Clinical trial NCT03397576: Adherence Through Home Education and Nursing Assessment, Indonesia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Medication Adherence
Substance Use
Keywords: Prisoner
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Indonesia University
First posted: 2018-01-12
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility 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:

* none

Primary outcomes:
measure: Adherence to antiretroviral therapy (ART)
timeFrame: 3 months after prison release
Secondary outcomes:
measure: Retention in HIV care
timeFrame: 3 months after prison release
measure: ART initiation
timeFrame: 3 months after prison release
measure: Viral load
timeFrame: 3 months after prison release
measure: CD4+ T-cell count
timeFrame: 3 months after prison release
measure: Quality of life
timeFrame: 3 months after prison release
measure: Hospitalization
timeFrame: 3 months after prison release
measure: Drug and Sexual Risk Behaviors
timeFrame: 3 months after prison release
Other outcomes:
Locations:
city: Depok
country: Indonesia
facility: University of Indonesia
state: Jawa Barat
Study officials:
affiliation: University of Illinois at Chicago
name: Gabriel J Culbert
role: PRINCIPAL_INVESTIGATOR
References: