The NIH announced the start of a clinical trial that will explore the preference among adolescent girls and young women between pre-exposure prophylaxis, or PrEP, and a vaginal ring for HIV prevention.
The phase 2a clinical — Reversing the Epidemic in Africa with Choices in HIV prevention (REACH) — will enroll 300 females aged 16 to 21 years at five sites in Kenya, South Africa, Uganda and Zimbabwe, according to an NIH news release.
The trial will evaluate the safety of and adherence to the dapivirine vaginal ring, which continuously releases the anti-HIV drug dapivirine. Replaced monthly, the investigational product was found to be well-tolerated and to reduce the risk for HIV infection by 30% in African women ages 18 to 45 in two separate studies. Participants also will be offered PrEP during the study to determine their preference.
Study participants will use each prevention method for 6 months and can then choose either of the methods, or neither, to use for another 6 months, according to the NIH. Researchers will evaluate product safety, the extent to which participants used the products and how much they liked them.
Carl W. Dieffenbach, PhD, director of the National Institute of Allergy and Infectious Diseases’ Division of AIDS, said the study will gather an important piece of information in a key population.
“They have a choice,” he told Infectious Disease News. “Either or neither.”
Dieffenbach said the ring is important because it provides an element of control for the users which should improve adherence, however, the issue remains.
“Women insert the ring in their vagina and then they take it out. Every time they take it out and put it back in it takes time for the drug concentration to get back, so, that has been one of the challenges,” he said.
“There is relatively low efficacy in the pivotal trials that have been done, so it’s not a slam dunk in the way that an injectable would be, but it is female controlled, and I think that’s very important.”
According to Dieffenbach, the ring is currently under regulatory review by the European Medicines Agency, which has delayed the release of its decision. He said that a decision should come in the spring.
Additional trials scheduled for the ring include testing in special populations, including pregnant and breastfeeding women, which are scheduled to take place later this year, Dieffenbach said. – by Caitlyn Stulpin
NIH. Study of PrEP and vaginal ring for HIV prevention begins in girls and young women. https://www.nih.gov/news-events/news-releases/study-prep-vaginal-ring-hiv-prevention-begins-girls-young-women. Accessed February 17, 2019.
Disclosures: Dieffenbach has no relevant financial disclosures.