INSPireD: Support for Perinatal Adherence and Depression

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03069417
Collaborator
Match Research (Other), National Institute of Mental Health (NIMH) (NIH)
23
Enrollment
2
Locations
2
Arms
11.7
Actual Duration (Months)
11.5
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Integrating Nuanced Support for Perinatal adherence and Depression
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Project INSPireD: Integrating Nuanced Support for Perinatal Adherence and Depression
Actual Study Start Date :
Nov 9, 2016
Actual Primary Completion Date :
Mar 24, 2017
Actual Study Completion Date :
Oct 31, 2017

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Adherence to Antiretroviral Therapy Per Self-Report [Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)]

      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.

    2. Adherence to Antiretroviral Therapy Per MEMS Caps [Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)]

      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.

    3. Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) [Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)]

      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.

    4. Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD [Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)]

      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.

    Secondary Outcome Measures

    1. 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)]

      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.

    2. 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)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Massachusetts General HospitalBostonMassachusettsUnited States02114
    2MatCH ResearchDurbanSouth Africa

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Christina Psaros, PhD, Massachusetts General Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Christina Psaros, Assistant Professor of Psychology, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03069417
    Other Study ID Numbers:
    • 2016P001887
    • K23MH096651
    First Posted:
    Mar 3, 2017
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Christina Psaros, Assistant Professor of Psychology, Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment DetailsParticipants were recruited between November 9, 2016 and March 3, 2017 from a district antenatal clinic in KwaZulu Natal, South Africa.
    Pre-assignment Detail
    Arm/Group TitleIntervention: INSPireDTreatment-as-usual + Abbreviated Intervention
    Arm/Group DescriptionThis 5-8 session, group-based intervention, "Integrating Nuanced Support for Perinatal Adherence and Depression", had three primary goals: (1) improving adherence to ART during pregnancy and the postpartum period; (2) planning for contraceptive use; and (3) improving depressive symptoms among HIV-infected pregnant and postpartum women. Intervention content was based on two established cognitive-behavioral interventions: problem-solving therapy and CBT for adherence and depression.The intervention was delivered by a trained lay counselor, who completed a five-day training on counseling skills and intervention content, and received bi-monthly clinical supervision throughout the study.The control group received treatment-as usual (standard of care counseling services), plus the option of completing an abbreviated version of the intervention (i.e., one session of problem-solving related to adherence and depression) at the conclusion of study.
    Period Title: Overall Study
    STARTED149
    Post-Treatment Assessment126
    COMPLETED82
    NOT COMPLETED67

    Baseline Characteristics

    Arm/Group TitleIntervention: INSPireDControl: Treatment-as-usual + Abbreviated InterventionTotal
    Arm/Group DescriptionThis 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 CBT for adherence and depression.The control 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.Total of all reporting groups
    Overall Participants14923
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    25
    24
    24
    Sex: Female, Male (Count of Participants)
    Female
    14
    100%
    9
    100%
    23
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Not Hispanic or Latino
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    14
    100%
    9
    100%
    23
    100%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    14
    100%
    9
    100%
    23
    100%
    White
    0
    0%
    0
    0%
    0
    0%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    South Africa
    14
    100%
    9
    100%
    23
    100%
    Highest Level of Schooling (Count of Participants)
    Up to Grade 12
    8
    57.1%
    5
    55.6%
    13
    56.5%
    Incomplete Post-Secondary
    5
    35.7%
    4
    44.4%
    9
    39.1%
    Complete Post-Secondary
    1
    7.1%
    0
    0%
    1
    4.3%
    Current Employment Status (Count of Participants)
    Not Employed
    10
    71.4%
    6
    66.7%
    16
    69.6%
    Full-Time Employed
    2
    14.3%
    2
    22.2%
    4
    17.4%
    Part-Time Employed
    2
    14.3%
    1
    11.1%
    3
    13%
    Monthly Income (Count of Participants)
    0-499 RAND
    3
    21.4%
    2
    22.2%
    5
    21.7%
    500-999 RAND
    0
    0%
    1
    11.1%
    1
    4.3%
    1000-1999 RAND
    1
    7.1%
    2
    22.2%
    3
    13%
    2000-2999 RAND
    0
    0%
    1
    11.1%
    1
    4.3%
    3000-3999 RAND
    0
    0%
    2
    22.2%
    2
    8.7%
    4000-4999 RAND
    2
    14.3%
    1
    11.1%
    3
    13%
    5000+ RAND
    4
    28.6%
    0
    0%
    4
    17.4%
    Don't know
    4
    28.6%
    0
    0%
    4
    17.4%
    Trying to Get Pregnant (Count of Participants)
    Yes, trying to get pregnant
    1
    7.1%
    2
    22.2%
    3
    13%
    No, not trying to get pregnant
    13
    92.9%
    7
    77.8%
    20
    87%
    In a Relationship with Father of Current Pregnancy (Count of Participants)
    No
    0
    0%
    1
    11.1%
    1
    4.3%
    Yes
    14
    100%
    8
    88.9%
    22
    95.7%
    Partner's HIV Status (Count of Participants)
    HIV Positive
    5
    35.7%
    3
    33.3%
    8
    34.8%
    HIV Negative
    0
    0%
    1
    11.1%
    1
    4.3%
    Don't know
    9
    64.3%
    5
    55.6%
    14
    60.9%

