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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH083550-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Partners in Health | OTHER |
| Harvard School of Public Health (HSPH) | OTHER |
| Harvard Medical School (HMS and HSDM) |
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Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru.
Community-based accompaniment with directly observed antiretroviral therapy (DOT-HAART) may improve adherence and clinical outcomes among impoverished individuals starting HAART in resource-poor settings. Furthermore, the utilization of community health workers may build social capital. This is cluster-randomized trial, with randomization at the level of health centers. Individuals in both intervention and control clusters will receive community-based adherence support (monthly adherence visits) and standard care. In addition, individuals residing in intervention clusters will receive 12 months of community-based DOT-HAART. We will enroll patients as well as community members (health providers, treatment supporters, and community health workers) to assess individual and community-level outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: DOT-HAART | Experimental | Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART. |
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| No DOT-HAART | No Intervention | Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DOT-HAART | Other | For 8 months, DOT-HAART of all doses in the participant's home or alternate location. DOT worker ensures that HIV medications are taken as indicated and witnesses ingestion of all medications including other medications prescribed by physician. The worker will be trained to identify, triage and notify providers of any psychosocial and medical problems/complications. Transition to self-administration begins in months 9-12 when DOT will be tapered and greater participation of treatment supporter to prepare patients for self-administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group. | 18 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Identify mediating mechanisms of CASA effect on individual outcomes. | 24 months | |
| Identify subgroups who respond best to CASA intervention. | 24 months |
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Inclusion Criteria for Patient Cohort:
Exclusion Criteria for Patient Cohort:
- Imprisoned or cannot give informed consent.
Inclusion Criteria for Community Cohort:
Exclusion Criteria for Community Cohort:
- Cannot give informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Sonya Shin, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Socios En Salud | Lima | Peru |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| OTHER |
Cluster randomization of sites assign individuals starting antiretroviral therapy to receive community-based directly observed therapy plus home visits / social support versus home visits / social support alone.
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| 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 |