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Category Archives: HIV

Will women who got HIV during the ECHO trial sue for damages?


The ECHO trial (Evidence for Contraceptive Options and HIV Outcomes) was both unethical and useless by design. The trial, reported June 2019, compared three birth control techniques: Depo-Provera (DMPA-IM) injections every three months, an IUD (intrauterine device), and levonorgestrel implants.[1]

  • Research to date has shown that Depo-Provera increases women’s risks to get HIV by 40%-50%.[2,3] By randomizing women to Depo-Provera, the trial violated articles 3, 4, and 9 of the World Medical Association’s Declaration of Helsinki on research ethics (eg, article 9: “It is the duty of physicians who are involved in medical research to protect the life [and] health…of research subjects).”[4]
  • Research to date has shown that birth control pills do not increase women’s risk for HIV.[2,3] By not including birth control pills among the contraceptive methods in the trial, the study violated article 33 of the Declaration of Helsinki (“The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s)…”).[4]

ECHO trial results have been widely misinterpreted. A report of the trial in The New York Times, for example, said the results show Depo-Provera “does not raise HIV risk.” Because the trial did not compare Depo-Provera to pills, it does not support that statement.[5]

The ECHO trial could have been both ethical and useful if it had compared birth control options for which there is limited evidence of their impact on women’s HIV risk (eg, IUDs, levonorgestrel implants, and monthly injections of norethisterone enanthate) to birth control pills, for which there is good evidence of little or no impact on women’s HIV risk.[2,3]

As it is, the trial suggests IUDs and levonorgestrel implants likely increase women’s risk for HIV less than does Depo-Provera, if at all. But how did women get HIV: from sex or skin-piercing health care procedures?[6] In countries where skin-piercing health care instruments are unreliably sterile, knowing how women got HIV is relevant for advising them about how to avoid HIV from health care, including skin-piercing birth control options.

Limited information on sexual risks for women in the trial suggests sex caused far less than half of new HIV infections during the trial. During quarterly follow-up visits, 49% of women reported more than 10 sex acts in the previous three months; to err on the high side, I assume all women averaged 15 sex acts per quarter or 60 per year. Fifty-five percent reported no condom use during their last sex act (see Table S11 in [1]). From this I estimate an average of 33 (= 55% x 60) unprotected sex acts per year for all women. I assume 25% of partners were HIV-positive. Using a transmission efficiency of 0.12 per 100 sex acts (from a study in Uganda[7]) I estimate women got HIV from sex at the rate of 1%/year (= 33 unprotected sex acts/year x 25% with an HIV-positive partner x 0.0012 transmissions per HIV-exposed sex act). This is far less than the observed 3.8%/year rate of new infections.[1]

Like many other studies in high-prevalence areas in Africa, the study withholds collected data relevant to assess sexual and non-sexual risks; eg, the study does not report if women with new infections during follow-up intervals reported any sex acts during those intervals. This, too, violates the Declaration of Helsinki (article 36: “Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports…”).[4]

Aside from not reporting all relevant collected information, by all accounts the study did not collect other relevant information. Like most other foreign-funded HIV research in Africa, the study ignored non-sexual risks and did not trace and test partners. Testing partners is not only good ethics, protecting HIV-negative partners,[8] but also good science, providing evidence to estimate how much HIV comes from sex and to identify factors to explain why heterosexual transmission of HIV may be more dangerous in Africa than elsewhere, if indeed that is so.

Unethical research funded from rich countries has harmed people in less developed countries for decades. The ECHO trial had no problem finding health care professionals willing to do the dirty work and no problem getting ethical approval: more than 750 people collaborated in ECHO research and 13 review boards approved it (supplementary appendix in [1]).

How to stop these outrages? Appealing to courts may get better results than waiting for health care professionals to change. Recently, a United States’ (US) court allowed Guatemalans harmed during medical research to sue private US institutions in US courts.[9] Does this mean that any woman in the ECHO trial randomized to Depo-Provera who got HIV during the trial could sue private US institutions involved in the trial in US courts?

References

1. Evidence for Contraceptive Options and HIV Outcomes (ECHO) Trial Consortium. HIV incidence among women using intramuscular depot medroxyprogesterone acetate, a copper intrauterine device, or a levonorgestrel implant for contraception: a randomised, multicentre, open-label trial. Lancet 2019; published online June 13. Available at: ht; tp://dx.doi.org/10.1016/S0140-6736(19)31288-7; supplementary appendix availabe at: http://echo-consortium.com/wp-content/uploads/2019/06/ECHO-primary-HIV-results-appendix-Lancet-online-first-June-2019.pdf (accessed 28 July 2019)

2. Morrison CS, Chen PL, Kwok C, et al. Hormonal contraception and the risk of HIV acquisition: an individual participant data meta-analysis. PLoS Med 2015; 12: e1001778. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4303292/ (accessed 26 July 2019).

3. Polis CB, Curtis KM, Hannaford PC, et al. An updated systematic review of epidemiological evidence on hormonal contraceptive methods and HIV acquisition in women. AIDS 2016; 30: 2665–83. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5106090/ (accessed 26 July 2019).

4. World Medical Association (WMA). Declaration of Helsinki – ethical principles for medical research involving human subjects. New York: WMA, 1964, revised 2013. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (accessed 26 July 2019).

5. McNeil DG. Depo-Provera, an injectable contraceptive, does not raise HIV risk. New York Times 13 June 2019. Available at: https://www.nytimes.com/2019/06/13/health/depo-provera-hiv-africa.html (accessed 27 July 2019).

6. Gisselquist D. Advice to Young Women in Africa: Sex May Not Be Your Biggest Risk for HIV. SSRN, posted 1 May 2019. Available at SSRN: https://ssrn.com/abstract=3381252 (accessed 28 July 2019)

7. Wawer MJ, Gray RH, Sewankambo NK, et al. Rates of HIV-1 transmission per coital act, by stage of HIV-1 infection, in Rakai, Uganda. J Infect Dis 2005; 191: 1403-1409. Available at: https://academic.oup.com/jid/article/191/9/1403/860169 (accessed 26 July 2019).

8. WHO. Guidelines on self-testing and partner notification: supplement to consolidated guidelines on HIV testing services. Geneva: WHO, 2016. Available at: https://www.who.int/hiv/pub/vct/hiv-self-testing-guidelines/en/ (accessed 26 July 2019).

