Using cabotegravir injections for HIV prevention in breastfeeding mothers in Botswana

Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk Breastfeeding Population in Botswana

This study is testing if cabotegravir injections can safely help breastfeeding mothers in Botswana prevent HIV after giving birth.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Beth Israel Deaconess Medical Center (other)
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT05986084 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, efficacy, and feasibility of long-acting cabotegravir (CAB-LA) as pre-exposure prophylaxis (PrEP) for HIV in postpartum women who are breastfeeding. It will enroll 500 women at risk for HIV shortly after delivery in Botswana and follow them for 24 months. Participants will receive their first CAB-LA injection in the maternity ward and subsequent doses at local clinics. The study will assess adherence, safety outcomes, and HIV incidence through a mixed methods approach, including questionnaires and interviews.

Who should consider this trial

Good fit: Ideal candidates are postpartum women aged 18 or older, within 14 days of delivery, who are HIV-negative and plan to stay in the Gaborone or Molepolole region for 24 months.

Not a fit: Patients with unstable medical or psychiatric conditions or those receiving certain medications that interact with CAB-LA may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safe and effective method for HIV prevention in breastfeeding mothers, potentially reducing transmission rates.

How similar studies have performed: While similar approaches have been explored, this specific implementation in a breastfeeding population is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Mother 18 years of age or older and willing and able to provide an informed consent
2. \< 14 days after delivery (calendar day of birth = day 0)
3. Negative HIV screening test (conducted at the time of enrollment)
4. Mother \<30 years old or has had \< 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)
5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months

Exclusion Criteria:

1. Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort
2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampin)
3. Previous hypersensitivity reaction to CAB or other INSTI
4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 8 weeks
5. Plan for pediatric and post-partum care outside the government system (private clinics)
6. Inflammatory skin condition that compromises the safety of the intramuscular injection
7. Weight \<35kg

Where this trial is running

Boston, Massachusetts and 1 other locations

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
• Botswana Harvard AIDS Institute Partnership — Gaborone, Botswana (RECRUITING)

Study contacts

• Principal investigator: Rebecca Zash, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Rebecca Zash, MD

Conditions: Pre-Exposure Prophylaxis, Breast Feeding, Botswana, Lactation, Infant PK, long acting injectable, HIV prevention, post-partum