MTN 032
Status:Completed
Phase:Open Label
Principal Investigator(s):Elizabeth Montgomery, PhD, MHS
Objective:In the first phase of MTN-032, up to 224 ASPIRE participants with varying levels of adherence to the dapivirine vaginal ring will be enrolled. Based upon participants’ ASPIRE plasma dapivirine levels and residual drug levels from returned vaginal rings, participants will be pre-selected and approached for study participation. Enrolled participants will be categorized into one of the following groups (with final group designation dependent on adequate sample size):
- Consistently low adherence- Inconsistent adherence- Consistently high adherencee
After being presented their ASPIRE ring adherence results (PK and residual drug level results), participants will be asked to complete a single in-depth interview (IDI) or a focus group discussion. Factors influencing adherence, as well as strategies used to overcome adherence challenges, will be explored.
The second phase of MTN-032 will examine the effect of known efficacy level on adherence in participants who take part in HOPE, an open label extension trial to ASPIRE. A single IDI will be conducted during the second phase of this study to explore:
- Motivations for enrollment into HOPE- What effect, if any, knowledge of the ring's efficacy had on adherence behavior- Motivation for continued study participation among those who were inconsistently or not adherent- VR uptake, marketing and other product roll-out issus
*Closed to accrual as of 10/28/16*
Last updated May 7, 2021
Prevention Option(s):Microbicides
Study Design:
Official Code:
NCT02702895
Trial Sponsors:
HIH, MTN, NIAID, NICHD, NIMH
Start Date
End Date
June 13, 2016
December 19, 2019
Enrollment:302
Age range:
↔
any
Population:Cisgender Men, Cisgender Women