9. Stempel J. Johns Hopkins, Bristol-Myers to face $1 billion syphilis infections suit. Reuters 4 January 2019. Available at: https://www.reuters.com/article/us-maryland-lawsuit-infections/johns-hopkins-bristol-myers-must-face-1-billion-syphilis-infections-suit-idUSKCN1OY1N3 (accessed 26 July 2019).

 

 

Government of Pakistan protects patients. African governments don’t. Why not?


On 21 July 2019, at an international HIV/AIDS conference in Mexico, Farima Mir reported an ongoing investigation in Ratodero, Pakistan, that has found hundreds of children with HIV from healthcare[1]:

“At the end of April, 46 children in the city tested positive for HIV. And within 2 days, 14 more children were reported in nearby towns. The government mounted a response, screening around 32,000 people… Ultimately, over 770 of the 997 reported new infections were in young children, most from ages 2 to 5 years… Mir said that almost all children who tested positive for HIV had ‘repeated injections for any illness,’ meaning reused syringes were likely to blame.”

What happened in Pakistan echoes what has been found elsewhere, for example, Russia in 1988, Romania in 1989, Libya in 1998, etc (for more information about these and other HIV outbreaks from health care click on “outbreaks and unexpected infections” in the menu at the right of this page).

Almost surely there are many similar outbreaks of HIV from reused and unsterilized syringes, needles, razors, needles and tubes for infusions, and other health care instruments in African countries with the world’s worst HIV epidemics. But no government in sub-Saharan Africa has looked to find and stop HIV from unsafe health care! Whereas Government of Pakistan protects people by investigating unexpected HIV infections, governments of sub-Saharan Africa stick their heads in the sand. How many more people will get HIV from health care in Africa before governments investigate unexpected infections to find and stop the problem?

References

1. Walker M. ‘Man-Made Disasters’ Stymie Progress on Global HIV. Medpage Today 22 July 2019. Available at: https://www.medpagetoday.com/meetingcoverage/ias/81150 (accessed 23 July 2019).

Let’s stop HIV in Africa. What are you waiting for?


Question for African governments: Why haven’t you investigated unexplained HIV infections?

Question for CDC, UNAIDS, WHO: How can you say you want health care to be safe in Africa, but then NOT challenge governments to investigate unexplained infections?

Questions for people living in African: Do you know anyone who is HIV-positive who denies sexual risks? Do you believe them? Have you heard of a child with HIV but with an HIV-negative mother? If they got HIV from health care, you and your loved ones are also at risk. When are you going to ask your government to investigate unexplained infections to find and stop any hospital or clinic that has been infecting patients?

Question for researchers: Why haven’t you tried to find out how people got HIV: trace and test partners: ask where people got skin-piercing treatments?

Question for anyone: Why do you accept racist, sexual fantasies to explain Africa’s HIV epidemics? Yes, sex is a personal risk for HIV, but what is different in Africa that could explain Africa’s terrible HIV epidemics is not sexual behavior but unreliably sterile injections, infusions, and other health care procedures.

Hundreds of children in Pakistan infected by HIV from health care; government investigates to protect children


Beginning end-April 2019, government of Pakistan has been investigating an outbreak of HIV from unsafe health care in Ratodero county. As part of the investigation, government set up camps to test people for HIV. As of 23 May, tests on 20,800 people in Ratodero found >608 to be infected, including >500 children.[1] Almost all HIV-infected children had HIV-negative mothers. 

According to a recent report[2]: “Adviser to the Prime Minister for Health Dr. Zafar Mirza has said that outbreak of HIV in Ratodero has not only shaken the country but entire world adding when he was in Geneva he was also asked about surfacing of HIV… He said root cause of large number of children must be detected… He said federal government along with UNICEF, WHO, UNAID, Aga Khan, Aga Khan University Hospital and other organizations is cooperating with the Sindh government in this connection and they will continue to coordinate till root cause is detected, he added.”

In sub-Saharan Africa, children get HIV from unsafe healthcare, but no government has investigated to protect them

Lots of HIV-positive children with HIV-negative mothers are reported in Africa, but unlike Pakistan, no government has investigated. Nor have WHO or UNAIDS advocated any investigation. Here are some of the many reports of HIV-positive children in Africa with HIV-negative mothers:

* Mozambique, 2015: A random sample national survey found 30 HIV-positive children aged 6-23 months; 10 (33%) of the 30 children had mothers who were HIV-negative.[3]

* Uganda, 2011: A random sample national survey tested adults and children aged 0-5 years for HIV. Based on reports from this survey,[4] an estimated 17% (12 of 70) HIV positive children had mothers who tested HIV-negative (click on “outbreaks and unexpected infections” and then “Uganda” country page).

* Mozambique, 2009: A random sample national survey in 2009 tested children as well as adults for HIV. The study found 63 HIV-positive children aged 0-11 years old, of which 18 (29%) had mothers who tested HIV-negative.[5,6]

* Swaziland, 2006-7: A random sample national survey tested 1,665 mother-child pairs with children aged 2-12 years. Fifty children were infected; 11 (22%) of their mothers tested HIV-negative.[7,8]

WHO’s double standard

WHO’s double standard goes back decades. For example, during 1990-93, WHO’s Global Programme on AIDS coordinated studies in four African countries – Kigali, Rwanda; Kampala, Uganda; Dar es Salaam, Tanzania; and Lusaka, Zambia – to test inpatient children and their mothers for HIV infection. Combining data from the four cities, 61 (1.1 percent) of 5,593 children aged 6-59 months were HIV-positive with HIV-negative mothers.[9] Only three children had been transfused. Although these infections suggested a lot of HIV transmission through unsafe healthcare, WHO, incredibly concluded ‘the risk of…patient-to-patient transmission of HIV among children in health care settings is low.’[10]

At least WHO in 2019 is acting to protect children in Pakistan from getting HIV from unsafe healthcare. Will this ongoing investigation lead WHO to change its long-standing policy of neglect in Africa?

References

1. Masood T. Situationer: dealing with HIV outbreak among children. Dawn 23 May 2019. Available at: https://www.dawn.com/news/1483999 (accessed 24 May 2019).

