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NCT05986084 · ClinicalTrials.gov registry record · Phase 4
Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana
A Phase 4 study of Breastfeeding and Preexposure Prophylaxis (PrEP), sponsored by Beth Israel Deaconess Medical Center.
- Active
- Registry status
- Phase 4
- Development phase
- 500
- Enrollment target
- 2
- Study locations
NCT05986084: Active Phase 4 study of Breastfeeding and Preexposure Prophylaxis (PrEP), sponsored by Beth Israel Deaconess Medical Center.
NCT05986084 is a Phase 4 study of Breastfeeding and Preexposure Prophylaxis (PrEP) that is active but no longer recruiting, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 500 participants, below the 583-participant average among 36 other Breastfeeding trials with a reported enrollment target (14% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05986084, a Phase 4 study of Breastfeeding and Preexposure Prophylaxis (PrEP), is active but no longer recruiting, sponsored by Beth Israel Deaconess Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 500 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The % of participants continuing CAB-LA PrEP at 5 months,11 months,17 months and 24 months
Conditions Studied
Interventions
- DRUG Cabotegravir Injection [Apretude]
Study Locations (2)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Other
- Botswana Harvard AIDS Institute Partnership - Gaborone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-11-30 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 4 |
What the registry record for NCT05986084 still lists
NCT05986084 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, below the 583-participant average among 36 other Breastfeeding trials with a reported enrollment target (14% lower).
The record links to 2 conditions, with Breastfeeding appearing as the primary indexed condition, and to 1 intervention - of which Cabotegravir Injection [Apretude] is the first listed.
NCT05986084 reports a single indexed study location in Massachusetts, Other.
Frequently Asked Questions
What is clinical trial NCT05986084 about?
NCT05986084 is a clinical study titled "Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana". 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...
What is the current status of trial NCT05986084?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 500 participants. The study started on 2023-11-30. Estimated completion is 2027-11-30.
What conditions does trial NCT05986084 study?
This clinical trial studies the following conditions: Breastfeeding, Preexposure Prophylaxis (PrEP).
What interventions are being tested in trial NCT05986084?
The interventions under investigation include: Cabotegravir Injection [Apretude] (DRUG).
Who is sponsoring clinical trial NCT05986084?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05986084 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breastfeeding
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05986084's enrollment target sits among peer trials
500 10th of 36 higher than 26 of 36 other Breastfeeding trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breastfeeding trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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