NCT03505866

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2015

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

April 1, 2018

Last Update Submit

April 20, 2018

Conditions

Keywords

HIVAnti-retroviral therapyInterventionMental Health

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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.

    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.

    6 months

Study Arms (1)

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

Behavioral: Community home-based care intervention

Interventions

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

Mutual support groups of HIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeDepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research and Program Development Advisor

Study Record Dates

First Submitted

April 1, 2018

First Posted

April 23, 2018

Study Start

March 1, 2015

Primary Completion

August 31, 2015

Study Completion

August 31, 2015

Last Updated

April 24, 2018

Record last verified: 2018-04