A Phase 4 interventional study of Cabotegravir Injection [Apretude] in Pre-Exposure Prophylaxis (PrEP) and Breast Feeding, sponsored by Beth Israel Deaconess Medical Center. Active, not recruiting at 2 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Beth Israel Deaconess Medical Center · Phase 4, Interventional, and Prevention
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:
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.
This is a hybrid implementation/safety study of long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) to prevent HIV infection in a post-partum cohort in Botswana where breastfeeding is common. The investigators will enroll 500 women at risk for HIV while they are admitted to the postpartum maternity ward after delivery at government-run health care facilities in Botswana and follow them for 24 months. The study sites will be located in two districts in Botswana, Gaborone and Molepolole.
The first CAB-LA injection will occur generally before discharge from the maternity ward. Follow up injections at 1 month, and then every 2 months, will be administered at clinics where the women and their infants receive routine care (or at research study sites when needed). The investigators will will measure uptake, adherence, persistence and implementation metrics using a mixed methods approach. The investigators will evaluate factors associated with uptake, adherence and persistence using data collected on all participants via questionnaires. The investigators will also conduct in-depth interviews of eligible participants who do not want CAB-LA and also a subset of enrolled participants at enrollment, 7 months and 19 moths. At each visit The investigators will screen for HIV using 4th generation HIV ag/ab point-of care tests and report HIV incidence over 24 months. The investigators will also evaluate safety outcomes, including postpartum depression, weight gain, and infant growth and INSTI resistance in incident HIV infections. Pharmacokinetics of CAB-LA in lactation (women, infants and breastmilk) will be evaluated in 30 mother-infant pairs in a PK substudy. HIV incidence and safety outcomes will be compared with a similar cohort of participants enrolled in a separate observational study in Botswana. This separate study also enrolls at the time of delivery from the same maternity sites.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 500 is above the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Cabotegravir Injection [Apretude]
Injection
Persistence of CAB-LA injections
The % of participants continuing CAB-LA PrEP at 5 months,11 months,17 months and 24 months
Time frame: 24 months
Uptake of CAB-LA injections
The % of eligible participants accepting CAB-LA PrEP
Time frame: 24 months
Adherence to CAB-LA injections
The % of injection visits attended by participants
Time frame: 24 months
HIV Incidence
The incidence of HIV infections will be calculated as the number of HIV infections infections identified during follow up, per person-year)
Time frame: 24 months
Composite Maternal Adverse Effects
The % of participants with any of the following: grade 2 or higher DAIDS-graded adverse event, obesity (24 month BMI \>30), new onset diabetes and pre-diabetes (HgBA1c \>5.8 or diagnosis during routine care), hypertension (systolic \>140 or diastolic \>90 on 2 separate measurements, or diagnosis during routine care) and prevalence of depression (PHQ-9 score \>9) or diagnosis during routine care
Time frame: 24 months
Composite Infant Adverse Effects
The % of infants with any of the following: incident pediatric HIV infections, Z-score \>=2 standard deviations (SD) below norms for length-for-age, weight-for-age or head-circumference-for-age based on WHO growth curves at 24 months
Time frame: 24 months
Maternal Cabotegravir Levels
Paired serum and breastmilk cabotegravir levels will be assessed just before the 1-month CAB-LA injection (early trough), 1 week after the 1-month CAB-LA injection (early peak), just before the 5-month CAB-LA injection (steady state trough) and 1 week after the 5-month CAB-LA injection (steady state peak)
Time frame: 5 months
Infant Cabotegravir Levels
In breastfed infants, infant serum cabotegravir levels will be assessed just before the 1-month CAB-LA injection (early trough), 1 week after the 1-month CAB-LA injection (early peak), just before the 5-month CAB-LA injection (steady state trough) and 1 week after the 5-month CAB-LA injection (steady state peak)
Time frame: 5 months
Median maternal weight change
The investigators will describe the median change in weight over the follow up period and the median weight gain from pre-pregnancy weight (when available)
Time frame: 24 months
Maternal Obesity
BMI \>30 at 24 months
Time frame: 24 months
Maternal Diabetes
New onset diabetes and pre-diabetes (HgBA1c \>5.8 or diagnosis during routine care)
Time frame: 24 months
Maternal Hypertension
Systolic blood pressure \>140 and/or diastolic blood pressure \>90 on 2 separate measurements, or diagnosis during routine care
Time frame: 24 months
Maternal Depression
PHQ-9 score \>9 or diagnosis of post partum depression in routine care
Time frame: 24 months
Infant HIV infection
The % of infants diagnosed with HIV infection, per person-years of follow up
Time frame: 24 months
INSTI resistance among incident HIV infections
The % of incident maternal and infant HIV infections found to have INSTI resistance
Time frame: 24 months
Inadequate infant growth
The % of infants with Z-score \>=2SD below WHO norms for length-for-age or weight-for-age
Time frame: 24 months
Infant microcephaly
Infants with head circumference \>=2SD below WHO norms for head-circumference for age
Time frame: 24 months
Plan to share: Yes — Researchers who provide a methodologically sound proposal (approved by the Tshireletso study team) for use of the data, including for pooling of data on the safety of medications in pregnancy and lactation to achieve aims, that have ethics approval from all involved institutions. Researchers of approved proposals will need to sign a Data Use Agreement with BIDMC before receiving the data.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available starting 3 months after the publication of the main outcomes of the Tshireletso study and be available until the end of the funding period for this study.
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Aug 2027, 45 months after the start.
Of 17 phase 4 interventional studies under Breast Feeding, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 45 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cabotegravir
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