Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902418
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : May 29, 2020
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Thomas J. Coates, University of California, Los Angeles

Tracking Information
First Submitted Date January 10, 2019
First Posted Date April 4, 2019
Last Update Posted Date May 29, 2020
Actual Study Start Date July 1, 2019
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2019)
  • 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 ]
    Percentage of participants initiating pre-exposure prophylaxis during pregnancy
  • Participants missing pre-natal visit [ Time Frame: Percentage of participants missing one monthly pre-natal visit between first pre-natal visit and birth of infant ]
    Percentage of participants missing one monthly pre-natal visit
  • Adherence to TDF at 3rd trimester delivery [ Time Frame: Measured at delivery ]
    Percentage of participants with red blood cells with >80% levels at >40ng/mL TDF-DP at 3rd trimester delivery
  • Women initiating pre-exposure prophylaxis post-partum [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Pre-Exposure Prophylaxis (PrEP) in Pregnant and Breastfeeding Women
Official Title Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women
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)
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum
Sampling Method Non-Probability Sample
Study Population 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.
Condition HIV-I Infection
Intervention Drug: emtricitabine/tenofovir
Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired
Other Name: Behavioral Counseling
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 1, 2019)
1200
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: THOMAS J COATES, PhD 3103679044 tcoates@mednet.ucla.edu
Contact: Dvora Joseph Davey, PhD
Listed Location Countries South Africa
Removed Location Countries  
 
Administrative Information
NCT Number NCT03902418
Other Study ID Numbers 1R01MH116771-01A1( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement Not Provided
Responsible Party Thomas J. Coates, University of California, Los Angeles
Study Sponsor University of California, Los Angeles
Collaborators University of Cape Town
Investigators
Principal Investigator: Landon Myer, MD PhD University of Cape Town
PRS Account University of California, Los Angeles
Verification Date May 2020