The CATALYST Study

Sponsor

FHI 360 (Other)

Overall Status

Recruiting

CT.gov ID

NCT05937698

Collaborator

Wits Reproductive Health and HIV Institute (Other), LVCT Health (Other), Pangaea Zimbabwe Aids Trust (Other), Jhpiego (Other), United States Agency for International Development (USAID) (U.S. Fed)

11,256

Enrollment

Locations

Anticipated Duration (Months)

402

Patients Per Site

16.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Prevention

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:

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

11256 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 30, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Outcome Measures

Primary Outcome Measures

Overall and method-specific PrEP method uptake [24 months]
Proportion of cohort members who initiate oral PrEP, the PrEP ring, CAB PrEP, or decline all PrEP or are ineligible for PrEP
Patterns of PrEP use [24 months]
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).
Qualitative assessment of health system feasibility [24 months]
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.
Delivery acceptability among providers measured using an adapted version of the Acceptability of Intervention Measure (AIM) [24 months]
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).

Other Outcome Measures

Cost of delivery at a subset of study sites [24 months]
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
Qualitative assessment of community acceptability of PrEP and PrEP choice [24 months]
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.
Product acceptability among users as assessed through a theory-informed questionnaire relating to different aspects of acceptability (Sekhon et al., 2022) [24 months]
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.
Prevention effective use of PrEP products [24 months]
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.
Rates of HIV infection among participants [24 months]
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).
Rates of HIV drug resistance among PrEP users who acquire HIV during study participation [24 months]
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
Pregnancy and selected infant outcomes among pregnant and breastfeeding populations for outcomes occurring during the study period. [24 months]
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
Frequency of reported side effects by PrEP product [24 months]
The type, number, and perceived severity of patient-reported side effects from PrEP product use

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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

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.

Contacts and Locations

Locations

	Site	City	Country
1	Chulaimbo sub-country hospital	Kisumu	Kenya
2	Migosi Health	Kisumu	Kenya
3	Likoni Sub-country hospital	Mombasa	Kenya
4	Tudor sub-country hospital	Mombasa	Kenya
5	Bar Hostess Empowerment & Support Programme (BHESP) Drop-In Centre	Nairobi	Kenya
6	Mukuru Public Health Centre	Nairobi	Kenya
7	Sefika	Maseru	Lesotho
8	Scott Hospital	Morija	Lesotho
9	Berea	Teyateyaneng	Lesotho
10	Phomolong Clinic	Hennenman	South Africa
11	FSW Esselen Street	Johannesburg	South Africa
12	TG Esselen Street	Johannesburg	South Africa
13	Hani Park Clinic	Welkom	South Africa
14	Matjhabeng Clinic	Welkom	South Africa
15	Welkom Clinic	Welkom	South Africa
16	Gulu RRH	Gulu	Uganda
17	Bufunda HC III	Ibanda	Uganda
18	Kitgum Hospital	Kitgum	Uganda
19	Namakwekwe HC III	Mbale	Uganda
20	Mbarara HC IV	Mbarara	Uganda
21	Bison HCCIII	Tororo	Uganda
22	Malaba HC III	Tororo	Uganda
23	Beitbridge Wellness Clinic	Beitbridge	Zimbabwe
24	Cowdray Park Clinic	Bulawayo	Zimbabwe
25	Plumtree District Hospital	Bulawayo	Zimbabwe
26	SHAZ! Hub (Citimed Hopstial)	Chitungwiza	Zimbabwe
27	Runyararo Clinic	Masvingo	Zimbabwe
28	Ngundu Rural Health Center	Ngundu	Zimbabwe