Status:
COMPLETED
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Perinatal Depression
HIV-1-infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 ant...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04094870
Start Date
October 30 2019
End Date
October 30 2020
Last Update
November 10 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Kamwala District Health Centre
Lusaka, Zambia
2
University Teaching Hospital
Lusaka, Zambia