 report, the Uganda study team has continued to say that circumcision is the way to go, and has said nothing more about waiting to clean as an effective option to reduce HIV risk for intact men.

Africans facing HIV risks from both blood exposures and sex need good information. Well-funded official fountains of stigmatizing misinformation blame Africa’s HIV epidemics on too much sex and too many foreskins. But there are also a lot of people offering good information and evidence. As more people speak up – telling what they know about HIV risks, even if it does not coincide with the party line – the African public will get a better idea about HIV risks and how to protect themselves.

The International (formerly African) Network of Religious Leaders living with or Affected by HIV/AIDS (INERELA+) promotes SAVE as a response to Africa’s HIV/AIDS epidemic. SAVE stands for: Safe sexual and skin-piercing behavior; Access to treatment; Voluntary counseling and testing; and Empowerment. This note considers some of the ways that SAVE could strengthen HIV prevention in Africa.

AIDS was first recognized in Africa in 1982. In 2010, 28 years later, the World Health Organization (WHO) estimated that 22.9 million Africans were living with HIV, including 1.9 million with new infections in that year. These infections are not distributed evenly. The people most at risk live in cities in 15 countries, primarily in Southern and Eastern Africa. In these cities, from 20% to more than 50% of men and women aged 15 years today can expect to get HIV at some time during their lives.

Help husbands and wives stop intra-familial HIV transmission

Unlike Western countries, where almost all HIV transmission occurs outside families, a lot of HIV transmission in Africa happens within families – mother-to-child and spouse-to-spouse transmission together account for an estimated 45% of new infections.

(a) Mother-to-child transmission: According to WHO estimates, 390,000 babies in Africa got HIV from HIV-positive mothers in 2010, accounting for an estimated 20% of 1.9 million new HIV infections in Africa in that year (390,000/1,900,000 = 20.5%, rounded to 20%).

(b) Spouse-to-spouse transmission: An estimated 30% of all HIV-positive adults in Africa are married to HIV-negative partners, and the resultant spouse-to-spouse transmission accounts for approximately 470,000 HIV infections per year, equivalent to 25% of all new infections each year (470,000/1,900,000 = 25%). (A note at the end of this blog shows the source of these data and explains this estimate.)

Most Western experts continue to identify high risk groups in Africa, as in the US and Europe, according to extramarital sex – prostitutes, clients, truck drivers, and youth are considered to be at high risk because they have more than average levels of extramarital sex. But in Africa, none of these groups defined by extramarital sex has risks as high as babies born to HIV-positive mothers (without treatment, 35% are infected in 2 years) or spouses not aware their partners are HIV-positive partners (8% per year). In other words, the term “high risk groups” in Africa applies first and foremost to persons with intra-familial risks.

With good information and with some medical assistance husbands and wives can work together to stop 700,000 infections per year – reducing mother-to-child transmission by 320,000 (from 390,000 to 70,000) and spouse-to-spouse transmission by 380,000 (from 470,000 to 90,000; see the note at the end of this blog). This would reduce total HIV transmission from all causes by 37% – from 1.9 million to 1.2 million infections per year. There are two major challenges to achieve this outcome.

The first challenge is to reform and extend couple counseling. A lot of men and women don’t think they could have HIV because they and their partner have had very conservative sex lives. Many women who test HIV-positive are afraid to tell their husbands and/or assume they got it from their husbands, so there is no reason to tell them. The best way to overcome these testing problems is to make it clear – both in public messages as well as in counseling – that a lot of HIV in Africa comes from blood exposures. This is important for couples to know – it means an HIV infection is not a reliable sign of sexual behavior. It also means that conservative sexual behavior provides no assurance that anyone is HIV-negative.

It will take some work to get people to realize that their own or their spouse’s HIV infection might well have come from a skin-piercing event, because this realization has to overcome several decades of stigmatizing and misleading half-truths – blaming victims for their infections rather than acknowledging that unsafe health care has been an important part of the problem.

Once husbands and wives can go get tested and talk with each other about their HIV test results without distrust and blame generating family crises, then couples will be better able to plan for what to do to protect babies and uninfected spouses, and to care for those who are infected. Aside from changing messages to de-link HIV from sex, testing should be readily available, with or without counseling. People should be able to buy kits to test themselves (as in South Africa). Opt-out testing is a good way to go. However, compulsory testing is almost always a bad idea.

The second challenge is for governments and donors to prioritize prevention of mother-to-child transmission in allocating scarce resources for HIV prevention. Protecting babies will take a lot of money and medical personnel. This requires: testing pregnant women; testing husbands to get them involved; giving anti-viral drugs to HIV-positive women and their new babies; and helping HIV-positive mothers wean early (after 6 months is a common recommendation, but some may want to do so earlier or later). With these interventions, infected mothers will infect less than 5% of their babies, which would cut the annual number of infections from mother-to-child by an estimated 320,000 (from 26% to 4.5% of babies born to 1,490,000 HIV-positive mothers). Even lower rates of mother-to-child transmission can be achieved with anticipated new drugs or other options.

Whereas preventing mother-to-child transmission requires substantial assistance from outside the family, once husbands and wives know one of them is HIV-positive, they can protect the HIV-negative partner with little or no outside assistance. Condoms are almost 100% effective against sexual transmission (some studies reporting lower efficacy did not consider that condom-users might have gotten HIV from bloodborne risks). If the HIV-positive partner is eligible for antiretroviral treatment and achieves a low viral load, unprotected sex may be safe. If the wife is HIV-positive, circumcising the husband might reduce his risk, but he would not be safe without other protection (eg, condoms). Couples must also take care to avoid blood-to-blood contact through shared razors, toothbrushes, syringes and needles, etc.

Stopping HIV from getting into families

Extra-familial HIV transmission threatens families as well. Some men but many more women get HIV before they are married and bring it into the marriage. But that’s not all – even among old married couples, most couples with HIV are discordant. Husbands and wives continue to import HIV into marriages. According to Western ideas about HIV epidemics that have been imposed on Africa, all these infections come from sex. But those ideas don’t fit facts. Surveys find a lot of HIV in babies with HIV-negative mothers, in young and old virgins, and in men and women married for years with no outside partners and an HIV-positive spouse.

The best way to protect families from outside risks is to warn them about all risks, from blood contacts as well as from sex. African governments could improve these warnings by belatedly asking researchers and investigators to trace a lot of HIV infections to their source to see what risks are infecting babies, young women, etc — including especially people with limited and no sexual risks.

Conclusion: focus on the family

Whereas HIV in the US and Europe has been a tragedy for men who have sex with men and has largely avoided families, in Africa it hits families hard – weakening and killing husbands and wives, interfering with child-bearing, killing babies, taking huge expenses for treatment, and threatening family trust.

African families are strong and can carry much more of the burden to fight the epidemic. To do so, they need honest information – that an unknown but important proportion of infections comes from unsterilized instruments in health care and cosmetic services. Such messages not only allow people to see and avoid risks, but also make is easier for husbands and wives to test and to share HIV test results – the foundation for intra-familial HIV prevention.

Enlisting families to cut intra-familial transmission and supporting them with programs to prevent mother-to-child transmission could cut HIV transmission in Africa by an estimated 700,000 infections per year (37% of total transmission). This can be achieved with available budgets and personnel; but because these resources are limited, governments and donors would have to prioritize. One program that competes for money and personnel asks for $1.5 billion–$2.7 billion and several thousand surgical teams to circumcise 20 million men by 2015. Critics argue, inter alia, that condoms are more reliable. But even if one ignores the critics, circumcision looks like an expensive distraction: even advocates estimate the 20 million circumcisions would reduce annual HIV transmission by less than 200,000 (10% of total transmissions) in 2015 – far less than can be achieved with the intra-familial focus proposed in this note.

Statistical note: According to WHO, 19.8 of the total 22.9 million Africans living with HIV in 2010 were adults (page 210 of this link). From national surveys in several dozen African countries over the last decade, the percentage of adults with HIV who are married ranges from roughly 53%-77% for men and 49%-69% for women (see Table below). From the same source, the percentage of adults with HIV who are married to HIV-negative partners ranges from roughly 10%-25% in the worst epidemics in Southern Africa to 25%-35% in mid-range epidemics in East Africa, to 50% in countries with low level epidemics (see Table below).

From these data, an estimated 5.9 million HIV-positive adults (30% of 19.8 million adults) are married to HIV-negative spouses. In studies that followed discordant couples who were not aware of their infections, approximately 8% of HIV-positive partners infected their spouses each year. Thus, 5.9 million HIV-positive adults in discordant couples infect an estimated 470,000 spouses each year (0.08 x 590,000 = 470,000). Assuming that expanded testing and couple counseling reaches all discordant couples, and that they use condoms and take other precautions to cut spouse-to-spouse transmission from 8% to 1.5% per year, this would reduce annual spouse-to-spouse HIV transmission in Africa by 380,000 per year, from 470,000 to 90,000.

Table: HIV in adults, married adults, and married adults with HIV-negative partners (selected countries in Africa)

Source: data are from country surveys available at this link; click on the country, and then on DHS (Demographic and Health Survey) or AIS (AIDS information surveys.

(A posting for International Women’s Day, 8 March)

For many years, WHO, USAID, UNAIDS, and other international and foreign aid organizations have misinformed women in Africa about risks for HIV. Experts inside and outside these organization have challenged bureaucrats to tell women what they need to know to protect themselves. But to no avail.

WHO, USAID, and other official organizations have blocked three messages that could help HIV-negative women to avoid HIV and help HIV-positive women to retain family trust: (a) Depo-Provera injections for birth control may boost women’s risk for HIV; (b) skin-piercing procedures in health care may infect women with HIV; and (a) an HIV infection is not a reliable sign of sexual behavior.

(a) Risks with Depo-Provera injections

Beginning in the early 1990s, studies that followed and re-tested HIV-negative women to see who got HIV found that women taking Depo-Provera got HIV faster than other women (Depo-Provera, injected every 3 months, mimics the hormone progesterone). As early as 1996, the South African Medical Journal reported high level debates about whether to promote Depo-Provera in Africa.

Evidence of risk to women had no apparent impact on donors’ efforts to inject hormones into African women. From 1996 to 2009, the number of women given hormone injections (primarily Depo-Provera) increased across Africa, especially in countries with the worst HIV epidemics. For example, among partnered women aged 15-49 years, the percentage using injected hormones increased from 5.5% to 17% in Swaziland, from 12% to 19% in Lesotho, from 20% to 28% in South Africa, and from 7.7% to 22% in Namibia. These rates are extraordinary on a world scale – outside Africa, only 3.1% of partnered women used injected hormones for birth control in 2009.

HIV is not the only health threat linked to Depo-Provera. In 2004, the United States (US) Food and Drug Administration forced Pfizer, the company that makes Depo-Provera, to add a “black box” warning to packages of Depo-Provera sold in the US: “Women who use Depo-Provera Contraceptive Injection may lose significant bone mineral density… Depo-Provera Contraceptive Injection should be used as a long-term birth control method (eg, longer than 2 years) only if other birth control methods are inadequate…”

Despite evidence linking Depo-Provera to HIV (and other health risks), WHO designates Depo-Provera as safe for general use (except for women with specific serious health problems, such as heart disease or breast cancer). WHO’s claim that Depo-Provera is safe came under renewed criticism in July 2011, when a study among discordant couples (one partner infected with HIV, the other not infected) in Africa reported that women using injected hormones were more than two times as likely to get HIV compared to women not using hormones for birth control.

WHO didn’t budge. Seven months later, in early 2012, WHO declared the new evidence – along with all previous evidence – to be inconclusive. WHO reissued its advice that “women…at high risk of HIV can safely continue to use hormonal contraceptives.” WHO’s only nod to the evidence was to say “women using progestogen-only injectable contraception [primarily Depo-Provera] should be strongly advised to also always use condoms…”

Why would WHO not warn women? Paula Donovan, co-director of AIDS-Free World and a long-time former UNICEF and UN official, explains that UN officials “were afraid that African women might abandon hormonal contraceptives altogether” leading to “more pregnancies…more maternal deaths…unsafe abortions” and more infected babies. Citing and quoting several UN documents about women’s rights, Donovan charges that “WHO and UNAIDS have violated [women’s] human rights by withholding the information. They have failed to inform women that using hormonal contraceptives may carry some risk… Women have the right to make fully informed sexual and reproductive health decisions, whether or not the UN likes those decisions.”

