HIV/AIDS, Medication Adherence, Substance Use
Conditions
Keywords
Prisoner
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.
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.
Interventions
BEHAVIORALATHENA
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.
Sponsors
Indonesia University
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor is blinded to treatment assignment
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to antiretroviral therapy (ART) | 3 months after prison release | Adherence to antiretroviral therapy \>90% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ART initiation | 3 months after prison release | Having initiated or continued ART |
| Viral load | 3 months after prison release | HIV-RNA viral load |
| CD4+ T-cell count | 3 months after prison release | CD4+ T-cell count |
| Retention in HIV care | 3 months after prison release | Being seen by an HIV care provider |
| Hospitalization | 3 months after prison release | Frequency of hospitalization or emergency department visits |
| Drug and Sexual Risk Behaviors | 3 months after prison release | Frequency of drug and sexual risk behaviors |
| Quality of life | 3 months after prison release | Quality of life as assessed by WHO Quality of Life scale |
Countries
Indonesia
Outcome results
None listed