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Retention in HIV Care for Hispanic Immigrants (ADELANTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03484117
Recruitment Status : Unknown
Verified March 2019 by Julie H Levison, Massachusetts General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 30, 2018
Last Update Posted : March 11, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Julie H Levison, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Community Health Worker Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Actual Study Start Date : May 26, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. HIV Viral Load [ Time Frame: From baseline to week 24 and from baseline to week 48 ]
    Change in HIV Viral Load

  2. CD4 T-cell Count [ Time Frame: From baseline to week 24 and from baseline to week 48 ]
    Change in CD4 T-cell count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484117


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Julie H Levison, MD Massachusetts General Hospital
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Responsible Party: Julie H Levison, MD, MPhil, MPH, Assistant Professor of Medicine at Harvard Medical School, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03484117    
Other Study ID Numbers: 2016P000252
5K23MH100978-04 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases