UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

Summary

The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is:

\- Do composite adverse pregnancy events, maternal health outcomes, and/or infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA?

Women who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period.

In addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.

Conditions

• Pre-exposure Prophylaxis
• HIV Prevention
• Pregnancy Related

Interventions

DRUG

Initiating daily oral PrEP during pregnancy

Group 1a will include pregnant women who initiate oral PrEP when already pregnant, at enrollment into the study.

DRUG

Already using daily oral PrEP at the time of pregnancy diagnosis

Group 1b will include women already using daily oral PrEP at the time of pregnancy diagnosis and enrollment in the study.

DRUG

Initiating injectable PrEP during pregnancy

Group 2a will include pregnant women who initiate injectable PrEP (CAB-LA) when already pregnant, at enrollment into the study.

DRUG

Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis

Group 2b will include women using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis and enrollment into the study.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• United States President's Emergency Plan for AIDS Relief

  collaborator FED

• Ministry of Health, Malawi

  collaborator OTHER_GOV

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Friday Saidi, MBBS, MMED · UNC Project Malawi

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

15 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-04-17

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• Malawi

Study Locations