Kristine Torjesen, FHI 360
Elizabeth Irungu, Jhpiego
We are excited to announce the launch of Catalyzing Access to New Prevention Products to Stop HIV (CATALYST), MOSAIC’s flagship product introduction study. CATALYST will provide and assess an enhanced service delivery package that includes oral pre-exposure prophylaxis (PrEP), the PrEP ring, and injectable cabotegravir for PrEP. The package of products and services for PrEP will be provided to women at 28 PEPFAR delivery sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. CATALYST will also use quality improvement methods to refine the program and identify a scalable service delivery package for delivering PrEP choice.
Although oral PrEP initiations have increased globally, uptake and effective use remain suboptimal among many populations. HIV incidence remains high in eastern and southern Africa, particularly among adolescent girls and young women younger than 25, pregnant and breastfeeding people, female sex workers, and transgender people. New PrEP methods are currently in development or nearing market entry. Two methods soon to be widely introduced are the dapivirine vaginal ring (PrEP ring) and injectable cabotegravir for PrEP (CAB PrEP). CATALYST is designed to generate the evidence necessary to accelerate access to a choice-based HIV prevention portfolio and ensure new prevention products reach and can be used by those who need them most.
What will CATALYST study?
In each country, CATALYST will be implemented by a local partner alongside ministries of health. The study will be implemented in two stages. Stage I will offer oral PrEP and the PrEP ring, which are currently approved for use in the study countries. In each country, Stage II will begin once CAB PrEP has been approved by the national regulatory authority and donated product is available on site.
CATALYST has three primary objectives:
- Characterize the implementation of an enhanced service delivery package for informed PrEP choice for women at public health service delivery sites supported by PEPFAR/USAID and assess facilitators of and barriers to the implementation process for individuals, providers, facilities, communities, and health systems.
- Describe patterns of PrEP use and use effectiveness in the context of informed PrEP choice and assess sociodemographic and contraceptive use correlates of PrEP use patterns.
- Describe clinically relevant indicators among PrEP users, including rates of HIV infection and drug resistance among PrEP users who acquire HIV following PrEP initiation or had undetected HIV prior to PrEP initiation.
For more information about CATALYST, including the study design, click here.
How will study findings be used?
CATALYST is designed to inform the introduction and scale-up of new PrEP methods and strengthen PrEP service delivery. Interim data analyses will be conducted every six to nine months, and results will be shared with ministries of health to inform national PrEP implementation plans. The quality improvement component of the study will facilitate rapid learning and sharing of evidence-based improvements across sites and will inform development of a refined and scalable service delivery package for offering PrEP choice.
Many research studies take a long time to share results, and they often test interventions that are too resource-intensive to scale in public programs. Through an intensive collaborative effort — with PEPFAR, local partners, communities, ministries of health, and young people — we have designed CATALYST to be different.
Using PEPFAR delivery sites rather than research sites will allow for learning from real-world experience. Using quality improvement will enable study staff and health care providers to tailor the intervention (delivery of PrEP choice) to the unique context and communities served by each site. And sharing interim data throughout the study will speed translation of evidence to national programming. We anticipate that the CATALYST results will spur governments and donors to rapidly increase access to the new products that women desperately need to protect themselves from HIV.
Featured Image: MOSAIC and CATALYST staff members strike a pose (Brian Ssewankambo/MOSAIC).