A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT04094870
Collaborator
National Institute of Mental Health (NIMH) (NIH)
80
2
2
12
40
3.3

Study Details

Study Description

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
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 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 Design

Study Type:
Interventional
Actual Enrollment :
80 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.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 :
Oct 30, 2019
Actual Primary Completion Date :
Oct 30, 2020
Actual Study Completion Date :
Oct 30, 2020

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Women Approached Who Agreed to Pre-Screening With EPDS [2-7 weeks postpartum]

      In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum

    2. Number of Women Pre-Screened Who Have an EPDS Score >/= 6 [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. The number of women with an EPDS >/= 6 out of all of the women who were pre-screened with an EPDS.

    3. Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI [2-7 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. MINI modules were used: 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. After pre screening with an EPDS, women with an EPDS >/=6 were invited to undergo MINI diagnostic testing after signed consent.

    4. Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study [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. MINI modules were used: 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.

    5. Number of Women Retained in the Study [Enrollment - final visit, approximately 24 weeks after enrollment]

      Number 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 [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 [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. Percentage of Women Experiencing Anti Depressant Medication Toxicity [Enrollment - final visit, approximately 24 weeks after enrollment]

      The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity

    4. Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM) [Enrollment - final visit, approximately 24 weeks after enrollment]

      Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report

    5. Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT) [Enrollment - final visit, approximately 24 weeks after enrollment]

      Number of women randomized to the IPT arm who complete all IPT sessions

    6. Acceptability of Trial Participation for Treatment of Postpartum Depression [Enrollment - final visit, approximately 24 weeks after enrollment]

      Participants completed a satisfaction survey at the final study visit addressing issues around 4 topics: (1) satisfaction with the study; (2) satisfaction with the intervention received; (3) self-perceived improvement of mental health; and (4) preference for study intervention not received. Responses were recorded using a Likert-type rating scale with the following responses: "Strongly disagree", "disagree", "neutral", "agree", and "strongly agree". For analysis purposes responses were combined into categories as follows: Agree and Strongly Agree, Disagree and Strongly Disagree, and neutral.

    7. Changes in the Viral Load Between Study Entry and the Last Visit [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kamwala District Health Centre Lusaka Zambia
    2 University Teaching Hospital Lusaka Zambia

    Sponsors and Collaborators

    • University of North Carolina, Chapel Hill
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Elizabeth Stringer, MD, University of North Carolina, Chapel Hill

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT04094870
    Other Study ID Numbers:
    • 17-3411
    • 1R21MH115806
    • Z 31801
    First Posted:
    Sep 19, 2019
    Last Update Posted:
    Nov 10, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Antidepressant Medication Interpersonal Therapy
    Arm/Group Description Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
    Period Title: Overall Study
    STARTED 40 40
    COMPLETED 39 39
    NOT COMPLETED 1 1

    Baseline Characteristics

    Arm/Group Title Antidepressant Medication Interpersonal Therapy Total
    Arm/Group Description Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period Total of all reporting groups
    Overall Participants 40 40 80
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    29.5
    (5.5)
    30.0
    (5.3)
    29.7
    (5.4)
    Sex: Female, Male (Count of Participants)
    Female
    40
    100%
    40
    100%
    80
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    40
    100%
    40
    100%
    80
    100%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    40
    100%
    40
    100%
    80
    100%
    White
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Count of Participants)
    Zambia
    40
    100%
    40
    100%
    80
    100%

    Outcome Measures

    1. Primary Outcome
    Title Number of Women Approached Who Agreed to Pre-Screening With EPDS
    Description In order to determine feasibility, the number of women who agree to be pre-screened with the Edinburgh Postnatal Depression Screen (EPDS) within 2-7 weeks postpartum
    Time Frame 2-7 weeks postpartum

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Approached Patients
    Arm/Group Description Eligible patients approached for participation
    Measure Participants 240
    Count of Participants [Participants]
    240
    600%
    2. Primary Outcome
    Title Number of Women Pre-Screened Who Have an EPDS Score >/= 6
    Description 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. The number of women with an EPDS >/= 6 out of all of the women who were pre-screened with an EPDS.
    Time Frame 2-7 weeks postpartum

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Approached Patients Who Completed Pre-Screening EPDS
    Arm/Group Description Potentially eligible patients who underwent pre-screening with EPDS
    Measure Participants 240
    Count of Participants [Participants]
    199
    497.5%
    3. Primary Outcome
    Title Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI
    Description 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. MINI modules were used: 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. After pre screening with an EPDS, women with an EPDS >/=6 were invited to undergo MINI diagnostic testing after signed consent.
    Time Frame 2-7 weeks postpartum

    Outcome Measure Data

    Analysis Population Description
    199 women were eligible for the MINI based on an EPDS >/= 6.
    Arm/Group Title All Participants With an EPDS >/=6
    Arm/Group Description Women eligible for the MINI based on an EPDS >/=6
    Measure Participants 199
    Count of Participants [Participants]
    120
    300%
    4. Primary Outcome
    Title Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
    Description 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. MINI modules were used: 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.
    Time Frame 6-8 weeks postpartum

