Clinical Trials

MainTitle

A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

This study is ongoing, but not recruiting participants.
Sponsor
University of North Carolina, Chapel Hill

Collaborator
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier
NCT04094870

First received: September 16, 2019
Last updated: May 7, 2020
Last Verified: May 2020
History of Changes
Purpose

Purpose

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 Intervention Phase
Perinatal Depression
HIV-1-infection

Drug : Sertraline
Behavioral : Interpersonal therapy
Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures

  • 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
Secondary Outcome Measures:
  • 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

Estimated Enrollment: 110
Study Start Date: October 30, 2019
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: July 30, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04094870

Locations

Zambia
Kamwala District Health Centre
Lusaka, Zambia
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
More Information

More Information


Responsible Party: University of North Carolina, Chapel Hill  
ClinicalTrials.gov Identifier: NCT04094870   History of Changes  
Other Study ID Numbers: 17-3411  
  1R21MH115806  
  Z 31801  
Study First Received: September 16, 2019  
Last Updated: May 7, 2020  
Individual Participant Data    
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:

perinatal depression
HIV
Antiretroviral Treatment
Interpersonal psychotherapy

Additional relevant MeSH terms:
Asphyxia Neonatorum
Depression
Depressive Disorder
Sertraline

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.