Medicines Control Authority of Zimbabwe

Public Clinical Trials Registry

List Applications   Download PDF

CT261/2023

01-11-2022

The CATALYST Study

Catalyzing access to new prevention products to stop HIV

Primary Sponsor Details
FHI 360

Secondary Sponsor Details
Jacqueline Kabongo
Country Study Coordinator
jkabongo@pzat.org
+263772956733
27 Rowland Square, Milton Park, Harare
Pangaea Zimbabwe AIDS Trust
Emily Gwavava
Co-Principal Investigator
egwavava@pzat.org
+263 775001862
27 Rowland Square, Milton Park Harare
Pangaea Zimbabwe AIDS Trust (PZAT)

Kenya, Lesotho, South Africa, Uganda, and Zimbabwe
U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)
HIV Pre-Exposure Prophylaxis
Dapivirine Vaginal Ring
7200

Eligibility criteria to enroll in the study cohort for Stages I and Stages II are:

  1. Tested HIV-negative as determined by the national HIV testing algorithm at a CATALYST site on the same day as enrollment
  2. 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
  3. Interested in learning about HIV prevention
  4. Willing to be contacted for follow-up by phone or other means (e.g., through a community health worker)
  5. Willing and able to provide informed written consent for participation

Participants will be excluded based on the following criteria:

  1. 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. 
    • In ZImbabwe we are not planning on enrolling unemancipated minors, as per current country legislation. Only emancipated minors, according to the Zimbabwean legislation, will be enrolled in the study. These are individuals below the age of 18 but are:-
      • legally married
      • financially independent
      • in cases of child-headed families.

The overall goal of the study is to characterize and assess the implementation of an enhanced service delivery package providing choice of PrEP products among women at PEPFAR/USAID delivery sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. 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.
9.0 DESIGN OF THE TRIAL
Opened

If controlled
2253
Enrollment in Stage I will continue until the target number of ring initiations is achieved (n=approximately 280 across the country), 12 months of recruitment in the country have elapsed, or cabotegravir is approved and enrollment in Stage II begins, whichever occurs sooner. Approximately 280 Oral PrEP users are expected to be enrolled in Stage I in the country. A total of 560 participants are expected to be enrolled during Stage I across all 6 Study sites in Zimbabwe, and enrolment is not competitive, therefore there will be no minimum or maximum number per site. Recruitment into Stage II will continue until the targeted number of cabotegravir initiations is achieved (n=approximately 845 per country) or until 12 months of recruitment have elapsed per country. Approximately 424 Oral PrEP, and 424 Ring users are expected to be enrolled in Stage II in the country. A total of 1693 participants are expected to be enrolled during Stage II across all 6 Study sites in Zimbabwe, and enrolment is not competitive, therefore there will be no minimum or maximum number per site.
11265
March 2023 - September 2025