Addressing Barriers to Retention in HIV Care for Hispanic Immigrants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Retention in Care - Yes Responses
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable to provide verbal consent due to unstable medical or psychiatric condition
结局指标
主要结局
Retention in Care - Yes Responses
时间窗: 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. Responses determined by review of the medical record for evidence of attended HIV clinic visits.
次要结局
- Change in CD4 T-cell Count Over 48 Weeks.(Baseline to week-48)
- Number of Participants With HIV Viral Load Suppression up to Week-24(From baseline to week-24)
- Change in CD4 T-cell Count Over 24 Weeks(From baseline to week-24)
- Number of Participants With HIV Viral Load Suppression up to 48 Weeks.(Baseline to week-48)
研究者
Julie H Levison
MD, MPhil, MPH, Assistant Professor of Medicine at Harvard Medical School
Massachusetts General Hospital