Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women

Study Overview
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Brief Summary
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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.

Detailed Description
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The objectives of the study are to: 1. Determine the distribution of women across the PrEP cascade: Evaluate the proportion of pregnant and breastfeeding women who initiate PrEP out of all women offered PrEP Evaluate the proportion of pregnant and breastfeeding women who are retained in the PrEP cohort 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 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)

Official Title
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Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women

Conditions
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HIV-I Infection

Intervention / Treatment
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* Drug: emtricitabine/tenofovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >16 years of age, confirmed HIV-negative (using 2 rapid tests, confirmed with a 4th generation antigen HIV test; lives within 20 km. of the clinic; confirmed to be pregnant; without psychiatric or medical contraindications to PrEP Exclusion Criteria: Concurrent enrollment in another HIV-1 vaccine or prevention trial; medical hospitalization in the past year for any reason; receipt of TB treatment in the past 30 days; history of renal disease; exhibiting psychotic symptoms (including hallucinations, suicidal or homicidal ideation, or violent behavior), currently or history of taking anti-psychotic medications; positive Hepatitis B surface antigen test on screening; history of bone fracture not related to trauma; any other medical, psychiatric, or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: emtricitabine/tenofovir|Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants initiating pre-exposure prophylaxis during pregnancy | Percentage of participants initiating pre-exposure prophylaxis during pregnancy | Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant | 
| Participants missing pre-natal visit | Percentage of participants missing one monthly pre-natal visit | Percentage of participants missing one monthly pre-natal visit between first pre-natal visit and birth of infant | 
| Adherence to TDF at 3rd trimester delivery | Percentage of participants with red blood cells with >80% levels at >40ng/mL TDF-DP at 3rd trimester delivery | Measured at delivery | 
| Women initiating pre-exposure prophylaxis post-partum | Percentage of women initiating pre-exposure prophylaxis | 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 | Measured at 6-month post-partum visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Pre-Exposure Prophylaxis (PrEP), Prevention in Pregnant and Breastfeeding Women