Table 1 Reasons for screening out
Stratified by HVTN trials | ||||
|---|---|---|---|---|
100sa 100/111/108 | 702a | 703/HPTN081b | Sig. | |
n | 85 | 410 | 166 | |
HIV test result, n (%) | 15 (17.6) | 152 (37.1) | 42 (25.3) | NA |
HIV risk criteria, n (%) | 4 (4.7) | 42 (10.2) | 3 (1.8) | NA |
Pregnancy/breastfeeding, n(%) | 2 (2.4) | 39 (9.5) | 9 (5.4) | NA |
Unwilling to use effective contraception as defined in the protocol, n (%) | 4 (4.7) | 5 (1.2) | 2 (1.2) | NA |
Age, n (%) | 1 (1.2) | 1 (0.2) | 0 (0.0) | NA |
Physical exam findings, local lab results, and/or medical or psychiatric history or condition, n (%) | 57 (67.1) | 139 (33.9) | 105 (63.3) | NA |
Site assessment of participant’s availability, n (%) | 0 (0.0) | 30 (7.3) | 12 (7.2) | NA |
Ongoing or planned participation in another clinical trial | 1 (1.2) | 0 (0.0) | 1 (0.6) | NA |
Site assessment of participant’s understanding, n(%) | 1 (1.2) | 2 (0.5) | 0 (0.0) | NA |
Participant’s willingness to undergo HIV testing, counselling, and receive HIV test results, n (%) | 0 (0.0) | 0 (0.0) | 5 (3) | NA |
History of organ or tissue transplant, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |
Receipt of experimental product, humanised/human mAbs, or contraindicated medications, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | NA |