Table 1.
Procedures | Screening | Postentry evaluations (months)a | |||||||||||||
0 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | |||
Informed consent | Xb | X | —c | — | — | — | — | — | — | — | — | — | — | — | |
Medical history | X | — | — | — | — | — | — | — | — | — | — | — | — | — | |
Medication history | X | — | — | — | — | — | — | — | — | — | — | — | — | — | |
Clinical assessment | X | — | X | — | X | — | — | X | — | — | X | — | — | X | |
Complete physical exam | X | — | — | — | — | — | — | — | — | — | — | — | — | — | |
Targeted physical exam | — | X | — | X | — | — | X | — | — | X | — | — | X | ||
Computer-assisted self-interview | X | — | — | — | X | — | — | X | — | X | — | — | X | ||
Complete blood count | X | — | X | — | X | — | — | X | — | — | — | — | — | X | |
Liver and renal function tests | X | — | X | — | X | — | — | X | — | — | — | — | — | X | |
Fasting glucose and lipids | X | — | — | — | — | — | X | — | — | — | — | — | X | ||
Estradiol and total testosterone | X | — | — | X | — | — | X | — | — | — | — | — | X | ||
Chest x ray and sputum samples | X | — | — | — | — | — | — | — | — | — | — | — | — | — | |
Risk reduction counseling, condoms, and lubricants | X | X | — | — | X | — | — | X | — | — | X | — | — | X | |
Sampling for Neisseria gonorrhoeae and Chlamydia trachomatis testing | X | — | — | — | — | — | — | — | — | — | — | — | — | — | |
Sampling for anal cytological abnormalities | X | — | — | — | — | — | — | — | — | — | — | — | — | — | |
Syphilis serology | X | — | — | — | X | — | — | X | — | — | X | — | — | X | |
Hepatitis B and hepatitis C serology | X | — | — | — | — | — | — | — | — | — | — | — | — | — | |
HIV serology | X | — | — | — | — | — | — | — | — | — | — | — | — | — | |
Care of HIV negative | — | — | — | — | — | — | — | — | — | — | — | — | — | ||
HIV serology | — | — | — | X | — | — | X | — | — | X | — | — | X | ||
Pre-exposure prophylaxis dispensation | X | X | — | X | — | — | X | — | — | X | — | — | X | ||
Care of HIV positive | — | — | — | — | — | — | — | — | — | — | — | — | — | ||
CD4+ cell count | X | — | — | — | — | — | X | — | — | — | — | — | X | ||
HIV-1 RNA | X | — | — | X | — | — | X | — | — | — | — | — | X | ||
Antiretroviral treatment dispensation | X | X | — | X | — | — | X | — | — | X | — | — | X | ||
Feminizing hormone therapy | — | — | — | — | — | — | — | — | — | — | — | — | — | ||
Adherence counseling and education | X | X | — | X | — | — | X | — | — | X | — | — | X | ||
Dispensation | X | X | X | X | X | X | X | X | X | X | X | X | X | ||
Peer health navigation support | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
aVisits to occur every 30 days ± 5 days.
bThe procedure is indicated at the specific study visit.
cNot applicable.