Addressing Depression and ART Adherence in HIV+ Latinos on the U.S.-Mexico Border
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a
研究概览
简要总结
The current HIV treatment adherence project was designed to adapt culturally and then pilot test an empirically supported cognitive-behavioral therapy program for adherence and symptoms of depression (CBT-AD)with HIV+ Latinos living on the U.S.-Mexico Border.
详细描述
Additionally, the investigators will assess the feasibility and efficacy of a novel medication monitoring and reminder system (MedSignals®) in the form of an electronic pillbox with monitoring and reminding functions that is available in a Spanish-language version. Our hypotheses are grounded in a conceptual model proposing that the CBT-AD intervention will improve problem-solving ability and decrease depressive symptomatology, which will directly improve biomedical outcomes of HIV-1 RNA viral load and CD4 as well as indirectly improve biomedical outcomes through increased motivation, improved memory, and better medication adherence. Evaluating and implementing generalizable and sustainable mental health and adherence interventions such as the ones proposed are urgently needed in the region to improve HIV treatment outcomes and thwart the development and transmission of drug resistant virus.
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
- •HIV+ participants (a) currently receiving HIV care at La Fe CARE Center (study site);
- •18 years of age or older;
- •Latino (i.e., self-identified as being of Mexican heritage);
- •English- or Spanish-speaking
- •capable of giving informed consent;
- •currently on a prescribed antiretroviral regimen;
- •suboptimally adherent (i.e., demonstrated either by a VL load taken in the last 12 months that is above the undetectable threshold of 50 mL copies or self-reporting a missed dose in the last two weeks);
- •exhibiting some depressive symptomatology (i.e., scoring on the Beck Depression Inventory-1A 10 or above), and (i) male or female (including transgender Female-to-Male and Male-To-Female.
排除标准
- •actively psychotic or so cognitively impaired that they cannot participate,
- •so physically ill as to be unable to come to the clinic to participate in the intervention, OR
- •Report The use of crack, cocaine, heroin, OR methamphetamines to any extent in the past 40 days.
- •Those who are planning on being away from the area for any extended period during the study (as in the case of seasonal workers) or whom
- •have household members already enrolled in the study will also be excluded. We did choose to restrict study eligibility to individuals of Mexican descent.
研究组 & 干预措施
Cognitive-Behavioral Therapy (CBT-AD)
This arm type is a cognitive-behavioral therapy program intervention for issues of medication adherence and depression. The intervention is a therapy program intervention involves 10-weekly or biweekly sessions, with 2 booster session, and focused on psychoeducation, behavioral activation, cognitive restructuring, and problem-solving. A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms.
干预措施: Cognitive-Behavioral Therapy (CBT-AD) (Behavioral)
Control-Standard Care
Those randomized to the control condition are not involved in the CBT-AD therapy intervention. They receive standard care as usual. A letter was sent to their medical provider indicating that mild symptoms of depression were detected and that they were enrolled in this intervention, but no details were provided regarding their assignment to one of two conditions/arms. The participants in the control arm are followed and matched to a participant in the intervention arm.
结局指标
主要结局
Depression From (1) Clinician-Administered MADRS Measure, and (2) Participant Self-Report Ratings With BDI-1a
时间窗: MADRS and BDI-1a scores at 6 and 9-month follow-up
1. Clinician-administered ratings are scored on the MADRS. The MADRS is a 10-item, past 7-day clinician administered scripted rating scale of depressive symptoms (each of the ten items is scored from 0-6, with total scores ranging from 0 to 60). The areas are: apparent and reported sadness, inner tension, reduced sleep/appetite, concentration difficulties, lassitude, inability to feel, pessimistic and suicidal thoughts. Higher scores indicate the presence of more depressive symptoms. 2. Participant self-report ratings are scored on the BDI-1a. The BDI-1a is assessed at each time point using the revised Beck Depression Inventory-Ia (BDI-Ia), which consists of 21 items, each with a 4-point response scale anchored with descriptive statements. Scores can range from 0-63, and scores of 10 or higher are presumptive of mild depressive severity. The BDI scores presented were added up and higher scores indicate worse depression. The MADRS and BDI-Ia is scored a total units on the scale.
次要结局
- Self-Report Adherence(Self-reported adherence at 6 and 9-month follow-up)
- MedSignals Electronic Pill-box for Adherence(6 and 9 month follow-up adherence scores)
研究者
Jane Simoni
Professor, Psychology; Adjunct Professor, Global Health
University of Washington