Table 2.
Schedule of events of the Brilhar e Transcender study.
|
|
Baseline | Week 12 | Week 24 | Week 36 | Week 48 or early terminationa | HIV seroconversion visit | |||||||
| Eligibility | ✓ |
|
|
|
|
|
|||||||
| Measures | |||||||||||||
|
|
Behavioral, partnership, network, and structural measures | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||||||
|
|
Adverse events |
|
✓ | ✓ | ✓ | ✓ |
|
||||||
|
|
Social harm |
|
✓ | ✓ | ✓ | ✓ |
|
||||||
|
|
Implementation science: participants |
|
|
|
|
✓ |
|
||||||
|
|
Implementation science: coordination | ✓ |
|
|
|
✓ |
|
||||||
|
|
Implementation science: peer navigators |
|
|
|
|
✓ |
|
||||||
| Laboratory procedures | |||||||||||||
|
|
HIV rapid test | ✓ | ✓b | ✓b | ✓b | ✓b | ✓ | ||||||
|
|
CD4+ and CD8+ cell counts | ✓c |
|
✓c |
|
✓d | ✓ | ||||||
|
|
HIV RNA viral load | ✓c,d | ✓d | ✓c,d | ✓d | ✓c,d | ✓ | ||||||
|
|
HIV recency testing | ✓c |
|
|
|
|
✓ | ||||||
|
|
HIV genotyping | ✓c |
|
|
|
|
✓ | ||||||
|
|
Treponemal syphilis rapid test | ✓ | ✓ | ✓ | ✓ | ✓ |
|
||||||
|
|
Nontreponemal syphilis (venereal disease research laboratory) testing | ✓e | ✓e | ✓e | ✓e | ✓e |
|
||||||
|
|
Hepatitis B rapid test | ✓ |
|
|
|
✓f |
|
||||||
|
|
Hepatitis B serology | ✓g |
|
|
|
|
|
||||||
|
|
Hepatitis C rapid test | ✓ |
|
|
|
✓h |
|
||||||
|
|
Anti–hepatitis C virus | ✓i |
|
|
|
✓i |
|
||||||
|
|
Hepatitis C viral load | ✓j |
|
|
|
✓j |
|
||||||
|
|
Rectal swab (Chlamydia trachomatis and Neisseria gonorrhoeae) | ✓ |
|
|
|
✓ |
|
||||||
|
|
Dried blood spot (pre-exposure prophylaxis adherence assessment) | ✓k | ✓k | ✓k | ✓k | ✓k | ✓k | ||||||
| Hormone dispensation | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |||||||
| Medical or psychiatric visit | ✓l | ✓l | ✓l | ✓l | ✓l |
|
|||||||
aWithdrawn or discontinued participants before the final visit.
bOnly for participants with a negative HIV test in the previous visit.
cFor all participants living with HIV.
dOnly for HIV-negative participants with recent HIV exposition according to the service guidelines.
eOnly for those with a positive treponemal test result.
fOnly for a negative hepatitis B rapid test result.
gOnly for a positive hepatitis B rapid test result.
hOnly for those with a negative hepatitis C rapid test result.
iOnly for those with a positive hepatitis C rapid test result.
jOnly for those with positive findings on an anti–hepatitis C virus antibody test.
kOnly for participants receiving pre-exposure prophylaxis, except those initiating pre-exposure prophylaxis at the current visit.
lIf clinically indicated.