University of Indonesia
Depok, West Java, 16424, Indonesia
NCT Number: NCT03397576
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.
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Not applicable
Depok, West Java, 16424, Indonesia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months after prison release
Adherence to antiretroviral therapy >90%
Time frame: 3 months after prison release
Being seen by an HIV care provider
Time frame: 3 months after prison release
Having initiated or continued ART
Time frame: 3 months after prison release
HIV-RNA viral load
Time frame: 3 months after prison release
CD4+ T-cell count
Time frame: 3 months after prison release
Quality of life as assessed by WHO Quality of Life scale
Time frame: 3 months after prison release
Frequency of hospitalization or emergency department visits
Time frame: 3 months after prison release
Frequency of drug and sexual risk behaviors
University of Illinois at Chicago
Other
A Randomized Controlled Trial of a Medication Adherence Intervention (ATHENA-I) to Increase Adherence to Antiretroviral Therapy Among HIV-Infected Prisoners in Indonesia
Acronym: ATHENA-I
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03282890
Acquired Immunodeficiency Syndrome, Behavior
New Haven, Connecticut, United States
View Trial DetailsNCT03681145
Acquired Immunodeficiency Syndrome, Behavior
San Francisco, California, United States
View Trial DetailsNCT03760211
Acquired Immunodeficiency Syndrome, Behavior
Atlanta, Georgia, United States
View Trial DetailsNCT03409328
Acquired Immunodeficiency Syndrome, Behavior
North Chicago, Illinois, United States
View Trial Details