Table 3.
TAPS Project secondary outcomes
| Variable | PrEP arm | ITx arm | Type of data |
|---|---|---|---|
| Knowledge | Assessment of HIV knowledge including PrEP | Assessment of HIV knowledge including ITx | Qualitative data (IDIs) and questionnaire data |
| Uptake and acceptability | Description of reasons for ineligibility after first eligibility assessment | Description of reasons for ineligibility after first eligibility assessment | Questionnaire data, complemented by qualitative data |
| Proportion of women accepting PrEP at baseline | Proportion of women accepting ITx at baseline | Programme data, complemented by qualitative data | |
| Comparison demographic characteristics of women accepting PrEP vs refusing at baseline | Comparison demographic characteristics of women accepting ITx vs refusing at baseline | Questionnaire data | |
| Retention | Proportion of women retained and adherent to PrEP at 3, 6, 18, 24 months | Proportion of women retained and adherent to ART at 3, 6, 18, 24 months | Programme data |
| Patterns of use | Proportion of women using PrEP continuously for 12 months | NA | Programme data |
| Description of length of use and repetitive uptake for women not using PrEP continuously for 12 months | Programme data and IDIs | ||
| Adherence | Proportion of women reporting taking >85% of pills (self-reported) at each routine visit during 12 months | Proportion of women reporting taking >85% of pills (self-reported) at each routine visit during 12 months | Questionnaire data |
| Proportion of women with drug level detectable in plasma at 12 months | Proportion of women with undetectable viral load at 12 months | Clinical (laboratory) data and IDIs | |
| Side effects | Number (by type) of all side effects reported at routine visits for 12 months | Number (by type) of all side effects reported at routine visits for 12 months | Clinical data, IDIs and clinic observations |
| HIV status | Number of seroconversion cases at 12 months and description of all resistance profiles | Proportion of women with plasma HIV-1 RNA level≥1000 copies/mL at 6 months or after initial suppression and description of all resistance profiles | Clinical (laboratory) data |
| Pregnancy | Pregnancy rates during follow-up | Pregnancy rates during follow-up | Clinical data |
| Sexual behaviour | Comparison of proportion of women reporting consistent condom use (stable partners, regular/new clients): baseline vs PrEP use after 12 months | Comparison of proportion of women reporting consistent condom use (stable partners, regular/new clients): baseline vs ART use after 12 months | Questionnaire data and IDIs |
| Proportion of women presenting with STI symptoms at each routine visit during 12 months | Proportion of women presenting with STI symptoms at each routine during 12 months | Questionnaire data | |
| Cell phone technology for adherence support | Proportion of women opting-out of SMS reminders at baseline and throughout the duration of the project | Proportion of women opting-out of SMS reminders at baseline and throughout the duration of the project | Programme data and IDIs |
| Cost of intervention | Cost per person-year on PrEP (health service perspective) | Cost per person-year on ITx (health service perspective) | Costing data |
| Cost per person-year on PrEP (participant perspective) | Cost per person-year on ITx (participant perspective) | Costing questionnaire data |
ART, antiretroviral therapy; IDIs, in depth interviews; ITx, immediate treatment; NA, not applicable; PrEP, pre-exposure prophylaxis; STI, sexually transmitted infection.