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

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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

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.

Condition or disease Intervention/treatment
HIV-I Infection Drug: emtricitabine/tenofovir

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)

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Pre-Exposure Prophylaxis (PrEP) Initiation, Retention, and Adherence in Pregnant and Breastfeeding Women
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: emtricitabine/tenofovir
    Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired
    Other Name: Behavioral Counseling


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902418


Contacts
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Contact: THOMAS J COATES, PhD 3103679044 tcoates@mednet.ucla.edu
Contact: Dvora Joseph Davey, PhD

Locations
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South Africa
University of Cape Town Recruiting
Cape Town, Western Cape, South Africa
Contact: Dvora J Davey, PhD    +27829430587    dvoradavey@gmail.com   
Sponsors and Collaborators
University of California, Los Angeles
University of Cape Town
Investigators
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Principal Investigator: Landon Myer, MD PhD University of Cape Town
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Responsible Party: Thomas J. Coates, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03902418    
Other Study ID Numbers: 1R01MH116771-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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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
Keywords provided by Thomas J. Coates, University of California, Los Angeles:
Prevention in Pregnant and Breastfeeding Women
HIV Pre-Exposure Prophylaxis (PrEP)
Additional relevant MeSH terms:
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Tenofovir
Emtricitabine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents