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Community Home-based Care Intervention and Its Health Outcome in HIV-positive People (HIV)

Primary Purpose

Human Immunodeficiency Virus, Depression, Stress

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community home-based care intervention
Sponsored by
Integrated Development Foundation Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Human Immunodeficiency Virus focused on measuring HIV, Anti-retroviral therapy, Intervention, Mental Health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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
  2. 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
  3. Those who received pre-ART counseling services and were receiving ART for at least one year
  4. Those who voluntarily agreed to enroll in a community home-based care program and received intervention after the baseline study.

Exclusion Criteria:

The exclusion criteria were being hospitalized for an intensive care at the time of data collection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Mutual support groups of HIV

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.
    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
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 1, 2018
    Last Updated
    April 20, 2018
    Sponsor
    Integrated Development Foundation Nepal
    Collaborators
    Tokyo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03505866
    Brief Title
    Community Home-based Care Intervention and Its Health Outcome in HIV-positive People
    Acronym
    HIV
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2015 (Actual)
    Primary Completion Date
    August 31, 2015 (Actual)
    Study Completion Date
    August 31, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Integrated Development Foundation Nepal
    Collaborators
    Tokyo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Immunodeficiency Virus, Depression, Stress, Anxiety, Quality of Life
    Keywords
    HIV, Anti-retroviral therapy, Intervention, Mental Health

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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)
    Allocation
    N/A
    Enrollment
    720 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mutual support groups of HIV
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Community home-based care intervention
    Intervention Description
    HIV-positive people who received community home-based care intervention on a monthly basis for six months after they enrolled in the program.
    Primary Outcome Measure Information:
    Title
    Depression
    Description
    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.
    Time Frame
    6 months
    Title
    Anti-retroviral therapy non-adherence
    Description
    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
    Time Frame
    6 months
    Title
    Anxiety
    Description
    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.
    Time Frame
    6 months
    Title
    stress
    Description
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: The exclusion criteria were being hospitalized for an intensive care at the time of data collection

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    29879916
    Citation
    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.
    Results Reference
    derived

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    Community Home-based Care Intervention and Its Health Outcome in HIV-positive People

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