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

Study acronym: Tshireletso
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion moved earlier from Nov 30, 2027 to Aug 31, 2027v6
  2. Trial status: Recruiting to Active, Not Recruiting Completion date: Aug 31, 2027 to Nov 30, 2027 · Site details revised at 2 of 2 sitesv5 Show 2 more changesShow less
    • Completion date: Aug 31, 2027 to Nov 30, 2027
    • Site details revised at 2 of 2 sites
  3. Primary completion date: Aug 1, 2027 to Aug 31, 2027 Site contacts updated at 1 of 2 sitesv4 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  4. Primary completion date: Aug 2027 to Aug 1, 2027 Completion date: Aug 2027 to Aug 31, 2027v3 Show 1 more changeShow less
    • Completion date: Aug 2027 to Aug 31, 2027
  5. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 2027 to Aug 2027 · Completion date: Jun 2028 to Aug 2027 · Start date changed from estimate of Oct 2023 to Nov 30, 2023 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Oct 2027 to Aug 2027
    • Completion date: Jun 2028 to Aug 2027
    • Start date changed from estimate of Oct 2023 to Nov 30, 2023
    • Site details revised at 2 of 2 sites
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05986084
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: Botswana Harvard AIDS Institute Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), ViiV Healthcare
Conditions Pre-Exposure Prophylaxis (PrEP), Breast Feeding
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov