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A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

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ClinicalTrials.gov Identifier: NCT04094870
Recruitment Status : Completed
First Posted : September 19, 2019
Last Update Posted : December 21, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE September 16, 2019
First Posted Date  ICMJE September 19, 2019
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE October 30, 2019
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • 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
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
  • Screening uptake of HIV infected women on ART in the postpartum period with the EPDS [ Time Frame: Enrollment - 30 weeks postpartum ]
    Proportion of women who agree to be screened with the EPDS within 2-7 weeks postpartum
  • Prevalence of postpartum depression among women screened with the EPDS [ Time Frame: Enrollment-30 weeks postpartum ]
    Proportion of women screened who have an EPDS >6
  • Enrollment uptake of those women who have a positive MINI for depression [ Time Frame: Enrollment-30 weeks postpartum ]
    Proportion of women with depression based on the MINI who agree to be enrolled and randomized into the study
  • The number of women retained in the study [ Time Frame: Enrollment-30 weeks postpartum ]
    Proportion of women who are enrolled in the study who complete the final study visit
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2019)
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2019)
  • Proportion of women with a response to the randomized depression treatment response [ Time Frame: Enrollment - 30 weeks postpartum ]
    Proportion of women with a mean decline in the 10-item EPDS by at least three points at the final visit in each arm of the study
  • Proportion of women with a response to the randomized depression treatment as measured by the CGI [ Time Frame: Enrollment - 30 weeks postpartum ]
    Proportion of patients in each treatment arm in whom the Clinical Global Impression (CGI) improves by at least 1 point
  • Proportion of women experiencing anti depressant medication toxicity [ Time Frame: Enrollment- 30 weeks postpartum ]
    The proportion of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity
  • Proportion of women who adhere to the prescribed antidepressant medication (ADM) [ Time Frame: Enrollment-30 weeks postpartum ]
    Proportion of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report
  • Proportion of women who adhere to the interpersonal therapy arm (IPT) [ Time Frame: Enrollment-30 weeks postpartum ]
    Proportion of women randomized to the IPT arm who complete all IPT sessions
  • Acceptability of use of different treatments for postpartum depression [ Time Frame: Enrollment-30 weeks postpartum ]
    Semi-structured interviews will be held with a random sample of participants who enroll and who decline enrollment.
  • Changes in the viral load between study entry and the last visit [ Time Frame: Enrollment-30 weeks postpartum ]
    The mean change in the viral load will be measured between all women enrolled between the first and last visits
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Official Title  ICMJE Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
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.
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 100 pregnant HIV infected women over the age of 18 seeking postnatal care and continuing antiretroviral therapy in pregnancy. An additional 20 women enrolled in the RCT will be invited to participate in SSIs. Each participant will be followed for 24 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Perinatal Depression
  • HIV-1-infection
Intervention  ICMJE
  • Drug: Sertraline
    daily SSRI (Sertraline 25mg)
    Other Name: SSRI
  • Behavioral: Interpersonal therapy
    11 sessions over a 24-week period
Study Arms  ICMJE
  • Active Comparator: Antidepressant medication
    Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table
    Intervention: Drug: Sertraline
  • Active Comparator: Interpersonal therapy
    Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization
    Intervention: Behavioral: Interpersonal therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2020)
80
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2019)
170
Actual Study Completion Date  ICMJE October 30, 2020
Actual Primary Completion Date October 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Zambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04094870
Other Study ID Numbers  ICMJE 17-3411
1R21MH115806 ( U.S. NIH Grant/Contract )
Z 31801 ( Other Identifier: UNC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Elizabeth Stringer, MD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP