HIV Prevention
Conditions
Keywords
Pre-exposure prophylaxis (PrEP), oral PrEP containing tenofovir, dapivirine vaginal ring, injectable cabotegravir, adolescent girls and young women (AGYW)
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
Interventions
None listed
Sponsors
Wits Reproductive Health and HIV Institute
LVCT Health
Pangaea Zimbabwe Aids Trust
Jhpiego
United States Agency for International Development (USAID)
FHI 360
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
Countries
Kenya, Lesotho, South Africa, Uganda, Zimbabwe
Outcome results
None listed