The CATALYST Study

NCT05937698 | Terminated

• 1 other identifier: FHI 360 CATALYST
• Study Type: observational
• Target: 6,069
• Locations: 5 countries
• Sites: 28

Brief 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.

Conditions

HIV Prevention

Keywords

Pre-exposure prophylaxis (PrEP); oral PrEP containing tenofovir; dapivirine vaginal ring; injectable cabotegravir; adolescent girls and young women (AGYW)

Outcome Measures

Primary Outcomes (4)

• 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

Other Outcomes (8)

• 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

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Individuals assigned female at birth of any gender identity or individuals assigned male at birth who identify as women are eligible to participate
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Certain sub-categories of participants may be excluded based on country guidelines.

Sponsors & Collaborators

• FHI 360: lead
• Wits Reproductive Health and HIV Institute: collaborator
• LVCT Health: collaborator
• Pangaea Zimbabwe Aids Trust: collaborator
• Jhpiego: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (28)

Chulaimbo sub-country hospital

Kisumu, Kenya

Location

Migosi Health

Kisumu, Kenya

Location

Likoni Sub-country hospital

Mombasa, Kenya

Location

Tudor sub-country hospital

Mombasa, Kenya

Location

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

Nairobi, Kenya

Location

Mukuru Public Health Centre

Nairobi, Kenya

Location

Sefika

Maseru, Lesotho

Location

Scott Hospital

Morija, Lesotho

Location

Berea

Teyateyaneng, Lesotho

Location

Phomolong Clinic

Hennenman, South Africa

Location

FSW Esselen Street

Johannesburg, South Africa

Location

TG Esselen Street

Johannesburg, South Africa

Location

Hani Park Clinic

Welkom, South Africa

Location

Matjhabeng Clinic

Welkom, South Africa

Location

Welkom Clinic

Welkom, South Africa

Location

Gulu RRH

Gulu, Uganda

Location

Bufunda HC III

Ibanda, Uganda

Location

Kitgum Hospital

Kitgum, Uganda

Location

Namakwekwe HC III

Mbale, Uganda

Location

Mbarara HC IV

Mbarara, Uganda

Location

Bison HCCIII

Tororo, Uganda

Location

Malaba HC III

Tororo, Uganda

Location

Beitbridge Wellness Clinic

Beitbridge, Zimbabwe

Location

Cowdray Park Clinic

Bulawayo, Zimbabwe

Location

Plumtree District Hospital

Bulawayo, Zimbabwe

Location

SHAZ! Hub (Citimed Hopstial)

Chitungwiza, Zimbabwe

Location

Runyararo Clinic

Masvingo, Zimbabwe

Location

Ngundu Rural Health Center

Ngundu, Zimbabwe

Location

Related Links

• PrEP Watch: CATALYST

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and/or dried blood spot

Study Officials

• Virginia Fonner

  FHI 360

  STUDY CHAIR

• Elizabeth Irungu

  Jphiego

  STUDY CHAIR

• Kevin K'Orimba

  LVCT Health

  PRINCIPAL INVESTIGATOR

• Nicolette Naidoo

  Wits RHI

  PRINCIPAL INVESTIGATOR

• Carolyne Akello

  FHI 360 Uganda

  PRINCIPAL INVESTIGATOR

• Emily Gwavava

  Pangaea Zimbabwe Aids Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 10, 2023
• Study Start: May 30, 2023
• Primary Completion: January 27, 2025
• Study Completion: January 27, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After study completion and manuscript submission.

Locations

UG (7); LE (3); ZI (6); KE (6); ZA (6)