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MTN 025 (HOPE)

Status
Completed
Phase
Open Label
III
Principal Investigator(s)
John Steytler
Objective


MTN-025 or the HIV Open-label Prevention Extension (HOPE) study is a follow-on trial to assess the continued safety of and adherence to a vaginal ring containing dapivirine in women.

Results summary: High uptake and persistent use in this open-label extension study support DVR as an HIV-1 prevention option for women.

Last updated October 20, 2022

Prevention Option(s)
Microbicides
Study Design
Open label
Arms and Assigned Interventions
Description
Following demonstration of safety and efficacy of the dapivirine vaginal ring in MTN-020, eligible MTN-020 participants will be offered enrollment into MTN-025, a trial designed to obtain additional safety and adherence data in women.
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Results
HIGH UPTAKE AND REDUCED HIV-1 INCIDENCE IN AN OPEN-LABEL TRIAL OF THE DAPIVIRINE RING
Official Code
NCT02858037
Related Publications
Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study
Sharing Objective Measures of Adherence to a Vaginal Microbicide Promotes Candor About Actual Use and Bolsters Motivation to Prevent HIV
Trial Sponsors
DAIDS, NICHD, NIMH, NIH
July 2016
October 2018
Enrollment
1 576
18
Years
40
Years
Population
Women
Sites

College of Medicine John Hopkins University Clinical Research Site

Blantyre
Malawi

University of North Carolina - Lilongwe

Lilongwe
Malawi

Botha's Hill CRS

Westville, KwaZulu-Natal
South Africa

CAPRISA eThekwini Clinical Research Site

Durban, KwaZulu-Natal
South Africa

Chatsworth CRS

Chatsworth, KwaZulu-Natal
South Africa

Emavundleni Desmond Tutu HIV Centre CRS

Cape Town
South Africa

Isipingo CRS

Westville, KwaZulu-Natal
South Africa

Tongaat CRS

Tongaat, KwaZulu-Natal
South Africa

Verulam CRS

Verulam, KwaZulu-Natal
South Africa

Wits Reproductive Health and HIV Institute / University of the Witwatersrand

Hillbrow
South Africa

Makerere University - Johns Hopkins University Research Collaboration

Kampala
Uganda

UZ-UCSF HIV Prevention Trials Unit - Seke South

Chitungwiza
Zimbabwe

UZ-UCSF HIV Prevention Trials Unit - Spilhaus

Harare
Zimbabwe

Zengeza 3 Clinic

Harare
Zimbabwe