Microbicide Trials Network

MTN-031/IPM 043

Details

Protocol Title: 
An Open-Label Trial of the Dapivirine Vaginal Ring to Assess whether Provision of Incentives Conditional on Use Increases Product Adherence
DAIDS Protocol ID: 
12064
Status: 
Withdrawn

Protocol Chair(s)

Barbara Mensch (Protocol Chair)
Jayajothi Moodley (Protocol Co-Chair)
Ariane van der Straten (Protocol Co-Chair)

Description

MTN-031/IPM 043 is a multi-site, randomized, open label study. 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.  The MTN-031/IPM 043 study population will consist of approximately 450 sexually active, HIV-uninfected, non-pregnant women 18-45 years of age. Participants will be randomized (1:1:1) to one of three groups:

·       Group 1: Participants receive adherence feedback and a financial incentive if adherent to study product

·       Group 2: Participants receive adherence feedback, but no financial incentive

·       Group 3: Participants do not receive adherence feedback, nor a financial incentive

Participants will attend monthly study visits for a total of 12 months. It is anticipated that this study will take approximately 9-12 months to enroll the target sample size.

Other Study Info

Sponsor: 

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US Eunice Kennedy Shriver National Institute of Child Health and Human Development

US National Institute of Mental Health

US National Institutes of Health

 

Co-Sponsor: IPM

 

Study Design: Multi-site, three-arm, randomized (1:1:1), open-label trial