Support for Perinatal Adherence and Depression

NCT03069417 | Completed Results

• 2 other identifiers: 2016P001887K23MH096651
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Human Immunodeficiency Virus; Depression

Keywords

HIV; Medication adherence; PMTCT; Depression

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)

  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

  Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

Study Arms (2)

Intervention: INSPireD

EXPERIMENTAL

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

Treatment-as-usual + abbreviated intervention

OTHER

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

Interventions

Integrating Nuanced Support for Perinatal adherence and Depression BEHAVIORAL

A 5-8 session intervention to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women

Also known as: INSPireD

Intervention: INSPireD; Treatment-as-usual + abbreviated intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Match Research: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MatCH Research

Durban, South Africa

Location

Related Publications (3)

• 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.

  PMID: 17577653 BACKGROUND

• 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. 2023 Feb;30(1):62-76. doi: 10.1007/s12529-022-10071-z. Epub 2022 Mar 8.

  PMID: 35260947 DERIVED

• 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.

  PMID: 30805768 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression; Medication Adherence

Interventions

Inhalation

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Limitations and Caveats

(1) The small sample size in this study limited our ability to detect consistent statistically significant differences between arms. (2) High baseline adherence likely impacted our ability to detect differences between study arms. (3) Session scheduling was an additional and substantial challenge. While women were largely able to complete most planned sessions, this required flexibility on the part of the interventionist, and all but precluded a group meeting format.

Results Point of Contact

• Title: Dr. Christina Psaros
• Organization: Massachusetts General Hospital

cpsaros@mgh.harvard.edu

617.726.7458

Study Officials

• Christina Psaros, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: March 3, 2017
• Study Start: November 9, 2016
• Primary Completion: March 24, 2017
• Study Completion: October 31, 2017
• Last Updated: December 14, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-12

Locations

ZA (1); US (1)