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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-01

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reducing Psychological Barriers to PrEP Persistence Among Pregnant and Postpartum Women in Cape Town, South Africa

NCT05624931

Depression Posttraumatic Stress Disorder Pregnancy Related +1 more

RECRUITING NA

Effectiveness of Nurse-delivered Care for Adherence/Mood in HIV in South Africa

NCT02696824

Immunodeficiency Virus, Human Depressive Symptoms

COMPLETED NA

Cognitive Behavior Therapy (CBT)-Based Group Intervention to Reduce Inflammation in Older People With HIV

NCT05434741

Aging HIV

COMPLETED NA

Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe

NCT03704805

Mental Disorder HIV Infections

COMPLETED NA

Preventing & Treating HIV Comorbidities in India: Multi-tiered Strategy for Women

NCT02319330

HIV Depression

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Human Immunodeficiency Virus Depression Stress Anxiety Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mutual support groups of HIV

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

Group Type OTHER

Community home-based care intervention

Intervention Type BEHAVIORAL

HIV-positive people who received community home-based care intervention on a monthly basis for six months after they enrolled in the program.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Community home-based care intervention

HIV-positive people who received community home-based care intervention on a monthly basis for six months after they enrolled in the program.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes