NCT03397576: ATHENA-I

Adherence Through Home Education and Nursing Assessment, Indonesia

Completed NA Last updated 12 July 2024

What this trial tests

NA trial testing ATHENA in HIV/AIDS in 150 participants. Completed in 9 November 2023.

Timeline

27 February 2017

Primary endpoint
9 November 2023

9 November 2023

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	150
Start date	27 February 2017
Primary completion	9 November 2023
Estimated completion	9 November 2023
Sites	1 location across Indonesia

Drugs / interventions tested

• ATHENA

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →
• Medication Adherence — all drugs for Medication Adherence →
• Substance Use — all drugs for Substance Use →

Sponsor

University of Illinois at Chicago

Who can join

18 and older, male only, with HIV/AIDS or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Accuracy of measures for antiretroviral adherence in people living with HIV.
   Smith R, Villanueva G, Probyn K, Sguassero Y, et al · · 2022 · cited 34× · PMID 35871531 · DOI 10.1002/14651858.cd013080.pub2
2. Exploring the acceptability of HIV partner notification in prisons: Findings from a survey of incarcerated people living with HIV in Indonesia.
   Culbert GJ, Waluyo A, Earnshaw VA. · · 2020 · cited 7× · PMID 32603363 · DOI 10.1371/journal.pone.0234697
3. Feasibility of a mHealth survey application for incarcerated and postrelease people living with HIV in a low-resource setting.
   Lopez KD, Cravero C, Krishnan A, Carvalho de Sousa Freire VE, et al · · 2021 · cited 1× · PMID 33341994 · DOI 10.1002/nur.22098