xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05986084</url>
    </required_header>
    <id_info>
      <org_study_id>2023P000415</org_study_id>
      <secondary_id>5R01HD108047</secondary_id>
      <nct_id>NCT05986084</nct_id>
    </id_info>
    <brief_title>Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana</brief_title>
    <acronym>Tshireletso</acronym>
    <official_title>Linking HIV Prevention and Postpartum Care: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a High-Risk Breastfeeding Population in Botswana</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beth Israel Deaconess Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Botswana Harvard AIDS Institute Partnership</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>ViiV Healthcare</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Beth Israel Deaconess Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this this hybrid safety/implementation study is to evaluate whether using&#xD;
        long-acting cabotegravir (CAB-LA) for HIV prevention (PrEP) is acceptable, feasible and safe&#xD;
        in post-partum people who are breastfeeding. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  Will CAB-LA injections work well as a way to prevent HIV infection in post-partum&#xD;
             people?&#xD;
  &#xD;
          -  Will CAB-LA injections be safe in post-partum people and their infants who will be&#xD;
             breastfeeding?&#xD;
  &#xD;
        Participants without HIV who are admitted to the maternity ward after having delivered a baby&#xD;
        will be offered to start CAB-LA PrEP. Those who choose to participate will receive their&#xD;
        first dose (injection) at the maternity ward and their follow up doses (injections) at their&#xD;
        local clinic when they come for routine post-partum and pediatric care. Participants and&#xD;
        their infants will be followed in the study for 24 months. We will be following how many&#xD;
        people come on-time for their CAB-LA injections, how often they keep coming back, and the&#xD;
        reasons they continue (or stop) these injections. We will also test people for HIV at all of&#xD;
        their visits to see how many people get HIV during the study. We will also measure the levels&#xD;
        of the medication in the blood of the post-partum people and their infants (who may be&#xD;
        getting some of the CAB-LA in breastmilk) and evaluate to see if their is any impact of&#xD;
        CAB-LA on the health of the post-partum person or their infants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a hybrid implementation/safety study of long-acting cabotegravir (CAB-LA) as&#xD;
        pre-exposure prophylaxis (PrEP) to prevent HIV infection in a post-partum cohort in Botswana&#xD;
        where breastfeeding is common. The investigators will enroll 500 women at risk for HIV while&#xD;
        they are admitted to the postpartum maternity ward after delivery at government-run health&#xD;
        care facilities in Botswana and follow them for 24 months. The study sites will be located in&#xD;
        two districts in Botswana, Gaborone and Molepolole.&#xD;
  &#xD;
        The first CAB-LA injection will occur generally before discharge from the maternity ward.&#xD;
        Follow up injections at 1 month, and then every 2 months, will be administered at clinics&#xD;
        where the women and their infants receive routine care (or at research study sites when&#xD;
        needed). The investigators will will measure uptake, adherence, persistence and&#xD;
        implementation metrics using a mixed methods approach. The investigators will evaluate&#xD;
        factors associated with uptake, adherence and persistence using data collected on all&#xD;
        participants via questionnaires. The investigators will also conduct in-depth interviews of&#xD;
        eligible participants who do not want CAB-LA and also a subset of enrolled participants at&#xD;
        enrollment, 7 months and 19 moths. At each visit The investigators will screen for HIV using&#xD;
        4th generation HIV ag/ab point-of care tests and report HIV incidence over 24 months. The&#xD;
        investigators will also evaluate safety outcomes, including postpartum depression, weight&#xD;
        gain, and infant growth and INSTI resistance in incident HIV infections. Pharmacokinetics of&#xD;
        CAB-LA in lactation (women, infants and breastmilk) will be evaluated in 30 mother-infant&#xD;
        pairs in a PK substudy. HIV incidence and safety outcomes will be compared with a similar&#xD;
        cohort of participants enrolled in a separate observational study in Botswana. This separate&#xD;
        study also enrolls at the time of delivery from the same maternity sites.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">June 2028</completion_date>
    <primary_completion_date type="Anticipated">October 2027</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Persistence of CAB-LA injections</measure>
      <time_frame>24 months</time_frame>
      <description>The % of participants continuing CAB-LA PrEP at 5 months,11 months,17 months and 24 months</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Uptake of CAB-LA injections</measure>
      <time_frame>24 months</time_frame>
      <description>The % of eligible participants accepting CAB-LA PrEP</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence to CAB-LA injections</measure>
      <time_frame>24 months</time_frame>
      <description>The % of injection visits attended by participants</description>
    </primary_outcome>
    <primary_outcome>
      <measure>HIV Incidence</measure>
      <time_frame>24 months</time_frame>
      <description>The incidence of HIV infections will be calculated as the number of HIV infections infections identified during follow up, per person-year)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Composite Maternal Adverse Effects</measure>
      <time_frame>24 months</time_frame>
      <description>The % of participants with any of the following: grade 2 or higher DAIDS-graded adverse event, obesity (24 month BMI &gt;30), new onset diabetes and pre-diabetes (HgBA1c &gt;5.8 or diagnosis during routine care), hypertension (systolic &gt;140 or diastolic &gt;90 on 2 separate measurements, or diagnosis during routine care) and prevalence of depression (PHQ-9 score &gt;9) or diagnosis during routine care</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Composite Infant Adverse Effects</measure>
      <time_frame>24 months</time_frame>
      <description>The % of infants with any of the following: incident pediatric HIV infections, Z-score &gt;=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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Maternal Cabotegravir Levels</measure>
      <time_frame>5 months</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Infant Cabotegravir Levels</measure>
      <time_frame>5 months</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Median maternal weight change</measure>
      <time_frame>24 months</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal Obesity</measure>
      <time_frame>24 months</time_frame>
      <description>BMI &gt;30 at 24 months</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal Diabetes</measure>
      <time_frame>24 months</time_frame>
      <description>New onset diabetes and pre-diabetes (HgBA1c &gt;5.8 or diagnosis during routine care)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal Hypertension</measure>
      <time_frame>24 months</time_frame>
      <description>Systolic blood pressure &gt;140 and/or diastolic blood pressure &gt;90 on 2 separate measurements, or diagnosis during routine care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maternal Depression</measure>
      <time_frame>24 months</time_frame>
      <description>PHQ-9 score &gt;9 or diagnosis of post partum depression in routine care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Infant HIV infection</measure>
      <time_frame>24 months</time_frame>
      <description>The % of infants diagnosed with HIV infection, per person-years of follow up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>INSTI resistance among incident HIV infections</measure>
      <time_frame>24 months</time_frame>
      <description>The % of incident maternal and infant HIV infections found to have INSTI resistance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inadequate infant growth</measure>
      <time_frame>24 months</time_frame>
      <description>The % of infants with Z-score &gt;=2SD below WHO norms for length-for-age or weight-for-age</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Infant microcephaly</measure>
      <time_frame>24 months</time_frame>
      <description>Infants with head circumference &gt;=2SD below WHO norms for head-circumference for age</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Pre-Exposure Prophylaxis (PrEP)</condition>
    <condition>Breast Feeding</condition>
    <arm_group>
      <arm_group_label>CAB-LA PrEP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cabotegravir Injection [Apretude]</intervention_name>
      <description>Injection</description>
      <arm_group_label>CAB-LA PrEP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Mother 18 years of age or older and willing and able to provide an informed consent&#xD;
  &#xD;
            2. &lt; 14 days after delivery (calendar day of birth = day 0)&#xD;
  &#xD;
            3. Negative HIV screening test (conducted at the time of enrollment)&#xD;
  &#xD;
            4. Mother &lt;30 years old or has had &lt; 3 prior pregnancies (Gravida 1, 2, or 3 including&#xD;
               this pregnancy)&#xD;
  &#xD;
            5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole&#xD;
               region for 24 months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Receiving carbemazapine, phenobarbital, phenytoin, oxycarbazepine, rifampin,&#xD;
               rifabutin, rifapentine, systemic dexamethasone (&gt;1 dose oral/IV), or St. John's wort&#xD;
  &#xD;
            2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction&#xD;
               with rifampin)&#xD;
  &#xD;
            3. Previous hypersensitivity reaction to CAB or other INSTI&#xD;
  &#xD;
            4. Unstable medical or psychiatric condition making it unlikely they will be able to&#xD;
               adhere to injections every 8 weeks&#xD;
  &#xD;
            5. Plan for pediatric and post-partum care outside the government system (private&#xD;
               clinics)&#xD;
  &#xD;
            6. Inflammatory skin condition that compromises the safety of the intramuscular injection&#xD;
  &#xD;
            7. Weight &lt;35kg&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rebecca Zash, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Beth Israel Deaconess Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rebecca Zash, MD</last_name>
      <phone>6172756630</phone>
      <email>rzash@bidmc.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beth Israel Deaconess Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecca Zash, MD</last_name>
