Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Populati… (NCT05986084) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana
United States, Botswana500 participantsStarted 2023-11-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically studying cabotegravir long-acting injections as PrEP in breastfeeding women — since I'm breastfeeding and concerned about HIV exposure, can you help me understand what is currently known and still unknown about whether CAB-LA is safe for my baby through breast milk?
2The trial is measuring both maternal and infant adverse effects as primary outcomes, which suggests there are real safety questions still being studied — what are the specific risks to me and my baby that I should weigh before considering CAB-LA versus daily oral PrEP options?
3This is a Phase 4 trial, meaning CAB-LA is already approved in some contexts — does that mean there's more safety data available than an earlier-phase trial, and how does what's known so far apply to breastfeeding women specifically?
4The trial is listed as active but no longer recruiting, so I likely can't enroll — but are there other ways I could access CAB-LA as PrEP while breastfeeding, or is it still considered experimental in this context in my country?
5Since the trial is measuring how many women actually stick with the injection schedule, what does that tell us about how demanding the CAB-LA injection schedule might be for someone in my situation, and is that something we should factor into deciding what PrEP option fits my life right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.