Phase 4
N=80
A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Perinatal Depression · HIV-1-infection
Bottom Line
View on ClinicalTrials.gov: NCT04094870 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Number of Women Approached Who Agreed to Pre-Screening With EPDS — 240 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sertraline (Drug); Interpersonal therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Women Approached Who Agreed to Pre-Screening With EPDS |
240 | — |
| PRIMARY Number of Women Pre-Screened Who Have an EPDS Score >/= 6 |
199 | — |
| PRIMARY Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI |
120 | — |
| PRIMARY Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study |
80 | — |
| PRIMARY Number of Women Retained in the Study |
39; 39 | — |
| SECONDARY Number of Women With an EPDS Score Decline of 3 Points From Baseline |
37; 39 | — |
| SECONDARY Number of Women With a CGI Score Decline of One Point From Baseline |
38; 39 | — |
| SECONDARY Percentage of Women Experiencing Anti Depressant Medication Toxicity |
— | — |
| SECONDARY Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM) |
14 | — |
| SECONDARY Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT) |
5 | — |
| SECONDARY Acceptability of Trial Participation for Treatment of Postpartum Depression |
39; 39; 37; 37; 2; 2 | — |
| SECONDARY Changes in the Viral Load Between Study Entry and the Last Visit |
0.6; 1.6 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04094870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.