Trial Outcomes & Findings for Prospective Cohort Study of HIV and Zika in Infants and Pregnancy (NCT NCT03263195)

Last Updated: 2022-01-14

Results Overview

This outcome measured feasibility of enrolling 150 pregnant women living with HIV and 50 pregnant women without HIV, with a minimum of 20 of these women having HIV/ZIKV co-infection by their end of pregnancy

Recruitment status

COMPLETED

Target enrollment

395 participants

Primary outcome timeframe

At the time of delivery of all those enrolled up to 1 year after the first enrollment

Results posted on

2022-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Women With HIV Only Pregnant women with HIV infection only	Women Without HIV or ZIKV Pregnant women without HIV or ZIKV infection	Infants of Women With HIV Only Infants of women with HIV infection during pregnancy	Infants of Women Without HIV or ZIKV Infants of women without HIV or ZIKV infection during pregnancy
Overall Study STARTED	174	26	170	25
Overall Study COMPLETED	168	23	155	19
Overall Study NOT COMPLETED	6	3	15	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Cohort Study of HIV and Zika in Infants and Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women With HIV Only n=174 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women with ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=26 Participants Pregnant women without HIV or ZIKV infection	Total n=200 Participants Total of all reporting groups
Age, Continuous	28.2 years n=5 Participants	—	—	29.2 years n=4 Participants	28.3 years n=21 Participants
Sex: Female, Male Female	174 Participants n=5 Participants	—	—	26 Participants n=4 Participants	200 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	—	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White (US)	4 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized Black (US)	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized Asian (US)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized More than one race (US)	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Other (US)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Not reported (US)	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	7 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized White (Brazil)	39 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	39 Participants n=21 Participants
Race/Ethnicity, Customized Black (Brazil)	40 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	40 Participants n=21 Participants
Race/Ethnicity, Customized Mulatto (Brazil)	8 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized Amarela/Yellow (Brazil)	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Indigenous (Brazil)	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Mixed Black (Brazil)	51 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	51 Participants n=21 Participants
Race/Ethnicity, Customized More than one race (Brazil)	21 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	21 Participants n=21 Participants
Region of Enrollment Puerto Rico	9 participants n=5 Participants	—	—	0 participants n=4 Participants	9 participants n=21 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	—	26 participants n=4 Participants	27 participants n=21 Participants
Region of Enrollment Brazil	164 participants n=5 Participants	—	—	0 participants n=4 Participants	164 participants n=21 Participants
Gestational age at enrollment	14.5 weeks n=5 Participants	—	—	16.0 weeks n=4 Participants	15.0 weeks n=21 Participants

PRIMARY outcome

Timeframe: At the time of delivery of all those enrolled up to 1 year after the first enrollment

Population: While the protocol was successful at enrolling at least 150 women living with HIV, it did not achieve its aim of enrolling 50 women without HIV and there were no ZIKV infections observed during the study period. Total enrollment into the expected arms is presented.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=174 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=26 Participants Pregnant women without HIV or ZIKV infection
Enrollment (150 HIV-infected and 50 HIV-uninfected Pregnant Women Within One Year, With a Minimum of 20 of These Women Having HIV/ZIKV Co-infection by Their End of Pregnancy).	174 Participants	0 Participants	0 Participants	26 Participants

PRIMARY outcome

Timeframe: Maternal viral load at delivery

Population: All women with HIV enrolled in HIV ZIP during pregnancy

This outcome intended to measure HIV suppression at the time of delivery among women living with HIV with and without ZIKV infection during pregnancy. Note there were no women with ZIKV infection in pregnancy. Viral suppression was defined at different thresholds (\<40 copies/mL, \<400 copies/mL, \<1000 copies/mL).

Outcome measures

Outcome measures
Measure	Women With HIV Only n=174 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV Pregnant women without HIV or ZIKV infection
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <40 copies/mL · Yes	101 Participants	—	—	—
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <40 copies/mL · No	22 Participants	—	—	—
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <40 copies/mL · Missing	51 Participants	—	—	—
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <400 copies/mL · Yes	110 Participants	—	—	—
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <400 copies/mL · No	13 Participants	—	—	—
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <400 copies/mL · Missing	51 Participants	—	—	—
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <1000 copies/mL · Yes	111 Participants	—	—	—
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <1000 copies/mL · No	12 Participants	—	—	—
Viral Suppression (in HIV-infected Women With ZIKV Co-infection Compared to Those Without ZIKV Co-infection During Pregnancy) at the Time of Delivery. VL <1000 copies/mL · Missing	51 Participants	—	—	—

PRIMARY outcome

Timeframe: Maternal baseline to delivery

Population: Women with HIV and women without HIV enrolled in HIV ZIP during pregnancy

Cumulative incidence of ZIKV infection during pregnancy (among pregnant women with HIV infection compared to those without HIV infection).

Outcome measures

Outcome measures
Measure	Women With HIV Only n=174 Participants Pregnant women with HIV infection only	Women With ZIKV Only n=26 Participants Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV Pregnant women without HIV or ZIKV infection
Incidence of ZIKV Infection (Among Pregnant Women With HIV Infection Compared to Those Without HIV Infection).	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: At time of delivery

Population: Women enrolled in HIV ZIP during pregnancy Miscarriage was defined as fetal demise \<20 weeks of gestation. Stillbirth was defined as fetal demise ≥20 weeks of gestation. Preterm delivery was defined as delivery at \<37 weeks of gestation.

Adverse pregnancy outcomes included miscarriage, stillbirth and preterm delivery. Note there were no women with ZIKV infection in pregnancy. Miscarriage was defined as fetal demise at \<20 weeks of gestation. Stillbirth was defined as fetal demise at ≥20 weeks of gestation. Preterm delivery was defined as delivery at \<37 weeks of gestation.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=174 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=26 Participants Pregnant women without HIV or ZIKV infection
Incidence of Adverse Pregnancy Outcomes (in Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women). Miscarriage	3 Participants	—	—	0 Participants
Incidence of Adverse Pregnancy Outcomes (in Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women). Stillbirth	1 Participants	—	—	0 Participants
Incidence of Adverse Pregnancy Outcomes (in Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women). Preterm delivery	16 Participants	—	—	1 Participants

PRIMARY outcome

Timeframe: Infant birth to 12 months

Population: Infants enrolled in HIV ZIP who were born to women with HIV or ZIKV infection in pregnancy.

Cumulative incidence of confirmed HIV infection among enrolled infants. Note there were no women with ZIKV infection in pregnancy so therefore no risk of transmission of ZIKV to any infants.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=170 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV Pregnant women without HIV or ZIKV infection
Incidence of Vertical Transmission of HIV and/or ZIKV (in Women Co-infected With HIV and ZIKV and Women Infected With Either HIV or ZIKV Alone).	0 Participants	—	—	—

PRIMARY outcome

Timeframe: Infant birth, 3 months

Population: Infants enrolled in HIV ZIP

Cumulative incidence of congenital malformations. Note there were no women with ZIKV infection in pregnancy. Observed major congenital malformations included: anhydramnios, cerebral ventriculomegaly, clubfoot (unresolved), Down syndrome, hydrops, hypospadias, patient ductus arteriosus, polydactyly (left foot), Potter syndrome, short stature, syndactyly (left foot, 1st and 2nd toes). Observed minor congenital malformations included: clubfoot (resolved), cryptorchidism (bilateral), dislocated hip, heart defect (patent foramen ovale), heart murmur (unresolved), hemangioma, hip dysplasia, hydrocele, inguinal hernia, head circumference -3 ≤ z-score \<-2, persistent ductus arteriosus (resolved), plagiocephaly, restrictive ductus arteriosus, renal pyelectasis, sacral dimple, small perimembranous ventricular septal defect, stenosis of nasolacrimal duct, umbilical hernia.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=170 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=25 Participants Pregnant women without HIV or ZIKV infection
Incidence of Congenital Malformations (Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women). Major malformations	6 Participants	—	—	2 Participants
Incidence of Congenital Malformations (Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone, and Doubly Uninfected Women). Minor malformations	32 Participants	—	—	5 Participants

PRIMARY outcome

Timeframe: Infant birth to 12 months

Population: Infants enrolled in HIV ZIP

Other adverse outcomes included microcephaly, neonatal dealth, central nervous system (CNS) malformation, hydrops, and ocular abnormalities. Note there were no women with ZIKV infection in pregnancy. Microcephaly was defined as head circumference less than a z-score of -3 at birth or 3 month visit. Neonatal death was defined as death within 28 days of life. Observed CNS malformations included: cerebral ventriculomegaly. Ocular abnormalities included both structural and functional ophthalmologic abnormalities.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=170 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=25 Participants Pregnant women without HIV or ZIKV infection
Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone. Microcephaly	0 Participants	—	—	0 Participants
Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone. Neonatal death	1 Participants	—	—	0 Participants
Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone. CNS malformations	0 Participants	—	—	1 Participants
Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone. Hydrops	2 Participants	—	—	0 Participants
Incidence of Other Adverse Outcomes Among Offspring of Women Co-infected With HIV and ZIKV, Women Infected With Either HIV or ZIKV Alone. Ocular abnormalities	18 Participants	—	—	5 Participants

PRIMARY outcome

Timeframe: Infant Birth, 3 months, 6 months, 12 months

Population: Infants enrolled in HIV ZIP

Weight as a measure of growth. Note there were no women with ZIKV infection in pregnancy.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=170 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=25 Participants Pregnant women without HIV or ZIKV infection
Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV Weight at birth	3.2 kg Interval 2.8 to 3.4	—	—	3.2 kg Interval 2.9 to 3.7
Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV Weight at 3 months	5.9 kg Interval 5.4 to 6.6	—	—	5.7 kg Interval 5.3 to 6.4
Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV Weight at 6 months	7.7 kg Interval 7.0 to 8.4	—	—	8.2 kg Interval 7.0 to 9.0
Weight Among Children With or Without in Utero Exposure to HIV and/or ZIKV Weight at 12 months	10.0 kg Interval 9.0 to 10.7	—	—	9.8 kg Interval 8.8 to 10.9

