Retention in HIV Care for Hispanic Immigrants

HIV/AIDS Clinical Trial

— ADELANTE  

Official title:

Addressing Barriers to Retention in HIV Care for Hispanic Immigrants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484117
• Other study ID #: 2016P000252
• Secondary ID: 5K23MH100978-04
• Status: Completed
• Phase: N/A
• Start date: May 26, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: December 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• Community Health Worker
Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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