Retention in HIV Care for Hispanic Immigrants (ADELANTE)

Addressing Barriers to Retention in HIV Care for Hispanic Immigrants

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.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Community Health Worker

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With HIV Viral Load Suppression up to Week-24	Participants with HIV viral load <200 copies/ml	From baseline to week-24
Change in CD4 T-cell Count Over 24 Weeks	Change in CD4 T-cell count from baseline to week-24 post-randomization	From baseline to week-24
Number of Participants With HIV Viral Load Suppression up to 48 Weeks.	Number of participants with HIV RNA <200 copies/ml	Baseline to week-48
Change in CD4 T-cell Count Over 48 Weeks.	Change in CD4 T-cell count from baseline to week-48 post-randomization	Baseline to week-48

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Julie H Levison, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 29, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 2016P000252; 5K23MH100978-04 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No