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Support for Perinatal Adherence and Depression

Project INSPireD: Integrating Nuanced Support for Perinatal Adherence and Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03069417
Acronym
INSPireD
Enrollment
23
Registered
2017-03-03
Start date
2016-11-09
Completion date
2017-10-31
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Human Immunodeficiency Virus

Keywords

HIV, Medication adherence, PMTCT, Depression

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.

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.

Interventions

BEHAVIORALIntegrating 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

Sponsors

Match Research
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Adherence to Antiretroviral Therapy Per Self-ReportBaseline, 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 CapsBaseline, 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 MDDBaseline, 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

MeasureTime frameDescription
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 QuestionnaireBaseline, 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.

Countries

South Africa, United States

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.

Participants by arm

ArmCount
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.
14
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.
9
Total23

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up20
Overall StudyReason Unknown47

Baseline characteristics

CharacteristicIntervention: INSPireDControl: Treatment-as-usual + Abbreviated InterventionTotal
Age, Continuous25 years24 years24 years
Current Employment Status
Full-Time Employed
2 Participants2 Participants4 Participants
Current Employment Status
Not Employed
10 Participants6 Participants16 Participants
Current Employment Status
Part-Time Employed
2 Participants1 Participants3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
14 Participants9 Participants23 Participants
Highest Level of Schooling
Complete Post-Secondary
1 Participants0 Participants1 Participants
Highest Level of Schooling
Incomplete Post-Secondary
5 Participants4 Participants9 Participants
Highest Level of Schooling
Up to Grade 12
8 Participants5 Participants13 Participants
In a Relationship with Father of Current Pregnancy
No
0 Participants1 Participants1 Participants
In a Relationship with Father of Current Pregnancy
Yes
14 Participants8 Participants22 Participants
Monthly Income
0-499 RAND
3 Participants2 Participants5 Participants
Monthly Income
1000-1999 RAND
1 Participants2 Participants3 Participants
Monthly Income
2000-2999 RAND
0 Participants1 Participants1 Participants
Monthly Income
3000-3999 RAND
0 Participants2 Participants2 Participants
Monthly Income
4000-4999 RAND
2 Participants1 Participants3 Participants
Monthly Income
5000+ RAND
4 Participants0 Participants4 Participants
Monthly Income
500-999 RAND
0 Participants1 Participants1 Participants
Monthly Income
Don't know
4 Participants0 Participants4 Participants
Partner's HIV Status
Don't know
9 Participants5 Participants14 Participants
Partner's HIV Status
HIV Negative
0 Participants1 Participants1 Participants
Partner's HIV Status
HIV Positive
5 Participants3 Participants8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
14 Participants9 Participants23 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
South Africa
14 participants9 participants23 participants
Sex: Female, Male
Female
14 Participants9 Participants23 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Trying to Get Pregnant
No, not trying to get pregnant
13 Participants7 Participants20 Participants
Trying to Get Pregnant
Yes, trying to get pregnant
1 Participants2 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 9
other
Total, other adverse events
0 / 140 / 9
serious
Total, serious adverse events
0 / 140 / 9

Outcome results

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention: INSPireDAdherence to Antiretroviral Therapy Per MEMS CapsBaseline99.4 percentage of MEMS-recorded adherenceStandard Deviation 2.2
Intervention: INSPireDAdherence to Antiretroviral Therapy Per MEMS CapsPost-Treatment98.6 percentage of MEMS-recorded adherenceStandard Deviation 3
Intervention: INSPireDAdherence to Antiretroviral Therapy Per MEMS Caps3-Month Follow-Up92.8 percentage of MEMS-recorded adherenceStandard Deviation 6.4
Control: Treatment-as-usual + Abbreviated InterventionAdherence to Antiretroviral Therapy Per MEMS CapsBaseline92.9 percentage of MEMS-recorded adherenceStandard Deviation 14.3
Control: Treatment-as-usual + Abbreviated InterventionAdherence to Antiretroviral Therapy Per MEMS CapsPost-Treatment100.0 percentage of MEMS-recorded adherenceStandard Deviation 0
Control: Treatment-as-usual + Abbreviated InterventionAdherence to Antiretroviral Therapy Per MEMS Caps3-Month Follow-Up85.7 percentage of MEMS-recorded adherence
p-value: <0.0595% CI: [-22.29, -3.15]Mixed Models Analysis
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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention: INSPireDAdherence to Antiretroviral Therapy Per Self-ReportBaseline85.3 percentage of self-reported adherenceStandard Deviation 12.9
Intervention: INSPireDAdherence to Antiretroviral Therapy Per Self-ReportPost-Treatment92.8 percentage of self-reported adherenceStandard Deviation 8.7
Intervention: INSPireDAdherence to Antiretroviral Therapy Per Self-Report3-Month Follow-Up88.7 percentage of self-reported adherenceStandard Deviation 9.3
Control: Treatment-as-usual + Abbreviated InterventionAdherence to Antiretroviral Therapy Per Self-ReportBaseline79.0 percentage of self-reported adherenceStandard Deviation 14
Control: Treatment-as-usual + Abbreviated InterventionAdherence to Antiretroviral Therapy Per Self-ReportPost-Treatment77.8 percentage of self-reported adherenceStandard Deviation 15.4
Control: Treatment-as-usual + Abbreviated InterventionAdherence to Antiretroviral Therapy Per Self-Report3-Month Follow-Up89.2 percentage of self-reported adherenceStandard Deviation 5.9
p-value: 0.11Mixed Models Analysis
p-value: 0.56Mixed Models Analysis
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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention: INSPireDLevel of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)Baseline20.8 score on a scaleStandard Deviation 5.7
Intervention: INSPireDLevel of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)Post-Treatment1.2 score on a scaleStandard Deviation 1.7
Intervention: INSPireDLevel of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)3-Month Follow-Up2.1 score on a scaleStandard Deviation 2.9
Control: Treatment-as-usual + Abbreviated InterventionLevel of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)Baseline20.3 score on a scaleStandard Deviation 6.1
Control: Treatment-as-usual + Abbreviated InterventionLevel of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)Post-Treatment11.8 score on a scaleStandard Deviation 9
Control: Treatment-as-usual + Abbreviated InterventionLevel of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)3-Month Follow-Up6.5 score on a scaleStandard Deviation 9.2
p-value: <0.00595% CI: [-18.41, -3.83]Mixed Models Analysis
p-value: <0.00595% CI: [-22.5, -5.17]Mixed Models Analysis
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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Intervention: INSPireDNumber of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDDBaseline12 Participants
Intervention: INSPireDNumber of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDDPost-Treatment0 Participants
Intervention: INSPireDNumber of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD3-Month Follow-Up0 Participants
Control: Treatment-as-usual + Abbreviated InterventionNumber of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDDBaseline7 Participants
Control: Treatment-as-usual + Abbreviated InterventionNumber of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDDPost-Treatment2 Participants
Control: Treatment-as-usual + Abbreviated InterventionNumber of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD3-Month Follow-Up1 Participants
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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention: INSPireDLevel of Social Support Per Duke-UNC Functional Social Support QuestionnaireBaseline33.9 score on a scaleStandard Deviation 5.8
Intervention: INSPireDLevel of Social Support Per Duke-UNC Functional Social Support QuestionnairePost-Treatment35.3 score on a scaleStandard Deviation 5.6
Intervention: INSPireDLevel of Social Support Per Duke-UNC Functional Social Support Questionnaire3-Month Follow-Up36.4 score on a scaleStandard Deviation 5.5
Control: Treatment-as-usual + Abbreviated InterventionLevel of Social Support Per Duke-UNC Functional Social Support QuestionnaireBaseline27.7 score on a scaleStandard Deviation 9.6
Control: Treatment-as-usual + Abbreviated InterventionLevel of Social Support Per Duke-UNC Functional Social Support QuestionnairePost-Treatment28.0 score on a scaleStandard Deviation 4.5
Control: Treatment-as-usual + Abbreviated InterventionLevel of Social Support Per Duke-UNC Functional Social Support Questionnaire3-Month Follow-Up36.5 score on a scaleStandard Deviation 3.5
p-value: <0.0595% CI: [0.5, 11.88]Mixed Models Analysis
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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention: INSPireDLevel of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)Baseline14.3 score on a scaleStandard Deviation 10.2
Intervention: INSPireDLevel of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)Post-Treatment6.3 score on a scaleStandard Deviation 10.2
Intervention: INSPireDLevel of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)3-Month Follow-Up2.5 score on a scaleStandard Deviation 6.7
Control: Treatment-as-usual + Abbreviated InterventionLevel of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)Baseline24.3 score on a scaleStandard Deviation 12.6
Control: Treatment-as-usual + Abbreviated InterventionLevel of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)Post-Treatment12.8 score on a scaleStandard Deviation 10.9
Control: Treatment-as-usual + Abbreviated InterventionLevel of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)3-Month Follow-Up12.5 score on a scaleStandard Deviation 17.7
p-value: <0.0595% CI: [-19.58, -0.67]Mixed Models Analysis
p-value: <0.0195% CI: [-22.14, -3.37]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026