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. 2019 Jun 27;8(6):e14091. doi: 10.2196/14091

Table 1.

Study schedule of events.

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.