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HIV PreventionNCT05937698

The CATALYST Study

An observational study of HIV Prevention, run by FHI 360 at 28 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Prevention
How many people
6,069 participants
Where
28 sitesin 5 countries
Study dates
30 May 2023to 27 Jan 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: 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.

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

28 sites in 5 countries.

28 sites in 5 countries

Uganda7 sites

  • Gulu RRH

    Gulu

  • Bufunda HC III

    Ibanda

  • Kitgum Hospital

    Kitgum

  • Namakwekwe HC III

    Mbale

  • Mbarara HC IV

    Mbarara

  • Bison HCCIII

    Tororo

  • Malaba HC III

    Tororo

Other trials in Uganda

Kenya6 sites

  • Chulaimbo sub-country hospital

    Kisumu

  • Migosi Health

    Kisumu

  • Likoni Sub-country hospital

    Mombasa

  • Tudor sub-country hospital

    Mombasa

  • Bar Hostess Empowerment & Support Programme (BHESP) Drop-In Centre

    Nairobi

  • Mukuru Public Health Centre

    Nairobi

Other trials in Kenya

South Africa6 sites

  • Phomolong Clinic

    Hennenman

  • FSW Esselen Street

    Johannesburg

  • TG Esselen Street

    Johannesburg

  • Hani Park Clinic

    Welkom

  • Matjhabeng Clinic

    Welkom

  • Welkom Clinic

    Welkom

Other trials in South Africa

Zimbabwe6 sites

  • Beitbridge Wellness Clinic

    Beitbridge

  • Cowdray Park Clinic

    Bulawayo

  • Plumtree District Hospital

    Bulawayo

  • SHAZ! Hub (Citimed Hopstial)

    Chitungwiza

  • Runyararo Clinic

    Masvingo

  • Ngundu Rural Health Center

    Ngundu

Other trials in Zimbabwe

Lesotho3 sites

  • Sefika

    Maseru

  • Scott Hospital

    Morija

  • Berea

    Teyateyaneng

Other trials in Lesotho

About this study

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

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.

Read the 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
  2. Descriptive nested cohort study to evaluate the performance characteristics of different HIV testing strategies among participants who initiate CAB PrEP
  3. Descriptive nested cohort study to evaluate the feasibility and validity of a prevention effective use (PEU) measure among a subset of PrEP users
  4. Component 2: Mixed-methods process evaluation involving implementers and key stakeholders
  5. Nested costing study across Lesotho, Uganda, and Zimbabwe study sites
  6. Nested qualitative study to understand community acceptance of PrEP and informed choice of PrEP products
Conditions
HIV Prevention
Keywords
Pre-exposure prophylaxis (PrEP), oral PrEP containing tenofovir, dapivirine vaginal ring, injectable cabotegravir, adolescent girls and young women (AGYW)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

  2. 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).

    Measured: 24 months

  3. 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.

    Measured: 24 months

  4. 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).

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2023
  2. Study start30 May 2023
  3. Primary completion27 Jan 2025
  4. Study completion27 Jan 2025

Why it stopped: Study was stopped due to the stop work order issued by USAID on January 27, 2025.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,069 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05937698
Sponsor's protocol ID
FHI 360 CATALYST
Status last verified
Mar 2025
First submitted
16 Jun 2023
Last updated
13 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Prevention, run by FHI 360 at 28 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Uganda, Kenya, South Africa, Zimbabwe, Lesotho. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study was stopped due to the stop work order issued by USAID on January 27, 2025.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall and method-specific PrEP method uptake (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05937698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.

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