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A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

NCT ID: NCT04094870

Last Updated: 2021-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2020-10-30

Brief Summary

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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

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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

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Perinatal Depression HIV-1-infection

Keywords

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perinatal depression HIV Antiretroviral Treatment Interpersonal psychotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antidepressant medication

Daily self-administered selective serotonin reuptake inhibitor (SSRI) Sertraline 25 mg table

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type DRUG

daily SSRI (Sertraline 25mg)

Interpersonal therapy

Up to 11 planned therapy sessions over a 24-week period beginning the day of randomization

Group Type ACTIVE_COMPARATOR

Interpersonal therapy

Intervention Type BEHAVIORAL

11 sessions over a 24-week period

Interventions

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Sertraline

daily SSRI (Sertraline 25mg)

Intervention Type DRUG

Interpersonal therapy

11 sessions over a 24-week period

Intervention Type BEHAVIORAL

Other Intervention Names

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SSRI

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Stringer, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Kamwala District Health Centre

Lusaka, , Zambia

Site Status

University Teaching Hospital

Lusaka, , Zambia

Site Status

Countries

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Zambia

References

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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.

Reference Type DERIVED
PMID: 35803896 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R21MH115806

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Z 31801

Identifier Type: OTHER

Identifier Source: secondary_id

17-3411

Identifier Type: -

Identifier Source: org_study_id