NCT05937698

The CATALYST Study

The CATALYST Study: Catalyzing Access to New Prevention Products to Stop HIV

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6,069 (actual)
• Sponsor: FHI 360 · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Accepted

Summary

The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at PEPFAR sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe.

Detailed description

The overall study goal is to characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at U.S. President's Plan for AIDS Relief/U.S. Agency for International Development (PEPFAR/USAID) delivery sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. The study will be conducted in two stages, with currently approved oral PrEP and PrEP rings offered in Stage I, and the addition of CAB PrEP in Stage II after it has been approved by the regulatory authority in each country. The study goal will be accomplished by conducting a mixed-methods implementation study involving several components: 1. Component 1: Prospective cohort study of women at PEPFAR/USAID delivery sites that are delivering HIV PrEP, including daily oral PrEP, monthly PrEP rings, and bimonthly CAB PrEP 1. Descriptive nested cohort study to evaluate the performance characteristics of different HIV testing strategies among participants who initiate CAB PrEP 2. Descriptive nested cohort study to evaluate the feasibility and validity of a prevention effective use (PEU) measure among a subset of PrEP users 2. Component 2: Mixed-methods process evaluation involving implementers and key stakeholders 1. Nested costing study across Lesotho, Uganda, and Zimbabwe study sites 2. Nested qualitative study to understand community acceptance of PrEP and informed choice of PrEP products

Conditions

• HIV Prevention

Timeline

• Start date: 2023-05-30
• Primary completion: 2025-01-27
• Completion: 2025-01-27
• First posted: 2023-07-10
• Last updated: 2025-03-13

Locations

28 sites across 5 countries: Kenya, Lesotho, South Africa, Uganda, Zimbabwe