Table 2.
Reasons of screening failure in the Antepartum component of PROMISE
| Screening failure reasona | Totalb |
|---|---|
| CD4 < 350 cells/mm3 | 1,960 (72%) |
| Otherc | 428 (16%) |
| Participant did not return to the clinic following consent | 148 (5%) |
| Requiring antiretroviral therapy for WHO Stage III or IV disease | 61 (2%) |
| Hemoglobin < 7.5 g/dL | 54 (2%) |
| Participant not willing to participate (reason provided) | 52 (2%) |
| History of antiretroviral therapy during current pregnancy | 30 (1%) |
| Active serious illness or medical condition | 23 (1%) |
| Participant not willing to participate (no reason provided) | 20 (1%) |
| Test result not available in protocol timeframe | 12 (0.4%) |
| Fetal death/condition incompatible with life | 6 (0.2%) |
| ALT > 2.5xULN | 5 (0.2%) |
| Platelets < 50,000 cells/mm3 | 4 (0.1%) |
| Fetus with serious congenital malformation | 3 (0.1%) |
| History of active TB or receipt of TB drugs within 30 days prior to study entry | 2 (<0.1%) |
| History of documented heart or cardiac defect | 2 (<0.1%) |
| Creatinine clearance < 60 mL/min | 1 (<0.1%) |
| Drug/alcohol use or dependence | 1 (<0.1%) |
| Total (2,812) | 2,812 |
More than one reason may be indicated for each participant who failed to enroll
Percentages calculated among the total number of those not enrolled
For the 1077BF protocol some of the most common “Other” reasons include but not are not limited to: the patient decided to formula-feed; participant was HIV negative; participant did not return to the clinic after consent (and relocated or is lost to follow-up); participant withdrew consent; discordant HIV results; indeterminate western-blot results; site is not screening/enrolling due to updated national guidelines; participant was not pregnant (confirmed by urine test and ultrasound scan); participant gave birth or had abortion or miscarried before enrollment; undetectable HIV-1 RNA; real time HIV-1 RNA < 5,000 copies/mL; no CD4 result or CD4 < 350 cells/mm3; participant was under age; negative perinatal transmission; low hemoglobin; Hepatitis B co-infection; previous pregnancy on triple antiretroviral therapy for her own health; participants requires antiretroviral therapy for her own health; participant was at high risk for pre-eclampsia; participant was willing to participate but her husband told her to decline participation to avoid status disclosure; social problems etc.
For the 1077FF protocol “Other” reasons include but not are not limited to: the patient decided to breastfeed (and enrolled to 1077BF); HIV test results inconclusive; participant was HIV negative; did not return to the clinic after consent (and relocated or is lost to follow-up); participant withdrew consent; site is not screening/enrolling due to updated national guidelines; participant gave birth before enrollment; administrative error (duplicate screening number; premature randomization)