An observational study in HIV-I Infection, sponsored by University of California, Los Angeles. Completed at 1 site in South Africa. Open to female participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-10-23.
Sponsored by University of California, Los Angeles · Observational
The investigators will conduct an observational cohort study in 1200 pregnant women who will be recruited at the first antenatal care (ANC) visit from the Gugulethu and one additional facility in the Klipfontein-Mitchell's Plain subdistrict of the Metro Region (to be identified in conjunction with provincial and local health authorities) Midwife Obstetric Units in Cape Town (n=600 pregnant women per site). The enrolled women will be followed through 12-months post-delivery.
The objectives of the study are to:
University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study counselors will enroll consecutive eligible, consenting pregnant adolescent girls (>16 years) and women in ANC (n=600 women per site; N=1200 pregnant women) and follow them up for 12-months postpartum or until censorship for a mean of 18-months' follow-up.
In a sub-study, STI and PrEP in Pregnancy Study (STIPPS), we will include n=268 women who recieve point of care STI results vs. those treated syndromically to evaluate PrEP initiation in pregnancy.
Exclusion Criteria:
Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired
Also known as: Behavioral Counseling
Participants Initiating Pre-exposure Prophylaxis During Pregnancy
Percentage of participants initiating pre-exposure prophylaxis during pregnancy
Time frame: Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant
Adherence to TDF at 3-months on PrEP
Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 3 months on PrEP
Time frame: Measured at 3 month follow up visit
Women Initiating Pre-exposure Prophylaxis Post-partum
Percentage of women initiating pre-exposure prophylaxis
Time frame: Percentage of participants initiating pre-exposure prophylaxis at first post-partum to final post-partum visit 12 months after birth
Adherence to TDF at 6 Months Post-partum
Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 6 month post-partum visit
Time frame: Measured at 6-month post-partum visit
Number of Participants With Adherence to TFV-DP at 6-month Visit
Quantifiable TFV (versus none) using dried blood spots (DBS) taken at 6-month study visit among subset of women who reported taking PrEP in the last 30-days at 6-months
Time frame: Measured at 6-month study visit
PrEP Initiation Among Those With STI POC Testing vs Syndromic Management
Proportion of those with POC (point of care) STI vs syndromic management who initiate oral PrEP
Time frame: Measured at enrollment and 1 month follow up
| Milestone | PrEP Use |
|---|---|
| Started | 1195 |
| Completed | 1092 |
| Not completed | 103 |
Percentage of participants initiating pre-exposure prophylaxis during pregnancy
| Participants | Pregnant Women Initiating PrEP |
|---|---|
| Participants Initiating Pre-exposure Prophylaxis During Pregnancy | 1089 |
Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 3 months on PrEP
| Participants | Pregnant Women Initiating PrEP |
|---|---|
| Adherence to TDF at 3-months on PrEP | 256 |
Percentage of women initiating pre-exposure prophylaxis
| Participants | Pregnant Women Initiating PrEP |
|---|---|
| Women Initiating Pre-exposure Prophylaxis Post-partum | 1009 |
Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 6 month post-partum visit
| Participants | Women With Quantifiable Adherence to TFV-DP at 6-month Visit |
|---|---|
| Adherence to TDF at 6 Months Post-partum | 51 |
Quantifiable TFV (versus none) using dried blood spots (DBS) taken at 6-month study visit among subset of women who reported taking PrEP in the last 30-days at 6-months
| Participants | Women With Quantifiable Adherence to TFV-DP at 6-month Visit |
|---|---|
| Number of Participants With Adherence to TFV-DP at 6-month Visit | 86 |
Proportion of those with POC (point of care) STI vs syndromic management who initiate oral PrEP
| Participants | Women Receiving POC STI Testing | Women Receiving STI Syndromic Management |
|---|---|---|
| PrEP Initiation Among Those With STI POC Testing vs Syndromic Management | 89 | 84 |
Collected over Between Aug 2019 and October 2021, we followed 1195 women and ascertained 1145 pregnancy outcomes, abstracted from maternal case files, infant road to health cards, and local obstetric records.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pregnant Women Offered PrEP | 0/1,195 (0%) | 67/1,195 (5.6%) | 201/1,082 (18.6%) |
| Event | Pregnant Women Offered PrEP |
|---|---|
| Pregnancy Loss, MiscarriagePregnancy, puerperium and perinatal conditions | 36/1145 |
| Pregnancy Loss, StillbirthPregnancy, puerperium and perinatal conditions | 25/1145 |
| HIV sero-conversionInfections and infestations | 16/1195 |
| Live Birth Outcome, Neonatal DeathPregnancy, puerperium and perinatal conditions | 6/1082 |
| Event | Pregnant Women Offered PrEP |
|---|---|
| Live Birth Outcome, Low Birth WeightPregnancy, puerperium and perinatal conditions | 110/1082 |
| Live Birth Outcome, Preterm DeliveryPregnancy, puerperium and perinatal conditions | 91/1082 |
Pregnant women in PrEP-PP study
| Age, Continuous(years) | PrEP Use |
|---|---|
| Median | 26 (23 to 31) |
| Sex: Female, Male(Participants) | PrEP Use |
|---|---|
| Female | 1195 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | PrEP Use |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1195 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | PrEP Use |
|---|---|
| South Africa | 1195 |
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University of California, Los Angeles