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Completed

NCT Number: NCT04094870

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.

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Key information

Conditions

Perinatal Depression HIV-1-infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Kamwala District Health Centre, Lusaka, Zambia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sertraline

Drug

daily SSRI (Sertraline 25mg)

Other names: SSRI

Interpersonal Therapy

Behavioral

11 sessions over a 24-week period

Primary outcomes

  1. Number of Women Approached Who Agreed to Pre-Screening With EPDS

    Time frame: 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

    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. 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

    Time frame: 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

    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. 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

    Time frame: Enrollment - final visit, approximately 24 weeks after enrollment

    Number of women who are enrolled in the study who complete the final study visit

Secondary outcomes

  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. Percentage of Women Experiencing Anti Depressant Medication Toxicity

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2019
Registry last updated
Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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