Pre-Exposure Prophylaxis (PrEP)Phase 4TshireletsoNCT05986084
Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana
A Phase 4 study testing Cabotegravir Injection [Apretude] in people with Pre-Exposure Prophylaxis (PrEP) and Breast Feeding, run by Beth Israel Deaconess Medical Center at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-Exposure Prophylaxis (PrEP), Breast Feeding
- What is being tested?
- Cabotegravir Injection [Apretude]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 30 Nov 2023to 31 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (>1 dose oral/IV), or St. John's wort
- Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampin)
- Previous hypersensitivity reaction to CAB or other INSTI
- Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 8 weeks
- Plan for pediatric and post-partum care outside the government system (private clinics)
- Inflammatory skin condition that compromises the safety of the intramuscular injection
- Weight <35kg
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk 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 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.
Read the detailed description
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.
- Conditions
- Pre-Exposure Prophylaxis (PrEP), Breast Feeding
- Being tested
- Cabotegravir Injection [Apretude]
- Keywords
- Botswana, Lactation, Infant PK, long acting injectable, HIV prevention, post-partum, integrase strand transfer inhibitor, cabotegravir
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabotegravir Injection [Apretude]Drug
Injection
| Study group | Role | What they receive |
|---|---|---|
| CAB-LA PrEP | Experimental | 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. Receives: Drug: Cabotegravir Injection [Apretude] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistence of CAB-LA injections
The % of participants continuing CAB-LA PrEP at 5 months,11 months,17 months and 24 months
Measured: 24 months
Uptake of CAB-LA injections
The % of eligible participants accepting CAB-LA PrEP
Measured: 24 months
Adherence to CAB-LA injections
The % of injection visits attended by participants
Measured: 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)
Measured: 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
Measured: 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
Measured: 24 months
Secondary outcomes (11)
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)
Measured: 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)
Measured: 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)
Measured: 24 months
Maternal Obesity
BMI >30 at 24 months
Measured: 24 months
Maternal Diabetes
New onset diabetes and pre-diabetes (HgBA1c >5.8 or diagnosis during routine care)
Measured: 24 months
Maternal Hypertension
Systolic blood pressure >140 and/or diastolic blood pressure >90 on 2 separate measurements, or diagnosis during routine care
Measured: 24 months
Maternal Depression
PHQ-9 score >9 or diagnosis of post partum depression in routine care
Measured: 24 months
Infant HIV infection
The % of infants diagnosed with HIV infection, per person-years of follow up
Measured: 24 months
INSTI resistance among incident HIV infections
The % of incident maternal and infant HIV infections found to have INSTI resistance
Measured: 24 months
Inadequate infant growth
The % of infants with Z-score >=2SD below WHO norms for length-for-age or weight-for-age
Measured: 24 months
Infant microcephaly
Infants with head circumference >=2SD below WHO norms for head-circumference for age
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start30 Nov 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-Exposure Prophylaxis (PrEP)Studies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), ViiV Healthcare
- Responsible party
- Principal investigator, Rebecca Zash, MD, Beth Israel Deaconess Medical Center
- Investigators
- Rebecca Zash, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986084
- Sponsor's protocol ID
- 2023P000415
- Other IDs
- 5R01HD108047
- Acronym
- Tshireletso
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk Breastfeeding Population in Botswana
- ClinicalTrials.gov ID
- NCT05986084
- Acronym / sponsor ID
- Tshireletso / 2023P000415
- Conditions
- Pre-Exposure Prophylaxis (PrEP), Breast Feeding
- Keywords
- Botswana, Lactation, Infant PK, long acting injectable, HIV prevention, post-partum, integrase strand transfer inhibitor, cabotegravir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Botswana Harvard AIDS Institute Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), ViiV Healthcare
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAB-LA PrEP | Experimental | Drug: Cabotegravir Injection [Apretude]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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (>1 dose oral/IV), or St. John's wort
- Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampin)
- Previous hypersensitivity reaction to CAB or other INSTI
- Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 8 weeks
- Plan for pediatric and post-partum care outside the government system (private clinics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabotegravir Injection [Apretude]Injection | Drug | CAB-LA PrEP |
Primary outcome
Persistence of CAB-LA injections
Time frame: 24 months
The % of participants continuing CAB-LA PrEP at 5 months,11 months,17 months and 24 months
Uptake of CAB-LA injections
Time frame: 24 months
The % of eligible participants accepting CAB-LA PrEP
Adherence to CAB-LA injections
Time frame: 24 months
The % of injection visits attended by participants
HIV Incidence
Time frame: 24 months
The incidence of HIV infections will be calculated as the number of HIV infections infections identified during follow up, per person-year)
Composite Maternal Adverse Effects
Time frame: 24 months
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
Composite Infant Adverse Effects
Time frame: 24 months
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
11 secondary outcomes
Maternal Cabotegravir Levels
Time frame: 5 months
Infant Cabotegravir Levels
Time frame: 5 months
Median maternal weight change
Time frame: 24 months
Maternal Obesity
Time frame: 24 months
Maternal Diabetes
Time frame: 24 months
Maternal Hypertension
Time frame: 24 months
Maternal Depression
Time frame: 24 months
Infant HIV infection
Time frame: 24 months
INSTI resistance among incident HIV infections
Time frame: 24 months
Inadequate infant growth
Time frame: 24 months
Infant microcephaly
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: 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.
Related trials for Pre-Exposure Prophylaxis (PrEP)
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
HIV Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Zash, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cabotegravir Injection [Apretude] in people with Pre-Exposure Prophylaxis (PrEP) and Breast Feeding, run by Beth Israel Deaconess Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Botswana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of CAB-LA injections (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.