Support for Perinatal Adherence and Depression (INSPireD)

Mass General Brigham

Status: Completed

Conditions: Human Immunodeficiency Virus; Depression

Treatments: Behavioral: Integrating Nuanced Support for Perinatal adherence and Depression

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03069417

K23MH096651

2016P001887

Details and patient eligibility

About

The main aim was to conduct a pilot field test of a group-based depression and adherence counseling intervention with HIV-infected women in the perinatal period. Participants were HIV-infected women living in KwaZulu-Natal, South Africa.

Full description

The main aim of this study was to conduct a pilot field test of a group-based counseling intervention with HIV-infected women in the perinatal period as delivered by a lay counselor. The primary goal of the intervention was to reduce symptoms of perinatal depression and increase adherence to antiretroviral therapy among HIV-infected women during pregnancy and the postpartum period.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently pregnant
• HIV-infected and diagnosed with HIV during the index pregnancy
• Meet criteria for a major depressive episode
• Currently on antiretroviral therapy
• Receiving antenatal care at PMMH Gateway clinic
• Primary language English or isiZulu
• Access to a phone and willing to give researchers permission to reach them via phone
• Resident of Umlazi

Exclusion criteria

• Unable or unwilling to provide informed consent
• Active untreated, major mental illness (untreated psychosis, bipolar disorder, dementia, or active suicidality) that would interfere with study participation
• Less than 18 years of age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Intervention: INSPireD

Experimental group

Description:

This 5-8 session group intervention, "Integrating Nuanced Support for Perinatal adherence and Depression", aimed to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women. Intervention content was based on two established cognitive-behavioral interventions: problem-solving therapy and Cognitive Behavioral Therapy for Adherence and Depression.

Treatment:

Behavioral: Integrating Nuanced Support for Perinatal adherence and Depression

Treatment-as-usual + abbreviated intervention

Other group

Description:

This group received treatment-as usual, plus the option of completing an abbreviated version of the intervention (one session of problem-solving related to adherence and mental health) at the conclusion of study.

Treatment:

Behavioral: Integrating Nuanced Support for Perinatal adherence and Depression