When people were offered preexposure prophylaxis (PrEP) outside of traditional clinics, regardless of specific risk factors, as part of the Sustainable East Africa Research in Community Health (SEARCH) study, new HIV acquisitions dropped by 74%.
It’s a valuable lesson to providers around the world, said Catherine Koss, MD, assistant professor of medicine in HIV, infectious disease, and global medicine at the University of California, San Francisco.
“We haven’t really seen PrEP being scaled up and offered at such a broad level in communities,” Koss said during the International AIDS Conference 2020.
The first part of SEARCH, which looked at the impact of universal testing and access to HIV treatment immediately after diagnosis, showed that the strategy resulted in a population-wide 30% reduction in new HIV acquisitions. In other words, treatment alone wasn’t enough to end the HIV epidemic.
But the researchers always knew “there were likely going to be new HIV infections,” even with universal HIV testing and treatment, Koss said.
So the second part of the study was designed to see whether PrEP — with the combination of tenofovir disoproxil fumarate plus emtricitabine (Truvada, Gilead Sciences) — could further reduce rates of HIV acquisition.
PrEP out in the community
During the PrEP part of the SEARCH study, researchers discussed HIV risk with adults in 16 communities in rural Kenya and Uganda during population-level testing that took place at health fairs, beaches, trading centers, other community sites, and even in participants’ homes. PrEP was offered to anyone in a relationship with someone living with HIV, to anyone determined to be at elevated risk for infection by a previously validated algorithm, and to anyone who did not fit those criteria but who wanted a prescription.
Of the 15,632 adults eligible for PrEP, 5,447 (35%) chose to start the HIV prevention pill.
A rapid-enrollment protocol meant that people received their prescription at the time of screening or soon after that. Participants underwent testing for HIV antibodies — also out in the community — at weeks 4 and 12, and every 12 weeks thereafter; this will continue out to week 144.
HIV-negative adults who were part of the larger SEARCH cohort in the year before PrEP was made available — and from the same communities — served as the control group.
Interim 60-week data show that the rate of acquisition was 74% lower in the PrEP group than in the control group (incidence rate ratio, 0.26; P = .01). In women, the acquisition rate was 76% lower (incidence rate ratio, 0.24; P = .04), and in men, it was 40% lower (incidence rate ratio, 0.60; P = .54).
The reduction was not significant for men, probably because so few men acquired HIV, Koss reported. The powerful drop in new HIV cases overall was related to PrEP use by women; cases in women fell from 1.52 to 0.40 per 100 person-years.
Blood tests showed that 72% of the people who acquired HIV during the study period had not taken a PrEP pill for at least 30 days before their diagnosis.
“Making PrEP more easily accessible and more community-based could be very powerful in the United States,” said Koss.
“Allowing people to test for HIV and start PrEP outside of health clinics or standard health facilities could help reach more people,” she told Medscape Medical News. “Many of the people who benefit from PrEP may not otherwise need to seek medical care regularly if they’re otherwise healthy and often young.”
When PrEP is made available — easily available — people will pick it up, they will take it away, they will put it in their mouths, and they will not get HIV.
The findings were hailed by others in the field of HIV prevention.
“They’re fantastic,” said Jared Baeten, MD, vice dean of the School of Public Health and professor of global health, medicine, and epidemiology at the University of Washington in Seattle. He was involved in Partners PrEP, a study of PrEP use in mixed-HIV-status couples, the Partners Demonstration Project, and HOPE, a study of the dapivirine ring for HIV prevention.
“These data provide real evidence that when PrEP is made available — easily available — people will pick it up, they will take it away, they will put it in their mouths, and they will not get HIV,” he said in an interview.
Even more, they clarify something that has stymied American regulators and clinicians.
Early studies of PrEP use by single women were stopped because participants weren’t taking the pills; adherence was so low that researchers couldn’t show efficacy. Since then, various trials — including Partners PrEP — have shown that PrEP works in women, but doubts have lingered, leading women to “get the short end of the stick in discussions about PrEP,” Baeten explained.
“There really shouldn’t be questions anymore,” he said. “These findings should put to rest any question about women in Africa being able to benefit from PrEP.”
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