The CATALYST Study (NCT05937698) | Clinical Trial Compass
TerminatedNot Applicable
The CATALYST Study
Stopped: Study was stopped due to the stop work order issued by USAID on January 27, 2025.
Kenya, Lesotho, South Africa6,069 participantsStarted 2023-05-30
Plain-language 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.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall and method-specific PrEP method uptake
Timeframe: 24 months
2
Patterns of PrEP use
Timeframe: 24 months
3
Qualitative assessment of health system feasibility
Timeframe: 24 months
4
Delivery acceptability among providers measured using an adapted version of the Acceptability of Intervention Measure (AIM)