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: 1\. Determine the distribution of women across the PrEP cascade: 1. Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP out of all women offered PrEP 2. Evaluate the proportion of pregnant and breastfeeding women who are retained in the PrEP cohort 3. Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP who adhere to PrEP using objective dried blood spot measures and subjective measures of self-reported pill count and adherence 4. Evaluate the proportion of pregnant and breastfeeding women on PrEP (and not on PrEP) who acquire HIV, who transmit HIV to their infant, and who report adverse events 2. Evaluate patient and provider-level factors associated with the PrEP cascade using quantitative and qualitative approaches (including in-depth interviews) 3. Apply an established mathematical model to simulate the impact of improvement in the PrEP cascade on HIV infections averted (maternal and perinatal)
Study Type
OBSERVATIONAL
Enrollment
1,195
Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired
University of Cape Town
Cape Town, Western Cape, South Africa
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
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