Clinical trial NCT04094870: A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Official title: Z 31801 - A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Perinatal Depression
HIV-1-infection
Keywords: perinatal depression
HIV
Antiretroviral Treatment
Interpersonal psychotherapy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-09-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline initial dose of 25 mg tablet versus IPT in a 1:1 ratio commenced between six and 8 weeks postpartum and continued through 30 weeks postpartum.
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Number of Women Approached Who Agreed to Pre-Screening With EPDS
timeFrame: 2-7 weeks postpartum
measure: Number of Women Pre-Screened Who Have an EPDS Score >/= 6
timeFrame: 2-7 weeks postpartum
measure: Number of Women With an EPDS >/= to 6 Who Were Consented and Underwent Diagnostic Testing With MINI
timeFrame: 2-7 weeks postpartum
measure: Number of Women With Anxiety or Depression Based on the MINI Who Agree to Participate in the Study
timeFrame: 6-8 weeks postpartum
measure: Number of Women Retained in the Study
timeFrame: Enrollment - final visit, approximately 24 weeks after enrollment
Secondary outcomes:
measure: Number of Women With an EPDS Score Decline of 3 Points From Baseline
timeFrame: Enrollment - final study visit, approximately 24 weeks after enrollment
measure: Number of Women With a CGI Score Decline of One Point From Baseline
timeFrame: Enrollment - final visit, approximately 24 weeks after enrollment
measure: Percentage of Women Experiencing Anti Depressant Medication Toxicity
timeFrame: Enrollment - final visit, approximately 24 weeks after enrollment
measure: Percentage of Women Who Adhere to the Prescribed Antidepressant Medication (ADM)
timeFrame: Enrollment - final visit, approximately 24 weeks after enrollment
measure: Number of Women Who Adhere to the Interpersonal Therapy Arm (IPT)
timeFrame: Enrollment - final visit, approximately 24 weeks after enrollment
measure: Acceptability of Trial Participation for Treatment of Postpartum Depression
timeFrame: Enrollment - final visit, approximately 24 weeks after enrollment
measure: Changes in the Viral Load Between Study Entry and the Last Visit
timeFrame: Enrollment - final visit, approximately 24 weeks after enrollment
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Kamwala District Health Centre
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Elizabeth Stringer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spelke MB, Paul R, Blette BS, Meltzer-Brody S, Schiller CE, Ncheka JM, Kasaro MP, Price JT, Stringer JSA, Stringer EM. Interpersonal therapy versus antidepressant medication for treatment of postpartum depression and anxiety among women with HIV in Zambia: a randomized feasibility trial. J Int AIDS Soc. 2022 Jul;25(7):e25959. doi: 10.1002/jia2.25959.