        <phone>617-275-6630</phone>
        <email>rzash@bidmc.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Rebecca Zash, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Botswana Harvard AIDS Institute Partnership</name>
        <address>
          <city>Gaborone</city>
          <country>Botswana</country>
        </address>
      </facility>
      <contact>
        <last_name>Marcella Yoseph</last_name>
        <phone>+267 3902671</phone>
        <email>myoseph@bhp.org.bw</email>
      </contact>
      <contact_backup>
        <last_name>Joseph Makhema</last_name>
        <phone>+267 3902671</phone>
        <email>jmakhema@bhp.org.bw</email>
      </contact_backup>
      <investigator>
        <last_name>Joseph Makhema</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Emily Shava</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marcella Yoseph</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sikhulile Moyo</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tendani Gaolathe</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Botswana</country>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
      <investigator_full_name>Rebecca Zash, MD</investigator_full_name>
      <investigator_title>Assistant Professor of Medicine</investigator_title>
    </responsible_party>
    <keyword>Botswana</keyword>
    <keyword>Lactation</keyword>
    <keyword>Infant PK</keyword>
    <keyword>long acting injectable</keyword>
    <keyword>HIV prevention</keyword>
    <keyword>post-partum</keyword>
    <keyword>integrase strand transfer inhibitor</keyword>
    <keyword>cabotegravir</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cabotegravir</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>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.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_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.</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05986084
  org study id: 2023P000415
  secondary id: 5R01HD108047
  nct id: NCT05986084
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Persistence of CAB-LA injections
  time frame: 24 months
  description: The % of participants continuing CAB-LA PrEP at 5 months,11 months,17 months and 24 months
  measure: Uptake of CAB-LA injections
  time frame: 24 months
  description: The % of eligible participants accepting CAB-LA PrEP
  measure: Adherence to CAB-LA injections
  time frame: 24 months
  description: The % of injection visits attended by participants
  measure: HIV Incidence
  time frame: 24 months
  description: The incidence of HIV infections will be calculated as the number of HIV infections infections identified during follow up, per person-year)
  measure: Composite Maternal Adverse Effects
  time frame: 24 months
  description: 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
  measure: Composite Infant Adverse Effects
  time frame: 24 months
  description: 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
  measure: Maternal Cabotegravir Levels
  time frame: 5 months
  description: 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)
  measure: Infant Cabotegravir Levels
  time frame: 5 months
  description: 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)
  measure: Median maternal weight change
  time frame: 24 months
  description: 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)
  measure: Maternal Obesity
  time frame: 24 months
  description: BMI >30 at 24 months
  measure: Maternal Diabetes
  time frame: 24 months
  description: New onset diabetes and pre-diabetes (HgBA1c >5.8 or diagnosis during routine care)
  measure: Maternal Hypertension
  time frame: 24 months
  description: Systolic blood pressure >140 and/or diastolic blood pressure >90 on 2 separate measurements, or diagnosis during routine care
  measure: Maternal Depression
  time frame: 24 months
  description: PHQ-9 score >9 or diagnosis of post partum depression in routine care
  measure: Infant HIV infection
  time frame: 24 months
  description: The % of infants diagnosed with HIV infection, per person-years of follow up
  measure: INSTI resistance among incident HIV infections
  time frame: 24 months
  description: The % of incident maternal and infant HIV infections found to have INSTI resistance
  measure: Inadequate infant growth
  time frame: 24 months
  description: The % of infants with Z-score >=2SD below WHO norms for length-for-age or weight-for-age
  measure: Infant microcephaly
  time frame: 24 months
  description: Infants with head circumference >=2SD below WHO norms for head-circumference for age
  arm group label: CAB-LA PrEP
  arm group type: Experimental
  description: 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.
  intervention type: Drug
  intervention name: Cabotegravir Injection [Apretude]
  description: Injection
  arm group label: CAB-LA PrEP
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rebecca Zash, MD
  role: Principal Investigator
  affiliation: Beth Israel Deaconess Medical Center
  last name: Rebecca Zash, MD
  phone: 6172756630
  email: rzash@bidmc.harvard.edu
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Botswana
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Beth Israel Deaconess Medical Center
  investigator full name: Rebecca Zash, MD
  investigator title: Assistant Professor of Medicine
  mesh term: Cabotegravir
  sharing ipd: Yes
  ipd description: 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.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd 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.