Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Aug 3, 2023

Keywords

ClinConnect Summary

The Tshireletso clinical trial is studying the safety and effectiveness of a medication called cabotegravir (CAB-LA) for preventing HIV in breastfeeding mothers in Botswana. The trial aims to find out if CAB-LA injections are a good option for post-partum women—those who have recently given birth—and if these injections are safe for both the mothers and their babies. Eligible participants are mothers who are at least 18 years old, have delivered their baby within the last 14 days, and have tested negative for HIV. They should also plan to stay in the Gaborone or Molepolole area for two years for follow-up care.

If a mother chooses to participate, she will receive her first CAB-LA injection in the maternity ward and then continue receiving injections every eight weeks at her local clinic during routine check-ups. The trial will last for 24 months, during which researchers will monitor how well mothers stick to their injection schedule, check for any new HIV infections, and examine the health of both the mothers and their infants. This study is important as it could help improve HIV prevention strategies for breastfeeding women and ensure the safety of both mothers and their babies during this critical time.

Gender

FEMALE

Eligibility criteria

• 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