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| Name | Class |
|---|---|
| Institute of Population, Health and Development, Vietnam | OTHER |
| Boston University | OTHER |
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The small RCT will assess feasibility, acceptability, and impact of a real-time intervention on ART adherence and clinical outcomes for HIV-positive adolescents. All subjects will use a wireless pill container (WPC) to monitor adherence. Intervention subjects will receive a personalized triggered reminder (cellphone message/call or bottle-based flash/alarm) when they miss a dose, and engage in monthly counseling sessions informed by their adherence data. Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits.
A major priority in HIV care and treatment is identifying effective interventions for adolescent patients, including those that make use of new technologies, to help them achieve and maintain high levels of adherence to antiretroviral treatment (ART), particularly as they take responsibility for their own medication-taking in the transition to adult care. The research planned here will contribute to the scientific evidence base on approaches to support ART adherence effectively among youth by 1) conducting formative research on adherence challenges among adolescents and refining options for a personalized adherence intervention package; and 2) implementing a small randomized controlled trial (RCT) to assess the feasibility, acceptability, and efficacy of a novel real-time feedback intervention that permits adolescent patients to tailor intervention features to suit their individual preferences.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored realtime triggered reminder pkg | Experimental | The core intervention will utilize innovative wireless technology to provide patients with 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. The core intervention will be personalized by each intervention arm patient, who may choose features to suit their preferences. |
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| Control | No Intervention | Comparison subjects will receive usual care and an offer of counseling at monthly clinic visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored realtime triggered reminder pkg | Combination Product | Core intervention: 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. Personalized features of the intervention will be selected by each patient and may include 1) reminders sent to the WPC (light or chimes) or to patient's or caregiver's cell phone if dose is late; 2) content of text messages from a menu of options; 3) use of "youth-friendly" WPC adherence reports for interactive counseling sessions; 4) additional counseling by clinic staff; 5) a "buddy" system, by choosing someone to review the adherence report with him/her; and 6) a "reward message" after a pre-selected time period of excellent adherence. |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal on-time adherence | Proportion of patients with ≥95% on-time adherence at end of 6-month intervention period in each study arm | End of intervention period (month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| CD4 count | Mean change in CD4 count in each study arm | Pre-intervention month (month 1) vs. last intervention month (month 7) |
| Viral load | Percent of patients with undetectable viral load (UDVL) in each study arm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary DeSilva, ScD | University of New England | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Population Health and Development | Hanoi | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30819228 | Derived | DeSilva M, Vu CN, Bonawitz R, Hai LT, Van Lam N, Yen LT, Gifford AL, Haberer J, Linh DT, Sabin L. The Supporting Adolescent Adherence in Vietnam (SAAV) study: study protocol for a randomized controlled trial assessing an mHealth approach to improving adherence for adolescents living with HIV in Vietnam. Trials. 2019 Feb 28;20(1):150. doi: 10.1186/s13063-019-3239-1. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2025 | Apr 14, 2025 | 5 |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| End of intervention period (month 7) |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D005159 | Health Care Facilities Workforce and Services |