- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04094870
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
October 12, 2021 updated by: University of North Carolina, Chapel Hill
Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
80
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lusaka, Zambia
- University Teaching Hospital
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Lusaka, Zambia
- Kamwala District Health Centre
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Antidepressant medication
Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table
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daily SSRI (Sertraline 25mg)
Other Names:
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Active Comparator: Interpersonal therapy
Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization
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11 sessions over a 24-week period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Women Approached Who Agreed to Pre-Screening With EPDS
Time Frame: 2-7 weeks postpartum
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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
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2-7 weeks postpartum
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Number of Women Pre-Screened Who Have an EPDS Score >/= 6
Time Frame: 2-7 weeks postpartum
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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.
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2-7 weeks postpartum
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Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI
Time Frame: 2-7 weeks postpartum
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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.
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2-7 weeks postpartum
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Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
Time Frame: 6-8 weeks postpartum
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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.
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6-8 weeks postpartum
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Number of Women Retained in the Study
Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment
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Number of women who are enrolled in the study who complete the final study visit
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Enrollment - final visit, approximately 24 weeks after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Enrollment - final study visit, approximately 24 weeks after enrollment
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Number of Women With a CGI Score Decline of One Point From Baseline
Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment
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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.
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Enrollment - final visit, approximately 24 weeks after enrollment
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Percentage of Women Experiencing Anti Depressant Medication Toxicity
Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment
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The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity
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Enrollment - final visit, approximately 24 weeks after enrollment
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Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)
Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment
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Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report
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Enrollment - final visit, approximately 24 weeks after enrollment
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Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment
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Number of women randomized to the IPT arm who complete all IPT sessions
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Enrollment - final visit, approximately 24 weeks after enrollment
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Acceptability of Trial Participation for Treatment of Postpartum Depression
Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment
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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.
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Enrollment - final visit, approximately 24 weeks after enrollment
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Changes in the Viral Load Between Study Entry and the Last Visit
Time Frame: Enrollment - final visit, approximately 24 weeks after enrollment
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The mean change in the viral load will be measured between all women enrolled between the first and last visits
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Enrollment - final visit, approximately 24 weeks after enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Elizabeth Stringer, MD, University of North Carolina, Chapel Hill
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start (Actual)
October 30, 2019
Primary Completion (Actual)
October 30, 2020
Study Completion (Actual)
October 30, 2020
Study Registration Dates
First Submitted
September 16, 2019
First Submitted That Met QC Criteria
September 16, 2019
First Posted (Actual)
September 19, 2019
Study Record Updates
Last Update Posted (Actual)
November 10, 2021
Last Update Submitted That Met QC Criteria
October 12, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Infant, Newborn, Diseases
- Depression
- Depressive Disorder
- Asphyxia Neonatorum
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- 17-3411
- 1R21MH115806 (U.S. NIH Grant/Contract)
- Z 31801 (Other Identifier: UNC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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.
IPD Sharing Time Frame
9 to 36 months following publication
IPD Sharing 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.
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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