Status:
RECRUITING
Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Botswana Harvard AIDS Institute Partnership
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Pre-Exposure Prophylaxis (PrEP)
Breast Feeding
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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...
Detailed Description
This is a hybrid implementation/safety study of long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) to prevent HIV infection in a post-partum cohort in Botswana where breastfeeding is...
Eligibility Criteria
Inclusion
- Mother 18 years of age or older and willing and able to provide an informed consent
- \< 14 days after delivery (calendar day of birth = day 0)
- Negative HIV screening test (conducted at the time of enrollment)
- Mother \<30 years old or has had \< 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)
- Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months
Exclusion
- Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort
- Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampin)
- Previous hypersensitivity reaction to CAB or other INSTI
- Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 8 weeks
- Plan for pediatric and post-partum care outside the government system (private clinics)
- Inflammatory skin condition that compromises the safety of the intramuscular injection
- Weight \<35kg
Key Trial Info
Start Date :
November 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05986084
Start Date
November 30 2023
End Date
August 31 2027
Last Update
April 25 2025
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
2
Botswana Harvard AIDS Institute Partnership
Gaborone, Botswana