PRIMARY outcome

Timeframe: Infant Birth, 3 months, 6 months, 12 months

Population: Infants enrolled in HIV ZIP

Length and head circumference as measures of growth. Note there were no women with ZIKV infection in pregnancy.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=170 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=25 Participants Pregnant women without HIV or ZIKV infection
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV Length at birth	48.2 cm Interval 47.0 to 50.0	—	—	48.3 cm Interval 46.9 to 52.0
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV Length at 3 months	58.5 cm Interval 57.0 to 60.5	—	—	59.5 cm Interval 55.8 to 61.0
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV Length at 6 months	65.0 cm Interval 64.0 to 67.0	—	—	67.0 cm Interval 62.0 to 69.5
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV Length at 12 months	75.0 cm Interval 73.0 to 77.5	—	—	74.2 cm Interval 71.5 to 77.2
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV Head circumference at birth	34.0 cm Interval 33.0 to 35.0	—	—	34.0 cm Interval 33.0 to 35.0
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV Head circumference at 3 months	40.0 cm Interval 39.0 to 41.0	—	—	40.3 cm Interval 39.0 to 41.0
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV Head circumference at 6 months	43.0 cm Interval 42.0 to 44.0	—	—	43.8 cm Interval 43.0 to 44.2
Length and Head Circumference Among Children With and Without in Utero Exposure to HIV and/or ZIKV Head circumference at 12 months	46.0 cm Interval 45.0 to 47.0	—	—	46.3 cm Interval 45.5 to 47.0

PRIMARY outcome

Timeframe: Within one month of infant birth, 3 months, 6 months, 12 months

Population: Infants enrolled in HIV ZIP

Audiologic function as assessed by OAE test reported. Note there were no women with ZIKV infection in pregnancy.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=170 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=25 Participants Pregnant women without HIV or ZIKV infection
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (12 months) · Test result not available	66 Participants	—	—	10 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (Birth) · Passed	108 Participants	—	—	3 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (Birth) · Passed	112 Participants	—	—	3 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (Birth) · Failed	12 Participants	—	—	0 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (Birth) · Test result not available	46 Participants	—	—	22 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (3 months) · Passed	99 Participants	—	—	17 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (3 months) · Failed	11 Participants	—	—	1 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (3 months) · Test result not available	60 Participants	—	—	7 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (6 months) · Passed	102 Participants	—	—	14 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (6 months) · Failed	21 Participants	—	—	1 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (6 months) · Test result not available	47 Participants	—	—	10 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (12 months) · Passed	84 Participants	—	—	13 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Right ear (12 months) · Failed	20 Participants	—	—	2 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (12 months) · Failed	21 Participants	—	—	2 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (12 months) · Test result not available	65 Participants	—	—	10 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (Birth) · Failed	16 Participants	—	—	0 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (Birth) · Test result not available	46 Participants	—	—	22 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (3 months) · Passed	100 Participants	—	—	17 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (3 months) · Failed	10 Participants	—	—	1 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (3 months) · Test result not available	60 Participants	—	—	7 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (6 months) · Passed	103 Participants	—	—	14 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (6 months) · Failed	20 Participants	—	—	1 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (6 months) · Test result not available	47 Participants	—	—	10 Participants
Audiologic Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Left ear (12 months) · Passed	84 Participants	—	—	13 Participants

PRIMARY outcome

Timeframe: Within one month of infant birth, 12 months;

Population: Infants enrolled in HIV ZIP

Ocular abnormalities included both structural and functional ophthalmologic abnormalities. Note there were no women with ZIKV infection in pregnancy.

Outcome measures

Outcome measures
Measure	Women With HIV Only n=170 Participants Pregnant women with HIV infection only	Women With ZIKV Only Pregnant women ZIKV infection only	Women With HIV and ZIKV Pregnant women with HIV and ZIKV infection	Women Without HIV or ZIKV n=25 Participants Pregnant women without HIV or ZIKV infection
Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV Ocular abnormalities	18 Participants	—	—	5 Participants
Ophthalmologic Structure and Function Among Children With or Without in Utero Exposure to HIV and/or ZIKV No ocular abnormalities	152 Participants	—	—	20 Participants

PRIMARY outcome

Timeframe: Infant 3 months, 6 months, 12 months

Population: Infants enrolled in HIV ZIP

Infant neurodevelopment was assessed by either the Bayley III or Ages and Stages Questionnaires- 3rd Edition. Combined results reported. Note there were no women with ZIKV infection in pregnancy.