2. Dawoodpoto J. “HIV in Ratodero has not only shaken the country but entire world.“ Daily Times 24 May 2019. Available at: https://dailytimes.com.pk/399789/hiv-in-ratodero-has-not-only-shaken-the-country-but-entire-world/ (accessed 24 May 2019).

3. page 231 in: Ministério da Saúde (MISAU), Instituto Nacional de Estatística (INE), e ICF, 2015. Inquérito de Indicadores de Imunização, Malária e HIV/SIDA em Moçambique 2015. Rockville, Maryland: ICF, 2018. Available at: https://dhsprogram.com/pubs/pdf/AIS12/AIS12.pdf

4. Table 8.13 in: Uganda Ministry of Health, and ICF International. Uganda AIDS Indicator Survey (UAIS) 2011. Calverton: ICF International, 2012. Available at: https://dhsprogram.com/publications/publication-AIS10-AIS-Final-Reports.cfm(accessed 6 December 2018).

5. pp. 177-181 in: INS, INE, and ICF Macro. Inquérito Nacional de Prevalência, Riscos Comportamentais e Informação sobre o HIV e SIDA em Moçambique 2009. Calverton, Maryland: ICF Macro, 2010. Available at: http://measuredhs.com/pubs/pdf/AIS8/AIS8.pdf (accessed 19 January 2012).

6. Brewer D. Scarification and male circumcision associated with HIV infection in Mozambican children and youth. Webmedcentral 2011, Article ID WMC002206. Available at: http://www.webmedcentral.com/article_view/2206(accessed 19 January 2012).

7. CSO, eSwatini, and Macro Int. Swaziland Demographic and Health Survey 2006-07. Mbabane, Swaziland: CSO and Macro International, 2008. Available at:  https://dhsprogram.com/pubs/pdf/FR202/FR202.pdf (accessed 8 November 2018).

8. Okinyi M, Brewer DD, Potterat JJ. Horizontally acquired HIV infection in Kenyan and Swazi children. Int J STD AIDS 2009; 20: 852-857. Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/19948900(accessed 27 October 2018); article available at: http://www.interscientific.net/IJSA2009Okinyi.html (accessed 15 October 2018).

9. Hitimana D, Luo-Mutti C, Madraa B, et al. ‘A multicentre matched case control study of possible nosocomial HIV-1 transmission in infants and children in developing countries’, 9thInt Conf AIDS, Berlin 6-11 June 1993. Abstract no. WS-C13-2.

10. Global Programme on AIDS. 1992-1993 Progress Report, Global Programme on AIDS. Geneva: WHO, 1993. p. 85.

Antimicrobial Resistance and PrEP: Medical Disasters


Here are two antimicrobial resistance (AMR) scenarios, one rapidly spiraling out of control, and the other (arguably) incipient:

The AMR scenario that is spiraling out of control is described in an article in The New York Times. The development of AMR is blamed on overuse and misuse of cheap antibiotics, usually without prescription. Ever-increasing use and misuse of antibiotics results in ever-increasing development of resistant strains of pathogens.

The NYT article describes the appalling conditions that an estimated one billion people live in; slums where waterborne, foodborne and airborne pathogens thrive. Unable to escape the risks, people try to treat the symptoms with antibiotics, inevitably leading to resistance to most or all available treatments.

The scenario described is a loop: widespread disease leads to overuse of antimicrobials; this leads to development of resistance; people with resistant conditions, if they survive, are taken to healthcare facilities, which also overuse antimicrobials, amplifying resistance and transmission of resistant strains; this loops back to the slum, resulting in an even higher disease burden, and greater levels of resistance.

The loop could be broken by: 1) improving the environment, including water, sanitation, habitation, food, etc and 2) improving conditions in healthcare facilities, infection control, safety, hygiene, etc. This will reduce antimicrobial use and, therefore, resistance.

The approach suggested by the Global AMR R&D Hub, on the other hand, risks speeding up the loop leading to AMR. They aim to “tackle the threat of resistant pathogens” by developing “new antibiotics and treatments against infections.” Producing antimicrobials of ever-increasing power, without addressing 1 and 2, above, only continues the cycle of ever-increasing resistance.

The other scenario is described on websites such as iwantprepnow.co.uk (and prepster.info and others). They advise on the use of PrEP (pre-exposure prophylaxis), antiretrovirals taken by HIV negative people to reduce the risk of HIV infection. For example, if “you have sex in a variety of situations where condoms are not easily used or not always used”, PrEP, if properly used, can reduce risk of infection with HIV by more than 90%.

There are (at least) two problems with this. Firstly, overuse or incorrect use of antiretrovirals can give rise to a resistant strain of HIV developing in an infected person, and that resistant strain can also be transmitted to others.

Secondly, the advice from iwantprepnow.co.uk (and other similar sites, such as PrEPster.info) is aimed at people who frequently have sex without protection from other sexually transmitted infections (STIs). Exposing yourself repeatedly to infection with STIs increases the development of resistant strains of, for example, gonorrhea, shigella and Mycoplasma genitalium.

Use of PrEP without condoms also increases transmission of hepatitis C virus: “Incidence of acute hepatitis C virus (HCV) among men who have sex with men who use PrEP in Lyon increased tenfold between 2016 and 2017”. HCV has doubled among HIV positive people.

The Center for Strategic and International Studies spectacularly fail to notice the positive feedback mechanism, whereby improper use of PrEP could increase transmission of STIs and the development of resistance in countries where HIV prevalence is highest, sub-Saharan African countries:

“In areas where there is so much HIV circulating, every sexual encounter is high risk, and widespread PrEP could be a prevention lynchpin.” The same article even acknowledges that “High rates of sexually transmitted infections (STIs) increase the risk of HIV acquisition”, without noticing how PrEP will increase STIs and resistance!

According to The WHO, health is a “State of complete physical, mental, and social well being, and not merely the absence of disease or infirmity.” In the two AMR scenarios described above, producing stronger antimicrobials and PrEP are examples of medicalization of health, viewing it as merely the absence of disease or infirmity. These kinds of medicalization will radically increase AMR.

Cherie Blair and ‘Rape in Africa’ Stereotypes


Cherie Blair was accused of perpetuating and reinforcing stereotypes and usurping African voices with her comment that “most African ladies’ first sexual experience is rape”. The English Guardian and NPR both weigh in, with a number of reasons why Blair’s remarks were met with outrage.

