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

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ClinicalTrials.gov Identifier: NCT03397576
Recruitment Status : Active, not recruiting
First Posted : January 12, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Indonesia University
Information provided by (Responsible Party):
Gabriel John Culbert, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Medication Adherence Substance Use Behavioral: ATHENA Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor is blinded to treatment assignment
Primary Purpose: Treatment
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
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.



Primary Outcome Measures :
  1. Adherence [ Time Frame: 3 months after prison release ]
    Adherence to antiretroviral therapy >90%


Secondary Outcome Measures :
  1. Retention [ Time Frame: 3 months after prison release ]
    Being seen by an HIV care provider

  2. ART initiation [ Time Frame: 3 months after prison release ]
    Having initiated or continued ART

  3. Viral load [ Time Frame: 3 months after prison release ]
    HIV-RNA viral load

  4. CD4+ T-cell count [ Time Frame: 3 months after prison release ]
    CD4+ T-cell count

  5. Quality of life [ Time Frame: 3 months after prison release ]
    Quality of life as assessed by WHO Quality of Life scale

  6. Hospitalization [ Time Frame: 3 months after prison release ]
    Frequency of hospitalization or emergency department visits

  7. Drug and Sexual Risk Behaviors [ Time Frame: 3 months after prison release ]
    Frequency of drug and sexual risk behaviors



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397576


Locations
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Indonesia
University of Indonesia
Depok, Jawa Barat, Indonesia, 16424
Sponsors and Collaborators
University of Illinois at Chicago
Indonesia University

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Responsible Party: Gabriel John Culbert, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03397576     History of Changes
Other Study ID Numbers: 2016-0196
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriel John Culbert, University of Illinois at Chicago:
Prisoner