NCT03397576Completed
Adherence Through Home Education and Nursing Assessment, Indonesia
A Randomized Controlled Trial of a Medication Adherence Intervention (ATHENA-I) to Increase Adherence to Antiretroviral Therapy Among HIV-Infected Prisoners in Indonesia
Source: ClinicalTrials.gov · Last updated 12 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 26 Sept 2017
- Start date
- 27 Feb 2017
- Primary completion date
- 9 Nov 2023
- Lead sponsor
- University of Illinois Chicago
- Diseases
- HIV
- NCT number
- NCT03397576
What you commit to
- Study type: Interventional
- Participants enrolled: 150
- From 27 Feb 2017 to the primary completion date, 9 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- none
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Indonesia Coordinator of this site? Confirm its status | Depok | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.