Clinical Trials

MainTitle

Retention in HIV Care for Hispanic Immigrants (ADELANTE)

This study is ongoing, but not recruiting participants.
Sponsor
Massachusetts General Hospital

Collaborator
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
Julie H Levison, Massachusetts General Hospital

ClinicalTrials.gov Identifier
NCT03484117

First received: March 7, 2018
Last updated: March 8, 2019
Last Verified: March 2019
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV/AIDS

Behavioral : Community Health Worker

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Addressing Barriers to Retention in HIV Care for Hispanic Immigrants

Further study details as provided by Julie H Levison, Massachusetts General Hospital:

Primary Outcome Measures

  • Retention in Care [ 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.
Secondary Outcome Measures:
  • HIV Viral Load [ Time Frame: From baseline to week 24 and from baseline to week 48 ]
    Change in HIV Viral Load
  • CD4 T-cell Count [ Time Frame: From baseline to week 24 and from baseline to week 48 ]
    Change in CD4 T-cell count

Estimated Enrollment: 70
Study Start Date: May 26, 2017
Estimated Study Completion Date: January 31, 2020
Estimated Primary Completion Date: January 31, 2020 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
No Intervention: 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.
Experimental: 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
Behavioral: Community Health Worker

Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03484117

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Julie H Levison, MD Massachusetts General Hospital
More Information

More Information


Responsible Party: Julie H Levison, MD, MPhil, MPH, Assistant Professor of Medicine at Harvard Medical School, Massachusetts General Hospital  
ClinicalTrials.gov Identifier: NCT03484117   History of Changes  
Other Study ID Numbers: 2016P000252  
  5K23MH100978-04  
Study First Received: March 7, 2018  
Last Updated: March 8, 2019  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.