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Taking people in MalawiPhase 4

Studies safety of HIV prevention drugs during pregnancy and breastfeeding in Malawi

Checks safety of injectable and oral PrEP in pregnant women and their infants.

Plain-language title generated from the registry record
Registry title: UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

Key facts

Where
Lilongwe, MalawiSee the site
Phase
Phase 4

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for pregnant women in Malawi who are HIV-negative and use or start PrEP, either an injection (CAB-LA) or daily pills.

Age
From 15 years to 55 years.
Sex
Women only.
Disease stage
Pregnancy confirmed by a urine pregnancy test or an ultrasound.
Earlier treatment
Women already using PrEP when pregnancy is found can join. Women who start PrEP during pregnancy can also join.
Biomarker or test result
Confirmed HIV-negative by the local HIV testing method. Hepatitis B surface antigen (HBsAg) negative.

Main reasons for not taking part

  • Known to be living with HIV
  • Known allergy to CAB-LA, TDF/3TC or FTC/TDF
  • Another current serious disease, substance use or life situation that makes taking part unsafe, in the site investigator's judgment
  • Plans to leave the study site's area (Bwaila) before the study ends
  • Weight of 35 kg (77 lb) or less

This trial only enrols pregnant participants. The registry sentence this rests on: Confirmed pregnancy by urine pregnancy test or ultrasound.

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 15 and 55 years old?

Source: NCT06158126, who can take part

Where in Malawi

  • Bwaila Distict HospitalLilongwe, MalawiTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
University of North Carolina, Chapel Hill
Trial code
NCT06158126
Record updated
5 May 2026
Original description
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:Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT06158126