The surprising failure of a large clinical trial of H.I.V.-prevention methods in Africa — and the elaborate deceptions employed by the women in it — have opened an ethical debate about how to run such studies in poor countries and have already changed the design of some that are now underway.
They are now testing participants’ blood more often and holding group discussions to quell rumors and urge participants to take their medications diligently.
As a result of the failed trial, scientists are arguing vigorously about the extent to which it is ethical to pay participants for their time, and whether results of trials that do so can be trusted.
The trial — known by the acronym Voice, for Vaginal and Oral Interventions to Control the Epidemic — was abruptly halted by independent safety monitors because it was not working: Women who were given pills or vaginal gels containing anti-H.I.V. drugs were becoming infected at roughly the same rate as women who were given placebos.
The study, paid for by the National Institutes of Health, was supposed to definitively establish whether pre-exposure prophylaxis — the use of small amounts of anti-AIDS drugs to prevent infection — would work for African women. It enrolled 5,029 women at 15 clinics in South Africa, Zimbabwe and Uganda, and cost $94 million.
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The Voice revelations, several scientists said, have profoundly changed how similar trials are run.
Investigators now test blood immediately, but doing so is tricky because trials must remain “double-blind,” meaning neither the patient nor the doctor can know who is getting the drug or the placebo.
Gita Ramjee, director of H.I.V. prevention at the South African Medical Research Council and a site leader for the vaginal ring trial, said the lab was not allowed to tell her any individual’s results, but it could say which sites had lower overall drug levels in participants’ blood.
If that happened, her nurses would hold group sessions gently telling the women that they were doing worse than women at other sites and reminding them that success would help women all over the world.
Also, she said, her trial was trying to get local men to be more sympathetic by sponsoring movie nights and soccer matches with free food, and pamphlets explaining the trial.
