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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH096651 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Match Research | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Psaros, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| MatCH Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17577653 | Background | 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. | |
| 35260947 | Derived | 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. |
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Participants were recruited between November 9, 2016 and March 3, 2017 from a district antenatal clinic in KwaZulu Natal, South Africa.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: INSPireD | This 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. |
| FG001 | Treatment-as-usual + Abbreviated Intervention | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 CBT for adherence and depression. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of self-reported adherence | Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) |
|
Up to 6 months post-baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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(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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Psaros | Massachusetts General Hospital | 617.726.7458 | cpsaros@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2016 | Oct 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D003863 | Depression |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Not provided
| ID | Term |
|---|---|
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) |
| 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) |
| Durban |
| South Africa |
| 30805768 | 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. |
| BG001 | Control: Treatment-as-usual + Abbreviated Intervention | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest Level of Schooling | Count of Participants | Participants |
|
| Current Employment Status | Count of Participants | Participants |
|
| Monthly Income | Count of Participants | Participants |
|
| Trying to Get Pregnant | Count of Participants | Participants |
|
| In a Relationship with Father of Current Pregnancy | Count of Participants | Participants |
|
| Partner's HIV Status | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
| OG001 | Control: Treatment-as-usual + Abbreviated Intervention | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of MEMS-recorded adherence | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline) |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Control: Treatment-as-usual + Abbreviated Intervention | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| Post-Treatment |
|
|
| 3-Month Follow-Up |
|
|
| Post-Treatment |
|
|
| 3-Month Follow-Up |
|
|
| Mixed Models Analysis |
| < 0.005 |
The threshold for statistical significance was p = 0.05. |
| Fixed effects coefficient (β) |
| -13.8 |
| 2-Sided |
| 95 |
| -22.50 |
| -5.17 |
| Superiority |
Main effect for time at 3-month follow-up time point. |
| Post-Treatment |
|
|
| 3-Month Follow-Up |
|
|
| Post-Treatment |
|
|
| 3-Month Follow-Up |
|
|
| Mixed Models Analysis |
| < 0.01 |
The threshold for statistical significance was p = 0.05. |
| Fixed effects coefficient (β) |
| -12.8 |
| 2-Sided |
| 95 |
| -22.14 |
| -3.37 |
| Superiority |
Main effect for time at post-treatment time point. |
| Post-Treatment |
|
|
| 3-Month Follow-Up |
|
|