Microbicide Trials Network

The REACH Study (MTN-034/IPM 045)


REACH (Reversing the Epidemic in Africa with Choices in HIV prevention), or MTN-034/IPM 045, is a Phase IIa trial that seeks to understand the HIV prevention needs and preferences of adolescent girls and young women, who are among those at highest risk of HIV in sub-Saharan Africa. Specifically, REACH will evaluate how adolescent girls and young women use the monthly dapivirine vaginal ring and Truvada® as daily PrEP, and their preferences for either or both approaches after using each for six months. The study will also collect much needed information on the safety of these approaches in young women and assess whether biological or physiological factors affect how the active drug in each of these products is taken up in the body or may contribute to HIV susceptibility. The study, which is expected to launch mid-2017, will enroll approximately 300 girls and young women ages 16-21 at four trial sites in Kenya, South Africa and Zimbabwe.

 

As part of the protocol development process, the MTN held a consultative meeting in Johannesburg, South Africa on 29 and 30 September 2016, to seek input from stakeholders from each of the trial site countries about the study and issues related to the study’s approval and implementation. MTN co-hosted the meeting with AVAC in close partnership with Impact Research and Development Organization in Kenya, Soul City Institute for Social Justice in South Africa and Pangaea Zimbabwe AIDS Trust.

 

The consultation included much discussion on the informed consent process, and is described in the Meeting Report (see link below). Based on this feedback, the informed consent and parental permission forms were made significantly shorter and the process itself made more simple.  Despite the study team’s desire and stakeholders' support in seeking a parental waiver, this path could not be pursued. U.S. regulations do not permit parental waivers for studies involving an Investigational New Drug (IND), i.e., an experimental product that has not yet been approved. While Truvada is approved for PrEP in some countries, including in South Africa and Kenya, the dapivirine vaginal ring is not a licensed product.

 

See

HIV prevention dapivirine vaginal ring found safe and acceptable in US adolescent girls

25-July-2017

 

MTN-023/IPM 030 and the REACH Study Q&A

25-July-2017

 

Meeting Report: Stakeholders consultation on REACH (MTN-034)

December-2016