Adherence Through Home Education and Nursing Assessment, Indonesia

NCT03397576 | Completed

• 1 other identifier: 2016-0196
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Adherence to antiretroviral therapy (ART) drops sharply after prison release. Effective medication adherence training immediately before and after prison release may improve health outcomes and limit transmission of Human Immunodeficiency Virus (HIV). ATHENA (Adherence Through Home Education and Nursing Assessment) is an evidence-based medication adherence intervention, which is delivered in the patient's home by nurses and peer educators working in teams. In this study, researchers will examine the acceptability and feasibility of the ATHENA intervention through a 2-arm randomized controlled trial conducted with HIV-infected prisoners in Indonesia. Eligible subjects will be \>18 years of age, HIV-infected, and may be treatment-experienced or treatment-naive. Subjects randomized to the intervention arm will participate in monthly medication adherence counseling sessions within prison and home visits up to four months after prison release. Subjects randomized to the control arm will receive standard care, which includes a referral for HIV care after prison release. The primary endpoint is the proportion of subjects demonstrating ART adherence \>90% at 3 months after prison release. Secondary endpoints are: 1) retention in HIV care, 2) ART initiation, 3) HIV- RNA viral load, 4) CD4+ T-cell count, 5) quality of life, 6) hospitalization, 6) substance use and sexual risk behaviors at 3 months after prison release.

Conditions

HIV/AIDS; Medication Adherence; Substance Use

Keywords

Prisoner

Outcome Measures

Primary Outcomes (1)

• Adherence to antiretroviral therapy (ART)

  Adherence to antiretroviral therapy \>90%

  3 months after prison release

Secondary Outcomes (7)

• Retention in HIV care

  3 months after prison release

• ART initiation

  3 months after prison release

• Viral load

  3 months after prison release

• CD4+ T-cell count

  3 months after prison release

• Quality of life

  3 months after prison release

Study Arms (2)

ATHENA

EXPERIMENTAL

Subjects in the experimental arm will participate in monthly group medication adherence counseling sessions within prison led by a nurse and peer educator. After prison release, subjects in the experimental group will participate in four home visits during which intervention staff (nurses and peer educators working in teams) will deliver individualized medication adherence counseling based on the Freirian educational model.

Behavioral: ATHENA

Control

NO INTERVENTION

Subjects in the control group will receive standard care, which includes a referral for HIV care and ART if prescribed ART within prison.

Interventions

ATHENA BEHAVIORAL

Adherence Through Home Education and Nursing Assessment (ATHENA), is an evidence-based ART adherence intervention delivered in the patient's home by nurses and peer educators working in teams.

ATHENA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV infection documented by a rapid HIV test or any licensed ELISA test; and confirmed by another test using a different method, including but not limited to rapid HIV tests, Western Blot, HIV culture, HIV antigen, or HIV pro-viral DNA at any time prior to study entry; and aware of HIV status
• age ≥ 18 years
• Karnofsky performance score \>40
• conversant in Bahasa Indonesia

You may not qualify if:

• none

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• Indonesia University: collaborator

Study Sites (1)

University of Indonesia

Depok, West Java, 16424, Indonesia

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Medication Adherence; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Gabriel J Culbert

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is blinded to treatment assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: January 12, 2018
• Study Start: February 27, 2017
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

ID (1)