    Outcome Measure Data

    Analysis Population Description
    91 met diagnostic criteria by MINI.
    Arm/Group Title Women Who Met Diagnostic Criteria by MINI and Agreed to Participate in the Study
    Arm/Group Description Eligible women diagnosed with anxiety or depression based on the MINI who agree to participate
    Measure Participants 91
    Count of Participants [Participants]
    80
    200%
    5. Primary Outcome
    Title Number of Women Retained in the Study
    Description Number of women who are enrolled in the study who complete the final study visit
    Time Frame Enrollment - final visit, approximately 24 weeks after enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Antidepressant Medication Interpersonal Therapy
    Arm/Group Description Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
    Measure Participants 40 40
    Count of Participants [Participants]
    39
    97.5%
    39
    97.5%
    6. Secondary Outcome
    Title Number of Women With an EPDS Score Decline of 3 Points From Baseline
    Description 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.
    Time Frame Enrollment - final study visit, approximately 24 weeks after enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Antidepressant Medication Interpersonal Therapy
    Arm/Group Description Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
    Measure Participants 39 39
    Count of Participants [Participants]
    37
    92.5%
    39
    97.5%
    7. Secondary Outcome
    Title Number of Women With a CGI Score Decline of One Point From Baseline
    Description 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.
    Time Frame Enrollment - final visit, approximately 24 weeks after enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Antidepressant Medication Interpersonal Therapy
    Arm/Group Description Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
    Measure Participants 39 39
    Count of Participants [Participants]
    38
    95%
    39
    97.5%
    8. Secondary Outcome
    Title Percentage of Women Experiencing Anti Depressant Medication Toxicity
    Description The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity
    Time Frame Enrollment - final visit, approximately 24 weeks after enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Women Assigned to the Antidepressant Medication Arm
    Arm/Group Description All women who were randomized to the medication arm
    Measure Participants 40
    Number [percentage of women who discontinued]
    0
    9. Secondary Outcome
    Title Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)
    Description Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report
    Time Frame Enrollment - final visit, approximately 24 weeks after enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title All Women Assigned to the Antidepressant Medication Arm
    Arm/Group Description All women who were randomized to the medication arm
    Measure Participants 40
    Number [percentage of participants]
    14
    35%
    10. Secondary Outcome
    Title Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
    Description Number of women randomized to the IPT arm who complete all IPT sessions
    Time Frame Enrollment - final visit, approximately 24 weeks after enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title All Women Assigned to the Therapy Arm
    Arm/Group Description Women who were randomized to the interpersonal therapy arm
    Measure Participants 40
    Count of Participants [Participants]
    5
    12.5%
    11. Secondary Outcome
    Title Acceptability of Trial Participation for Treatment of Postpartum Depression
    Description Participants completed a satisfaction survey at the final study visit addressing issues around 4 topics: (1) satisfaction with the study; (2) satisfaction with the intervention received; (3) self-perceived improvement of mental health; and (4) preference for study intervention not received. Responses were recorded using a Likert-type rating scale with the following responses: "Strongly disagree", "disagree", "neutral", "agree", and "strongly agree". For analysis purposes responses were combined into categories as follows: Agree and Strongly Agree, Disagree and Strongly Disagree, and neutral.
    Time Frame Enrollment - final visit, approximately 24 weeks after enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Antidepressant Medication Interpersonal Therapy
    Arm/Group Description Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
    Measure Participants 39 39
    Satisfaction with the study: Strongly Agree or Agree
    39
    97.5%
    39
    97.5%
    Satisfaction with the intervention received: Strongly Agree or Agree
    37
    92.5%
    37
    92.5%
    Satisfaction with the intervention received: Strongly Disagree or Disagree
    2
    5%
    2
    5%
    Self-perceived improvement of mental health: Strongly Agree or Agree
    39
    97.5%
    39
    97.5%
    Preference for study intervention not received: Strongly Agree or Agree
    6
    15%
    4
    10%
    Preference for study intervention not received: Neutral
    10
    25%
    16
    40%
    Preference for study intervention not received: Strongly Disagree or Disagree
    23
    57.5%
    19
    47.5%
    12. Secondary Outcome
    Title Changes in the Viral Load Between Study Entry and the Last Visit
    Description The mean change in the viral load will be measured between all women enrolled between the first and last visits
    Time Frame Enrollment - final visit, approximately 24 weeks after enrollment

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Antidepressant Medication Interpersonal Therapy
    Arm/Group Description Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
    Measure Participants 39 39
    Mean (Standard Deviation) [log copies/mL]
    0.6
    (4.0)
    1.6
    (3.7)

    Adverse Events

    Time Frame From the time of signing the Informed Consent through the last follow-up visit, a total of approximately 6 months.
    Adverse Event Reporting Description
    Arm/Group Title Antidepressant Medication Interpersonal Therapy
    Arm/Group Description Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table Sertraline: daily SSRI (Sertraline 25mg) Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization Interpersonal therapy: 11 sessions over a 24-week period
    All Cause Mortality
    Antidepressant Medication Interpersonal Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/40 (0%)
    Serious Adverse Events
    Antidepressant Medication Interpersonal Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/40 (0%)
    Other (Not Including Serious) Adverse Events
    Antidepressant Medication Interpersonal Therapy
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/40 (22.5%) 9/40 (22.5%)
    Gastrointestinal disorders
    Mild Medication Toxicity - Gastrointestinal 3/40 (7.5%) 3 0/40 (0%) 0
    Nervous system disorders
    Mild medication toxicity - Central nervous system 4/40 (10%) 4 0/40 (0%) 0
    Psychiatric disorders
    Suicidal Ideation 2/40 (5%) 2 9/40 (22.5%) 9

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Elizabeth Stringer, MD, MSc
    Organization University of North Carolina at Chapel Hill
    Phone 919-966-1601
    Email elizabeth_stringer@med.unc.edu
    Responsible Party:
    University of North Carolina, Chapel Hill
    ClinicalTrials.gov Identifier:
    NCT04094870
    Other Study ID Numbers:
    • 17-3411
    • 1R21MH115806
    • Z 31801
    First Posted:
    Sep 19, 2019
    Last Update Posted:
    Nov 10, 2021
    Last Verified:
    Dec 1, 2020