HOPE MTN-025: A Phase 3B Open-Label Follow-on Trial to Assess the Continued Safety of and Adherence to a Vaginal Ring Containing Dapivirine in WomenPrincipal Investigator: Ivan C. Balán, PhDSharon Hillier, PhDJared Baeten, MD, PhDCo-Investigator(s):Nyaradzo Mgodi, MBChB, MMed Thesla Palanee-Phillips, PhD Bonus Makanani, MBBS, FCOB(SA) Gonasagrie Nair, MBChB Danielle Crida, MBChB Francis Martinson, MBChB, PhD Logashvari Naidoo, MBChB Nishanta Singh Anamika Premrajh Brenda Gati, MBChB, Msc Felix Muhlanga, MBChB, MMedFunding Agency:National Institute of Allergy and Infectious Diseases (NIAID)Collaborating Institution: Microbicide Trials Network University of Zimbabwe University of California at San Francisco Makerere University, Kampala, Uganda Johns Hopkins University Medical Research Council-HIV Prevention Research Unit, KwaZulu-Natal, South Africa UNV Project, Tidziwe Centre, Kamazu Central Hospital, Lilongwe, Malawi Emavundleni Research Centre, Cape Town, South Africa eThekwini Clinical Research Site, Durban, South Africa Wits Reproductive Health and HIV InstituteStudy Location:Durban, South Africa Johannesburg, South Africa Cape Town, South Africa Kampala, Uganda Harare, Zimbabwe Lilongwe, Malawi (2 study sites)Description:The HOPE open-label extension study follows MTN-020 (ASPIRE), which showed that the dapivirine vaginal ring is safe and prevents HIV infection. ASPIRE study participants are offered enrollment in the HOPE study, which is designed to learn more about the ring's safety and its use by women. Participating women can choose to receive a vaginal ring with the dapivirine to use for four weeks. They return monthly for the first three months and can receive a new study ring at each visit. Starting at month 3, they are given 3 rings at each visit and have visits every three months, returning at months 6, 9 and 12, with instructions to use a new ring every four weeks.The purpose of the client-centered counseling intervention is to explore participants' use of the vaginal ring, the reasons they decide to use (or not use) the ring, and factors that help them use it or keep them from using it. In order to accomplish this goal, the team trained counselors at the study sites to deliver the counseling sessions and is responsible for quality control monitoring of the counseling intervention.