Adherence Through Home Education and Nursing Assessment, Indonesia

HIV/AIDS Clinical Trial

— ATHENA-I  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03397576
• Other study ID #: 2016-0196
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: May 1, 2025

Study information

• Verified date: May 2023
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS
• Medication Adherence
• Substance Use
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Indonesia	University of Indonesia	Depok	Jawa Barat

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to antiretroviral therapy (ART)	Adherence to antiretroviral therapy >90%	3 months after prison release
Secondary	Retention in HIV care	Being seen by an HIV care provider	3 months after prison release
Secondary	ART initiation	Having initiated or continued ART	3 months after prison release
Secondary	Viral load	HIV-RNA viral load	3 months after prison release
Secondary	CD4+ T-cell count	CD4+ T-cell count	3 months after prison release
Secondary	Quality of life	Quality of life as assessed by WHO Quality of Life scale	3 months after prison release
Secondary	Hospitalization	Frequency of hospitalization or emergency department visits	3 months after prison release
Secondary	Drug and Sexual Risk Behaviors	Frequency of drug and sexual risk behaviors	3 months after prison release