Microbicide Trials Network

MTN-032

Details

Protocol Title: 
Assessment of ASPIRE and HOPE Adherence
DAIDS Protocol ID: 
12058
Status: 
Pending

Protocol Chair(s)

Elizabeth Montgomery (Protocol Chair)
Sarita Naidoo (Protocol Co-Chair)

Description

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 adherence

 

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 (e.g., with other participants with similar adherence levels) where factors influencing adherence, as well as strategies used to overcome adherence challenges, will be explored. Intermittent and strategic use around study visits will also be discussed.

 

The second phase of MTN-032 will explore both female participant and male partner attitudes toward the ring. Specifically, female IDIs will examine the effect of known efficacy level on adherence in participants who take part in HOPE, an open label extension trial to ASPIRE. These IDIs will explore:

·       Motivations for participant enrollment into HOPE among participants with varying levels of adherence in ASPIRE

·       What effect, if any, knowledge of the ring’s efficacy had on adherence behavior

·       Motivation for continued study participation among those participants who were inconsistently or not adherent

·       VR uptake, marketing and other product roll-out issues

 

Male partner attitudes will be explored through focus group discussions and, if needed, IDIs, to examine:

·       Male partner experiences of and support for partner ring use

·       Male partner understanding of ASPIRE trial results and the impact on support for ring use

·       Male partner perception of sexual health risk and impact on support for female partner’s use of HIV prevention products

 

Study management will also decide whether female focus group discussions will be conducted in light of findings from the HOPE study.

 

It is anticipated that Phase 1 and 2 of this study will take approximately 4-6 months and 9-12 months to enroll the target sample size, respectively.