NCT05937698|Terminated
Study Stopped
Study was stopped due to the stop work order issued by USAID on January 27, 2025.
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Study was stopped due to the stop work order issued by USAID on January 27, 2025.
Sponsor study identifier
observational
6,069
5 countries
28
Study Start
May 30, 2023
Actual (reported)Primary Completion
January 27, 2025
Actual (reported)Study Completion
January 27, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 27, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2023
Actual (reported)June 16, 2023
Actual (reported)July 10, 2023
Actual (reported)January 27, 2025
Actual (reported)January 27, 2025
Actual (reported)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
Cost of delivery at a subset of study sites
24 months
Qualitative assessment of community acceptability of PrEP and PrEP choice
24 months
Product acceptability among users as assessed through a theory-informed questionnaire relating to different aspects of acceptability (Sekhon et al., 2022)
24 months
HIV-negative women\* attending PEPFAR/USAID-supported facilities who are interested in learning about HIV prevention and are otherwise eligible to participate in the study \*Presumed HIV-negative based on results from the national testing algorithm. For this study, the term "women" is inclusive of individuals assigned female at birth of any gender identity or individuals assigned male at birth who identify as women, although this definition is subject to local country guidelines.
Chulaimbo sub-country hospital
Kisumu, Kenya
Migosi Health
Kisumu, Kenya
Likoni Sub-country hospital
Mombasa, Kenya
Tudor sub-country hospital
Mombasa, Kenya
Bar Hostess Empowerment & Support Programme (BHESP) Drop-In Centre
Nairobi, Kenya
Mukuru Public Health Centre
Nairobi, Kenya
Sefika
Maseru, Lesotho
Whole blood and/or dried blood spot
Virginia Fonner
FHI 360
Elizabeth Irungu
Jphiego
Kevin K'Orimba
LVCT Health
Nicolette Naidoo
Wits RHI
6,069 participants (actual enrollment reported by the registry).
First Submitted
June 16, 2023
First Posted
July 10, 2023
Study Start
May 30, 2023
Actual (reported)PrEP Restart for Adolescent Girls and Young Women Using STI Self Testing and Assessment of Risk
Contact the study team to confirm eligibility.
Scott Hospital
Morija, Lesotho
Berea
Teyateyaneng, Lesotho
Phomolong Clinic
Hennenman, South Africa
FSW Esselen Street
Johannesburg, South Africa
TG Esselen Street
Johannesburg, South Africa
Hani Park Clinic
Welkom, South Africa
Matjhabeng Clinic
Welkom, South Africa
Welkom Clinic
Welkom, South Africa
Gulu RRH
Gulu, Uganda
Bufunda HC III
Ibanda, Uganda
Kitgum Hospital
Kitgum, Uganda
Namakwekwe HC III
Mbale, Uganda
Mbarara HC IV
Mbarara, Uganda
Bison HCCIII
Tororo, Uganda
Malaba HC III
Tororo, Uganda
Beitbridge Wellness Clinic
Beitbridge, Zimbabwe
Cowdray Park Clinic
Bulawayo, Zimbabwe
Plumtree District Hospital
Bulawayo, Zimbabwe
SHAZ! Hub (Citimed Hopstial)
Chitungwiza, Zimbabwe
Runyararo Clinic
Masvingo, Zimbabwe
Ngundu Rural Health Center
Ngundu, Zimbabwe
Carolyne Akello
FHI 360 Uganda
Emily Gwavava
Pangaea Zimbabwe Aids Trust
Primary Completion
January 27, 2025
Actual (reported)Study Completion
January 27, 2025
Actual (reported)Last Updated
March 13, 2025
Record last verified: 2025-03
In accordance with the USAID Automated Directives System 579, after acceptance of any knowledge product presenting study findings and after being cleaned of any information that could be used to personally identify participants, the quantitative survey dataset along with relevant documentation will be registered with USAID's Development Data Library (DDL) and made publicly available in an open data repository, to the extent permissible by participating countries' privacy and data sharing regulations.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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