Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2017-05-26
2019-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
No interventions assigned to this group
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.
Interventions
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Community Health Worker
Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* Born in Puerto Rico or Spanish-speaking Latin American country
* HIV-infected or HIV-positive
* New HIV diagnosis or unable to regularly attend HIV primary care appointments
Exclusion Criteria
18 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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Julie H Levison
MD, MPhil, MPH, Assistant Professor of Medicine at Harvard Medical School
Principal Investigators
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Julie H Levison, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2016P000252
Identifier Type: -
Identifier Source: org_study_id