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Completed

NCT Number: NCT03826199

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Gugulethu Midwife Obstetric Unit

Cape Town, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • No previous exposure triple-drug antiretroviral therapy
  • Age 18 years or older
  • Lives within 20 kilometers of a clinic
  • Without psychiatric or medical contraindications to PrEP use
  • Able to provide informed consent for research

Exclusion criteria

Failure to meet any of the inclusion criteria

Treatment and study plan

TDF-FTC

Drug

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

Counselling on PrEP in antenatal and postnatal care

Behavioral

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 outcomes

  1. 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

  2. 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 outcomes

  1. PrEP Initiation

    Time frame: 18 months

    number of women who initiate PrEP over time/ total number of women in active cohort

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Desmond Tutu HIV Foundation
  • University of Cape Town

Registry information

Official study title

Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town, South Africa (Formative Study)

Acronym: PrEP-PP

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Feb 1, 2019
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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