The CATALYST Study

Study Overview
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Brief Summary
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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
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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: 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 Descriptive nested cohort study to evaluate the performance characteristics of different HIV testing strategies among participants who initiate CAB PrEP Descriptive nested cohort study to evaluate the feasibility and validity of a prevention effective use (PEU) measure among a subset of PrEP users Component 2: Mixed-methods process evaluation involving implementers and key stakeholders Nested costing study across Lesotho, Uganda, and Zimbabwe study sites Nested qualitative study to understand community acceptance of PrEP and informed choice of PrEP products

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

Conditions
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HIV Prevention

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Tested HIV-negative as determined by the national HIV testing algorithm at a CATALYST site on the same day as enrollment Self-identify with at least one of the following populations: Adolescent girl or young women (AGYW) ages 15-24 years Female sex worker (FSW) ages 18 years and older Pregnant and breastfeeding populations (PBFP) ages 15 years and older Individuals assigned female at birth of any gender identity ages 15 years and older Individuals assigned male at birth who identify as women ages 15 years and older Other women ages 25 years and older Interested in learning about HIV prevention Willing to be contacted for follow-up by phone or other means (e.g., through a community health worker) Willing and able to provide informed written consent for participation Exclusion Criteria: For participants ages 15-17 years, potential participants under the age of 18 may be excluded from study participation based on country guidelines and the age of consent. This determination will vary by country, including countries' definitions of emancipated minors. Country-specific informed consent forms will outline the country-specific inclusion criteria related to age. Certain sub-categories of participants may be excluded based on country guidelines.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall and method-specific PrEP method uptake | Proportion of cohort members who initiate oral PrEP, the PrEP ring, CAB PrEP, or decline all PrEP or are ineligible for PrEP | 24 months | 
| Patterns of PrEP use | Person-time of continued use of a certain PrEP method, until switching to another method or missed resupply; Person-time of pause between missed resupply and reinitiation or switching (subset). | 24 months | 
| Qualitative assessment of health system feasibility | The extent to which PrEP choice and the enhanced service delivery package can be successfully carried out at facilities within health systems involved in CATALYST. This measure will be assessed through qualitative data collected through periodic in-depth interviews conducted among PrEP providers, community stakeholders, and key informants at selected sites. | 24 months | 
| Delivery acceptability among providers measured using an adapted version of the Acceptability of Intervention Measure (AIM) | Perception that offering informed choice of PrEP products and the provision of the enhanced service delivery package are agreeable or satisfactory in this setting as measured though an adapted version of the acceptability of intervention measure (Weiner et al. 2017), a 5-item scale with higher scores representing greater acceptability (range: 5-25). | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-exposure prophylaxis (PrEP), oral PrEP containing tenofovir, dapivirine vaginal ring, injectable cabotegravir, adolescent girls and young women (AGYW)