A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04094870
• Other study ID #: 17-3411
• Secondary ID: 1R21MH115806Z 31
• Status: Completed
• Phase: Phase 4
• Start date: October 30, 2019
• Est. completion date: October 30, 2020

Study information

• Verified date: December 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asphyxia Neonatorum
• Depression
• Depressive Disorder
• HIV-1-infection
• Perinatal Depression

Intervention

Drug:
• Sertraline
daily SSRI (Sertraline 25mg)

Behavioral:
• Interpersonal therapy
11 sessions over a 24-week period

Locations

Country	Name	City	State
Zambia	Kamwala District Health Centre	Lusaka
Zambia	University Teaching Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Women Approached Who Agreed to Pre-Screening With EPDS	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	2-7 weeks postpartum
Primary	Number of Women Pre-Screened Who Have an EPDS Score >/= 6	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.	2-7 weeks postpartum
Primary	Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI	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.	2-7 weeks postpartum
Primary	Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study	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.	6-8 weeks postpartum
Primary	Number of Women Retained in the Study	Number of women who are enrolled in the study who complete the final study visit	Enrollment - final visit, approximately 24 weeks after enrollment
Secondary	Number of Women With an EPDS Score Decline of 3 Points From Baseline	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.	Enrollment - final study visit, approximately 24 weeks after enrollment
Secondary	Number of Women With a CGI Score Decline of One Point From Baseline	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.	Enrollment - final visit, approximately 24 weeks after enrollment
Secondary	Percentage of Women Experiencing Anti Depressant Medication Toxicity	The percentage of women who are taking the antidepressant medication who discontinue the medication due to a grade II or higher toxicity	Enrollment - final visit, approximately 24 weeks after enrollment
Secondary	Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)	Percentage of women randomized to the ADM arm with adequate adherence defined as taking >90% of pills assessed by pill count and report	Enrollment - final visit, approximately 24 weeks after enrollment
Secondary	Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)	Number of women randomized to the IPT arm who complete all IPT sessions	Enrollment - final visit, approximately 24 weeks after enrollment
Secondary	Acceptability of Trial Participation for Treatment of Postpartum Depression	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.	Enrollment - final visit, approximately 24 weeks after enrollment
Secondary	Changes in the Viral Load Between Study Entry and the Last Visit	The mean change in the viral load will be measured between all women enrolled between the first and last visits	Enrollment - final visit, approximately 24 weeks after enrollment