A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

University of North Carolina, Chapel Hill80 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Perinatal Depression HIV-1-infection

Interventions

SertralineDRUG

daily SSRI (Sertraline 25mg)

Interpersonal therapyBEHAVIORAL

11 sessions over a 24-week period

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Kamwala District Health Centre

Lusaka, Zambia

University Teaching Hospital

Lusaka, Zambia

Outcomes

Primary Outcomes

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

Time frame: 2-7 weeks postpartum

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.

Time frame: 2-7 weeks postpartum

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.

Time frame: 2-7 weeks postpartum

Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

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

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.