Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk Breastfeeding Population in Botswana

2023P000415

The goal of this this hybrid safety/implementation study is to evaluate whether using long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe in post-partum people who are breastfeeding. The main question\[s\] it aims to answer are: * Will CAB-LA injections work well as a way to prevent HIV infection in post-partum people? * Will CAB-LA injections be safe in post-partum people and their infants who will be breastfeeding? Participants without HIV who are admitted to the maternity ward after having delivered a baby will be offered to start CAB-LA PrEP. Those who choose to participate will receive their first dose (injection) at the maternity ward and their follow up doses (injections) at their local clinic when they come for routine post-partum and pediatric care. Participants and their infants will be followed in the study for 24 months. We will be following how many people come on-time for their CAB-LA injections, how often they keep coming back, and the reasons they continue (or stop) these injections. We will also test people for HIV at all of their visits to see how many people get HIV during the study. We will also measure the levels of the medication in the blood of the post-partum people and their infants (who may be getting some of the CAB-LA in breastmilk) and evaluate to see if their is any impact of CAB-LA on the health of the post-partum person or their infants.

2023-11-30

2027-08-01

2027-08-01

Recruiting

Early phase I

500

Inclusion Criteria: 1. Mother 18 years of age or older and willing and able to provide an informed consent 2. \< 14 days after delivery (calendar day of birth = day 0) 3. Negative HIV screening test (conducted at the time of enrollment) 4. Mother \<30 years old or has had \< 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy) 5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months Exclusion Criteria: 1. Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort 2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampin) 3. Previous hypersensitivity reaction to CAB or other INSTI 4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 8 weeks 5. Plan for pediatric and post-partum care outside the government system (private clinics) 6. Inflammatory skin condition that compromises the safety of the intramuscular injection 7. Weight \<35kg

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

2024-02-05