Pregnancy Related Clinical Trial
— PrIMOOfficial title:
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) 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 receiving PrEP at the time of pregnancy diagnosis or initiating 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 at the start of the study 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.
Status | Recruiting |
Enrollment | 621 |
Est. completion date | December 2027 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 55 Years |
Eligibility | Inclusion 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 specific eligibility criteria for infant participation otherwise. Exclusion Criteria: 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. |
Country | Name | City | State |
---|---|---|---|
Malawi | Bwaila Distict Hospital | Lilongwe |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Ministry of Health, Malawi, United States President's Emergency Plan for AIDS Relief |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of composite adverse pregnancy outcomes | Rate will be calculated as the number of women with an adverse pregnancy outcome, defined as the occurrence of any one of the following events: spontaneous miscarriage (pregnancy lost before 28 weeks gestation), stillbirth (fetal death at or after 28 weeks gestation), preterm birth (delivery before 37 weeks gestation), infant born small for gestational age (birth weight of less than 10th percentile for gestational age) over the accumulated person time from enrollment through birth. | Enrollment through birth | |
Secondary | Proportion of women developing grade 3 or higher clinical or laboratory events | Proportions will be calculated as the number of women developing grade three or higher clinical or laboratory events over the total number of enrollees in the cohort. Grade 3 or higher clinical or laboratory events will be assessed and graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. | Enrollment through 52 weeks postpartum | |
Secondary | Proportion of infants developing stage 3 or higher clinical or laboratory events | Proportions will be calculated as the number of infants developing stage three or higher clinical or laboratory events over the total number of infants in the cohort. Stage 3 or higher clinical or laboratory events will be accessed and graded using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. | Birth through 52 weeks of life | |
Secondary | Proportion of infants born with congenital anomalies | Proportions will be calculated as the number of infants born with congenital anomalies over the total number of infants in the cohort. Congenital anomalies will be diagnosed with neonatal surface exam and fetal anatomic ultrasound | Birth through 52 weeks of life | |
Secondary | Number of infants who are underweight | Number of infants who are underweight, defined as weight for age z-score (WAZ) <-2, assessed at weeks 1, 6, 12, 26 and 52 weeks after birth. | Birth through 52 weeks of life | |
Secondary | Proportion of infants who are underweight | Proportions will be calculated as the number of infants who are underweight over the total number of infants in the cohort. Underweight will be defined as weight for age z-score (WAZ) <-2, assessed at weeks 1, 6, 12, 26 and 52 weeks after birth. | Birth through 52 weeks of life | |
Secondary | Number of infants who are stunted | A child will be considered stunted if s/he has a length for age z-score (LAZ) <-2, assessed at weeks 1, 6, 12, 26 and 52 after birth. | Birth through 52 weeks of life | |
Secondary | Proportion of infants who are stunted | Proportions will be calculated as the number of infants who are stunted over the total number of infants in the cohort. Infants will be considered stunted if s/he has a length for age z-score (LAZ) <-2, assessed at weeks 1, 6, 12, 26 and 52 after birth. | Birth through 52 weeks of life | |
Secondary | Number of infants who have moderate or severe acute malnutrition | Malnourishment based on anthropometrics per World Health Organization (WHO) definitions. Moderate acute malnutrition defined as a weight for length z-score (WLZ) between -3 and <-2, or mid-upper arm circumference (MUAC) between 115 millimeters and <125 millimeters. Severe acute malnutrition defined as a weight for length z-score (WLZ) of < -3 or MUAC < 115 millimeters, or the presence of bilateral pitting edema, or both. Assessed at weeks 1, 6, 12, 26 and 52 after birth. | Birth through 52 weeks of life | |
Secondary | Proportion of infants who have moderate or severe acute malnutrition | Proportions will be calculated as the number of infants who have moderate or severe acute malnutrition over the total number of infants in the cohort. Malnourishment based on anthropometrics per World Health Organization (WHO) definitions. Moderate acute malnutrition defined as a weight for length z-score (WLZ) between -3 and <-2, or mid-upper arm circumference (MUAC) between 115 millimeters and <125 millimeters. Severe acute malnutrition defined as a weight for length z-score (WLZ) of < -3 or MUAC < 115 millimeters, or the presence of bilateral pitting edema, or both. Assessed at weeks 1, 6, 12, 26 and 52 after birth. | Birth through 52 weeks of life | |
Secondary | Number of infants with poor neurodevelopment outcomes | Defined as a low Caregiver-Reported Early Development Index (CREDI) and/or Mullen Scales of Early Learning (MSEL) score for age, assessed at weeks 1, 6, 12, 26 and 52 after birth | Birth through 52 weeks of life | |
Secondary | Acceptability of oral PrEP or CAB-LA | Based on analysis of in-depth interviews with approximately 50 women in the study. Content analysis and NVivo version 1.7 will be used to develop a codebook using domains and constructs from theoretical framework for acceptability by Sekhon. Data will then be displaced on matrices using the framework to display the patterns emerging from the text. Assessed at delivery, 12 weeks postpartum, and 52 weeks postpartum | Delivery through 52 weeks postpartum | |
Secondary | Adoption of PrEP in Pregnancy Registry | Adoption will be defined as the number of targeted settings (including districts, sites, and providers) who initiated register use by the end of the study. Adoption will be assessed at 6, 12, and 24 months after register implementation. | 6 to 24 months after implementation | |
Secondary | Reach of PrEP in Pregnancy Registry | Reach will be defined as the total number of entries in the register at each site. Reach will be assessed at 6, 12, and 24 months after register implementation. | 6 to 24 months after implementation | |
Secondary | Fidelity to PrEP in Pregnancy Registry | Fidelity is defined as the number of pregnant women who have complete entries for all infant and obstetric outcomes in the register as per protocol. Fidelity will be assessed at 6, 12, and 24 months after register implementation. | 6 to 24 months after implementation |
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