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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).

 

 

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