February 15, 2022

 

Dear MTN Friends and Family,

Although, technically, we are no longer a network, we are still MTN Family, and it is in that spirit, that I am writing about new and long-awaited results from the REACH (MTN-034) study, which were presented as a late-breaker at the Conference on Retroviruses and Opportunistic Infections (CROI) a short time ago by Kenneth Ngure, protocol co-chair.

REACH was designed to fill important gaps in information about the safety and acceptability of the monthly dapivirine vaginal ring and Truvada as daily oral PrEP in adolescent girls and young women as well as to understand what kind of support they need to use these products as best they can, and, when given the choice, which of the two they would rather use. We enrolled 247 participants ages 16 to 21, who for the first two periods of the study used the ring and oral PrEP each for six months and then for the third and final six months of the study could decide which one to use or to use neither.  REACH was conducted by a stellar team of site investigators in Uganda, South Africa and Zimbabwe, which even in the throes of COVID-19, was able to complete the study and bring us to where we are today, reporting the much-anticipated results from the last period.

And so, what do adolescent girls and young women want? They want choice!

  • Nearly all (98%) of the 227 participants who took part in the choice period opted to use one of the two HIV prevention products being offered.
  • Of these, 67% chose to use the ring and 31% chose to use PrEP – only 2% didn’t want to use either.
  • Most participants used their product of choice some or most of the time.

The results from the first two periods, which were reported by Lulu Nair, protocol chair, at IAS 2021, found:

  • No safety concerns with either product, including in adolescent girls, which for the dapivirine ring, is especially important.
  • Both the ring and oral PrEP were highly acceptable -- when participants were assigned to use the dapivirine ring, 88.5% found it acceptable, and when assigned to use oral PrEP, 64% found it acceptable.
  • For both products, adherence was higher than what had been observed in previous studies of either the ring or oral PrEP in adolescent girls and young women.

Why are these results significant? For too long now, oral PrEP has been the only option available to adolescent girls and young women. No single method can be expected to appeal to everyone, and so it’s no surprise that many young women do not choose to take oral PrEP or cannot persist with its use. The dapivirine ring is a new HIV prevention method that received a positive opinion from the European Medicines Agency and has been recommended by the WHO as an additional option for women at high risk of HIV. Indeed, results of REACH suggest the ring would be a viable option for those young women who can’t or choose not to use oral PrEP. The International Partnership for Microbicides (IPM) is seeking the ring’s approval in a number of African countries; some, including Zimbabwe, have already approved the ring for use in women ages 18 and older.  Data from REACH on the ring’s safety in girls under age 18 will enable regulators to consider expanding the ring’s use to include adolescent girls.

The stellar REACH team was led by Lulu Nair, alongside Ngure and Connie Celum, but credit also goes to Morgan Garcia and others at FHI 360 for keeping everyone in step. Of course, none of this work could have been possible without each and every person at the trial sites – the investigators, clinicians, nurses, recruiters, community staff, counsellors, pharmacists, laboratory scientists, receptionists and drivers – all of whom play a critical role. But it’s the extraordinary participants who we owe our immense gratitude, whose commitment to this work ensured that the study was successfully completed.  We would also like to acknowledge our partners at IPM and Gilead, and of course, our funders.  Please, everyone stand and take a bow!!

And while the focus of REACH was on daily oral PrEP and the monthly dapivirine ring, remember that what adolescent girls and young women want is choice, and the more options we can make available to them, the more likely one can and will be used. In another oral session during CROI, Raphy Landowitz, who led the impressive HPTN-083 study, stated “No one biomedical prevention option will address all issues in HIV prevention.” I couldn’t agree more!

With gratitude,

Sharon Hillier