HIV-I Infection
Conditions
Keywords
Prevention in Pregnant and Breastfeeding Women, HIV Pre-Exposure Prophylaxis (PrEP)
Brief summary
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
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)
Interventions
Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired
Sponsors
University of Cape Town
University of California, Los Angeles
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Initiating Pre-exposure Prophylaxis During Pregnancy | Percentage of participants initiating pre-exposure prophylaxis between first ante-natal clinic visit and birth of infant | Percentage of participants initiating pre-exposure prophylaxis during pregnancy |
| Adherence to TDF at 3-months on PrEP | Measured at 3 month follow up visit | Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 3 months on PrEP |
| Women Initiating Pre-exposure Prophylaxis Post-partum | Percentage of participants initiating pre-exposure prophylaxis at first post-partum to final post-partum visit 12 months after birth | Percentage of women initiating pre-exposure prophylaxis |
| Adherence to TDF at 6 Months Post-partum | Measured at 6-month post-partum visit | Percentage of participants with red blood cells with \>80% levels at \>40ng/mL TDF-DP at 6 month post-partum visit |
| Number of Participants With Adherence to TFV-DP at 6-month Visit | Measured at 6-month study 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Initiation Among Those With STI POC Testing vs Syndromic Management | Measured at enrollment and 1 month follow up | Proportion of those with POC (point of care) STI vs syndromic management who initiate oral PrEP |
Countries
South Africa
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PrEP Use Evaluation of PrEP use among pregnant and breastfeeding women including initiation, continuation and adherence (self report and objective outcomes) | 1,195 |
| Total | 1,195 |
Baseline characteristics
| Characteristic | PrEP Use |
|---|---|
| Age, Continuous | 26 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1195 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment South Africa | 1195 Participants |
| Sex: Female, Male Female | 1195 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,195 |
| other Total, other adverse events | 201 / 1,082 |
| serious Total, serious adverse events | 67 / 1,195 |
Outcome results
Primary
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
Population: 382 women on PrEP with dried blood spots measured for TFV-DP
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Initiating PrEP | Adherence to TDF at 3-months on PrEP | 256 Participants |
Primary
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
Population: Women with TFV-DP in DBS at 6m visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Initiating PrEP | Adherence to TDF at 6 Months Post-partum | 51 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Initiating PrEP | Number of Participants With Adherence to TFV-DP at 6-month Visit | 86 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Initiating PrEP | Participants Initiating Pre-exposure Prophylaxis During Pregnancy | 1089 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Initiating PrEP | Women Initiating Pre-exposure Prophylaxis Post-partum | 1009 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregnant Women Initiating PrEP | PrEP Initiation Among Those With STI POC Testing vs Syndromic Management | 89 Participants |
| Women Receiving STI Syndromic Management | PrEP Initiation Among Those With STI POC Testing vs Syndromic Management | 84 Participants |