A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Perinatal Depression, HIV-1-infection

Intervention / Treatment
-----------------
* Drug: Sertraline
* Behavioral: Interpersonal therapy


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antidepressant medication<br>Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table | Drug: Sertraline<br>* daily SSRI (Sertraline 25mg)<br>* Other names: SSRI;|
| Active Comparator: Interpersonal therapy<br>Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization | Behavioral: Interpersonal therapy<br>* 11 sessions over a 24-week period<br>|

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 | 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
perinatal depression, HIV, Antiretroviral Treatment, Interpersonal psychotherapy