BridgeMD
New treatment option for Pre-exposure Prophylaxis
Official title UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study
ClinicalTrials.gov ID: NCT06158126
What this study is testing
What is Initiating daily oral PrEP during pregnancy?
Initiating daily oral PrEP during pregnancy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pre-exposure prophylaxis.
Also referred to as Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) or lamivudine (3TC) (FTC/TDF or TDF/3TC).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 55, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Maternal participants will not be eligible to enter the prospective cohort study if any of the following conditions are identified during the...
- Known to be living with HIV
- Known allergies to CAB-LA, TDF/3TC or FTC/TDF
- Other current significant disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator...
- Intention to leave the study site's catchment area of Bwaila before scheduled study exit.
See the full eligibility criteria
- 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...
- Maternal participants will not be eligible to enter the prospective cohort study if any of the following conditions are identified during the screening process:
- Known to be living with HIV
- Known allergies to CAB-LA, TDF/3TC or FTC/TDF
- Other current significant disease process (active or chronic), substance use, or social circumstances that, in the judgment of the site investigator would make participation in the study unsafe.
- Intention to leave the study site's catchment area of Bwaila before scheduled study exit.
The study team makes the final eligibility decision.
Where it's taking place
- Lilongwe, Malawi
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 15 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lilongwe, Malawi. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.