A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

University of North Carolina (UNC)

Status and phase: Completed; Phase 4

Conditions: Perinatal Depression; HIV-1-infection

Treatments: Behavioral: Interpersonal therapy; Drug: Sertraline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04094870

17-3411

Z 31801 (Other Identifier)

1R21MH115806 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Antidepressant medication

Active Comparator group

Description:

Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table

Treatment:

Drug: Sertraline

Interpersonal therapy

Active Comparator group

Description:

Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization

Treatment:

Behavioral: Interpersonal therapy