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Retention in HIV Care for Hispanic Immigrants (ADELANTE)

Primary Purpose

HIV/AIDS

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Health Worker
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Treatment as Usual

Community Health Worker

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 7, 2018
Last Updated
December 1, 2022
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03484117
Brief Title
Retention in HIV Care for Hispanic Immigrants
Acronym
ADELANTE
Official Title
Addressing Barriers to Retention in HIV Care for Hispanic Immigrants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
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.
Arm Title
Community Health Worker
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Community Health Worker
Intervention Description
Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
Primary Outcome Measure Information:
Title
Retention in Care - Yes Responses
Description
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.
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With HIV Viral Load Suppression up to Week-24
Description
Participants with HIV viral load <200 copies/ml
Time Frame
From baseline to week-24
Title
Change in CD4 T-cell Count Over 24 Weeks
Description
Change in CD4 T-cell count from baseline to week-24 post-randomization
Time Frame
From baseline to week-24
Title
Number of Participants With HIV Viral Load Suppression up to 48 Weeks.
Description
Number of participants with HIV RNA <200 copies/ml
Time Frame
Baseline to week-48
Title
Change in CD4 T-cell Count Over 48 Weeks.
Description
Change in CD4 T-cell count from baseline to week-48 post-randomization
Time Frame
Baseline to week-48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie H Levison, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Retention in HIV Care for Hispanic Immigrants

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