RECRUITING

Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-11-30
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05986084

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Mother 18 years of age or older and willing and able to provide an informed consent
  2. 2. \< 14 days after delivery (calendar day of birth = day 0)
  3. 3. Negative HIV screening test (conducted at the time of enrollment)
  4. 4. Mother \<30 years old or has had \< 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)
  5. 5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months
  1. 1. Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\>1 dose oral/IV), or St. John's wort
  2. 2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampin)
  3. 3. Previous hypersensitivity reaction to CAB or other INSTI
  4. 4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 8 weeks
  5. 5. Plan for pediatric and post-partum care outside the government system (private clinics)
  6. 6. Inflammatory skin condition that compromises the safety of the intramuscular injection
  7. 7. Weight \<35kg

Contacts and Locations

Study Contact

Rebecca Zash, MD
CONTACT
6172756630
rzash@bidmc.harvard.edu

Principal Investigator

Rebecca Zash, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Rebecca Zash, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-30
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-11-30
Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

  • Botswana
  • Lactation
  • Infant PK
  • long acting injectable
  • HIV prevention
  • post-partum
  • integrase strand transfer inhibitor
  • cabotegravir

Additional Relevant MeSH Terms

  • Pre-Exposure Prophylaxis (PrEP)
  • Breast Feeding