The CATALYST Study

Last updated: July 29, 2024
Sponsor: FHI 360
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05937698
FHI 360 CATALYST
  • Ages > 15
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Tested HIV-negative as determined by the national HIV testing algorithm at aCATALYST 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 andolder

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

  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 acommunity health worker)

  • Willing and able to provide informed written consent for participation

Exclusion

Exclusion Criteria:

  • For participants ages 15-17 years, potential participants under the age of 18 may beexcluded from study participation based on country guidelines and the age ofconsent. This determination will vary by country, including countries' definitionsof emancipated minors. Country-specific informed consent forms will outline thecountry-specific inclusion criteria related to age.

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

Study Design

Total Participants: 11256
Study Start date:
May 30, 2023
Estimated Completion Date:
June 30, 2025

Study 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

Connect with a study center

  • Chulaimbo sub-country hospital

    Kisumu,
    Kenya

    Site Not Available

  • Migosi Health

    Kisumu,
    Kenya

    Site Not Available

  • Likoni Sub-country hospital

    Mombasa,
    Kenya

    Site Not Available

  • Tudor sub-country hospital

    Mombasa,
    Kenya

    Site Not Available

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

    Nairobi,
    Kenya

    Site Not Available

  • Mukuru Public Health Centre

    Nairobi,
    Kenya

    Site Not Available

  • Sefika

    Maseru,
    Lesotho

    Active - Recruiting

  • Scott Hospital

    Morija,
    Lesotho

    Active - Recruiting

  • Berea

    Teyateyaneng,
    Lesotho

    Active - Recruiting

  • Phomolong Clinic

    Hennenman,
    South Africa

    Active - Recruiting

  • FSW Esselen Street

    Johannesburg,
    South Africa

    Active - Recruiting

  • TG Esselen Street

    Johannesburg,
    South Africa

    Active - Recruiting

  • Hani Park Clinic

    Welkom,
    South Africa

    Active - Recruiting

  • Matjhabeng Clinic

    Welkom,
    South Africa

    Active - Recruiting

  • Welkom Clinic

    Welkom,
    South Africa

    Active - Recruiting

  • Gulu RRH

    Gulu,
    Uganda

    Site Not Available

  • Bufunda HC III

    Ibanda,
    Uganda

    Site Not Available

  • Kitgum Hospital

    Kitgum,
    Uganda

    Site Not Available

  • Namakwekwe HC III

    Mbale,
    Uganda

    Site Not Available

  • Mbarara HC IV

    Mbarara,
    Uganda

    Site Not Available

  • Bison HCCIII

    Tororo,
    Uganda

    Site Not Available

  • Malaba HC III

    Tororo,
    Uganda

    Site Not Available

  • Beitbridge Wellness Clinic

    Beitbridge,
    Zimbabwe

    Active - Recruiting

  • Cowdray Park Clinic

    Bulawayo,
    Zimbabwe

    Active - Recruiting

  • Plumtree District Hospital

    Bulawayo,
    Zimbabwe

    Active - Recruiting

  • SHAZ! Hub (Citimed Hopstial)

    Chitungwiza,
    Zimbabwe

    Active - Recruiting

  • Runyararo Clinic

    Masvingo,
    Zimbabwe

    Active - Recruiting

  • Ngundu Rural Health Center

    Ngundu,
    Zimbabwe

    Active - Recruiting

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