In a later publication, Donovan reminds those who wish to promote specific birth control methods that “No global experts or family planning organizations have the right to censor the life-and-death information women need in order to weigh their own risks… Women need information: complete, uncensored, and factually correct.”

(b) Risks to get HIV from skin-piercing health care procedures

Just as international and foreign aid organizations don’t warn women in Africa about evidence that Depo-Provera increases their risk to get HIV, these organizations also don’t warn them about risks to get HIV from reused and unsterilized instruments during skin-piercing health care procedures.

From the time AIDS was first recognized in Africa in 1982, there has been a lot of evidence that women have gotten HIV during health care. National surveys find that many clinics and hospitals do not sterilize instruments. Studies link HIV to injections, operations, blood tests, and other skin-piercing procedures. And studies and surveys report unexpected infections – for example, among women aged 15-49 years in Congo (Brazzaville) in 2009, more women who claimed to be virgins were HIV positive (4.2%) than all women (4.1%).

It’s clear from what WHO and UNAIDS tell UN employees that pretty much everyone throughout the UN system knows that health care available to the African public sometimes transmits HIV. In a 2004 booklet for UN employees, WHO and UNAIDS warn (p. 9): “In several regions, unsafe blood collection and transfusion practices and the use of contaminated syringes account for a notable share of new infections.” But, “[b]ecause we are UN employees, we and our families are able to receive medical services in safe healthcare settings, where only sterile syringes and medical equipment are used, eliminating any risk to you of HIV transmission as a result of health care.”

Outside an approved clinic or hospital, WHO advises UN employees to (p. 23): “Avoid any procedures that pierce the skin, such as acupuncture and dental work, unless they are genuinely necessary. Before submitting to any treatment that may give an entry point to HIV, ask whether the instruments to be used have been properly sterilized.”

These organizations do not extend similar warnings and advice to African women. Just as not warning women about risks with Depo-Provera violates their human rights, similarly not warning women about risks to get HIV from unsterile instruments in health care violates their human rights.

(c) An HIV infection is not a reliable sign of sexual (mis)behavior 

Surveys and studies routinely find HIV-positive women who report no sexual exposure to HIV – some say they are virgins, others have an HIV-negative spouse and report no other sexual partners. The almost universal response to these findings by study teams has been that women lied – no matter what they said, they got HIV from sex.

By routinely disbelieving women, researchers protect and preserve the theory that almost all HIV in African women comes from sex. This theory – which grew out of racial stereotypes of sexual behavior and survives despite evidence – guides HIV prevention messages to misinform Africans that almost all HIV infections in adults come from sex.

What happens next completes a circle of distrust: These messages encourage men who are HIV-negative to think their HIV-positive wives got HIV from sex, no matter what their wives say (and similarly, encourage wives to think HIV-positive husbands were unfaithful). This is not a trivial matter. Most African couples living with HIV are discordant – only one is infected. Among discordant couples, the wife is equally likely to be HIV-positive as the husband.

Telling men and women in discordant couples that HIV surely comes from sex is like the town trouble-maker telling people their husband or wife is running around when there’s no evidence that’s so. An HIV infection is not enough evidence to show a wife was unfaithful. Many African women get HIV from health care. HIV prevention messages that focus only on sex add insult to injury, encouraging husbands, families, and friends to blame them for sexual misbehavior.

Conclusion: Getting good information to women is a do-it-yourself challenge

If international and foreign aid organizations waste – misuse – their money to misinform women about risks, that’s too bad. But let’s not let a bunch of irresponsible bureaucrats get in the way. Women’s lives are at stake. We can get these three messages to women through churches, NGOs, community groups, unions, and just talking to friends. Even bureaucrats who keep their jobs by telling approved official half-truths during working hours can pass these messages privately to friends and other contacts. Abraham Lincoln, the US president who ended slavery, said: “You may deceive all the people part of the time, and part of the people all the time, but not all the people all the time.” So despite the well-funded official half-truths from too many places, let’s take heart, and do what we can to get life-saving messages to women.

