Overview

A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

Status:
Completed
Trial end date:
2020-10-30
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Institute of Mental Health (NIMH)
Treatments:
Sertraline
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.