Human Immunodeficiency VirusINSPireDNCT03069417

Support for Perinatal Adherence and Depression

A study testing Integrating Nuanced Support for Perinatal adherence and Depression in people with Human Immunodeficiency Virus and Depression, run by Massachusetts General Hospital at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Human Immunodeficiency Virus, Depression
What is being tested?: Integrating Nuanced Support for Perinatal adherence and Depression
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 2 sitesin 2 countries
Study dates: 9 Nov 2016to 31 Oct 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

South Africa1 site

MatCH Research
Durban

Other trials in South Africa

About this study

Official title: Project INSPireD: Integrating Nuanced Support for Perinatal Adherence and Depression

Read the 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.

Conditions: Human Immunodeficiency Virus, Depression
Being tested: Integrating Nuanced Support for Perinatal adherence and Depression
Keywords: HIV, Medication adherence, PMTCT, Depression
Medical subject headings: Acquired Immunodeficiency Syndrome, Depression, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Integrating Nuanced Support for Perinatal adherence and DepressionBehavioural
Also called INSPireD
A 5-8 session intervention to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women

Study groups in NCT03069417
Study group	Role	What they receive
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. Receives: Behavioral: Integrating Nuanced Support for Perinatal 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. Receives: Behavioral: Integrating Nuanced Support for Perinatal adherence and Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

Secondary outcomes (2)

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.
Measured: 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.
Measured: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 201631 Oct 2017

First posted3 Mar 2017
Study start9 Nov 2016
Primary completion24 Mar 2017
Study completion31 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03069417
Sponsor's protocol ID: 2016P001887
Other IDs: K23MH096651
Acronym: INSPireD
Status last verified: Dec 2021
First submitted: 1 Feb 2017
Last updated: 14 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 17577653
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.
PubMed 35260947
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.
PubMed 30805768

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Human Immunodeficiency Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Project INSPireD: Integrating Nuanced Support for Perinatal Adherence and Depression
ClinicalTrials.gov ID: NCT03069417
Acronym / sponsor ID: INSPireD / 2016P001887
Conditions: Human Immunodeficiency Virus, Depression
Keywords: HIV, Medication adherence, PMTCT, Depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: Match Research, National Institute of Mental Health (NIMH)
Study start: 9 Nov 2016 (actual)
Primary completion: 24 Mar 2017 (actual)
Study completion: 31 Oct 2017 (actual)
First posted: 3 Mar 2017 (actual)
Results: Posted 3 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention: INSPireD	Experimental	Behavioral: Integrating Nuanced Support for Perinatal adherence and DepressionThis 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	Behavioral: Integrating Nuanced Support for Perinatal adherence and DepressionThis 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.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Integrating Nuanced Support for Perinatal adherence and DepressionAlso: INSPireDA 5-8 session intervention to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women	Behavioural	Intervention: INSPireD, Treatment-as-usual + abbreviated intervention

Primary outcome

Adherence to Antiretroviral Therapy Per Self-Report
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.

2 secondary outcomes

Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)
Time frame: 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
Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)

Results and safety

Results posted to the registry on 3 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention: INSPireD	14	8
Treatment-as-usual + Abbreviated Intervention	9	2

Primary outcome: Adherence to Antiretroviral Therapy Per Self-Report

Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline). Mean (Standard Deviation). Unit: percentage of self-reported adherence

Measure	Intervention: INSPireD n = 14	Control: Treatment-as-usual + Abbreviated Intervention n = 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)

Intervention: INSPireD vs Control: Treatment-as-usual + Abbreviated Intervention: p = 0.11, Mixed Models Analysis
Intervention: INSPireD vs Control: Treatment-as-usual + Abbreviated Intervention: p = 0.56, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Adherence to Antiretroviral Therapy Per MEMS Caps

Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline). Mean (Standard Deviation). Unit: percentage of MEMS-recorded adherence

Measure	Intervention: INSPireD n = 12	Control: Treatment-as-usual + Abbreviated Intervention n = 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)

Intervention: INSPireD vs Control: Treatment-as-usual + Abbreviated Intervention: Fixed effects coefficient (β): -12.7 (95% CI -22.29 to -3.15), p < 0.05, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)

Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline). Mean (Standard Deviation). Unit: score on a scale

Measure	Intervention: INSPireD n = 14	Control: Treatment-as-usual + Abbreviated Intervention n = 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)

Intervention: INSPireD vs Control: Treatment-as-usual + Abbreviated Intervention: Fixed effects coefficient (β): -11.1 (95% CI -18.41 to -3.83), p < 0.005, Mixed Models Analysis
Intervention: INSPireD vs Control: Treatment-as-usual + Abbreviated Intervention: Fixed effects coefficient (β): -13.8 (95% CI -22.50 to -5.17), p < 0.005, Mixed Models Analysis

Primary outcome: Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD

Time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline). Count of participants. Unit: Participants

Measure	Intervention: INSPireD n = 14	Control: Treatment-as-usual + Abbreviated Intervention n = 9
Baseline	12	7
Post-Treatment	0	2
3-Month Follow-Up	0	1

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months post-baseline. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention: INSPireD	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Control: Treatment-as-usual + Abbreviated Intervention	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): (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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17577653Lu 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.
Derived from this study: PubMed 35260947Psaros 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.
Derived from this study: PubMed 30805768Choi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christina Psaros, PhD principal investigator

Massachusetts General Hospital

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to Antiretroviral Therapy Per Self-Report (time frame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03069417, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.