    Outcome Measures

    1. Primary Outcome
    TitleAdherence to Antiretroviral Therapy Per Self-Report
    DescriptionAdherence 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.
    Time FrameBaseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

    Outcome Measure Data

    Analysis Population Description
    In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
    Arm/Group TitleIntervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Arm/Group DescriptionThis 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.The control 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.
    Measure Participants149
    Baseline
    85.3
    (12.9)
    79.0
    (14.0)
    Post-Treatment
    92.8
    (8.7)
    77.8
    (15.4)
    3-Month Follow-Up
    88.7
    (9.3)
    89.2
    (5.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Intervention: INSPireD, Control: Treatment-as-usual + Abbreviated Intervention
    Comments
    Type of Statistical Test Superiority
    Comments Conducted at post-treatment time point.
    Statistical Test of Hypothesisp-Value0.11
    Comments
    MethodMixed Models Analysis
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Intervention: INSPireD, Control: Treatment-as-usual + Abbreviated Intervention
    Comments
    Type of Statistical Test Superiority
    Comments Conducted at 3-month follow-up time point.
    Statistical Test of Hypothesisp-Value0.56
    Comments
    MethodMixed Models Analysis
    Comments
    2. Primary Outcome
    TitleAdherence to Antiretroviral Therapy Per MEMS Caps
    DescriptionObjective 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.
    Time FrameBaseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

    Outcome Measure Data

    Analysis Population Description
    Sixteen participants (12 intervention, 4 control) were included in the MEMS analysis at baseline, 12 (10 intervention, 2 control) were included at post-treatment, and 7 (6 intervention, 1 control) were included at 3-month follow-up. Data for 7 participants were not included at baseline due to: inconsistent use or non-use (n=2), lost to follow-up (n=4), and relocated (n=1).Three were excluded from final analyses due to broken caps or consistent cap non-use over the three measurement periods.
    Arm/Group TitleIntervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Arm/Group DescriptionThis 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.The control 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.
    Measure Participants124
    Baseline
    99.4
    (2.2)
    92.9
    (14.3)
    Post-Treatment
    98.6
    (3.0)
    100.0
    (0.0)
    3-Month Follow-Up
    92.8
    (6.4)
    85.7
    (NA)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Intervention: INSPireD, Control: Treatment-as-usual + Abbreviated Intervention
    Comments
    Type of Statistical Test Superiority
    Comments Main effect for time calculated at 3-month follow-up time point.
    Statistical Test of Hypothesisp-Value< 0.05
    CommentsThe threshold for statistical significance was p = 0.05.
    MethodMixed Models Analysis
    Comments
    Method of EstimationEstimation ParameterFixed effects coefficient (β)
    Estimated Value-12.7
    Confidence Interval (2-Sided) 95%
    -22.29 to -3.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    TitleLevel of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)
    DescriptionThe 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.
    Time FrameBaseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

    Outcome Measure Data

    Analysis Population Description
    In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
    Arm/Group TitleIntervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Arm/Group DescriptionThis 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.The control 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
    Measure Participants149
    Baseline
    20.8
    (5.7)
    20.3
    (6.1)
    Post-Treatment
    1.2
    (1.7)
    11.8
    (9.0)
    3-Month Follow-Up
    2.1
    (2.9)
    6.5
    (9.2)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Intervention: INSPireD, Control: Treatment-as-usual + Abbreviated Intervention
    Comments
    Type of Statistical Test Superiority
    Comments Interaction evaluated at post-treatment time point.
    Statistical Test of Hypothesisp-Value< 0.005
    CommentsThe threshold for statistical significance was p = 0.05.
    MethodMixed Models Analysis
    Comments
    Method of EstimationEstimation ParameterFixed effects coefficient (β)
    Estimated Value-11.1
    Confidence Interval (2-Sided) 95%
    -18.41 to -3.83
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Intervention: INSPireD, Control: Treatment-as-usual + Abbreviated Intervention
    Comments
    Type of Statistical Test Superiority
    Comments Main effect for time at 3-month follow-up time point.
    Statistical Test of Hypothesisp-Value< 0.005
    CommentsThe threshold for statistical significance was p = 0.05.
    MethodMixed Models Analysis
    Comments
    Method of EstimationEstimation ParameterFixed effects coefficient (β)
    Estimated Value-13.8
    Confidence Interval (2-Sided) 95%
    -22.50 to -5.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Primary Outcome
    TitleNumber of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD
    DescriptionCurrent 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.
    Time FrameBaseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

    Outcome Measure Data

    Analysis Population Description
    In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
    Arm/Group TitleIntervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Arm/Group DescriptionThis 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.The control 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
    Measure Participants149
    Baseline
    12
    85.7%
    7
    77.8%
    Post-Treatment
    0
    0%
    2
    22.2%
    3-Month Follow-Up
    0
    0%
    1
    11.1%
    5. Secondary Outcome
    TitleLevel of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)
    DescriptionHIV-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.
    Time FrameBaseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

    Outcome Measure Data

    Analysis Population Description
    In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
    Arm/Group TitleIntervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Arm/Group DescriptionThis 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.The control 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.
    Measure Participants149
    Baseline
    14.3
    (10.2)
    24.3
    (12.6)
    Post-Treatment
    6.3
    (10.2)
    12.8
    (10.9)
    3-Month Follow-Up
    2.5
    (6.7)
    12.5
    (17.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Intervention: INSPireD, Control: Treatment-as-usual + Abbreviated Intervention
    Comments
    Type of Statistical Test Superiority
    Comments Main effect for condition.
    Statistical Test of Hypothesisp-Value< 0.05
    CommentsThe threshold for statistical significance was p = 0.05.
    MethodMixed Models Analysis
    Comments
    Method of EstimationEstimation ParameterFixed effects coefficient (β)
    Estimated Value-10.1
    Confidence Interval (2-Sided) 95%
    -19.58 to -0.67
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Intervention: INSPireD, Control: Treatment-as-usual + Abbreviated Intervention
    Comments
    Type of Statistical Test Superiority
    Comments Main effect for time at post-treatment time point.
    Statistical Test of Hypothesisp-Value< 0.01
    CommentsThe threshold for statistical significance was p = 0.05.
    MethodMixed Models Analysis
    Comments
    Method of EstimationEstimation ParameterFixed effects coefficient (β)
    Estimated Value-12.8
    Confidence Interval (2-Sided) 95%
    -22.14 to -3.37
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    6. Secondary Outcome
    TitleLevel of Social Support Per Duke-UNC Functional Social Support Questionnaire
    DescriptionSocial 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.
    Time FrameBaseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

    Outcome Measure Data

    Analysis Population Description
    In the intervention arm, 14 participants completed a baseline assessment, 12 completed a post-treatment assessment, and 9 completed a three-month follow-up assessment. In the control arm, 9 participants completed a baseline assessment, 6 completed a post-treatment assessment, and 2 completed a three-month follow-up assessment.
    Arm/Group TitleIntervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Arm/Group DescriptionThis 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.The control 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.
    Measure Participants149
    Baseline
    33.9
    (5.8)
    27.7
    (9.6)
    Post-Treatment
    35.3
    (5.6)
    28.0
    (4.5)
    3-Month Follow-Up
    36.4
    (5.5)
    36.5
    (3.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Intervention: INSPireD, Control: Treatment-as-usual + Abbreviated Intervention
    Comments
    Type of Statistical Test Superiority
    Comments Main effect for condition.
    Statistical Test of Hypothesisp-Value< 0.05
    CommentsThe threshold for statistical significance was p = 0.05.
    MethodMixed Models Analysis
    Comments
    Method of EstimationEstimation ParameterFixed effects coefficient (β)
    Estimated Value6.2
    Confidence Interval (2-Sided) 95%
    0.50 to 11.88
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time FrameUp to 6 months post-baseline
    Adverse Event Reporting Description
    Arm/Group TitleIntervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Arm/Group DescriptionThis 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.The control 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.
    All Cause Mortality
    Intervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/14 (0%) 0/9 (0%)
    Serious Adverse Events
    Intervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/14 (0%) 0/9 (0%)
    Other (Not Including Serious) Adverse Events
    Intervention: INSPireDControl: Treatment-as-usual + Abbreviated Intervention
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/14 (0%) 0/9 (0%)

    Limitations/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.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDr. Christina Psaros
    OrganizationMassachusetts General Hospital
    Phone617.726.7458
    Emailcpsaros@mgh.harvard.edu
    Responsible Party:
    Christina Psaros, Assistant Professor of Psychology, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT03069417
    Other Study ID Numbers:
    • 2016P001887
    • K23MH096651
    First Posted:
    Mar 3, 2017
    Last Update Posted:
    Dec 14, 2021
    Last Verified:
    Dec 1, 2021