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| Name | Class |
|---|---|
| Institute for Social Development Studies (ISDS) | UNKNOWN |
| Fogarty International Center of the National Institute of Health | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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The overall goals of the study are to deepen understanding of the spectrum of stigma experienced by YLHIV in Vietnam, to develop a multi-level stigma intervention for YLHIV delivered by telephone, and to evaluate the feasibility, acceptability, and preliminary efficacy of the intervention on intra- and inter-personal stigma, psychological wellbeing, and treatment adherence.
The project has the following Specific Aims:
The study will assess the feasibility and acceptability of this approach among YLVIV in Vietnam, and generate preliminary evidence for the potential effect of the intervention on important endpoints including stigma, psychosocial wellbeing, adherence, CD4 count, and viral load (VL).
For the pilot, the investigators will recruit YLHIV on ART who self-report intrapersonal stigma and implement a 12-week pre-post intervention study in which participants will receive the phone-based intervention developed in the first phase. YLHIV will use an electronic adherence monitoring device for their ART medications.
In the pre-post intervention study, each of 40 patients will be followed for a total of 16 weeks. All patient subjects will be given an eCAP wireless pill container (WPC) that will be used to measure their adherence throughout the 16-week period. Study participation will involve two phases, with the following activities:
I. Adherence monitoring, pre-intervention period (Weeks 1-2). Once enrolled, the investigators will provide each subject with a WPC and instruction on correct use. The investigators will select one medication for each WPC. While subjects continue to receive care as usual, the investigators will collect their adherence data using the WPC.
II. Intervention period (Weeks 3-12). The intervention will be implemented for about 10 weeks; adherence data will be collected via WPCs through Week 16. They will remain blinded to the adherence information generated by the devices, as will their care providers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive life skills coaching | Experimental | CBT-based supportive like skills delivered by phone by lay coaches |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-based supportive skills delivered by phone by lay coaches | Behavioral | 8-10 weekly coaching sessions delivered by telephone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intrapersonal (self) Stigma | modified 21-item self stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome) | change between Week 1-Week 12 |
| Interpersonal Stigma | modified 21-item enacted stigma subscale of Vietnam Stigma Index Studies instrument (People living with HIV: Stigma Index 2014; higher score=worse outcome) | change between Week 1 and Week 12 |
| Depression | 7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome) | change between Week 1 and Week 12 |
| Anxiety | 7-item depression subscale of the Depression, Anxiety and Stress Scale (DASS-21; higher score=worse outcome) | change between Week 1 and Week 12 |
| Adherence | %≥95% on-time adherence | Week 12 (endline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary DeSilva, ScD, MS | University of New England | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Social Development Studies | Hanoi | Vietnam |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Participants will use a wireless pill container to monitor their adherence passively. Participants, lay coaches, and clinicians will all be blinded to adherence monitoring.
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| 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 |
| D012919 | Social Behavior |
| D001519 | Behavior |