Table 3.
Primary and secondary outcomes.
| Indicator | Source | |
|---|---|---|
| Primary Outcome | ||
| Time to detectable VL | Time to VL > 1000 copies/ml | Maternal blood at 3, 6, 12, 18 and 24 months pp |
| Secondary Outcomes | ||
| Time to detectable VL | Time to VL > 400 copies/ml | Maternal blood at 3, 6, 12, 18 and 24 months pp |
| Time to detectable VL | Time to VL > 50 copies/ml | Maternal blood at 3, 6, 12, 18 and 24 months pp |
| Time to virological failure | Time to two consecutive VLs >1000 copies/ml | Maternal blood at 3, 6, 12, 18 and 24 months pp |
| Time to LTFU | Time to missed clinic visit and no visit within 3 months of scheduled clinic visit | Data abstraction from routine facility records |
| Time to combined LTFU/detectable VL | Time to VL > 1000 copies/ml, or missed clinic visit and no visit within 3 months of scheduled clinic visit | Maternal blood at 3, 6, 12, 18 and 24 months pp and data abstraction from routine facility records |
| Maternal Health | Includes maternal health care service use (including hospitalisation), mental health and maternal deaths | Participant questionnaires, data abstraction from routine facility records |
| Infant Health | Includes infant health care service use (including hospitalisation, HIV PCR testing uptake, vaccination uptake), feeding practices, infant HIV infection and infant deaths | Participant questionnaires, data abstraction from routine facility records |
| Cost and Cost-Effectiveness | Mean cost per woman from the start of postnatal care | Facility and provincial expenditure reports and accounts, participant questionnaires |
| Acceptability | Assessed using patient provider relationship scale and qualitative interviews | Questionnaires, qualitative interviews |
LTFU: Loss to follow-up; PCR: Polymerase chain reaction; pp: Postpartum; VL: Viral load.