MU-JHU Care Ltd is in the preparatory stages for a new drug trial study called IMPOWER 022. The Study Investigators/Co-Investigators comprising of Dr. Brenda Gati, Dr. Carolyne Akello, and Dr. Clemensia Nakabiito received the invitation letter from Merck Sharp and Dohme Corporation(MSD) last November and have undertaken the task of preparing the site for the activities. As part of the preparatory process, a series of stakeholder meetings were held to announce the study protocol. In the first major series of events, members of the Community Advisory Board (CAB) and community influencers were invited to a half-day discussion on the changing landscape of HIV prevention studies and an overview of the IMPOWER-022 protocol.
This took place on 17th March 2021. The group received an in-depth presentation on the transforming landscape of HIV prevention and the need to continue expanding healthcare options for HIV prevention. Dr. Brenda Gati was on hand to explain the IMPOWER-022 protocol. Teopista Nakyanzi the Community Coordinator further engaged the group through an interactive brainstorming session discussing creative ways in which recruitment for this new study can be achieved. At the end of March, a larger meeting was organized targeting policymakers, members of the civil society, researcher partners and health reporters.
Dr. Andrew Mujugira a Senior Research Scientist with IDI was invited to speak on the impact of PrEP on the youth. His presentation helped set the stage for the discussion on the expanding options for PrEP. While Dr. Andrew expounded on the facts and statistics of PrEP use, real-world testimonies were provided by two young women with PrEP participant experience. Dr. Brenda carried the main presentation of the day. She gave a broad introduction to the new study with a description of the main study drug, Islatravir as well as an elaborate breakdown of the study protocol. Many questions were fielded from both in-person and virtual guests concerning the inclusion of the male perspective in HIV prevention. All in all, the team was able to reach over 100 stakeholders.
Study Name: IMPOWER-022 or MK-8591
Study cycle:1-3 years
Aim: Test the efficacy and safety of once-a-month Islatravir drug on high-risk Cisgender women in Sub-Saharan Africa
Primary target audience: HIV negative at high-risk Cisgender women, 16-45 years old
Focus: The safety and efficacy of once a month HIV prevention treatment drug called Islatravir
Methods: Sample size of 4500 participants randomized into two groups of 2250 each who will receive either active and placebo doses of Truvada and Islatravir (across all sites)
MU-JHU Study Team:
Investigator of Record- Dr. Brenda Gati; Co-investigators- Dr. Clemensia Nakabiito and Dr. Carolyne Akello; Community Liaison- Teopista Nakyanzi