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
2
2
11.7
11.5
1
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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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.
- 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
- 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.
- 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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | MatCH Research | Durban | South 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 Details | Participants 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 Title | Intervention: INSPireD | Treatment-as-usual + Abbreviated Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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 | ||
| STARTED | 14 | 9 |
| Post-Treatment Assessment | 12 | 6 |
| COMPLETED | 8 | 2 |
| NOT COMPLETED | 6 | 7 |
Baseline Characteristics
| Arm/Group Title | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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 Participants | 14 | 9 | 23 |
| 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
| Title | Adherence to Antiretroviral Therapy Per Self-Report |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 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 Title | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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 Participants | 14 | 9 |
| 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 Hypothesis | p-Value | 0.11 |
| Comments | ||
| Method | Mixed 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 Hypothesis | p-Value | 0.56 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Title | Adherence to Antiretroviral Therapy Per MEMS Caps |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 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 Title | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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 Participants | 12 | 4 |
| 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 Hypothesis | p-Value | < 0.05 |
| Comments | The threshold for statistical significance was p = 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Fixed effects coefficient (β) |
| Estimated Value | -12.7 | |
| Confidence Interval |
(2-Sided) 95% -22.29 to -3.15 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 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 Title | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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 Participants | 14 | 9 |
| 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 Hypothesis | p-Value | < 0.005 |
| Comments | The threshold for statistical significance was p = 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Fixed 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 Hypothesis | p-Value | < 0.005 |
| Comments | The threshold for statistical significance was p = 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Fixed effects coefficient (β) |
| Estimated Value | -13.8 | |
| Confidence Interval |
(2-Sided) 95% -22.50 to -5.17 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 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 Title | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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 Participants | 14 | 9 |
| Baseline |
12
85.7%
|
7
77.8%
|
| Post-Treatment |
0
0%
|
2
22.2%
|
| 3-Month Follow-Up |
0
0%
|
1
11.1%
|
| Title | Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 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 Title | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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 Participants | 14 | 9 |
| 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 Hypothesis | p-Value | < 0.05 |
| Comments | The threshold for statistical significance was p = 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Fixed 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 Hypothesis | p-Value | < 0.01 |
| Comments | The threshold for statistical significance was p = 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Fixed effects coefficient (β) |
| Estimated Value | -12.8 | |
| Confidence Interval |
(2-Sided) 95% -22.14 to -3.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Level of Social Support Per Duke-UNC Functional Social Support Questionnaire |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 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 Title | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention |
|---|---|---|
| Arm/Group Description | 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. | 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 Participants | 14 | 9 |
| 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 Hypothesis | p-Value | < 0.05 |
| Comments | The threshold for statistical significance was p = 0.05. | |
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Fixed effects coefficient (β) |
| Estimated Value | 6.2 | |
| Confidence Interval |
(2-Sided) 95% 0.50 to 11.88 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Up to 6 months post-baseline | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention | ||
| Arm/Group Description | 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. | 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: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/9 (0%) | ||
Serious Adverse Events |
||||
| Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (0%) | 0/9 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Intervention: INSPireD | Control: Treatment-as-usual + Abbreviated Intervention | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/14 (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/Title | Dr. Christina Psaros |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 617.726.7458 |
| cpsaros@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