UNCPM 22314 - Evaluating the Safety of Pregnancy, Infant and Maternal Health Outcomes Among PrEP Users in Malawi

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 55
Healthy Volunteers: t
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⁃ Maternal participants:

• Confirmed pregnancy by urine pregnancy test or ultrasound.

• Aged 15 years or older

• PrEP-eligible by Malawi local guidelines

• Confirmed HIV-negative based on the local HIV testing algorithm

• Hepatitis B surface antigen (HBsAg) negative

• Weight \>35 kg

• Provided informed consent and expressed willingness to participate in study activities with their infants.

⁃ Infant participants: Infant participants will enter the study with their mother as unborn infants. There are no specific eligibility criteria for infant participation otherwise.

Locations
Other Locations
Malawi
Bwaila Distict Hospital
RECRUITING
Lilongwe
Contact Information
Primary
Charity Nakanga, MBBS, MSc
cnakanga@unclilongwe.org
265 88 556 5888
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2027-12
Participants
Target number of participants: 621
Treatments
Active_comparator: Oral PrEP (FTC/TDF or TDF/3TC) during pregnancy
The arm will include pregnant women who have met eligibility criteria, consented, and chosen to initiate or remain on oral PrEP (FTC/TDF or TDF/3TC) during pregnancy. Within the arm, they will be grouped according to whether they started oral PrEP before or after pregnancy diagnosis. All participants will continue to be offered oral PrEP throughout the study and will be followed up for the duration of the study. All women will be registered into the PrEP Pregnancy Registry as part of routine care.
Experimental: Long-acting injectable cabotegravir (CAB-LA) during pregnancy
The arm will include pregnant women who have met eligibility criteria, consented, and chosen to initiate or remain on injectable PrEP (CAB-LA) during pregnancy. Within the arm, they will be grouped according to whether they started CAB-LA before or after pregnancy diagnosis. All participants will continue to be offered CAB-LA throughout the study and will be followed up for the duration of the study. All women will be registered into the PrEP Pregnancy Registry as part of routine care.
Related Therapeutic Areas
Sponsors
Leads: University of North Carolina, Chapel Hill
Collaborators: United States President's Emergency Plan for AIDS Relief, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ministry of Health, Malawi

This content was sourced from clinicaltrials.gov