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Title: Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk Breastfeeding Population in Botswana
Brief Title: Tshireletso
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 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.
For info regarding 2023P000415
please contact Rebecca Zash at 617-632-7706 or
rzash@bidmc.harvard.edu