Adherence Through Home Education and Nursing Assessment, Indonesia (ATHENA-I)

A Randomized Controlled Trial of a Medication Adherence Intervention (ATHENA-I) to Increase Adherence to Antiretroviral Therapy Among HIV-Infected Prisoners in Indonesia

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS; Medication Adherence; Substance Use
• Intervention / Treatment: Behavioral: ATHENA

Detailed Description

The acceptability and feasibility of the adapted ATHENA intervention will be assessed through a 2-arm randomized controlled trial conducted in two phases with HIV-infected prisoners recruited from 2 correctional facilities in Jakarta, Indonesia.

Phase 1: HIV+ prisoners who are already aware of their status will be recruited through prison clinics and randomized to receive either the adapted ATHENA intervention or standard care as a control. Uniform data collection at baseline will include measures of ART adherence, HIV stigma, and drug dependence and CD4+ T-cell and viral load testing.

Phase 2: Subjects receiving the ATHENA intervention will participate in monthly medication adherence counseling sessions within prison, and home visits up to four months after prison release, during which intervention staff (nurses and peer educators working in teams) will deliver individualized medication adherence counseling based on the Freirian educational model.

Phase 3: Participants in both groups will be followed for 12 months after prison release, and asked to complete monthly study visits to evaluate primary and secondary outcomes.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Barat
    • Depok, Jawa Barat, Indonesia, 16424
      • University of Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ATHENA; 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; 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.
No Intervention: Control; Subjects in the control group will receive standard care, which includes a referral for HIV care and ART if prescribed ART within prison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to antiretroviral therapy (ART)	Adherence to antiretroviral therapy >90%	3 months after prison release

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in HIV care	Being seen by an HIV care provider	3 months after prison release
ART initiation	Having initiated or continued ART	3 months after prison release
Viral load	HIV-RNA viral load	3 months after prison release
CD4+ T-cell count	CD4+ T-cell count	3 months after prison release
Quality of life	Quality of life as assessed by WHO Quality of Life scale	3 months after prison release
Hospitalization	Frequency of hospitalization or emergency department visits	3 months after prison release
Drug and Sexual Risk Behaviors	Frequency of drug and sexual risk behaviors	3 months after prison release

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: Indonesia University
• Investigators: Principal Investigator: Gabriel J Culbert, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2017
• Primary Completion (Actual): November 9, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Prisoner
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2016-0196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No