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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Other Locations
Botswana
Botswana Harvard AIDS Institute Partnership
RECRUITING
Gaborone
Contact Information
Primary
Rebecca Zash, MD
rzash@bidmc.harvard.edu
6172756630
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 500
Treatments
Experimental: CAB-LA PrEP
Following a negative HIV test, long-acting Cabotegravir Injection (CAB-LA) 600mg will be administered as a 3mL intramuscular (IM) injection in the gluteal muscle at enrollment, 1 month, and then every 2 months, for a maximum of 13 injections over 24 months of follow up.
Related Therapeutic Areas
Sponsors
Collaborators: ViiV Healthcare, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Botswana Harvard AIDS Institute Partnership
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov