Table 1.

Schedule of study visits (initial study).

Study activities	S/E Visit	Visit 1a	Visit 2b	Visit 3c	Visit 4	Visit 5	Visit 6	Visit 7
Weeks from contraceptive initiation		a	b	0	Day 3	4	13	26
Informed consent	X
Detailed clinical assessment	X
Interval history assessment		X	X	X	X	X	X	X
Randomization and contraceptive initiation				X
Follow-up DMPA injection (if applicable)							X	X
Lab tests and exams
Urine for pregnancy test	X			X		X	X	X
Urine for GC/CT		X	X		X	X	X	X
Urine for schistosomiasis, T. vaginalis, M. genitalium		X
Fingerstick for HIV screening	X
Blood for RPR/HSV		X
Blood for serum hormone levels		X	X		X	X	X	X
Speculum pelvic examination		X	X		X	X	X	X
Vaginal swabs for wet mount, vaginal microbiome, PSA		X	X		X	X	X	X
CVL for immune markers+		X	X		X	X	X	X
For HIV-positive women only:
Blood for CD4		X			X		X	X
Blood for HIV RNA		X	X		X	X	X	X
Blood and CVL ART levels		X	X		X	X	X	X
Cervical and CVL HIV RNA/DNA		X	X		X	X	X	X
HIV resistance testing		X
For HIV-negative women only:
Fingerstick for follow-up HIV test					X		X	X
Cellular activation markers in blood and cervical cytobrush		X	X		X	X	X	X

⁺Immune markers include IL-6, IL-1, IL-Ra, IFN-a, TNF-a, IP-10, MCP-1, MIP-1a, MIP-3a, CCL22, sCD14, sCD163, sE-selectin, SP-selectin, IL-10, TGF-b, SLPI, HBD-2, HBD-3.

Abbreviations: S/E — Screening/Enrollment; DMPA — Depot Medroxyprogesterone Acetate; GC — Neisseria gonorrhoeae; CT — Chlamydia trachomatis; RPR — rapid plasma re-agin; HSV — herpes simplex virus; PSA — prostate-specific antigen (a marker of recent semen exposure); CVL — cervicovaginal lavage; RNA — ribonucleic acid; ART — antiretro-viral therapy; DNA — deoxyribonucleic acid.

^aVisit 1 occurs within 3 days after completion of the 1st menses following the Screening Visit, during the follicular phase.

^bVisit 2 occurs 2 weeks after Visit 1, in the luteal phase.

^cVisit 3 should occur within 7 days of the onset of the 2nd menses following the Screening Visit.