Immunodeficiency Virus, HumanNCT02696824
Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
A study testing Cognitive Behavioral Therapy for Adherence and Depression in people with Immunodeficiency Virus, Human and Depressive Symptoms, run by University of Miami at 3 sites in 2 countries.
Trial summary
The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for depression and adherence, integrated into the HIV care setting in patients with HIV who did not achieve viral suppression from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunodeficiency Virus, Human, Depressive Symptoms
- What is being tested?
- Cognitive Behavioral Therapy for Adherence and Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 19 Jul 2016to 9 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-seropositive
- Current diagnosis of depression
- Did not attain viral suppression from first-line ARV per local clinic standard
Who cannot join
- Unable or unwilling to provide informed consent.
- Active untreated, major mental illness (untreated psychosis or mania) that would interfere with CBT-AD.
- Has not received CBT for depression.
- Less than 18 years of age.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
The General Hospital Corp dba Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Miami
Miami, Florida, 33146
About this study
The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for depression and adherence, integrated into the HIV care setting in patients with HIV who did not achieve viral suppression from first-line treatment. The CBT treatment will be compared to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described in study endpoints section below).
Read the detailed description
Clinical Clinical depression is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. Based on our prior work, and given that CBT is an evidenced-based treatment for depression, this is a two-arm effectiveness randomized controlled trial of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who did not achieve viral suppression from their first line ART, and have a unipolar depressive mood disorder.
- Conditions
- Immunodeficiency Virus, Human, Depressive Symptoms
- Being tested
- Cognitive Behavioral Therapy for Adherence and Depression
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Adherence and DepressionBehavioural
This treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach.
| Study group | Role | What they receive |
|---|---|---|
| CBT-AD | Experimental | Those assigned to the CBT-AD [cognitive behavioral therapy for adherence and depression) condition, will have up to 8 additional sessions delivered by the study clinic nurse. Additionally, those assigned to CBT-AD will have the procedures available to those assigned to ETAU. Receives: Behavioral: Cognitive Behavioral Therapy for Adherence and Depression |
| ETAU | No intervention | Participants in both conditions receive usual care plus the following procedures below. All participant will have the benefit of the psychosocial assessment, and the clinic nurse will provide feedback to the participant and to their clinic doctor about their depression. Additionally, all participants will undergo standard of care "second line treatment" adherence counseling in the clinic . The clinic doctor will not be restricted in terms of referral or treatment of depression for their patient with respect to antidepressant medications or other interventions available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HIV medication adherence throughout intervention phase
Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device
Measured: Assessed between baseline and the 4 month assessment
Depression scores as assessed by an independent (blind assessor) after intervention.
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.
Measured: 4 month assessment
Secondary outcomes (4)
HIV viral load
Percentage of patients with a detectable viral load at the 12 month assessment
Measured: 12-month assessment
CD4
Mean CD4 cell counts at the 12 month assessment
Measured: 12-month assessment
HIV medication adherence over follow-up
Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device
Measured: Aggregate across 4,8, and 12-month assessment
Depression scores as assessed by an independent (blind assessor) over follow-up
Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.
Measured: Aggregate across 4,8, and 12-month assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study start19 Jul 2016
- Primary completion17 Oct 2019
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Immunodeficiency Virus, HumanStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Cape Town, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Steven Safren, University of Miami
- Investigators
- Steven A Safren, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696824
- Sponsor's protocol ID
- 20150399
- Other IDs
- 1R01MH103770-01A1
- Status last verified
- Jan 2021
- First submitted
- 18 Feb 2016
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, Lee JS, Bainter SA, Musinguzi N, Simoni J, Kagee A, Joska JA. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial. J Int AIDS Soc. 2021 Oct;24(10):e25823. doi: 10.1002/jia2.25823.
PubMed 34708929Joska JA, Andersen LS, Smith-Alvarez R, Magidson J, Lee JS, O'Cleirigh C, Safren SA. Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 3;9(2):e14200. doi: 10.2196/14200.
PubMed 32012114
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa
- ClinicalTrials.gov ID
- NCT02696824
- Acronym / sponsor ID
- 20150399
- Conditions
- Immunodeficiency Virus, Human, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Cape Town, National Institute of Mental Health (NIMH)
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to conduct a two-arm effectiveness trial in Cape Town, South Africa of a Xhosa-adapted, nurse-delivered, cognitive behavioral therapy (CBT) treatment for depression and adherence, integrated into the HIV care setting in patients with HIV who did not achieve viral suppression from first-line treatment. The CBT treatment will be compared to enhanced usual care (Enhanced Treatment As Usual - ETAU) on study endpoints (as described in study endpoints section below).
Detailed description
Clinical Clinical depression is one of the highest comorbidities to HIV/AIDS, with estimated rates up to 34.9 percent. Depression, in the context of HIV, leads to poor self-care behavior such as non-adherence to ART and worse retention in care, which are critical for treatment success. Based on our prior work, and given that CBT is an evidenced-based treatment for depression, this is a two-arm effectiveness randomized controlled trial of nurse-delivered cognitive behavioral therapy for depression and adherence integrated into the HIV primary care setting in S. Africa. To ensure that those who need this intervention the most will receive it, participants will be patients with HIV who did not achieve viral suppression from their first line ART, and have a unipolar depressive mood disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-AD | Experimental | Behavioral: Cognitive Behavioral Therapy for Adherence and DepressionThose assigned to the CBT-AD [cognitive behavioral therapy for adherence and depression) condition, will have up to 8 additional sessions delivered by the study clinic nurse. Additionally, those assigned to CBT-AD will have the procedures available to those assigned to ETAU. |
| ETAU | No intervention | –Participants in both conditions receive usual care plus the following procedures below. All participant will have the benefit of the psychosocial assessment, and the clinic nurse will provide feedback to the participant and to their clinic doctor about their depression. Additionally, all participants will undergo standard of care "second line treatment" adherence counseling in the clinic . The clinic doctor will not be restricted in terms of referral or treatment of depression for their patient with respect to antidepressant medications or other interventions available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HIV-seropositive
- Current diagnosis of depression
- Did not attain viral suppression from first-line ARV per local clinic standard
Key exclusion criteria (4 listed)
- Unable or unwilling to provide informed consent.
- Active untreated, major mental illness (untreated psychosis or mania) that would interfere with CBT-AD.
- Has not received CBT for depression.
- 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 |
|---|---|---|
| Cognitive Behavioral Therapy for Adherence and DepressionThis treatment involves integrating CBT for depression with CBT for adherence following our "Life-Steps" approach. | Behavioural | CBT-AD |
Primary outcome
Changes in HIV medication adherence throughout intervention phase
Time frame: Assessed between baseline and the 4 month assessment
Percentage of prescribed antiviral therapy agent (medications ) taken as measured by real time wireless motoring device
Depression scores as assessed by an independent (blind assessor) after intervention.
Time frame: 4 month assessment
Hamilton Depression Rating Scale The Hamilton Depression Rating Scale has a total score ranging from 0-54, with higher scores indicated greater depressive symptoms.
4 secondary outcomes
HIV viral load
Time frame: 12-month assessment
CD4
Time frame: 12-month assessment
HIV medication adherence over follow-up
Time frame: Aggregate across 4,8, and 12-month assessment
Depression scores as assessed by an independent (blind assessor) over follow-up
Time frame: Aggregate across 4,8, and 12-month assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 34708929Safren SA, O'Cleirigh C, Andersen LS, Magidson JF, Lee JS, Bainter SA, Musinguzi N, Simoni J, Kagee A, Joska JA. Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial. J Int AIDS Soc. 2021 Oct;24(10):e25823. doi: 10.1002/jia2.25823.
- Derived from this study: PubMed 32012114Joska JA, Andersen LS, Smith-Alvarez R, Magidson J, Lee JS, O'Cleirigh C, Safren SA. Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Feb 3;9(2):e14200. doi: 10.2196/14200.
- Individual participant dataSharing planned: No
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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.
Steven A Safren, PhD principal investigator
University of Miami
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Adherence and Depression in people with Immunodeficiency Virus, Human and Depressive Symptoms, run by University of Miami at 3 sites in 2 countries.
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 3 inclusion and 4 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 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in HIV medication adherence throughout intervention phase (time frame: Assessed between baseline and the 4 month assessment). The study lists 2 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 NCT02696824, which also lists 2 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 19 Jan 2021.