Support for Perinatal Adherence and Depression

Depression Clinical Trial

— INSPireD  

Official title:

Project INSPireD: Integrating Nuanced Support for Perinatal Adherence and Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069417
• Other study ID #: 2016P001887
• Secondary ID: K23MH096651
• Status: Completed
• Phase: N/A
• Start date: November 9, 2016
• Est. completion date: October 31, 2017

Study information

• Verified date: December 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: October 31, 2017
• Est. primary completion date: March 24, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Depression
• Depressive Disorder
• HIV Infections
• Human Immunodeficiency Virus

Intervention

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

Locations

Country	Name	City	State
South Africa	MatCH Research	Durban
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Match Research, National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  South Africa, 

References & Publications (1)

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. Epub 2007 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)