Critics of Blair are not wrong in calling her out on these comments. But they don’t go far enough. Yes, Blair should have acknowledged, for example, that rape and gender based violence are faced by women everywhere, not just in African countries. But Blair is only repeating stereotypes she would find throughout the mainstream media, and in a lot of specialized published sources.

Blair is far from being alone in perpetuating and reinforcing stereotypes, such as those of the ‘promiscuous African’, ‘the violent African male’, ‘the widespread exchange of sex for money’, ‘the disempowered African female’, etc. Most of these stereotypes are a lot older than Blair, and date back to colonial times, at least.

Nor have the long-held stereotypes mellowed with age. The bulk of HIV programming (and spending) is based on the very assumption that “sexual transmission [is] the major mode of spread of HIV-1 in Africa”, with some estimates suggesting that sex accounts for 80-90% of all transmissions in high prevalence countries (which are all in sub-Saharan Africa).

On the subject of rape, the Center for Strategic and International Studies (CSIS) claims that: “Girls and women [in South Africa] also face an epidemic of rape and gender-based violence; many young women express more concerns about getting raped or getting pregnant than getting HIV. At one site we visited, the girls stated that getting raped was their number one fear.”

CSIS was commenting on the fact that in some parts of South Africa, 60% of women are HIV positive. Many new infections are among girls 15-24 years old. However, the entire CSIS article assumes, without ever arguing for it, that all HIV transmission is sexual. This assumption may suggest that stereotypes such as those above are based on empirical findings, rather than being rank prejudice.

Far from being based on research, stereotypes about ‘African’ sexual behavior are flatly contradicted by vast quantities of data collected by Demographic and Health Surveys, every five years, about sexual behavior in African countries. Just select any sub-Saharan country; rates of ‘unsafe’ sexual behavior are low, and there is little or no correlation with HIV prevalence.

Cherie Blair is unlikely to have come across views that diverge from the mainstream prejudices about HIV in SSA, and that challenge those prejudices. But many of those challenges can be found, for example, in a paper by John Potterat, and in the bibliography for that paper. One of the main suspects in high rates of HIV transmission is unsafe healthcare; others are unsafe cosmetic and traditional practices.

If Blair would like to reconsider the sort of stereotypes about sexual behavior and violence also expressed in the CSIS article, this is a good time to do so. Those outraged by her comments about ‘Africans’ and their alleged sexual behavior may wish to avail of the same research. Otherwise they all risk reinforcing and perpetuating stereotypes.

Ebola: A Strategy of Misinformation?


In an article in The New England Journal of Medicine entitled ‘An Epidemic of Suspicion — Ebola and Violence in the DRC’ Vinh-Kim Nguyen writes about violent attacks on Ebola treatment units and other health facilities. Nguyen argues that: “Epidemics thrive on fear — when they are frightened, patients flee hospitals, sick people stay away to begin with, and affected communities distrust groups trying to respond to the epidemic.”

But there’s an important sense in which the opposite may be true. When people fear something that has proven dangerous in the past, avoiding that something may be the only rational response, the only way to avoid the danger. After all, several well-documented epidemics have been shown to thrive on unsafe healthcare. Examples are Ebola Virus Disease (EVD), hepatitis C (HCV), extensively drug resistant tuberculosis (XDR TB) and MRSA (Methicillin-resistant Staphylococcus aureus).

The second ever outbreak of EBV, which occurred in Yambuku (in Zaire) in 1976, was a result of unsafe healthcare: “Peter Piot…concluded that it was inadvertently caused by the Sisters of Yambuku Mission Hospital, who had given unnecessary vitamin injections to pregnant women in their prenatal clinic without sterilizing the needles and syringes.”

WHO has recently announced that “The outbreak [of EBD] in Katwa and Butembo health zones [in DRC] is partly being driven by nosocomial [=originating in a hospital] transmission events in private and public health centres. Since 1 December 2018, 86% (125/145) of cases in these areas had visited or worked in a health care facility before or after their onset of illness. Of those, 21% (30/145) reported contact with a health care facility before their onset of illness, suggesting possible nosocomial transmission.”

Globally, hepatitis C virus (HCV) has infected an estimated 130 million people…. [T]he wave of increased HCV-related morbidity and mortality that we are now facing is the result of an unprecedented increase in the spread of HCV during the 20th century. Two 20th century events appear to be responsible for this increase; the widespread availability of injectable therapies and the illicit use of injectable drugs. A significant healthcare associated outbreak occurred in Egypt in the 1970s.

Associated with poor infection control in health facilities, one of the first outbreaks of XDR-TB was discovered in Tugela Ferry Hospital, KZN, South Africa, in 2005. And a significant proportion of healthcare associated infections are resistant to methicillin (ie, MRSA).

Nguyen goes on: “In areas where the epidemic response has not involved security forces…people ask to be vaccinated.”

But rolling out vaccinations in environments where infection control is inadequate (for example, healthcare facilities) might increase the risk of viral strains developing resistance (for example, among healthcare practitioners). Going to a healthcare facility during an outbreak of Ebola may be the worst thing a person can do. When people didn’t go to health facilities during earlier outbreaks, case numbers were limited, and the outbreak didn’t last long.

Nguyen has also highlighted the importance of trust, and the consequences of mistrust of authority, experts and science. But if people are right to question the safety of healthcare facilities, as it would appear from above considerations, how can the trust of people at risk of exposure to ebola and other pathogens be regained?

As long as continued Ebola transmission is blamed on what is depicted as an irrational fear of healthcare and vaccinations, people will stay away from healthcare. Because their fear is far from irrational, it is supported by scholarly research, expert opinion and even communications from the WHO. XDR TB, MRSA, HCV and other outbreaks have been shown to be healthcare associated outbreaks. Healthcare facilities also contribute the lion’s share to anti-microbial resistance (AMR).

Modern healthcare facilities are potentially dangerous places. If patients were informed about the dangers, they would know better how to avoid them, and healthcare facilities would be compelled to address those dangers. Some of the earliest EBV outbreaks occurred when people came together around healthcare facilities, and died out when healthcare facilities closed, often because healthcare staff had been wiped out by Ebola.

Trust in healthcare in developing countries may be regained, slowly, if people are adequately informed about the greatest risks they face, such as poor infection control, lack of hygiene, AMR, etc. Trust will not be regained by dreaming up new misinformation, nor by reinforcing old misinformation.

Addressing a running sore: HIV in South Africa


Introduction

South Africa, where doctors achieved the first human heart transplant and one of the wealthiest countries in Africa, has a terrible HIV epidemic. In 2015, an estimated 30.8% of pregnant women were HIV-positive at their first antenatal visit, with more pregnant women infected in parts of the country: for example, 44.5% in KwaZulu-Natal province and 48.4% in Zululand district of that province.[1] Even more adults were infected in some age cohorts and regions: for example, in a 2014 survey of a study population in uMungundlovu district, KwaZulu-Natal, more than 66% of women aged 30-39 years were HIV-positive as were 59.6% of men aged 40-44 years.[2] Although South Africa has only 0.75% of the world’s population, a 2017 national survey estimated 7.9 million South Africans infected,[3] more than a fifth of the world’s total HIV infections.[4]

The South African government is doing a lot of what is required to respond to this epidemic with one glaring exception: the government has not investigated any unexpected and unexplained infections (i.e., not from sex, mother-to-child, or injection drug use) to find and stop blood-borne HIV transmission during health care and cosmetic services.

Doing things right: 90-90-90

In 2014, UNAIDS launched the 90-90-90 initiative, setting targets for testing and treatment to be achieved by 2020: 90% of people with HIV know they are infected, 90% who know are on antiretroviral therapy (ART), and 90% on ART have suppressed viral loads.[5]

Government of South Africa has made encouraging progress towards 90-90-90 targets. In a 2017 national survey, 84.9% of HIV-positive adults aged 15-64 years knew they were infected, 70.6% of those who knew were on ART, and 89.5% of people taking ART were virally suppressed. Putting these numbers together, 54% of HIV-positive adults were virally suppressed (54% = 84.9% x 70.6% x 89.5%).[6] The 90-90-90 targets are intended not only to reduce AIDS sickness and deaths but also to reduce HIV transmission. People with suppressed viral loads are not likely to transmit sexually because they have so little virus in semen or vaginal fluids.

Government of South Africa has also done well with prevention of mother-to-child transmission. As of 2017, more than 95% of pregnant women were tested for HIV and those found infected were given ART both to protect them and to prevent HIV transmission to their babies.[4] In 2016-17, less than 1% of HIV-positive mothers transmitted HIV to their babies before and during birth.[7]

Even before the 90-90-90 initiative, government of South Africa in 2010 began an HIV testing campaign, testing 13.3 million people over 18 months, finding 2 million with HIV, and putting 400,000 on treatment.[8] Also in 2010, government told providers to offer an HIV test to anyone seeking health care at a public facility.[9] To make testing easier, government in 2016 approved sale of self-testing kits through private pharmacies and other outlets.[10] These policies and programs support efforts to reach the testing target for 2020 – that 90% of people who are infected know it. More testing contributes to prevention by making it easier for people to know if their (potential) sex partner is HIV-positive, so they know to use condoms or otherwise protect themselves.

Doing things wrong: not investigating unexpected infections

With more testing, treatment, and other factors, the annual number of new HIV infections in South Africa fell 40% from 386,000 in 2010 to 231,000 in 2017.[3] Even so, South Africa’s HIV/AIDS disaster is reaching the next generation: in 2017 young women aged 15-24 years were getting HIV at the rate of 1.5% per year.[3]

The terrible scale of South Africa’s HIV epidemic is due in part to government not doing what it could to protect people. Over the years, public media and medical journals have recognized and reported unexpected HIV infections in South Africa. Nevertheless, as of early 2019, government has not investigated any unexpected infection by identifying suspected source facilities and then tracing and testing others treated at those facilities. For example, beginning in 1999, a group of doctors in Cape Town from time to time asked about and identified possible health care risks for more than 20 HIV-positive children with HIV-negative mothers.[11,12] But government did not subsequently trace and test others treated at suspected source facilities. Without tracing and testing to find others infected at the same facilities it is not possible to determine the extent of any outbreak or to find and fix the specific lapses in standard precautions responsible; and the public remains at risk.

Government of South Africa’s response to unexpected infections contrasts sharply with responses by governments outside sub-Saharan Africa. For example, in 1988 doctors in Elista, Russia (part of the USSR at the time), found and reported unexpected HIV infections in a hospitalized baby with an HIV-negative mother and a blood donor with no sexual risk. Government investigated, testing thousands, tracing transmission from one child directly and indirectly to 265 children in 13 hospitals, and ending the outbreak by August 1989.[13,14] From 1989 through 2014, nine other governments (Cambodia, China, India, Kazakhstan, Kyrgyzstan, Libya, Mexico, Romania, and Uzbekistan) investigated unexpected infections to uncover nosocomial (through health care) HIV outbreaks with more than 100 to more than 55,000 infections [15-17]). Many other governments have investigated unexpected infections to find smaller outbreaks.[16]

A lot of evidence suggests HIV transmission through skin-piercing procedures in health care, and possibly also during cosmetic services, have been and remain common in South Africa. Following paragraphs summarize selected evidence from later to earlier reports.

Incidence in children aged 2-14 years: The fifth South African National HIV Prevalence, Incidence, Behavior and Communication Survey, 2017, reported children aged 2-14 years acquired new HIV infections at the rate of 0.13% per year.[6]

Higher HIV prevalence in Black Africans than in other groups: The same 2017 national survey reported much higher HIV prevalence in Black Africans of all ages (16.6%) than in Whites (1.1%), Coloured (5.3%), or Indian/Asians (0.8%).[6] The survey gives no explanation for these differences in terms of sexual behavior. Male circumcision is not a factor: as of 2012, it was more common among Black African adults (52.4%) compared to Whites (23.3%), Coloured (26.4%), or Indian/Asians (33.5%).[18] There is, however, a big difference in where people get health care: in the second national HIV survey in 2005, 80% of Whites reported they usually get health care from private providers, while 80% of Black Africans reported they got most health care from public services.[19]

Unexplained infections in high school women: A 2011-2017 study in Mpumalanga province tested 2,533 high school women aged 13-20 years; 81 were HIV-positive, including 38 who reported never having vaginal or anal sex.[20] The study then followed and retested the women for 1-6 years during which 190 got HIV, including 44 who reported no lifetime sex.[21] At annual surveys during the first three years of follow-up an average of only 9% of women reported any sex without a condom in the previous three months[22]; and from what women reported about partners’ ages (less than 9% were aged over 24 years) less than 10% were HIV-positive.[22,23] Even if all women reporting unprotected sex in the previous three months had unprotected sex 104 times per year (or twice per week; an intended overestimate, considering most were in school), one could expect to see only 0.1% of women get HIV from sex each year, far less than observed incidence of 1.8% per year[22] (0.1% = 9% of women reporting unprotected sex in the previous three months x 104 sex acts per year x 10% of partners are HIV-positive x transmission efficiency of 1 per 1,000 coital acts; the next paragraph references this estimated transmission efficiency)

(This paper estimates transmission efficiencies of HIV through unprotected vaginal sex at 1 per 1,000 coital acts or 10% per year from an infected spouse based on the following references. The United States Centers for Disease Control and Prevention estimates transmission per unprotected coital act at 0.8 per 1,000 from men to women and 0.4 per 1,000 from women to men[24]. A widely cited estimate from a study in Uganda is 1.2 per 1,000 coital acts (with some condom use, which had no impact on estimated transmission efficiency).[25] Six studies in Africa followed discordant couples in which most partners were not aware of their infections or risks and/or did not use condoms; from these six studies both the mean and average rates of HIV incidence in initially HIV-negative partners were less than 10% per year.[26-31] Here and elsewhere I report rates of HIV incidence as percentages per year, a statistic more familiar for non-technical readers than the technical term, infections per 100 person-years.)

HIV-positive virgin men and women: In a 2014-15 survey among adults aged 15-49 years in uMgungundlovu district, KwaZulu-Natal, 11.2% of (self-reported) virgin women were HIV-positive as were 9.0% of virgin men.[2]

Higher incidence in young women than can be explained by sex: Repeated surveys of a study population in mKhanyakude district, KwaZulu-Natal, reported young women aged 15-24 years acquired new HIV infections at the rate of 5.9% per year (486 infections in 8,211 person-years) during 2011-15.[32] Such high incidence is difficult to reconcile with women’s limited sexual exposures to HIV, suggesting most infections come from risks other than sex. In the 2015 survey, 34% (847/2,467) of young women reported at least one coital act without condoms in the previous year,[32] and HIV prevalence was 10% among men who reported sex with a young woman in the past year.[33] Assuming women who reported unprotected sex in the past year averaged 104 unprotected coital acts per year (an intended over-estimate) and a transmission efficiency of 1 per 1,000 coital acts, sex explains incidence of only 0.4% per year, far less than the observed rate of 5.9% per year (0.4% = 34% of women with any unprotected sex in the past year x 104 coital acts per year x 10% of partners were HIV-positive x 0.001 transmissions per unprotected coital act[24,25]).

Cluster of 63 recent and linked infections: The African Health Research Institute found a cluster of 63 very similar HIV (similar sequences of amino acids) in blood collected during 2011-14 from 1,376 adults in a study population in uMkhanyakude district, KwaZulu-Natal. The Institute estimated HIV from one (unidentified) person in mid-2013 was somehow transmitted directly and indirectly over 18 months to 63 men and women.[34] Such fast transmission does not seem possible through sex, with transmission through vaginal sex requiring on average circa 1,000 coital acts; even for receptive anal sex an estimated average of 70 events are required for each transmission.[24] However, such rapid transmission is seen in nosocomial outbreaks; compare, for example, the phylogenetic tree of HIV genetic sequences from an outbreak in Cambodia[35] with the cluster of 63 HIV sequences from KwaZulu-Natal (slide 10 in [34]).

Unexplained infections in pregnant women: Four studies reported numbers of new HIV infections and rates of HIV incidence ranging from 10.7%-11.2% per year (or data to calculate these statistics[36]) in pregnant women during 2002-12. Women would not get HIV through sex at such rates unless all or almost all of their partners were infected. But during those years, less than 15% of adult men in South Africa were HIV-positive[4]; and many HIV-positive married men were married to women who were already infected.[37] The four studies are as follows: Wand and colleagues followed pregnant women in Durban during 2002-5, reporting data to calculate 81 incident infections in pregnant women and incidence of 10% per year[38]; Moodley and colleagues followed pregnant women in Mpumulanga, Eastern Cape, and Free State during 2006-7, observing 72 incident infections and incidence of 10.7% per year[39]; Kharsany and colleagues followed pregnant women in KwaZulu-Natal during 2007-8, observing four incident infections and calculating incidence of 11.2% per year[40]; and Dinh and colleagues reported 212 incident infections in a national sample of pregnant women and data to calculate incidence at 11% per year.[41]

HIV in high school virgin boys and girls: A 2012 survey of students in grades 8-12, averaging 15.8 years old, in KwaZulu-Natal reported 21 (55%) of 38 HIV-positive boys said they were virgins as did 56 (54%) of HIV-positive girls.[42]

HIV incidence in adults with no reported sex risks: The South Africa HIV Prevalence, Incidence, Behaviour and Communication Survey, 2005 (the second such national survey) reported HIV incidence of 1.5% per year in self-reported virgin adults, 2.4% per year in non-virgin adults who reported no sex in the previous year, and a similar 2.4% per year in adults who said they had been sexually active in the previous year.[43]

South Africa’s early epidemic doubles in 9-14 months: At the beginning of the HIV epidemic among Black South Africans in the late 1980s, the number of HIV-positive people doubled in about nine months[44]. During 1990-94, the doubling time for HIV prevalence in pregnant women throughout South Africa averaged 14 months (from 0.7% in 1990 to 7.6% in 1994).[45] The speed of transmission required for such rapid epidemic expansion is much faster can be explained by estimated rates of sexual transmission (1 per 1,000 coital acts or 10% per year between discordant couples[24-31]).

Fixing South Africa’s incomplete HIV prevention program: investigating unexplained infections

South Africa’s promotion of testing and treatment to reach 90-90-90 targets can be expected to slash sexual transmission. As targets are reached, more than 70% (~90% x 90% x 90%) of those infected will have suppressed viral loads and very little risk to transmit to a sexual partner. And with more testing, more people will know if partners are infected, so they will know to be careful.

