Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy (Project APPEAL)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment approaches
研究概览
简要总结
This study assesses the feasibility and acceptability of the APPEAL program, a 3-session intervention designed to promote positive affect among men and women living with HIV infection. Forty participants will be randomly assigned to receive the APPEAL program, and another 40 will receive standard of care. All participants will complete self-reported assessments at baseline and at 3 and 6 months, and will have their HIV antiretroviral medication adherence monitored as part of study participation.
详细描述
There is strong reason to expand the scope of current adherence programs to include consideration of a group of health protective variables known as 'psychosocial assets'. These assets include cognitive factors, such as optimism, emotional factors, such as positive affect, and positive social relationships. Increased psychosocial assets such as positive affect are associated with reduced morbidity and mortality, slower slower HIV progression, and reduced burden of depression symptoms. However, there has been limited translation of positive affect interventions to support patient self-management. In this study, we extend previous research on positive affect and adherence through the APPEAL program. The Affect, Promoting Positive Engagement, and Adherence for Life (APPEAL) program is an intervention that combines positive affect approaches to promote adherence in patients who have suboptimal adherence. We seek to implement the program, assess its feasibility, and describe associations with theoretically derived mechanisms of change, including positive affect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Receiving HIV care at site of recruitment
- •Prescribed an HIV antiretroviral regimen
- •HIV RNA viral load less than 200 copies/mL in last six months
排除标准
- •Unable to communicate in English
- •Prior participation in formative components of the study
- •Plans to move outside of New York City in next six months
- •Has cognitive impairment that would limit ability to provide informed consent
研究组 & 干预措施
APPEAL Program
Participants receive the APPEAL program, consisting of three one-on-one sessions, each lasting approximately one hour, and spaced one month apart. Sessions are designed to promote positive affect. Participants receive optional weekly check-ins to support behavior change efforts. All participants continue to receive standard of care.
干预措施: APPEAL (Behavioral)
Standard of care
Participants receive standard of care.
结局指标
主要结局
Feasibility of recruitment approaches
时间窗: Baseline to 6 months
The percentage of eligible individuals consented and randomized
Feasibility of retention methods
时间窗: Baseline to 3 months
The percentage of enrolled individuals who complete baseline, three-month, and six-month self-report evaluation measures
Acceptability of intervention
时间窗: Baseline to 6 months
The percentage of individuals in the intervention condition who complete all three sessions
Changes in the proposed mechanistic target of positive and negative emotions, assessed using the Positive and Negative Affect Scale (PANAS)
时间窗: Baseline, 3 months, 6 months
The PANAS is a 20 item measure which assesses emotions utilizing 5 response options for each question, ranging in value from 1 to 5. PANAS includes two 10-item subscales: positive affect and negative affect. Positive affect and negative affect items are summed separately, with each subscale ranging from 10 to 50. Higher scores for positive affect subscale indicate higher levels of positive affect and lower scores for negative affect items indicate lower levels of negative affect
次要结局
- Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Patient Health Questionnaire-8 item (PHQ8)(Baseline, 3 months, 6 months)
- Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Modified Differential Emotions Scale (MDES).(Baseline, 3 months, 6 months)
- Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Perceived Stress Scale (PSS4)(Baseline, 3 months, 6 months)
- Feasibility of electronic medication adherence(Baseline through 6 months)
- Self-reported adherence missed doses of medication(Baseline, 3 months, 6 months)
- Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Coping Strategies Inventory, Short Form (CSISF)(Baseline, 3 months, 6 months)
- Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Revised Life Orientation Test (LOT-R)(Baseline, 3 months, 6 months)
- Retention in care(Baseline through six months)
- Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Drug Abuse Screening Test (DAST 10)(Baseline, 3 months, 6 months)
- HIV RNA viral load(Baseline through 6 months)
- Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Alcohol Use Disorders Identification Test - Concise (AUDIT-C)(Baseline, 3 months, 6 months)
- Frequency of endorsement of stressful life events utilizing a modification of the Crisis in Family Systems (CRYSIS)(Baseline, 3 months, 6 months)
- Self-reported values of percent adherence(Baseline, 3 months, 6 months)
- Self-reported adherence with medication taking instructions(Baseline, 3 months, 6 months)
研究者
Tracey Wilson
Professor, Community Health Sciences
State University of New York - Downstate Medical Center