The CATALYST Study

FHI 360

Status: Terminated

Conditions: HIV Prevention

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05937698

FHI 360 CATALYST

Details and patient eligibility

About

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.

Full 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

Enrollment: 6,069 patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

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.