Trial Outcomes & Findings for Support for Perinatal Adherence and Depression (NCT NCT03069417)
NCT ID: NCT03069417
Last Updated: 2021-12-14
Results Overview
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.
COMPLETED
NA
23 participants
Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
2021-12-14
Participant Flow
Participants were recruited between November 9, 2016 and March 3, 2017 from a district antenatal clinic in KwaZulu Natal, South Africa.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
9
|
|
Overall Study
Post-Treatment Assessment
|
12
|
6
|
|
Overall Study
COMPLETED
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Reason Unknown
|
4
|
7
|
Baseline Characteristics
Support for Perinatal Adherence and Depression
Baseline characteristics by cohort
| Measure |
Intervention: INSPireD
n=14 Participants
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.
|
Control: Treatment-as-usual + Abbreviated Intervention
n=9 Participants
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
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
24 years
n=7 Participants
|
24 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
14 participants
n=5 Participants
|
9 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Highest Level of Schooling
Up to Grade 12
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Highest Level of Schooling
Incomplete Post-Secondary
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Highest Level of Schooling
Complete Post-Secondary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Current Employment Status
Not Employed
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Current Employment Status
Full-Time Employed
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Current Employment Status
Part-Time Employed
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Monthly Income
0-499 RAND
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Monthly Income
500-999 RAND
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Monthly Income
1000-1999 RAND
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Monthly Income
2000-2999 RAND
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Monthly Income
3000-3999 RAND
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Monthly Income
4000-4999 RAND
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Monthly Income
5000+ RAND
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Monthly Income
Don't know
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Trying to Get Pregnant
Yes, trying to get pregnant
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Trying to Get Pregnant
No, not trying to get pregnant
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
In a Relationship with Father of Current Pregnancy
No
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
In a Relationship with Father of Current Pregnancy
Yes
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Partner's HIV Status
HIV Positive
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Partner's HIV Status
HIV Negative
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Partner's HIV Status
Don't know
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)Population: 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.
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.
Outcome measures
| Measure |
Intervention: INSPireD
n=14 Participants
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.
|
Control: Treatment-as-usual + Abbreviated Intervention
n=9 Participants
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.
|
|---|---|---|
|
Adherence to Antiretroviral Therapy Per Self-Report
Baseline
|
85.3 percentage of self-reported adherence
Standard Deviation 12.9
|
79.0 percentage of self-reported adherence
Standard Deviation 14.0
|
|
Adherence to Antiretroviral Therapy Per Self-Report
Post-Treatment
|
92.8 percentage of self-reported adherence
Standard Deviation 8.7
|
77.8 percentage of self-reported adherence
Standard Deviation 15.4
|
|
Adherence to Antiretroviral Therapy Per Self-Report
3-Month Follow-Up
|
88.7 percentage of self-reported adherence
Standard Deviation 9.3
|
89.2 percentage of self-reported adherence
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)Population: 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.
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.
Outcome measures
| Measure |
Intervention: INSPireD
n=12 Participants
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.
|
Control: Treatment-as-usual + Abbreviated Intervention
n=4 Participants
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.
|
|---|---|---|
|
Adherence to Antiretroviral Therapy Per MEMS Caps
Baseline
|
99.4 percentage of MEMS-recorded adherence
Standard Deviation 2.2
|
92.9 percentage of MEMS-recorded adherence
Standard Deviation 14.3
|
|
Adherence to Antiretroviral Therapy Per MEMS Caps
Post-Treatment
|
98.6 percentage of MEMS-recorded adherence
Standard Deviation 3.0
|
100.0 percentage of MEMS-recorded adherence
Standard Deviation 0.0
|
|
Adherence to Antiretroviral Therapy Per MEMS Caps
3-Month Follow-Up
|
92.8 percentage of MEMS-recorded adherence
Standard Deviation 6.4
|
85.7 percentage of MEMS-recorded adherence
Standard Deviation NA
MEMS data were available for only 1 participant from the control arm at the 3-month follow-up timepoint.
|
PRIMARY outcome
Timeframe: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)Population: 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.
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.
Outcome measures
| Measure |
Intervention: INSPireD
n=14 Participants
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.
|
Control: Treatment-as-usual + Abbreviated Intervention
n=9 Participants
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.
|
|---|---|---|
|
Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)
Baseline
|
20.8 score on a scale
Standard Deviation 5.7
|
20.3 score on a scale
Standard Deviation 6.1
|
|
Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)
Post-Treatment
|
1.2 score on a scale
Standard Deviation 1.7
|
11.8 score on a scale
Standard Deviation 9.0
|
|
Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)
3-Month Follow-Up
|
2.1 score on a scale
Standard Deviation 2.9
|
6.5 score on a scale
Standard Deviation 9.2
|
PRIMARY outcome
Timeframe: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)Population: 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.
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.
Outcome measures
| Measure |
Intervention: INSPireD
n=14 Participants
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.
|
Control: Treatment-as-usual + Abbreviated Intervention
n=9 Participants
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.
|
|---|---|---|
|
Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD
Baseline
|
12 Participants
|
7 Participants
|
|
Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD
Post-Treatment
|
0 Participants
|
2 Participants
|
|
Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD
3-Month Follow-Up
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)Population: 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.
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.
Outcome measures
| Measure |
Intervention: INSPireD
n=14 Participants
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.
|
Control: Treatment-as-usual + Abbreviated Intervention
n=9 Participants
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.
|
|---|---|---|
|
Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)
Post-Treatment
|
6.3 score on a scale
Standard Deviation 10.2
|
12.8 score on a scale
Standard Deviation 10.9
|
|
Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)
Baseline
|
14.3 score on a scale
Standard Deviation 10.2
|
24.3 score on a scale
Standard Deviation 12.6
|
|
Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)
3-Month Follow-Up
|
2.5 score on a scale
Standard Deviation 6.7
|
12.5 score on a scale
Standard Deviation 17.7
|
SECONDARY outcome
Timeframe: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)Population: 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.
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.
Outcome measures
| Measure |
Intervention: INSPireD
n=14 Participants
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.
|
Control: Treatment-as-usual + Abbreviated Intervention
n=9 Participants
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.
|
|---|---|---|
|
Level of Social Support Per Duke-UNC Functional Social Support Questionnaire
Post-Treatment
|
35.3 score on a scale
Standard Deviation 5.6
|
28.0 score on a scale
Standard Deviation 4.5
|
|
Level of Social Support Per Duke-UNC Functional Social Support Questionnaire
Baseline
|
33.9 score on a scale
Standard Deviation 5.8
|
27.7 score on a scale
Standard Deviation 9.6
|
|
Level of Social Support Per Duke-UNC Functional Social Support Questionnaire
3-Month Follow-Up
|
36.4 score on a scale
Standard Deviation 5.5
|
36.5 score on a scale
Standard Deviation 3.5
|
Adverse Events
Intervention: INSPireD
Control: Treatment-as-usual + Abbreviated Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place