Skip to main content
Clinical Trials/NCT03484117
NCT03484117
Completed
Not Applicable

Addressing Barriers to Retention in HIV Care for Hispanic Immigrants

Massachusetts General Hospital1 site in 1 country67 target enrollmentMay 26, 2017
ConditionsHIV/AIDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV/AIDS
Sponsor
Massachusetts General Hospital
Enrollment
67
Locations
1
Primary Endpoint
Retention in Care - Yes Responses
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 26, 2017
End Date
May 1, 2019
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Julie H Levison

MD, MPhil, MPH, Assistant Professor of Medicine at Harvard Medical School

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older and able to communicate in Spanish or English
  • 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

  • Unable to provide verbal consent due to unstable medical or psychiatric condition

Outcomes

Primary Outcomes

Retention in Care - Yes Responses

Time Frame: 32 weeks

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.

Secondary Outcomes

  • Change in CD4 T-cell Count Over 48 Weeks.(Baseline to week-48)
  • Number of Participants With HIV Viral Load Suppression up to Week-24(From baseline to week-24)
  • Change in CD4 T-cell Count Over 24 Weeks(From baseline to week-24)
  • Number of Participants With HIV Viral Load Suppression up to 48 Weeks.(Baseline to week-48)

Study Sites (1)

Loading locations...

Similar Trials