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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MH100978-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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A randomized trial to test the feasibility and acceptability of an intervention to improve retention in HIV primary care in HIV-infected Hispanic immigrants compared to a "treatment as usual" condition. We will measure feasibility, acceptability, study retention, and effect sizes of outcomes in order to inform a larger trial. The intervention design is based on qualitative research with HIV-infected Hispanic immigrants and their HIV providers. The intervention will be led by a Spanish-speaking community health worker trained in HIV health promotion.
Overview:
Participants will be HIV-infected Hispanic immigrants age ≥18 years. Participants will be recruited from Partners-affiliated infectious disease and primary care clinics as well as clinics and community-based organizations in the Greater Boston area with high contact with HIV-infected Hispanics. In the intervention, a bilingual (English-Spanish speaking) community health worker (CHW) will deliver personalized sessions framed around a Spanish-language multi-media health communication tool. The CHW will deliver the intervention over a 16 to 24 week period.
Study procedures:
Participants will be HIV-infected Hispanic immigrants age ≥18 years at risk for inconsistent attendance (as measured during study screening). Participants will be recruited via provider referral, peer referral, flyers, and social media. Once an individual expresses interest in the study, a study staff member will screen that individual to assess eligibility. Individuals who are eligible will be invited to enroll through an informed consent process and complete a baseline survey. After completion of the baseline survey, study staff will randomize participants into a treatment as usual (TAU) group or intervention group. At trial exit, all participants, including the TAU group, will complete an in-depth assessment to measure their barriers to HIV care and provide feedback about their experience in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | No Intervention | Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants. | |
| Community Health Worker | Experimental | Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Health Worker | Behavioral | Participants will receive 5 one-on-one sessions with a CHW over 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention in Care - Yes Responses | A dichotomized outcome (yes/no) with yes defined as at least one visit to HIV clinic at both time periods (week 1-16 and week 17-32), and no defined as no HIV visit from at least one time period. Responses determined by review of the medical record for evidence of attended HIV clinic visits. | 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With HIV Viral Load Suppression up to Week-24 | Participants with HIV viral load <200 copies/ml | From baseline to week-24 |
| Change in CD4 T-cell Count Over 24 Weeks | Change in CD4 T-cell count from baseline to week-24 post-randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie H Levison, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual | Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants. |
| FG001 | Community Health Worker | Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Data obtained from 67 participants who enrolled and completed baseline assessment
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual | Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Retention in Care - Yes Responses | A dichotomized outcome (yes/no) with yes defined as at least one visit to HIV clinic at both time periods (week 1-16 and week 17-32), and no defined as no HIV visit from at least one time period. Responses determined by review of the medical record for evidence of attended HIV clinic visits. | Posted | Count of Participants | Participants | 32 weeks |
|
through study completion up to 48 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment as Usual | Participants in this arm will receive bilingual written materials on healthy living with HIV at the baseline visit. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Julie Levison, PI | Massachusetts General Hospital | 617-724-4698 | jlevison@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2022 | Jul 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003150 | Community Health Workers |
| ID | Term |
|---|---|
| D000488 | Allied Health Personnel |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| From baseline to week-24 |
| Number of Participants With HIV Viral Load Suppression up to 48 Weeks. | Number of participants with HIV RNA <200 copies/ml | Baseline to week-48 |
| Change in CD4 T-cell Count Over 48 Weeks. | Change in CD4 T-cell count from baseline to week-48 post-randomization | Baseline to week-48 |
| Community Health Worker |
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| HIV Viral suppression | Number of participants with HIV RNA <200 copies/ml | Number of individuals analyzed were the total number of participants with available laboratory data. | Count of Participants | Participants |
|
| Baseline CD4 cell count | Number of participants analyzed were the total number of participants with available laboratory data. | Count of Participants | Participants |
|
Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants
Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
|
|
| Secondary | Number of Participants With HIV Viral Load Suppression up to Week-24 | Participants with HIV viral load <200 copies/ml | HIV viral load laboratory data at week-24 available for a total of 66 participants. | Posted | Count of Participants | Participants | From baseline to week-24 |
|
|
|
| Secondary | Change in CD4 T-cell Count Over 24 Weeks | Change in CD4 T-cell count from baseline to week-24 post-randomization | CD4 count laboratory data at week-24 available for 66 participants. | Posted | Mean | Standard Deviation | 1000 cells/uL | From baseline to week-24 |
|
|
|
| Secondary | Number of Participants With HIV Viral Load Suppression up to 48 Weeks. | Number of participants with HIV RNA <200 copies/ml | HIV viral load laboratory data at week-48 available for 59 participants. | Posted | Count of Participants | Participants | Baseline to week-48 |
|
|
|
| Secondary | Change in CD4 T-cell Count Over 48 Weeks. | Change in CD4 T-cell count from baseline to week-48 post-randomization | CD4 count laboratory data at week-48 available for 59 participants. | Posted | Mean | Standard Deviation | 1000 cells/uL | Baseline to week-48 |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Community Health Worker | Participants in the intervention arm will receive 5 one-on-one sessions over 24 weeks with a Spanish-speaking CHW. At baseline and exit, all participants will be assessed using instruments to measure demographics and self-perceived barriers to care for Hispanic immigrants Community Health Worker: Participants will receive 5 one-on-one sessions with a CHW over 24 weeks. | 0 | 35 | 0 | 35 | 0 | 35 |
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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 |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| >500 cells/mm^3 |
|