But 90-90-90 may have less limited impact on blood-borne transmission. Based on outbreak investigations in other countries, blood-borne infections are often found in bunches. For example, HIV went from one in-patient baby to 265 children in 16 months in Russia,[14] from one to 418 infections in 3-4 years in Libya,[46] and from two to more than 200 infections in several years in Cambodia.[35] Large outbreaks characteristically come from facilities giving repeat treatments, where some people infected earlier get another procedure within weeks to month when they have primary infections and high viral loads, making their blood more dangerous and contributing to later transmissions.

The frequent bunching of blood-borne infections from specific facilities means that any identified unexpected HIV infection should be considered – until proven otherwise – to be one of many in an outbreak. When onward transmission occurs within several months, routine testing is not likely to find people with new blood-borne infections before they infect others through the outbreak. Moreover, even if someone tests HIV-positive with a very early infection, if the only risk anyone thinks about is sex, knowing he or she is infected would have no impact on their getting more skin-piercing procedures at the facility that is the source of the outbreak.

Educating health care workers – a continuing effort – has not stopped unexpected infections. Without outbreak investigations, no one knows the specific skin-piercing procedures and facilities responsible for unexpected infections, so there is no way to know where and how to focus efforts to repair dangerous procedures. Investigations in other countries have implicated a long list of health care procedures, including intra-muscular and intravenous injections, flushing intravenous lines, taking medicine from multi-dose vials, dental care, blood tests, blood and plasma donation, and others. Skin-piercing cosmetic procedures, such as tattooing, shaving, and manicures may also be involved.

Getting from no to yes: Officials in the government of South Africa have for decades consistently decided not to investigate unexpected infections. Increasing public awareness of unexpected infections could create public pressure for investigations. Libya and Cambodia provide examples of public pressure successfully pushing governments to investigate.

  • In Libya in August 1998, a magazine reported HIV infections in children traced to the El Fatah Hospital, Benghazi. The government’s initial response was to close the magazine. But parents did not take “no” for an answer. In November 1998 “a group of desperate fathers interrupted a medical conference Ghadafi was attending in Benghazi and appealed to him for help.”[47] Gaddafi ordered treatment for infected children and an investigation that offered HIV tests to all children treated at El Fatah Hospital in the previous year. The investigation found 418 children with HIV from healthcare.
  • In Roka, Cambodia, in November 2014, a 74-year-old man tested HIV-positive. Surprised, he sent his son-in-law and granddaughter for tests; both were infected. More villagers, alerted and worried, went for tests; many found they were infected. Acting on this information, government began an investigation in mid-December. The investigation reported 242 infections, attributing most if not all to skin-piercing procedures from a local private health care provider.[48,49]

With South Africa pursuing 90-90-90 targets, more people are getting tested. In the 2017 national HIV survey, 75.2% said they had ever been tested for HIV, and 66.8% had been tested within the past 12 months.[3] For many South Africans, an HIV-positive test comes as a surprise. In the previous 2012 survey 80% of adults considered themselves at low risk for HIV, giving reasons such as: “I use condoms”; “I abstain from sex”; “I am faithful to my partner.” But many self-assessed low risk adults were infected, accounting for 56% of adult HIV infections (calculated from data in Table 3.56 in [18]). As testing expands, more people are finding themselves with unexpected infections.

What happens next may well depend on whether people who have unexpected infections are able to get a respectful hearing from counselors, the media, churches, lawyers, support groups, non-government organizations, etc. To date, too few of those who manage or participate in public dialogue about HIV have been willing to believe people who report unexpected infections and to push government to mount the proper response to protect public health, i.e., to investigate, to look for outbreaks.

Making investigations work for public health: From a public health point of view, the priority for investigations is to determine the extent of the problem (to find all who were infected in each investigated outbreak) and to identify specific procedural lapses and facilities responsible. What might be ideal under such circumstances is for government to legislate to allow no-fault investigations along the lines of the post-apartheid Truth and Reconciliation Commission.

Attempting to punish or to collect compensation can create situations of conflict in which people who know what happened are motivated not to tell, investigators are pressured not to look, and blame and punishment fall on scapegoats. Open and thorough investigations educate and alert everyone – health care staff, cosmetic service providers, and the public – to be more aware of blood-borne risks. Punishing past mistakes is not necessary to improve health care safety; many health care staff will no doubt be mortified to learn that what they thought was safe may have infected patients. As for compensation, considering decades of inaction and inattention, it is not easy to identify anyone other than the government which both shares responsibility and has resources commensurate with whatever the problem might be. In any case, those who have been harmed already have free treatment.

Public trust in healthcare safety: Although officials have not explained why they have not investigated unexpected HIV infections, one reason may have been to maintain public trust in health care safety. Outbreak investigations that ask former patients at specific facilities to come for HIV tests challenge that trust by making the public aware of possible mistakes. But that is only a short term view of the matter. Acknowledging, investigating, and fixing problems builds trust in the long term.

Conclusion

No one has identified differences in sexual behavior that could explain much higher HIV prevalence in South Africa than in all non-African countries as well as in all but a few regional countries in Africa. One possible explanation is that lapses in health care safety have been driving South Africa’s epidemic. If that is so, then investigations of unexpected infections could lead to a dramatic drop in HIV transmission.

But even if blood-borne risks make only a limited contribution to South Africa’s epidemic, investigations protect public health. According to the World Medical Association’s Declaration of Lisbon on the Rights of the Patient, health care managers and providers have a responsibility to give patients “medical care of good quality” and “health education that will assist him/her in making informed choices about personal health and about the available health services.”[51] Without outbreak investigations, this is not possible.

Similarly, even if blood-borne risks make only a limited contribution to South Africa’s epidemic, investigations that recognize blood-borne transmission at any level undermine the stigmatizing belief that an HIV infection is a sign of sexual behavior.

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Guardian: Another Fine Press Excess Mess


If I wrote that health facilities may be contributing to the spread of diseases, such as Ebola (or HIV), I’d be accused of spreading scare stories. But because it’s the English Guardian, and it’s about sex in an African country, they can publish with impunity a story with the title ‘Ebola vaccine offered in exchange for sex, say women in Congo‘.

