Retention in HIV Care for Hispanic Immigrants (ADELANTE)
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|ClinicalTrials.gov Identifier: NCT03484117|
Recruitment Status : Unknown
Verified March 2019 by Julie H Levison, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : March 30, 2018
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: Community Health Worker||Not Applicable|
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.
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 (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Addressing Barriers to Retention in HIV Care for Hispanic Immigrants|
|Actual Study Start Date :||May 26, 2017|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
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.
- Retention in Care [ Time Frame: 32 weeks ]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.
- HIV Viral Load [ Time Frame: From baseline to week 24 and from baseline to week 48 ]Change in HIV Viral Load
- CD4 T-cell Count [ Time Frame: From baseline to week 24 and from baseline to week 48 ]Change in CD4 T-cell count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484117
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Julie H Levison, MD||Massachusetts General Hospital|