Table 3

TAPS Project secondary outcomes

VariablePrEP armITx armType of data
KnowledgeAssessment of HIV knowledge including PrEPAssessment of HIV knowledge including ITxQualitative data (IDIs) and questionnaire data
Uptake and acceptabilityDescription of reasons for ineligibility after first eligibility assessmentDescription of reasons for ineligibility after first eligibility assessmentQuestionnaire data, complemented by qualitative data
Proportion of women accepting PrEP at baselineProportion of women accepting ITx at baselineProgramme data, complemented by qualitative data
Comparison demographic characteristics of women accepting PrEP vs refusing at baselineComparison demographic characteristics of women accepting ITx vs refusing at baselineQuestionnaire data
RetentionProportion of women retained and adherent to PrEP at 3, 6, 18, 24 monthsProportion of women retained and adherent to ART at 3, 6, 18, 24 monthsProgramme data
Patterns of useProportion of women using PrEP continuously for 12 monthsNAProgramme data
Description of length of use and repetitive uptake for women not using PrEP continuously for 12 monthsProgramme data and IDIs
AdherenceProportion of women reporting taking >85% of pills (self-reported) at each routine visit during 12 monthsProportion of women reporting taking >85% of pills (self-reported) at each routine visit during 12 monthsQuestionnaire data
Proportion of women with drug level detectable in plasma at 12 monthsProportion of women with undetectable viral load at 12 monthsClinical (laboratory) data and IDIs
Side effectsNumber (by type) of all side effects reported at routine visits for 12 monthsNumber (by type) of all side effects reported at routine visits for 12 monthsClinical data, IDIs and clinic observations
HIV statusNumber of seroconversion cases at 12 months and description of all resistance profilesProportion of women with plasma HIV-1 RNA level≥1000 copies/mL at 6 months or after initial suppression and description of all resistance profilesClinical (laboratory) data
PregnancyPregnancy rates during follow-upPregnancy rates during follow-upClinical data
Sexual behaviourComparison of proportion of women reporting consistent condom use (stable partners, regular/new clients): baseline vs PrEP use after 12 monthsComparison of proportion of women reporting consistent condom use (stable partners, regular/new clients): baseline vs ART use after 12 monthsQuestionnaire data and IDIs
Proportion of women presenting with STI symptoms at each routine visit during 12 monthsProportion of women presenting with STI symptoms at each routine during 12 monthsQuestionnaire data
Cell phone technology for adherence supportProportion of women opting-out of SMS reminders at baseline and throughout the duration of the projectProportion of women opting-out of SMS reminders at baseline and throughout the duration of the projectProgramme data and IDIs
Cost of interventionCost 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.