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
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Medication Adherence Substance Use||Behavioral: ATHENA||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes assessor is blinded to treatment assignment|
|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|
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.
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.
- Adherence [ Time Frame: 3 months after prison release ]Adherence to antiretroviral therapy >90%
- Retention [ Time Frame: 3 months after prison release ]Being seen by an HIV care provider
- ART initiation [ Time Frame: 3 months after prison release ]Having initiated or continued ART
- Viral load [ Time Frame: 3 months after prison release ]HIV-RNA viral load
- CD4+ T-cell count [ Time Frame: 3 months after prison release ]CD4+ T-cell count
- Quality of life [ Time Frame: 3 months after prison release ]Quality of life as assessed by WHO Quality of Life scale
- Hospitalization [ Time Frame: 3 months after prison release ]Frequency of hospitalization or emergency department visits
- Drug and Sexual Risk Behaviors [ Time Frame: 3 months after prison release ]Frequency of drug and sexual risk behaviors
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
|University of Indonesia|
|Depok, Jawa Barat, Indonesia, 16424|