Retention in HIV Care for Hispanic Immigrants

NCT03484117 | Completed Results

• 2 other identifiers: 2016P0002525K23MH100978-04
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• Change in CD4 T-cell Count Over 48 Weeks.

  Baseline to week-48

Study Arms (2)

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

Behavioral: Community Health Worker

Interventions

Community Health Worker BEHAVIORAL

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

Community Health Worker

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Julie Levison, PI
• Organization: Massachusetts General Hospital

jlevison@partners.org

617-724-4698

Study Officials

• Julie H Levison, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPhil, MPH, Assistant Professor of Medicine at Harvard Medical School

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 30, 2018
• Study Start: May 26, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: December 23, 2022
• Results First Posted: December 23, 2022

Record last verified: 2022-12

Locations

US (1)