Clinical trial NCT03484117: Retention in HIV Care for Hispanic Immigrants
Official title: Addressing Barriers to Retention in HIV Care for Hispanic Immigrants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-03-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Retention in Care - Yes Responses
timeFrame: 32 weeks
Secondary outcomes:
measure: Number of Participants With HIV Viral Load Suppression up to Week-24
timeFrame: From baseline to week-24
measure: Change in CD4 T-cell Count Over 24 Weeks
timeFrame: From baseline to week-24
measure: Number of Participants With HIV Viral Load Suppression up to 48 Weeks.
timeFrame: Baseline to week-48
measure: Change in CD4 T-cell Count Over 48 Weeks.
timeFrame: Baseline to week-48
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Julie H Levison, MD
role: PRINCIPAL_INVESTIGATOR
References: