MTN-032

MTN-032 was an exploratory study primarily designed to identify factors that may have affected participant adherence to study product in MTN-020 (ASPIRE) and MTN-025 (HOPE). The study also elicited perceptions about various participant engagement and adherence promotion interventions implemented in ASPIRE and explored the potential use of incentives to promote adherence to VR use as well as suitable approaches to market the study product.

In the first phase of MTN-032, 187 ASPIRE participants with varying levels of adherence to the dapivirine VR were enrolled. Based upon participants’ ASPIRE plasma dapivirine levels and residual drug levels from returned VRs, participants were pre-selected and approached for study participation.  Enrolled participants were categorized into groups of low or high adherence. After being presented their ASPIRE ring adherence results (plasma dapivirine levels and residual drug level results), participants were asked to complete a single in-depth interview (IDI) or a focus group discussion (FGD) (e.g., with other participants with similar adherence levels) about factors influencing adherence as well as strategies used to overcome adherence challenges. Intermittent and strategic use around study visits were also discussed.

In the second phase of MTN-032, 115 participants who took part in HOPE, an open-label extension trial to ASPIRE, were enrolled. This phase explored both female participant and male partner attitudes toward the ring. Specifically, female IDIs examined the effect of known efficacy level on adherence. Other aspects, such as their motivation to enroll and continue study participation, the effect of any knowledge of the ring’s efficacy on adherence, and VR uptake, marketing and roll-out were also explored. The attitudes of male partners were explored through focus group discussions, specifically their experiences of and support for partner ring use, their understanding of ASPIRE trial and the impact on support for ring use and their perception of sexual health risk and support for partner’s use of HIV prevention products.

The study completed follow-up on December 19, 2018. Phase 1 primary results were presented at the International AIDS Society (IAS), HIV Pathogenesis, Treatment & Prevention held on July 23-26, 2017 in Paris, France. The primary manuscript was published in AIDS on July 17, 2018. Phase 2 results from female participants were presented at the 10th International AIDS Society (IAS) Conference on HIV Science held on July 21-24, 2019 in Mexico City, Mexico. The manuscript on female participants was published in Journal of Acquired Immune Deficiency Syndromes on April 1, 2021. Phase 2 results from male partner participants were presented at the 23rd International AIDS Conference held virtually on July 6-10, 2020. The manuscript on male partner participants was published in AIDS and Behavior on January 2, 2021.

Protocol Chair(s)
Montgomery, Elizabeth (Protocol Chair)
Naidoo, Sarita (Protocol Co-Chair)
Protocol Title
Assessment of ASPIRE and HOPE Adherence
DAIDS Protocol ID
12058
Status
Participants off Study and Primary Analysis Completed
Formulation
Vaginal Ring
Drug
Dapivirine
Placebo
Study Focus/Product Administration
Vaginal
Study Type
Behavioral
Countries
Malawi
South Africa
Uganda
Zimbabwe
Population
Women (cisgender women, non‐transgender women)
Funder(s)
US Division of AIDS (DAIDS)/National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
US National Institute of Mental Health (NIMH)
US Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Source URL: https://www.mtnstopshiv.org/research/studies/mtn-032