Mass circumcision based on assumption, not evidence

Programs to circumcise millions of men in Africa are based on selected evidence from three trials in South Africa, Kenya, and Uganda.[1-4] Many people think these trials show that getting circumcised reduces men’s risk to get HIV from sex by more than 50%.

The trials don’t say that; specifically, the trials don’t say men’s infections came from sex. None of the studies collected all information needed to measure the impact of circumcision on men’s risk to get HIV from sex — asking about all blood and sexual risks and tracing and testing sexual partners.[5]

Trials in South Africa and Uganda report new infections in men according to whether the men reported any possible sexual exposure to HIV (any sex without a condom). The evidence from these two trials suggests less than 1/3rd of men’s infections came from sex (see details below). It is, of course, possible that men misreported their sexual behavior. In other words, programs to circumcise men in Africa are not based on evidence, but rather on assuming away evidence.

Were men’s sexual partners HIV-positive? We don’t know. The Ugandan trial (including a linked study) tested most of the men’s spouses and live-in partners for HIV (including women who did not want to know their HIV status [see “eligibility criteria” in reference 6]). The trial observed most new infections in men who reported no non-marital partner. But the trial has not reported the HIV status of the long-term partner of any circumcised or intact man who got HIV during the trial.

The South African trial found most new infections in men who reported only 0-1 sexual partner after the last HIV-negative test. The Kenyan study collected but has not reported information on men’s sexual behavior during the trial; at baseline a majority reported 0-1 partners in the previous 6 months. There is no indication either trial made any effort to trace and test the sexual partners of men who got HIV during the trial. This would have been not only good research, but was also ethical — protecting women who were not the source of men’s new infections.

Evidence from these trials supports other recommendations

Beware skin-piercing risks: As noted above (and detailed below), evidence from two trials says less than 1/3rd of men’s infections came from sex. Moreover, two studies report new infections in men with specific healthcare encounters. In the South African trial: men who “attended a clinic for a health problem related to the genitals” vs. men who did not were 5.7 times more likely to get HIV; and men who reported an injection, transfusion, and/or hospitalization vs. men with none of these risks were 1.7 times more likely to get HIV.  The Kenyan trial found four men new infections one month after they were circumcised. (See details below.)

Trust your body’s natural defenses: In Uganda, not washing one’s penis after sex cut men’s risk (whether circumcised or intact) for HIV. Thus, one message from the Ugandan trial is that natural defenses against HIV in sexual fluids may be as effective as circumcision (see details below and on two other pages).

Beware unethical research: The circumcision trial in Uganda (together with research in a linked trial) tested many of the men’s wives and stable partners for HIV, but did not insist that women learn their HIV status or warn their husbands if women were HIV-positive. The trial followed men to see them get HIV, without warning them. The trial in South Africa followed men, at least some of whom did not know their HIV status. None of the trials required testing and warning wives and other partners when men got new HIV infections (see details below).

More details from the three trials

South Africa: The first study of the three studies to report was carried out in South Africa during 2002-05.[2] The study team solicited men willing to be circumcised, then on a random basis assigned half the men to an intervention group to be circumcised first and the other half to a control group to remain intact until the end of the study. The study team then followed and retested the men – circumcised and intact – at scheduled visits over as long as two years.

During follow-up, 20 men in the intervention (circumcision) group got HIV at the rate of 0.85% per year, while 49 men in the control (intact) group got HIV at the rate of 2.11% per year. If all the men’s infections came from sex, this says that circumcision cuts men’s risk to get HIV from sexual partners from 2.11% to 0.85% per year.

But did all or even most infections come from sex? Not according to evidence the study collected and reported. Twenty-three of the 69 men with new infections said they had no sexual partner or always used condoms from their last HIV-negative test to their first HIV-positive test. Men reporting no sexual risks got HIV at the rate of 1.11% per year. If these men are telling the truth, they apparently got HIV from blood during injections, dental care, tattooing, and other skin-piercing events. If men with no sexual risks got HIV from blood, we can estimate that men with sexual risks also got HIV from blood contact at the same rate. The rate of getting new HIV infections in men who reported at least one unprotected (without a condom) sex event was 1.86% per year. The modestly faster rate to get HIV in men reporting vs not reporting any sexual risk explains less than 1/3 of the men’s infections (using standard epidemiological terms, the crude population attributable fraction of incident HIV associated with reporting any vs. no unprotected sex is 27%).

The study reported two health care exposure in men with and without new HIV infections: (a) men who “attended a clinic for a health problem related to the genitals” were 5.7 times more likely to get HIV than men without this risk;[2] and (b) men who reported injections and/or transfusion and/or hospitalization were 1.7 times more likely to get HIV than men who reported none of those events (see Authors’ reply in this link).[7]

The study team has not said what procedures men got at clinics treating genital health problems; it has also not reported HIV incidence separately for injections, transfusions, or hospitalizations. The study has not reported other healthcare procedures, such as infusions and dental care. The study has also not reported any data on skin-piercing cosmetic procedures; did they ask?

The study team could have done a better job identifying the sources of men’s infections if they had asked more questions and reported more data. But where is the failure? Did they not ask, or are they not telling? Like most studies on HIV in Africa, this study does  not give other researchers’ free access to collected data (with safeguards to protect participants’ confidentiality). Also, like most studies on HIV risk in Africa, this study has not disclosed its questionnaire and data collection forms – so there is no public record of what information they collected and chose not to report (chose to withhold).

Table: What information on sex and blood risks did the three studies collect and report for men with and without new HIV infections?

Sources: see references in the text.

Kenya: The Kenya study,[3] 2002-06, was similar in design to the South Africa study. The study circumcised some men, then followed and retested circumcised and intact men for as long as two years to see who got HIV. Nineteen men in the intervention (circumcised) group got HIV at the rate of 1.9% over two years, while 46 men in the control (intact) group got HIV at the rate of 4.1% over two years.

How many of the 65 men got HIV from sex? The study asked men about sexual partners and condom use, but reports this information for only seven men infected during the first three months of follow-up. Five of the seven reported no sexual partners from the time they entered the trial (using sensitive tests, the study could not find HIV in blood collected then) until their first HIV-positive test after 1-3 months. The study team has said nothing about tracing and testing men’s sexual partners – did they do it and not report it, or just not do it?

As for blood-borne risks, the study reports four men circumcised in the trial had new HIV infections one month later. Contaminated local anaesthetic or instruments could have infected the men during circumcision, but the study team says nothing about what might have gone wrong. Aside from circumcisions, the study says nothing about blood-borne risks. This is a glaring oversight, because the study team had in hand evidence linking HIV in the community to blood-borne risks: While recruiting men for the trial, men who reported one or more injections in the previous six months were 2.5 time more likely to be HIV-positive vs other men; men with tattoos were 2.2 times more likely to be infected; men who had ever received saro (traditional blood-letting) were 2.1 times more likely to be infected,[8] and men who reported “blood exchange” were 18.6 times more likely to be HIV-positive.[9]

Uganda: The study in Uganda, 2003-06, followed the same design as studies in South Africa and Kenya: assigning men randomly to be circumcised or to remain intact, then following them for as long as long as two years to see who got HIV. Twenty-two men in the intervention (circumcised) group got HIV at the rate of 0.66% per year, and 45 men in the control (intact) group got HIV at the rate of 1.33% per year.[4]

During follow-up, researchers asked men whether and how they cleaned their penis after sex, expecting that washing or wiping might be protective. Intact men who cleaned their genitals after sex, but waited at least 10 minutes to do so, got HIV at the rate of 0.39% per year. Also, men who wiped only without using water got less HIV than men who used water. The authors proposed that acid in vaginal fluids “may impair HIV survival,” so that washing these away with water may “facilitate viral survival and possible infectivity.”[10]

How did the men get HIV? Six men with new HIV infections reported having no sex partners during the period between their last HIV-negative and first HIV-positive test; 10 others with new infections reported always using condoms. Taken together, the 16 men who reported no possible sexual exposure to HIV got HIV at the rate of 0.72% per year, presumably from skin-piercing events that exposed them to HIV in blood. Men who reported any unprotected sex got HIV at the rate of 1.17% per year. As in South Africa, the marginally faster rate at which men who reported sexual risks got HIV explains less than a third of the new infections observed during the trial (using standard epidemiological analyses and terms, the crude population attributable fraction of incident HIV associated with having any vs no unprotected sex is 29%).

Unlike the other two studies, the Uganda study team traced and tested most of the men’s wives (and other long-term partners) for HIV.[6] However, the study has not reported the wives’ HIV status for men who got HIV. Did they get HIV from their wives? The study team is sitting on that information.

The Uganda study team provides no data on injections and other skin-piercing events for men with and without new HIV infections, and does not say if they collected any such data.

Ethical short-comings

The three studies treated research participants in ways that would not be allowed in the US, Canada, and France, non-African countries that funded the studies:

• The South Africa study recruited men and the Uganda study recruited wives without insisting they hear their HIV test results. Neither study has said how many participants did not hear their results.
• The Uganda study followed men who did not know the study had found some of their wives to be HIV-positive (some of the wives also did not know) to watch the men get HIV.
• None of the studies insisted that men who acquired HIV bring their wives for couple counseling. This ethical lapse – leaving wives with unknown risks – undermined the objective of the research, which was to see how much circumcision reduced sexual transmission.

Study teams for two of the three trials did not register the trials (ie, document what they were planning to do in their human subjects research) before the trial began. Both were registered only after follow-up was completed and less than one month before publication.[11, para 35 in reference 12]

References

1. WHO, UNAIDS. New data on male circumcision and HIV prevention: policy and programme implications. Geneva: WHO, 2007. Available at: http://apps.who.int/iris/bitstream/handle/10665/43751/9789241595988_eng.pdf?sequence=1 (accessed 2 May 2018).

2. Auvert B, Taljaard D, Lagarde E, et al. Randomized controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS t1265 trial. PLoS Med 2005; 2: 1112-1122. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1262556/pdf/pmed.0020298.pdf (accessed 2 May 2018).

3. Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet 2007; 369: 643-656. Available at: https://www.ncbi.nlm.nih.gov/pubmed/17321310 (accessed 2 May 2018).

4. Gray RH, Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomized controlled trial. Lancet 2007; 369: 657-666. Available at: https://www.ncbi.nlm.nih.gov/pubmed/17321311 (accessed 3 May 2018).

5. Brewer, D. D., Rothenberg, R. B., Potterat, J. J., Brody, S., & Gisselquist, D. (2004). HIV epidemiology in sub-Saharan Africa: rich in conjecture, poor in data (reply to letter by Boily et al.). International Journal of STD & AIDS, 15, 63-65. Available at: http://www.interscientific.net/ijsa2004.html (accessed 2 May 2018).

6. Wawer M. Trial of male circumcision: HIV, sexually transmitted disease (STD) and behavioral effects men, women and the community. ClinicalTrials.gov, 2007. Available at: https://clinicaltrials.gov/ct2/show/NCT00124878 (accessed 2 May 2018).

7. Auvert B, Sobngwi-Tambekou J, Taljaard, et al. Author’s reply. PLoS Med 2006; 3: 0141-0143. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1360639/pdf/pmed.0030065.pdf (accessed 2 May 2018).

8. Mattson CL, Bailey RC, Agot K, et al. A nested case-control study of sexual practices and risk factors for prevalent HIV-1 infection among young men in Kisumu, Kenya. Sex Transm Dis 2007; 34: 731-736. Available at: https://www.ncbi.nlm.nih.gov/pubmed/17321310 (accessed 2 May 2018).

9. Mattson et al. Sexual practices and risk factors for HIV among young men in Kisumu, Kenya. Available at: http://www.abstract-archive.org/ (accessed 2 May 2018).

10. Makumbi et al. Male post-coital penile cleansing and the risk of HIV-acquisition in uncircumcised men, Rakai District, Uganda. Abstract WEAC1LB, 4^th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Australia, 25 July 2007. Available at: http://www.abstract-archive.org/ (accessed 3 May 2018).

11. Thornton J. Circumcision and HIV. Blog post 18 September 2012. Available at: https://ripe-tomato.org/2012/09/18/circumcision-and-hiv/ (accessed 2 May 2018).

12. World Medical Association. Declaration of Helsinki 2013. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (accessed 3 May 2018).