An observational study in HIV Prevention, sponsored by FHI 360. Terminated at 28 sites in 5 countries. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-13.
Sponsored by FHI 360 · Observational
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.
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
Component 2: Mixed-methods process evaluation involving implementers and key stakeholders
FHI 360 is the lead sponsor of 59 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Self-identify with at least one of the following populations:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 24 months
Cost of delivery at a subset of study sites
The cost of the implementation effort, including average unit cost estimates for oral PrEP, the PrEP ring, and CAB PrEP in Lesotho, Uganda, and Zimbabwe and the incremental unit cost of adding PrEP ring and CAB PrEP at sites already providing oral PrEP
Time frame: 24 months
Qualitative assessment of community acceptability of PrEP and PrEP choice
Perception that PrEP (and PrEP choice) are agreeable, satisfactory, and welcomed in the community, especially among primary PrEP influencers (partners and parents/caregivers). This measure will be assessed through qualitative in-depth interviews conducted among primary PrEP influencers in select CATALYST communities, including parents/caregivers of existing and potential PrEP users and partners of existing and potential PreP users.
Time frame: 24 months
Product acceptability among users as assessed through a theory-informed questionnaire relating to different aspects of acceptability (Sekhon et al., 2022)
Perception that PrEP product is agreeable or satisfactory. This measure will be assessed through administration of an adapted version of the theory-informed questionnaire developed by Sekhon et al., 2022. Item scores will be reported separately for each acceptability construct.
Time frame: 24 months
Prevention effective use of PrEP products
Percent of risk-days (days with condomless sex) when participants were protected from HIV acquisition by taking PrEP based on reported daily occurrence within certain periods. Note that this measure will only be reported if measure passes validation assessment conducted early in the implementation period.
Time frame: 24 months
Rates of HIV infection among participants
Number of study cohort members who become infected with HIV at any point during the study disaggregated by PrEP use status after enrollment (but not including the enrollment visit).
Time frame: 24 months
Rates of HIV drug resistance among PrEP users who acquire HIV during study participation
Number and type of HIV drug resistance-associated polymorphisms and/or mutations identified among participants who become infected with HIV and were exposed to PrEP
Time frame: 24 months
Pregnancy and selected infant outcomes among pregnant and breastfeeding populations for outcomes occurring during the study period.
Among pregnant participants reporting exposure to PrEP during pregnancy: type and frequency of pregnancy outcomes (term live birth \[≥37 weeks\], preterm live birth \[\<37 weeks\], pre-term birth, stillbirth, birth weight and sex, spontaneous abortion, congenital anomalies, gestational age, neonatal death) among outcomes occurring during the study period
Time frame: 24 months
Frequency of reported side effects by PrEP product
The type, number, and perceived severity of patient-reported side effects from PrEP product use
Time frame: 24 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
Time frame: After study completion and manuscript submission.
This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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