Objectives and endpoints for PC952 (Zimbabwe) and PC953 (South Africa)
| Objective | Endpoint | Type of endpoint (country) |
| Preference | ||
| To determine preference for taking a single DPP capsule vs 2 separate tablets (PrEP and COC) once daily among women after using each regimen for three 28-day cycles. | Proportion of women who prefer the DPP (regimen A) vs 2 separate tablets (regimen B) after using each regimen for 3 28-day cycles, per self-report on computer-assisted self-interviewing (CASI). | Primary (South Africa and Zimbabwe) |
| To determine if more women choose regimen A vs regimen B for the choice period. | Proportion of women who choose regimen A vs B for the choice period. | Primary (South Africa) |
| Adherence | ||
| To compare adherence to the DPP capsule (regimen A) vs 2 separate tablets (regimen B) among women using each regimen daily for 3 28-day menstrual cycles during the cross-over period. | TFV-DP levels in dried blood spots (DBS) by regimen, and overall, at follow-up visits every 4 weeks during cross-over period. | Primary (South Africa) |
| To compare adherence among women who choose the DPP capsule (regimen A) vs adherence among women who choose 2 separate tablets (regimen B), each taken daily during the choice period. | TFV-DP levels in DBS by regimen, and overall, at follow-up visits every 4 weeks during choice period. | Primary (South Africa) |
| To assess and compare self-reported adherence to regimen A vs regimen B during the cross-over period, and to the chosen method during the choice period. | Self-assessment of ability to adhere to instructions for product use (DPP capsule, FTC/TDF and COCs as applicable) in CASI interviews at follow-up visits every 4 weeks during the cross-over and choice periods. | Primary (South Africa) |
| To assess and compare adherence to regimen A vs regimen B during the cross-over period, and to the chosen method during the choice period based on pill count. | Proportion of doses taken versus expected by pill count (DPP capsule, FTC/TDF and COCs as applicable) at follow-up visits every 4 weeks during the cross-over and choice periods. | Primary (South Africa) |
| To assess and compare daily adherence to PrEP for six 28-day cycles among AGYW when taken in the DPP capsule (regimen A) or as a separate tablet (regimen B) via a biomarker. | TFV-DP drug levels in DBS. | Secondary (Zimbabwe) |
| To assess and compare self-reported adherence to PrEP for six 28-day cycles among AGYW when taken in the DPP capsule (regimen A) or as a separate tablet (regimen B). | Proportion of PrEP doses taken compared with total no of doses expected per self-report based on a CASI questionnaire. | Secondary (Zimbabwe) |
| To assess and compare adherence to the DPP (regimen A) vs PrEP as a separate tablet (regimen B) each used for 3 28-day cycles by pill count. | Proportion of DPP and PrEP doses taken compared with total no of doses expected per pill count. | Secondary (Zimbabwe) |
| To explore if socioecological factors, product characteristics and product use experiences are associated with adherence to PrEP whether taken as part of the DPP capsule or as a separate tablet. | Results of multivariate modelling indicating which, if any, factors are associated with adherence. | Secondary (Zimbabwe) |
| To explore facilitators and barriers to use, as well as socioecological factors that may be associated with adherence. | Results of multivariate modelling indicating which, if any, factors are associated with adherence. | Secondary (South Africa) |
| Acceptability | ||
| To assess the acceptability of taking the DPP capsule vs two separate tablets once daily to prevent HIV and unintended pregnancy among women who use each regimen for three 28-day cycles. | Acceptability scores by regimen and overall, per a quantitative acceptability questionnaire via CASI. | Primary (Zimbabwe) |
| To assess the acceptability of the DPP vs 2 separate tablets taken daily to prevent HIV and unintended pregnancy among women using each regimen for 3 28-day cycles during the cross-over period, and for up to 6 28-day cycles during the choice period. | Scores by regimen and overall, as measured in a quantitative acceptability questionnaire via CASI at the cross-over visit, the start of the choice period and the end of the study. | Secondary (South Africa) |
| To assess if preuse opinions are associated with actual experiences and preferences after using each regimen. | Proportion of women whose preuse preference matches postuse experience based on a CASI questionnaire at baseline and at the end of the cross-over period. | Secondary (South Africa) |
| To qualitatively understand barriers and facilitators to product use and adherence. | Results of thematic qualitative data analysis from in-depth interviews with participants at study exit focusing on facilitators and barriers of product use and adherence. | Secondary (South Africa and Zimbabwe) |
| To explore if socioecological factors, product characteristics and product use experiences are associated with acceptability of the DPP and of 2 separate tablets. | Results of multivariate modelling indicating which, if any, factors are associated with acceptability. | Secondary (South Africa and Zimbabwe) |
| Safety | ||
| To compare the safety of regimen A vs regimen B among women using each regimen for 3 28-day cycles during the cross-over period, and the safety of regimen A vs regimen B among women choosing each regimen during the choice period. | Number of AEs by regimen (including social harms, drug side effects) during the cross-over and choice periods. | Secondary (South Africa) |
AE, adverse event; COC, combined oral contraceptive; DPP, dual prevention pill; FTC, emtricitabine; PrEP, pre-exposure prophylaxis; TDF, tenofovir disoproxil fumarate; TFV-DP, tenofovir-diphosphate.