Scientists working on HIV vaccines and cures would like to know what happens during very early HIV infections, in the first several days and weeks after the virus enters the body. To study very early infections, researchers recruited women aged 18-23 years from the Umlazi Township in KwaZulu-Natal, South Africa, where the percentage of women HIV-positive had been seen to “rise from less than 1% at age 15 to 66% at age 23.” To see new HIV infections, this location was a good choice. Women in the study got HIV at the rate of 8.2% per year.
Because women in the community were at such high risk to get HIV, they were a vulnerable group, for which the Declaration of Helsinki mandates special protection (article 20): “Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group…” Given the very high rate at which young women in the community were getting HIV, the priority was to identify how women in the study got HIV, so women in the community could be warned about what risks to avoid. The study was unethical, ignoring women’s priority while taking advantage of their vulnerability (high risk for HIV) to study new infections. (If the study had addressed the priority – how women got HIV – but had also collected information from new infections that might help to develop vaccines and cures, that was arguably ethical.)
The study tested women’s blood for HIV virus twice per week. Because virus generally shows up in blood 1-2 weeks after the event that caused the infection, the study was ideally designed to identify specific events that led to infections. The study saw 42 new infections. Most women had one partner, so testing partners at the beginning of the study and new partners during the study was one way not only to protect women in the study but also to see how they got HIV. The study says nothing about tracing and testing partners to see if they were the sources of women’s new infections, and has not reported women’s sexual events in the 1-3 weeks before virus appeared in their blood.
Considering the very high rate at which women were getting HIV, the study team should have considered blood exposures as well. Did women with new infections have an injection, manicure, or other skin- piercing event 1-3 weeks ago? Aside from injections for birth control, the study does not report anything about skin-piercing events, and there is no indication it asked.
An early report from the study says women who reported injections for birth control (mostly Depo, but also some NET-EN) got HIV at the rate of 12% per year compared to 3.7% for women who reported not using any long-term birth control; “behavioural differences… could not explain this increased risk.” Considering that Depo use increases women’s HIV risk by 40%-50% only, most new infections in women getting injections for birth control likely came from contaminated injections. But the study does not say if women reported birth control injections 1-3 weeks before showing up with a new infection, or if they reported sex with an HIV-positive man or with any man during that time. That would help to determine if the injections infected women or if Depo use increased their susceptibility to sexual transmission.
Even if women had not been vulnerable, researchers had “a duty” according to article 6 in the Declaration of Helsinki “to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.” Not identifying the events that infected women was not only unethical, it was also bad science. Bodies respond differently if HIV enters through a skin-piercing event or through sex. Assuming all women got HIV from sex could lead to a lot of confusion if many or most of their infections came from blood risks.
- Dong KL, Moodley A, Kwon DS, et al. Detection and treatment of Fiebig stage 1 HIV-1 infection in young at-risk women in South Africa: a prospective cohort study. Lancet HIV 2018; 5: e35-e44.
2. Fresh. Ragon Institute of MHG, MIT and Harvard [internet], 2020. Available at: https://www.ragoninstitute.org/international/fresh/#:~:text=The%2%200FRESH%20study%20(Females%20Rising,they%20are%20infected%2%200with%20HIV (accessed 7 July 2020).
3. World Medical Association (WMA). WMA Declaration of Helsinki – ethical principles for medical research involving human subject, amended October 2013.Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ (accessed 29 January 2021).
4. Byrne EH, Anahtar MN, Coneh KE, et al. Association between injectable progestin-only contraceptives and HIV acquisition and HIV target cell frequency in the female genital tract in South African women: a prospective cohort study. Lancet Infect Dis 2016; 16: 441-448.