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Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study) (PrEP-PP)

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ClinicalTrials.gov Identifier: NCT03826199
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborators:
University of Cape Town
Desmond Tutu HIV Foundation
Information provided by (Responsible Party):
Dvora Joseph Davey, PhD, MPH, University of California, Los Angeles

Brief Summary:
The overarching goal of this proposal is to evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal care, to describe the cascade in women initiating PrEP in this setting, and to evaluate the reasons for attrition along the PrEP cascade in a cohort of pregnant and breastfeeding women. The specific aims are to: (1) Evaluate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services; (2) Describe the PrEP cascade of initiation, retention, and adherence in a cohort of 220 HIV-uninfected pregnant and breastfeeding women, (3) Evaluate attrition and associated factors across the PrEP cascade.

Condition or disease Intervention/treatment Phase
Hiv Drug: TDF-FTC Behavioral: Counselling on PrEP in antenatal and postnatal care Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label cohort study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: TDF-FTC
    We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.
    Other Names:
    • PrEP
    • Truvada
  • Behavioral: Counselling on PrEP in antenatal and postnatal care
    Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.


Primary Outcome Measures :
  1. PrEP initiation [ Time Frame: 18 months ]
    number of women who initiate PrEP over time/ total number of women in active cohort= proportion of women who initiate PrEP

  2. PrEP retention [ Time Frame: 18 months ]
    number of women on PrEP who return for study visits (do not miss more than 1 visit) / total number of women in active cohort who are prescribed PrEP = proportion of women on PrEP who are retained in PrEP study

  3. PrEP adherence [ Time Frame: 3 months ]
    number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time on PrEP in active cohort = PrEP adherence rate (objective)


Secondary Outcome Measures :
  1. PrEP adherence (peri-sexual) [ Time Frame: 3 months ]
    number of women taking PrEP who have >80 percent levels at >40ng/mL tenofovir diphosphate (indicating dosing in past 24 hours) / total woman-time when women report condomless sex in past week= PrEP adherence rate (peri-sexual)

  2. PrEP adherence (subjective, self-reported) [ Time Frame: 3 months ]
    number of women taking PrEP, who self-report taking their medication daily (and pill count to confirm this) during periods of sexual risk over time / total woman time on PrEP in active cohort = PrEP adherence rate (subjective)



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only pregnant women will be included
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Documented HIV-negative according to two fingerpick rapid tests (per routine antenatal care protocol in this setting), confirmed with a 4th generation antigen HIV test at study enrollment
  2. No previous exposure triple-drug antiretroviral therapy
  3. Age 18 years or older
  4. Lives within 20 kilometers of a clinic
  5. Without psychiatric or medical contraindications to PrEP use
  6. Able to provide informed consent for research

Exclusion Criteria:

Failure to meet any of the inclusion criteria


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): NCT03826199


Contacts
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Contact: Dvora L Joseph Davey, PhD 3107011526 dvoradavey@ucla.edu

Locations
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South Africa
Gugulethu Midwife Obstetric Unit Recruiting
Cape Town, South Africa
Contact: Landon Myer, MD    +27 829430578    landon.myer@uct.ac.za   
Sponsors and Collaborators
University of California, Los Angeles
University of Cape Town
Desmond Tutu HIV Foundation
  Study Documents (Full-Text)

Documents provided by Dvora Joseph Davey, PhD, MPH, University of California, Los Angeles:
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Responsible Party: Dvora Joseph Davey, PhD, MPH, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03826199    
Other Study ID Numbers: K01TW011187 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019

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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 Dvora Joseph Davey, PhD, MPH, University of California, Los Angeles:
pre-exposure prophylaxis
PrEP
pregnancy
prevention of mother to child transmission
PMTCT
Additional relevant MeSH terms:
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Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents