Human Immunodeficiency VirusHIVNCT03505866
Community Home-based Care Intervention and Its Health Outcome in HIV-positive People
A study testing Community home-based care intervention in people with Human Immunodeficiency Virus and Depression, run by Integrated Development Foundation Nepal.
Trial summary
An intervention study was designed to examine the impact of impact of community home-based care intervention on mental health and treatment outcome in HIV-positive people. The intervention comprised a home-based counseling on anti-retroviral therapy (ART) adherence, psycho social support, basic health care services at… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Depression, Stress
- What is being tested?
- Community home-based care intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 31 Aug 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-positive people who did not enroll in a community home-based care program before the baseline data collection for intervention. Those who were referred by an ART center or a voluntary counseling and testing center for care and support services
- Those who were diagnosed as HIV-positive within five years of baseline data collection and living in the selected districts for at least one year
- Those who received pre-ART counseling services and were receiving ART for at least one year
- Those who voluntarily agreed to enroll in a community home-based care program and received intervention after the baseline study.
Who cannot join
- The exclusion criteria were being hospitalized for an intensive care at the time of data collection
About this study
Official title: Investigating the Impact of Community Home-based Care Intervention on Mental Health Outcomes and Anti-retroviral Therapy Adherence in People Living With HIV
An intervention study was designed to examine the impact of impact of community home-based care intervention on mental health and treatment outcome in HIV-positive people. The intervention comprised a home-based counseling on anti-retroviral therapy (ART) adherence, psycho social support, basic health care services at the home of HIV-positive people. The intervention started in March, 2018 and completed in August 2018. The major measurements of the interventions were ART adherence, status of depression, anxiety, and stress levels.
Read the detailed description
HIV continues to be a global health problem, particularly mental health status and non-adherence to ART remains challenges in people living with HIV (PLHIV) in low- and middle-income countries. Mental health disorders, particularly those who experience depression and anxiety may endure poor satisfaction or trust to the treatment, leading to non-adherence to ART. Also, those, who have high level of perceived stress may not seek adequate social support from care givers and service providers, that may worsen their ART adherence. Substance use also induces poor coping skills and poor dependence on treatment.
HIV positive people also experience co-occurring mental health disorders and substance use. For instance, those who experienced depression are more likely to develop the risk of substance use compared to those who did not experience depression. Similarly, those who engage in substance use such as amphetamine, cocaine, and opioid may develop the risk of chronic stress. However, evidence is limited about the prevalence of co-occurring pattern of these conditions on ART adherence among them worldwide.
Psychosocial support may be an integral part of HIV care and support to meet the mental health needs of people living with HIV. To address the need for psychosocial support, WHO provided the guideline to manage their psychological and social problems. The guideline recommends that HIV-positive people, their families, and caregivers receive psychosocial support at family, community, and health facility level. It also suggests that psychosocial support should be an integral part of care and support framework for HIV services.
Community and home-based care program is designed as a WHO framework for providing psychosocial support and basic health care to PLHIV. According to this framework, it is defined as any form of care given to ill people in their homes. Such care includes physical, psychosocial, palliative, and spiritual activities. The goal of this program is to provide hope through high-quality and appropriate care that helps ill people and families to maintain their independence and achieve the best possible QOL. The program may incur low cost or can be sustainable strategy for providing comprehensive services at the home of PLHIV.
In Nepal, 23 non-governmental organizations (NGOs) provide care and support services through community home-based care program in Nepal. The program comprises psychosocial support, ART adherence and support, peer counseling, basic health care, referral for further care. However, little is known about the role of community home-based care program in reducing depression, anxiety and high stress level among people living with HIV in the country. In addition, they receive peer counseling about their substance use, however, no study examined the role of such intervention to reduce substance use. Also, the program comprises ART support and counseling to HIV positive people and their family, no study has examined its effect on non-adherence to ART. This study is aimed to assess the impact of community home based care program on depressive symptoms, anxiety, high stress, and substance use and non-adherence to ART.
A intervention study was conducted among 682 PLHIV in Nepal. Among them, 344 participants were assigned for community and home-based care intervention and 338 were assigned for control. Baseline information was collected including sociodemographic characteristics, HIV/AIDS clinical staging, depressive symptoms, anxiety, and stress scores, substance use. Depressive symptoms were measured using center for epidemiological study depression scale (CESD). Anxiety was measured with composite international diagnostic interview-short form (CIDI-SF). Perceived Stress Scale measured stress scores. ART non-adherence was measured if participants missed at least two pills in past months.
After six months, a follow up survey was done and collected the information as baseline. The analysis was done with mainly three strategies. First, the associations of independent and combined mental health disorders and substance use with non-adherence to ART were examined using logistic regressions stratified by gender. Separate models for generalized estimating equation (GEE) were applied to measure the effect of community home-based care intervention on various outcomes. Two models for GEE were developed. First, the effect of community home-based care intervention on depression, anxiety, high stress and substance use were assessed. Second GEE model examined the effect of intervention on non-adherence to ART. In all GEE multivariable models, age, gender, marital status, education, employment, HIV/AIDS clinical staging, and presence of physical symptoms were controlled.
Keywords: Mental health, Anti-retroviral therapy adherence, intervention, Nepal
- Conditions
- Human Immunodeficiency Virus, Depression, Stress, Anxiety, Quality of Life
- Being tested
- Community home-based care intervention
- Keywords
- HIV, Anti-retroviral therapy, Intervention, Mental Health
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community home-based care interventionBehavioural
HIV-positive people who received community home-based care intervention on a monthly basis for six months after they enrolled in the program.
| Study group | Role | What they receive |
|---|---|---|
| Mutual support groups of HIV | Other | HIV-positive people who did not enroll in a community home-based care intervention and receiving regular HIV services and support from mutual support groups of HIV Receives: Behavioral: Community home-based care intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Depression was measured using a Center for Epidemiologic Studies Depression (CESD) scale. This scale consists of 20 items that are designed to measure the participant's experience of depressive symptoms in the past week of data collection. The total scores range from 0 to 60, and, a cut off point was set as scores ≥ 16 designating the occurrence of depressives symptoms.
Measured: 6 months
Anti-retroviral therapy non-adherence
Adherence to anti-retroviral therapy was measured using AIDS Clinical Trial Group Questionnaires. The questionnaires are designed to measure non-adherence whether the HIV-positive person missed at least one dose of anti-retroviral therapy in the past month of the data collection. The questionnaire assess
Measured: 6 months
Anxiety
Anxiety was measured anxiety using Composite International Diagnostic Interview Short-Form (CIDI-SF) the scale use nine screening stem questions that were designed to measure the episodes of anxiety and their control over their worries and anxious state.
Measured: 6 months
stress
Stress was in the past month using the Perceived Stress Scale (PSS). It consists of 10 items with scores ranging from "0" (never) to 4 (very often). The total score ranges from 0-40. Higher stress scores indicate high level of stress.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2018
- Study start1 Mar 2015
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The intervention was started in February and March, 2015 and was completed six month later. The program comprises of psychosocial support/peer counseling, ART adherence support and counseling, basic health care, and referral for further care. The support team comprises of a community health worker, a trained HIV-positive person, and a social worker.
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrated Development Foundation Nepal
- Sponsor type
- University, hospital or other
- Collaborators
- Tokyo University
- Responsible party
- Principal investigator, Khem Narayan Pokhrel, Integrated Development Foundation Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03505866
- Sponsor's protocol ID
- 1523
- Acronym
- HIV
- Status last verified
- Apr 2018
- First submitted
- 1 Apr 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pokhrel KN, Sharma VD, Pokhrel KG, Neupane SR, Mlunde LB, Poudel KC, Jimba M. Investigating the impact of a community home-based care on mental health and anti-retroviral therapy adherence in people living with HIV in Nepal: a community intervention study. BMC Infect Dis. 2018 Jun 7;18(1):263. doi: 10.1186/s12879-018-3170-1.
PubMed 29879916
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Community Home-based Care Intervention on Mental Health Outcomes and Anti-retroviral Therapy Adherence in People Living With HIV
- ClinicalTrials.gov ID
- NCT03505866
- Acronym / sponsor ID
- HIV / 1523
- Conditions
- Human Immunodeficiency Virus, Depression, Stress, Anxiety, Quality of Life
- Keywords
- HIV, Anti-retroviral therapy, Intervention, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Integrated Development Foundation NepalUniversity, hospital or other
- Collaborators
- Tokyo University
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 23 Apr 2018 (actual)
- 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.
An intervention study was designed to examine the impact of impact of community home-based care intervention on mental health and treatment outcome in HIV-positive people. The intervention comprised a home-based counseling on anti-retroviral therapy (ART) adherence, psycho social support, basic health care services at the home of HIV-positive people. The intervention started in March, 2018 and completed in August 2018. The major measurements of the interventions were ART adherence, status of depression, anxiety, and stress levels.
Detailed description
HIV continues to be a global health problem, particularly mental health status and non-adherence to ART remains challenges in people living with HIV (PLHIV) in low- and middle-income countries. Mental health disorders, particularly those who experience depression and anxiety may endure poor satisfaction or trust to the treatment, leading to non-adherence to ART. Also, those, who have high level of perceived stress may not seek adequate social support from care givers and service providers, that may worsen their ART adherence. Substance use also induces poor coping skills and poor dependence on treatment.
HIV positive people also experience co-occurring mental health disorders and substance use. For instance, those who experienced depression are more likely to develop the risk of substance use compared to those who did not experience depression. Similarly, those who engage in substance use such as amphetamine, cocaine, and opioid may develop the risk of chronic stress. However, evidence is limited about the prevalence of co-occurring pattern of these conditions on ART adherence among them worldwide.
Psychosocial support may be an integral part of HIV care and support to meet the mental health needs of people living with HIV. To address the need for psychosocial support, WHO provided the guideline to manage their psychological and social problems. The guideline recommends that HIV-positive people, their families, and caregivers receive psychosocial support at family, community, and health facility level. It also suggests that psychosocial support should be an integral part of care and support framework for HIV services.
Community and home-based care program is designed as a WHO framework for providing psychosocial support and basic health care to PLHIV. According to this framework, it is defined as any form of care given to ill people in their homes. Such care includes physical, psychosocial, palliative, and spiritual activities. The goal of this program is to provide hope through high-quality and appropriate care that helps ill people and families to maintain their independence and achieve the best possible QOL. The program may incur low cost or can be sustainable strategy for providing comprehensive services at the home of PLHIV.
In Nepal, 23 non-governmental organizations (NGOs) provide care and support services through community home-based care program in Nepal. The program comprises psychosocial support, ART adherence and support, peer counseling, basic health care, referral for further care. However, little is known about the role of community home-based care program in reducing depression, anxiety and high stress level among people living with HIV in the country. In addition, they receive peer counseling about their substance use, however, no study examined the role of such intervention to reduce substance use. Also, the program comprises ART support and counseling to HIV positive people and their family, no study has examined its effect on non-adherence to ART. This study is aimed to assess the impact of community home based care program on depressive symptoms, anxiety, high stress, and substance use and non-adherence to ART.
A intervention study was conducted among 682 PLHIV in Nepal. Among them, 344 participants were assigned for community and home-based care intervention and 338 were assigned for control. Baseline information was collected including sociodemographic characteristics, HIV/AIDS clinical staging, depressive symptoms, anxiety, and stress scores, substance use. Depressive symptoms were measured using center for epidemiological study depression scale (CESD). Anxiety was measured with composite international diagnostic interview-short form (CIDI-SF). Perceived Stress Scale measured stress scores. ART non-adherence was measured if participants missed at least two pills in past months.
After six months, a follow up survey was done and collected the information as baseline. The analysis was done with mainly three strategies. First, the associations of independent and combined mental health disorders and substance use with non-adherence to ART were examined using logistic regressions stratified by gender. Separate models for generalized estimating equation (GEE) were applied to measure the effect of community home-based care intervention on various outcomes. Two models for GEE were developed. First, the effect of community home-based care intervention on depression, anxiety, high stress and substance use were assessed. Second GEE model examined the effect of intervention on non-adherence to ART. In all GEE multivariable models, age, gender, marital status, education, employment, HIV/AIDS clinical staging, and presence of physical symptoms were controlled.
Keywords: Mental health, Anti-retroviral therapy adherence, intervention, Nepal
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The intervention was started in February and March, 2015 and was completed six month later. The program comprises of psychosocial support/peer counseling, ART adherence support and counseling, basic health care, and referral for further care. The support team comprises of a community health worker, a trained HIV-positive person, and a social worker.
| Arm | Type | Receives |
|---|---|---|
| Mutual support groups of HIV | Other | Behavioral: Community home-based care interventionHIV-positive people who did not enroll in a community home-based care intervention and receiving regular HIV services and support from mutual support groups of HIV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-positive people who did not enroll in a community home-based care program before the baseline data collection for intervention. Those who were referred by an ART center or a voluntary counseling and testing center for care and support services
- Those who were diagnosed as HIV-positive within five years of baseline data collection and living in the selected districts for at least one year
- Those who received pre-ART counseling services and were receiving ART for at least one year
- Those who voluntarily agreed to enroll in a community home-based care program and received intervention after the baseline study.
Key exclusion criteria (1 listed)
- The exclusion criteria were being hospitalized for an intensive care at the time of data collection
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 |
|---|---|---|
| Community home-based care interventionHIV-positive people who received community home-based care intervention on a monthly basis for six months after they enrolled in the program. | Behavioural | Mutual support groups of HIV |
Primary outcome
Depression
Time frame: 6 months
Depression was measured using a Center for Epidemiologic Studies Depression (CESD) scale. This scale consists of 20 items that are designed to measure the participant's experience of depressive symptoms in the past week of data collection. The total scores range from 0 to 60, and, a cut off point was set as scores ≥ 16 designating the occurrence of depressives symptoms.
Anti-retroviral therapy non-adherence
Time frame: 6 months
Adherence to anti-retroviral therapy was measured using AIDS Clinical Trial Group Questionnaires. The questionnaires are designed to measure non-adherence whether the HIV-positive person missed at least one dose of anti-retroviral therapy in the past month of the data collection. The questionnaire assess
Anxiety
Time frame: 6 months
Anxiety was measured anxiety using Composite International Diagnostic Interview Short-Form (CIDI-SF) the scale use nine screening stem questions that were designed to measure the episodes of anxiety and their control over their worries and anxious state.
stress
Time frame: 6 months
Stress was in the past month using the Perceived Stress Scale (PSS). It consists of 10 items with scores ranging from "0" (never) to 4 (very often). The total score ranges from 0-40. Higher stress scores indicate high level of stress.
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 24 Apr 2018.
- Derived from this study: PubMed 29879916Pokhrel KN, Sharma VD, Pokhrel KG, Neupane SR, Mlunde LB, Poudel KC, Jimba M. Investigating the impact of a community home-based care on mental health and anti-retroviral therapy adherence in people living with HIV in Nepal: a community intervention study. BMC Infect Dis. 2018 Jun 7;18(1):263. doi: 10.1186/s12879-018-3170-1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Community home-based care intervention in people with Human Immunodeficiency Virus and Depression, run by Integrated Development Foundation Nepal.
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 4 inclusion and 1 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Depression (time frame: 6 months). 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 NCT03505866, which also lists 1 linked publication.
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 24 Apr 2018.