A quick read through the article shows that the title is wholly unmerited. And even the WHO has acknowledged that 86% of people infected with ebola in several hotspots have worked at or visited health centers recently. So the “deep mistrust of health workers” in the DRC may not be as misguided as the Guardian seems to suggest.

The Guardian continues: “Suspicion of authorities and health agencies has further hampered efforts to contain the response”. The Guardian tends to avoid suggestions that suspicion of health agencies is ever justified. They prefer to point the finger at gender based violence, sex, bats, women, corpse touchers, anything to avoid the admission that ebola epidemics cannot possibly be a simple matter of individual behavior, traditional practices, etc.

The article is not an isolated example of the Guardian’s fantasies about exotic sexual behavior, occult practices, primitive people, violent men and hapless female and child victims, without power or agency. Another in the series had the title ‘Women in sub-Saharan Africa forced into sex to pay hospital bills‘, based on research that did not warrant anything so salacious.

A third article in the Guardian screams “Girls are literally selling their bodies to get sanitary pads“, which is a quote from a researcher more anxious to get publicity for her work than to address some very serious issues in developing countries. Read the research in question and you will not come away with the impressions that the Guardian would have us believe.

And a fourth claims that dating apps in Pakistan (a very low HIV prevalence developing country, where several outbreaks of healthcare associated HIV have been described) are leading to an increase in transmission rates (there is no evidence of any correlation, let alone a causal connection, it’s just speculation).

It’s not just the English Guardian that plumbs the depths of tabloid journalism when it comes to ‘Africa’, nor are all the bizarre, not too credible and very badly researched issues always about sex. For example, some may remember reading articles about people on ARVs eating cow dung because they had no other food, in the BBC and elsewhere.

This story was repeated in a few other countries. Less attention was given to a woman who said she made up the story because she was told she would have to come up with something good in order to get money to buy food.

Other stories that seem belittling and (often obviously) untrue include one about men who have anal sex having to use adult diapers, people renting out used condoms and washing them before renting them out again, assumptions about ‘African’ sexuality (which can also be found on the BBC site, for example), etc.

Other news outlets that seem unable to resist trivial, belittling and often simply untrue stories about some African countries include IRIN (condom recycling), and Reuters, whose articles, like the BBC’s, are often used to back up newspaper articles, or are syndicated in African newspapers.

Aside from being insulting and demeaning, especially to people from African countries and women, these stories deflect attention from extremely serious risks that people in developing countries face, such as unsafe healthcare (which has been shown to contribute to outbreaks of HIV, Ebola, TB, hepatitis C and others), lack of sanitary and reproductive health services and supplies, misuse of medicines and many others.

The consequences of such irresponsible reporting by some of the most trusted news outlets go far beyond the often trivial gossip that purports to be news. If healthcare facilities are unsafe, people should avoid them, especially if authorities (and the press) try to cover up and lie about the risks, at least until healthcare associated outbreaks of deadly conditions are investigated and addressed adequately.

But if unsafe healthcare is deadly, so is the press that lies about it, the press that slings muck at anyone who dares to suggest that ‘professionals’ don’t always know best, the press that loves to brand people as ‘denialists’ if they don’t fall in with whatever is currently fashionable in ‘expert opinion’.

WHO’s early AIDS experts misdirected HIV prevention


Michael Merson, the second head of WHO’s Global Program on AIDS and co-author Steven Inrig describe WHO’s early AIDS response in The AIDS Pandemic: Searching for a Global Response.[1] Unfortunately, their otherwise excellent and detailed history ignores a tragic and continuing failure: the decision by WHO’s experts to accept an unknown  number of HIV infections from unsafe healthcare.

This misdirection has continued. Daniel Fernando reviews the confusion that led to this misdirection in a recent article[2]: “Already by 1985, WHO staff declared ‘Heterosexual promiscuity (large number of partners) is the most important risk factor among adult AIDS patients in Africa.’[quoted from page 9 in reference 3]…If iatrogenic transmissions had been taken seriously and addressed early, HIV in Africa would have been different.” (If you want a pdf Daniel’s article, email him at: dfernando@jjay.cuny.edu.)

In a prominent 1986 paper in the prestigious journal Science, the first head of WHO’s Global Program on AIDS, 1986-91, and the subsequent first director of UNAIDS, 1996-2008, wrote [p 962 in reference 4]: “…one cannot expect public health officials to upgrade blood transfusion services to prevent HIV infection when the proposed intervention is likely to cost, per person, approximately 30 times the annual per capita public health budget. Similarly, one cannot hope to prevent reuse of disposable injection equipment when many hospital budgets are insufficient for the purchase of antibiotics.”

As if this wasn’t enough, when WHO’s experts decided to give a pass to unsafe healthcare in Africa, they didn’t know how serious it would be. There was no evidence at the time – and there still is no evidence – to say with any confidence that blood exposures account for not more than 10% or as much as 50% or 75% or more. The almost exclusive focus on sex was and is based on insufficient evidence.

Although Merson and Inrig recount many events in WHO’s early response to AIDS, they all but ignore what WHO’s experts knew and thought about HIV from unsafe healthcare. The index at the end of the book doesn’t even include these terms: “blood,” “nosocomial,” “iatrogenic,” “injections, medical,” and “scarification.”

Unsafe healthcare was and is the forgotten risk. Africans in large numbers are still getting HIV from this forgotten risk. How many? No one knows.

References

1. Merson M, Inrig S. The AIDS pandemic: searching for a global response. Switzerland: Springer International, 2018.

2. Fernando D. The AIDS pandemic: searching for a global response. J Assoc Nurses AIDS Care 2018: 29: 635-641. Article available by request from Daniel Fernando at: dfernando@jjay.cuny.edu. Abstract available at: https://www.sciencedirect.com/science/article/abs/pii/S105532901830133X?via%3Dihub(accessed 9 January 2019).

3. World Health Organization (WHO). Workshop on AIDS in Central Africa: Bangui, Central African Republic from 22 to 25 October 1985. Geneva; WHO: 1985. Retrieved from http://www.who.int/hiv/strategic/en/bangui1985report.pdf

4. Quinn T. C., Mann J. M., Curran J. W., Piot P. (1986). AIDS in Africa: An epidemiologic paradigm. Science, 234(4779), 955-963. Retrieved from https://doi.org/10.1126/science.3022379.