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Status
Withdrawn
Phase
II
Objective
The primary objective of this study is to determine if a financial incentive conditional on the prior month’s product use promotes adherence to a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine, when inserted once every 4 weeks. Another primary purpose of this study is to assess what effect, if any, the provision of adherence results has on participant adherence.
Prevention Option(s)
Microbicides
Study Design
Randomized
Open label
Arms and Assigned Interventions
Description
Participants receive adherence feedback and a financial incentive if adherent to study product
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Participants receive adherence feedback, but no financial incentive
Mode of Delivery
Ring
Products
Dapivirine Ring
ARMs
Experimental
Description
Participants do not receive adherence feedback, nor a financial incentive
Mode of Delivery
Ring
Products
Dapivirine Ring
Official Code
Trial Sponsors
NIAID, NICHD, NIMH, NIH
Enrollment
450
18
Years
45
Years
Population
Women
Sites
Verulam CRS
Verulam, KwaZulu-Natal
South Africa
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg
South Africa
UNC Lilongwe CRS
Lilongwe
Malawi