Table 1.

Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals data collection

	Pregnant or recently delivered at enrolment				Not pregnant at enrolment
	Enrolment				Enrolment	Annual follow-up
	Pregnancy	Delivery	6 weeks post partum	1-year post partum and annually
	In person	In person	In person	Remote	In person	Remote
Residential address information/location for geocoding purposes	X	(X)			X
Contact and check-in between visits	X	X	X	X	X	X
Change in pregnancy status	X		X	X		X
Clinical assessments (collected in-person)
Height	X	(X)	X		X
Weight	X	X	X	X	X	X
Waist and hip circumference			X	X	X
Blood pressure	X	X	X	X	X	X
Interview
Family and personal medical history	X	(X)			X
Reproductive history	X	(X)			X
Depression*	X	(X)	X		X
Anxiety†	X	(X)	X		X
PTSD‡	X	(X)			X
Health literacy§	X	(X)			X
Social history	X	(X)			X
Online survey (detail provided in table 2)	X	X	X	X	X	X
Medical chart abstraction
Weight	X	X	X	X	X	X
Blood pressure	X	X	X	X		X
HIV RNA level, lymphocytes and subsets	X	X	X	X	X	X
ART medications	X	X	X	X	X	X
Non-ART medications	X	X	X	X	X	X
HIV, primary care, OB, gynaecologic, mental healthcare engagement	X	X	X	X	X	X
Immunisations	X	X	X	X	X	X
Medical and mental health diagnoses and hospitalisation	X	X	X	X	X	X
Laboratory test results	X	X	X	X	X	X
Pregnancy and pregnancy outcomes	X	X		X	X	X
Cervical and anal dysplasia screening	X	X	X	X	X	X
STI testing and results	X	X		X	X	X
Sample collection/repository
Serum, plasma (EDTA and heparin) and non-viable PBMCs	X	X			X
Rectal swab for microbiome	X	(X)			X
Vaginal swab for microbiome	X	(X)			X
Vaginal swab for metabolomics	X	(X)			X
Vaginal swab for STI testing	X	X			X
Oral swab	X	X			X
Saliva	X	X			X
Hair	X	X			X

Brackets () indicate that the assessment takes place at the delivery visit only if the delivery visit is an enrolment visit.

*Depressive symptoms assessed via interview using the Patient Health Questionnaire-9.⁷⁵

†Anxiety symptoms assessed via interview using the Generalised Anxiety Disorder-7.⁷⁶

‡Post-traumatic stress disorder assessed via interview using the Primary Care Post-Traumatic Stress Disorder Screen for DSM-5.⁷⁷

§Health literacy assessed via interview using the Newest Vital Sign.⁷³

ART, antiretroviral therapy; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; OB, obstetrical; PBMC, peripheral blood mononuclear cells; STI, sexually transmitted infection.