Clinical trial NCT05937698: The CATALYST Study
Official title: The CATALYST Study: Catalyzing Access to New Prevention Products to Stop HIV
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV Prevention
Keywords: Pre-exposure prophylaxis (PrEP)
oral PrEP containing tenofovir
dapivirine vaginal ring
injectable cabotegravir
adolescent girls and young women (AGYW)
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Wits Reproductive Health and HIV Institute
name: LVCT Health
name: Pangaea Zimbabwe Aids Trust
name: Jhpiego
name: United States Agency for International Development (USAID)
First posted: 2023-07-10
Enrollment: 6069
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

   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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall and method-specific PrEP method uptake
timeFrame: 24 months
measure: Patterns of PrEP use
timeFrame: 24 months
measure: Qualitative assessment of health system feasibility
timeFrame: 24 months
measure: Delivery acceptability among providers measured using an adapted version of the Acceptability of Intervention Measure (AIM)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: Cost of delivery at a subset of study sites
timeFrame: 24 months
measure: Qualitative assessment of community acceptability of PrEP and PrEP choice
timeFrame: 24 months
measure: Product acceptability among users as assessed through a theory-informed questionnaire relating to different aspects of acceptability (Sekhon et al., 2022)
timeFrame: 24 months
measure: Prevention effective use of PrEP products
timeFrame: 24 months
measure: Rates of HIV infection among participants
timeFrame: 24 months
measure: Rates of HIV drug resistance among PrEP users who acquire HIV during study participation
timeFrame: 24 months
measure: Pregnancy and selected infant outcomes among pregnant and breastfeeding populations for outcomes occurring during the study period.
timeFrame: 24 months
measure: Frequency of reported side effects by PrEP product
timeFrame: 24 months
Locations:
city: Kisumu
country: Kenya
facility: Chulaimbo sub-country hospital
city: Kisumu
country: Kenya
facility: Migosi Health
city: Mombasa
country: Kenya
facility: Likoni Sub-country hospital
city: Mombasa
country: Kenya
facility: Tudor sub-country hospital
city: Nairobi
country: Kenya
facility: Bar Hostess Empowerment & Support Programme (BHESP) Drop-In Centre
city: Nairobi
country: Kenya
facility: Mukuru Public Health Centre
city: Maseru
country: Lesotho
facility: Sefika
city: Morija
country: Lesotho
facility: Scott Hospital
city: Teyateyaneng
country: Lesotho
facility: Berea
city: Hennenman
country: South Africa
facility: Phomolong Clinic
city: Johannesburg
country: South Africa
facility: FSW Esselen Street
city: Johannesburg
country: South Africa
facility: TG Esselen Street
city: Welkom
country: South Africa
facility: Hani Park Clinic
city: Welkom
country: South Africa
facility: Matjhabeng Clinic
city: Welkom
country: South Africa
facility: Welkom Clinic
city: Gulu
country: Uganda
facility: Gulu RRH
city: Ibanda
country: Uganda
facility: Bufunda HC III
city: Kitgum
country: Uganda
facility: Kitgum Hospital
city: Mbale
country: Uganda
facility: Namakwekwe HC III
city: Mbarara
country: Uganda
facility: Mbarara HC IV
city: Tororo
country: Uganda
facility: Bison HCCIII
city: Tororo
country: Uganda
facility: Malaba HC III
city: Beitbridge
country: Zimbabwe
facility: Beitbridge Wellness Clinic
city: Bulawayo
country: Zimbabwe
facility: Cowdray Park Clinic
city: Bulawayo
country: Zimbabwe
facility: Plumtree District Hospital
city: Chitungwiza
country: Zimbabwe
facility: SHAZ! Hub (Citimed Hopstial)
city: Masvingo
country: Zimbabwe
facility: Runyararo Clinic
city: Ngundu
country: Zimbabwe
facility: Ngundu Rural Health Center
Study officials:
affiliation: FHI 360
name: Virginia Fonner
role: STUDY_CHAIR
affiliation: Jphiego
name: Elizabeth Irungu
role: STUDY_CHAIR
affiliation: LVCT Health
name: Kevin K'Orimba
role: PRINCIPAL_INVESTIGATOR
affiliation: Wits RHI
name: Nicolette Naidoo
role: PRINCIPAL_INVESTIGATOR
affiliation: FHI 360 Uganda
name: Carolyne Akello
role: PRINCIPAL_INVESTIGATOR
affiliation: Pangaea Zimbabwe Aids Trust
name: Emily Gwavava
role: PRINCIPAL_INVESTIGATOR
References: