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

• ClinicalTrials.gov Identifier: NCT03826199
• Recruitment Status: Active, not recruiting
• First Posted: February 1, 2019
• Last Update Posted: January 14, 2021
• Sponsor: University of California, Los Angeles
• Collaborators: University of Cape Town; Desmond Tutu HIV Foundation
• Information provided by (Responsible Party): Dvora Joseph Davey, PhD, MPH, University of California, Los Angeles

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 222 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

Arms and Interventions

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.

Outcome Measures

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)

Eligibility Criteria

• 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

Contacts and Locations

Locations

South Africa

Gugulethu Midwife Obstetric Unit

Cape Town, South Africa

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:

Study Protocol and Statistical Analysis Plan  [PDF] November 11, 2018

More Information

• 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
• Last Update Posted: January 14, 2021
• Last Verified: January 2021

• 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:

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