Support for Perinatal Adherence and Depression (INSPireD)

Project INSPireD: Integrating Nuanced Support for Perinatal Adherence and Depression

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.

Study Overview

• Status: Completed
• Conditions: Depression; Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: Integrating Nuanced Support for Perinatal adherence and Depression

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Durban, South Africa
    • MatCH Research
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: INSPireD; 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.	Behavioral: Integrating Nuanced Support for Perinatal adherence and Depression; A 5-8 session intervention to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women; Other Names: INSPireD
Other: Treatment-as-usual + abbreviated intervention; 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.	Behavioral: Integrating Nuanced Support for Perinatal adherence and Depression; A 5-8 session intervention to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women; Other Names: INSPireD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Antiretroviral Therapy Per Self-Report	Adherence to ART during the previous month was measured through a composite score developed by Lu et al. (2008). The composite score combines the scores of three items into a single self-reported adherence score; the three items assess medication use frequency, percentage of time that the medication was taken as prescribed, and a rating of one's ability to take prescribed medication. The percent item had 11 response categories (0, 10, 20…100%), whereas the frequency and ability items had six response categories that were assigned scores of 0, 20, 40, 60, 80, and 100, with 100 considered to be perfect adherence.	Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Adherence to Antiretroviral Therapy Per MEMS Caps	Objective ART adherence data were collected using the Medication Event Monitoring System (MEMS), which comprises a pill bottle with a digitized cap that measures and records when the bottle was opened each day. MEMS timepoints were defined as average MEMS use across the two-week period prior to each of the three assessment visits.	Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)	The 10-item Edinburgh Postnatal Depression Scale (EPDS) was used to measure depressive symptoms at baseline, post-treatment, and three-month follow-up; higher scores indicate more severe depressive symptoms. The minimum possible score is 0, and maximum score is 30. A standard clinical cutoff of 13 on the EPDS was used to distinguish women with and without probable depression.	Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD	Current and past major depressive disorder was measured using the 17-item Major Depressive Episode Module of the Mini International Neuropsychiatric Interview (MINI). If an individual indicates either that they were "consistently depressed or down, most of the day, nearly every day for the past two weeks" or that they were "less interested in doing most things or less able to enjoy the things that they used to enjoy most of the time," they are asked about 7 symptoms of depression. To meet criteria for a current major depressive episode, at least three symptoms must be endorsed.	Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)	HIV-related stigma was measured at baseline, post-treatment, and 3-month follow-up using the HIV/AIDS Stigma Instrument - People Living with AIDS (HASI-P). Three sub-scales from the full scale were used: negative self-perception (5 items), social isolation (5 items), and verbal abuse (8 items). Responses are rated on a four-point Likert scale from "never" (0) to "most of the time" (3). Subscale score ranges were 0-15 (negative self-perception and social isolation) and 0-24 (verbal abuse); subscale scores were summed to compute a total score (range 0-54). Higher scores indicate higher levels of stigma.	Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Level of Social Support Per Duke-UNC Functional Social Support Questionnaire	Social support was assessed using a modified version of the Duke-UNC Functional Social Support Questionnaire, a 10-item scale evaluating availability of emotional, informational, and tangible support. Items are rated on a 4-point Likert scale; number of persons providing support is also assessed. The maximum possible score is 40 and minimum score is 0; higher scores indicate greater perceived social support.	Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH); Match Research
• Investigators: Principal Investigator: Christina Psaros, PhD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.
• Psaros C, Stanton AM, Raggio GA, Mosery N, Goodman GR, Briggs ES, Williams M, Bangsberg D, Smit J, Safren SA. Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial. Int J Behav Med. 2022 Mar 8. doi: 10.1007/s12529-022-10071-z. [Epub ahead of print]
• Choi KW, Smit JA, Coleman JN, Mosery N, Bangsberg DR, Safren SA, Psaros C. Mapping a Syndemic of Psychosocial Risks During Pregnancy Using Network Analysis. Int J Behav Med. 2019 Apr;26(2):207-216. doi: 10.1007/s12529-019-09774-7.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2016
• Primary Completion (Actual): March 24, 2017
• Study Completion (Actual): October 31, 2017

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 6, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Depression; HIV; Medication adherence; PMTCT
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; RNA Virus Infections; Virus Diseases; Infections; Mood Disorders; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Depression; Depressive Disorder; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2016P001887; K23MH096651 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No