ABOUT OUR CLINICAL RESEARCH CENTER (CRC)
The Mwotaji CRC will be administrative based at the Center of Excellence in Health Monitoring and Evaluation (COEHME) of Mzumbe University in Morogoro, Tanzania. Mzumbe is perfectly positioned with the support of UC and HPON to be the anchor institution for the CRC, ensuring that capacity remains in Tanzania and lives beyond the PATC3H-IN initiative. Key partners are:
Health for a Prosperous Nation (HPON)
A Tanzania NGO with expertise in HIV and SRH and with field offices in Kagera, Geita, Shinyanga, Mwanza, and Dar es Salaam.
University of California (UC)
UC Berkeley and UC San Francisco (UCSF) will extend a decade of research and capacity building collaborations with Mzumbe and HPON.
PROJECT OBJECTIVES
THE OVERARCHING GOAL OF THE RESEARCH ACTIVITIES CONDUCTED AS PART OF THE MWOTAJ I CLINICAL RESEARC H
CENTER IS TO DETERMINE THE STRONGEST AND MOST SUSTAINABLE VERSION OF THE MALKIA KLABU (“QUEEN CLUB”)
IMPLEMENTATION STRATEGY FOR PHARMACY-BASED PREP AND HIV SELF-TESTING (HIVST) DELIVERY TO AGYW.
AIM 1: Primary Outcomes: Our outcomes have been defined using the ‘RE-AIM’ implementation science framework and include: adoption: Proportion of pharmacies still implementing assigned model at 12 months; implementation: Consistent screening of AGYW for PrEP; and maintenance: % revenue from AGYW and proportion of pharmacies willing to continue.
Type 3 Hybrid Implementation-Effectiveness cluster randomized study of four pharmacy-based differentiated PrEP delivery models of Malkia Klabu for AGYW in 50 pharmacies in Tanzania, examining implementation outcomes before and after the addition of user cost-sharing which is essential for real-world sustainability. Each of the 5 geographic regions will be randomly assigned to either standard of care in pharmacies or one of the four PrEP models:
- PrEP referrals only (n=10 pharmacies)
- PrEP referrals plus PrEP refills (n=10 pharmacies)
- PrEP referrals plus PrEP refills plus PrEP initiation (n=10 pharmacies)
- PrEP referrals plus PrEP refills plus PrEP initiation plus peer navigator (n=10 pharmacies)
- Fee-for-service: each PrEP refill is provided for 200Tsh, a standard cash-based transaction for user fees.
- Loyalty hybrid: PrEP refills are free with any shop purchase or a fee of 200Tsh without a shop purchase.
AIM 2: Primary Outcomes: Effective use of PrEP at 12 months among AGYW enrolled in the cohort. Specifically, among AGYW who remain at high risk of HIV at 12 months, effective use is defined as PrEP continuation at 12 months; Reach: the proportion of AGYW in each study region who have engaged with the Malkia Klabu program; defined as stating in the household survey that they have been a member of the Malkia Klabu loyalty club at any time in the past 12 months.
We will examine the success of the Malkia Klabu delivery models on effective use of PrEP among a cohort of 575 AGYW, reach of the program in a cross-sectional household survey with 750 AGYW in study areas; and conduct pharmacy exit surveys with ~200 AGYW to describe the success of pharmacy-based PrEP service offerings.
AIM 3: CREATE AN IMPLEMENTATION SCIENCE CERTIFICATE PROGRAM AT MZUMBE UNIVERSITY TO BUILD TANZANIA’S CAPACITY TO LEAD POLICY-RELEVANT IMPLEMENTATION SCIENCE RESEARCH TO BENEFIT AGYW AND BEYOND
We will create an Implementation Science Certificate program at Mzumbe University to build Tanzania’s capacity to lead policy-relevant implementation science research to benefit AGYW and beyond. We plan to put three certificate cohorts through the new program, leveraging the planned clinical research center resources by including local government staff within the study regions who may also apply for 1-yr seed grants of ≤$10,000 for implementation science-based sub-studies related to Malkia Klabu.
