Table 4 SCOPE-PP Outcomes, Measures, Data Sources, and Timing (Aims 1 and 2)
Outcomes | Measures | Data Sources | Follow-up timing |
|---|---|---|---|
Aim 1: Efficacy of SCOPE-PP (Primary Outcomes) | |||
 Efficacy of SCOPE-PP | Perfect Persistence: Persistence on PrEP (%, time on PrEP adherent). Perfect persistence in postpartum = > 950 fmol/punch in DBS TFV-DP), by study arm | DBS TDF-DP | RCT 1: 6 months RCT 2: 15 months postpartum |
Prevention-Effective Persistence: Persistence on PrEP when sexually active (in postpartum women = > 950 fmol/punch in DBS TFV-DP), by study arm | DBS TDF-DP | RCT 1: 6 months RCT 2: 15 months postpartum | |
Self-reported persistence: self-reported measures of PrEP use and pill counts over the phone | Self-reported PrEP persistence &pill count | Quarterly | |
Secondary outcomes: HIV incidence (maternal and infant), adverse events and IPV | RedCap clinical data | Monthly | |
Nested implementation science evaluation of SCOPE-PP acceptability, feasibility using CFIR | |||
 Ickovic’ and Meisler’s Conceptual Factors | Evaluate factors associated with PrEP persistence in conceptual model: individual level (including partner PrEP support), facility level, HIV level (partner HIV testing & serostatus) | Quantitative surveys at each visit | Baseline, 1 month, 6 months, 12 months postpartum |
 Acceptability and uptake of intervention | Organizational, providers, woman and partner views on acceptability of SCOPE-PP including HIVST, urine TFV testing for persistence monitoring, and differentiated care | Mixed methods | At 6 months & 12 months follow-up of all participants (survey); IDIs in 20 providers working with PrEP, 30 participants & 30 partners |
 Feasibility of intervention | Organizational, providers, woman and partner views on feasibility & scalability of implementation of SCOPE-PP | Mixed methods surveys | |
Aim 2: Evaluate cost effectiveness of SCOPE-PP | |||
 Incremental cost of Scope-PP | Based on micro-costing, evaluate incremental cost per participant of SCOPE-PP from baseline to 6, 12 and 15 months postpartum by trial step | Quantitative surveys at each visit | RCT 1: 6 months RCT 2: 15 months postpartum |
 Incremental cost per improved PrEP continuation and persistence | Using trial-based cost-effectiveness analysis, evaluate incremental cost per improved PrEP continuation and persistence at 6, 12 and 15 months postpartum for SCOPE-PP (integrating step 1 and step 2 trials) | Quantitative surveys at each visit | RCT 1: 6 months RCT 2: 15 months postpartum |
 Incremental cost per DALY averted | Using model-based cost-utility analysis, evaluate incremental lifetime cost and DALYs averted for SCOPE-PP and assess value for money | N/A | N/A (model-based analysis) |