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 Women


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, MMed

Funding 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 Institute

Study Location:

Durban, South Africa
Johannesburg, South Africa
Cape Town, South Africa
Kampala, Uganda
Harare, Zimbabwe
Lilongwe, Malawi (2 study sites)


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.