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A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094870
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This pilot study will evaluate, through quantitative and qualitative methods, whether different treatments for postpartum depression are feasible and acceptable in postpartum HIV infected women on antiretrovirals (ART). The study will take place at several clinics in Lusaka, Zambia.

Condition or disease Intervention/treatment Phase
Perinatal Depression HIV-1-infection Drug: Sertraline Behavioral: Interpersonal therapy Phase 4

Detailed Description:

The standard of care for treating postpartum depression in the US is antidepressants, psychotherapy or both. Little data exist on the best method for treating perinatal depression (PND) in Sub-Saharan Africa. This is a mixed method study including a pilot randomized controlled trial (RCT) of antidepressant medication (ADM) versus interpersonal psychotherapy (IPT) and qualitative semi-structured interviews (SSIs). The study will enroll 150 pregnant HIV infected women over the age of 18 seeking postnatal care and continuing antiretroviral therapy in pregnancy. An additional 20+ eligible women who decline to participate in the RCT will be invited to participate in semi-structured interviews (SSIs) and 20 women enrolled in the RCT will be invited to participate in SSIs.

Each participant will be followed for 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline initial dose of 25 mg tablet versus IPT in a 1:1 ratio commenced between six and 8 weeks postpartum and continued through 30 weeks postpartum.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Antidepressant medication
Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table
Drug: Sertraline
daily SSRI (Sertraline 25mg)
Other Name: SSRI

Active Comparator: Interpersonal therapy
Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization
Behavioral: Interpersonal therapy
11 sessions over a 24-week period




Primary Outcome Measures :
  1. Screening uptake of HIV infected women on ART in the postpartum period with the EPDS [ Time Frame: 2-7 weeks postpartum ]
    In order to determine feasibility, the proportion of women who agree to be screened with the EPDS within 2-7 weeks postpartum

  2. Proportion of Women Screened Who have an EPDS Score > 6 [ Time Frame: 2-7 weeks postpartum ]
    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of > 6 is indicative of a woman being at risk of perinatal depression.

  3. Proportion of women with depression based on the MINI who agree to participate in the study [ Time Frame: 6-8 weeks postpartum ]
    MINI International Neuropsychiatric Interview (MINI) is a brief structured diagnostic interview and is designed to assess the most common psychiatric disorders in ICD-10 and DSM-5. We will use the following MINI modules: major depressive disorder and generalized anxiety disorder. Questions are rated dichotomously (yes/no) and clinical judgment should be used in coding the responses, asking for examples if needed. Participants will be eligible for the study if they are diagnosed with depression or anxiety based on the MINI assessment.

  4. The number of women retained in the study [ Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment ]
    Proportion of women who are enrolled in the study who complete the final study visit


Secondary Outcome Measures :
  1. Number of Women with an EPDS Score Decline of 3 Points from baseline [ Time Frame: Enrollment - final study visit, approximately 24 weeks after enrollment ]
    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression with score range 0-30, a higher score indicates greater symptom burden. A score of > 6 is indicative of a woman being at risk of perinatal depression.

  2. Number of Women with a CGI Score Decline of one point from baseline [ Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment ]
    The Clinical Global Impression (CGI) is a 7-point scale (range 1-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with the patient. Lower scores correlate with clinical improvement.

  3. Proportion of women experiencing anti depressant medication toxicity [ Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment ]
    The proportion of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity

  4. Proportion of women who adhere to the prescribed antidepressant medication (ADM) [ Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment ]
    Proportion of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report

  5. Proportion of women who adhere to the interpersonal therapy arm (IPT) [ Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment ]
    Proportion of women randomized to the IPT arm who complete all IPT sessions

  6. Acceptability of use of different treatments for postpartum depression [ Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment ]
    Semi-structured interviews will be held with a random sample of participants who enroll and who decline enrollment.

  7. Changes in the viral load between study entry and the last visit [ Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment ]
    The mean change in the viral load will be measured between all women enrolled between the first and last visits



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 18 years of age or older
  • Documentation of confirmed HIV-1 infection
  • Six to eight weeks postpartum
  • Currently taking ART treatment
  • Able and willing to provide written informed consent
  • Willing to adhere to study visit schedule
  • PND diagnosis confirmed by Mini-International Neuropsychiatric Interview

Exclusion criteria:

  • Taking an ADM in the prior 12 months prior to enrollment
  • Actively suicidal
  • Known or suspected allergy or contraindication to first line Sertraline
  • Any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094870


Contacts
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Contact: Margaret Kasaro, MBChB, MSc +260 963 22 32 10 margaret.kasaro@unclusaka.org

Locations
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Zambia
Kamwala District Health Centre Recruiting
Lusaka, Zambia
Contact: Bellington Vwalika, MBChB       vwalikab@gmail.com   
University Teaching Hospital Not yet recruiting
Lusaka, Zambia
Contact: Bellington Vwalika, MBChB, MMed, MPH    +260 966 668 312    vwalikab@gmail.com   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Elizabeth Stringer, MD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04094870    
Other Study ID Numbers: 17-3411
1R21MH115806 ( U.S. NIH Grant/Contract )
Z 31801 ( Other Identifier: UNC )
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Time Frame: 9 to 36 months following publication
Access Criteria: Investigator who proposes to use the data has IRB, IEC, or REB approval, as applicable, and an executed data use/sharing agreement with UNC.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of North Carolina, Chapel Hill:
perinatal depression
HIV
Antiretroviral Treatment
Interpersonal psychotherapy
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Infant, Newborn, Diseases
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs