NCT04094870

A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Perinatal Depression
• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Sertraline	daily SSRI (Sertraline 25mg)
BEHAVIORAL	Interpersonal therapy	11 sessions over a 24-week period

Timeline

• Start date: 2019-10-30
• Primary completion: 2020-10-30
• Completion: 2020-10-30
• First posted: 2019-09-19
• Last updated: 2021-11-10
• Results posted: 2021-11-10

Locations

2 sites across 1 country: Zambia

Regulatory

• FDA-regulated drug study