The CATALYST Study

HIV Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937698
• Other study ID #: FHI 360 CATALYST
• Status: Recruiting
• Start date: May 30, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: FHI 360
• Contact: Kristine Torjesen
• Phone: +19196276448
• Email: ktorjesen[@]fhi360.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 1. Descriptive nested cohort study to evaluate the performance characteristics of different HIV testing strategies among participants who initiate CAB PrEP 2. Descriptive nested cohort study to evaluate the feasibility and validity of a prevention effective use (PEU) measure among a subset of PrEP users 2. Component 2: Mixed-methods process evaluation involving implementers and key stakeholders 1. Nested costing study across Lesotho, Uganda, and Zimbabwe study sites 2. Nested qualitative study to understand community acceptance of PrEP and informed choice of PrEP products

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11256
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. Adolescent girl or young women (AGYW) ages 15-24 years

2. Female sex worker (FSW) ages 18 years and older

3. Pregnant and breastfeeding populations (PBFP) ages 15 years and older

4. Individuals assigned female at birth of any gender identity ages 15 years and older

5. Individuals assigned male at birth who identify as women ages 15 years and older

6. 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• HIV Prevention

Locations

Country	Name	City	State
Kenya	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
Lesotho	Sefika	Maseru
Lesotho	Scott Hospital	Morija
Lesotho	Berea	Teyateyaneng
South Africa	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
Uganda	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
Zimbabwe	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

Sponsors (6)

Lead Sponsor	Collaborator
FHI 360	Jhpiego, LVCT Health, Pangaea Zimbabwe Aids Trust, United States Agency for International Development (USAID), Wits Reproductive Health and HIV Institute

Countries where clinical trial is conducted

Kenya,  Lesotho,  South Africa,  Uganda,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	24 months
Other	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.	24 months
Other	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.	24 months
Other	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.	24 months
Other	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).	24 months
Other	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	24 months
Other	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	24 months
Other	Frequency of reported side effects by PrEP product	The type, number, and perceived severity of patient-reported side effects from PrEP product use	24 months
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   PrEP Watch: CATALYST