Clinical trial NCT04035759: Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy
Official title: Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy (Project APPEAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV/AIDS
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of recruitment approaches
timeFrame: Baseline to 6 months
measure: Feasibility of retention methods
timeFrame: Baseline to 3 months
measure: Acceptability of intervention
timeFrame: Baseline to 6 months
measure: Changes in the proposed mechanistic target of positive and negative emotions, assessed using the Positive and Negative Affect Scale (PANAS)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Modified Differential Emotions Scale (MDES).
timeFrame: Baseline, 3 months, 6 months
measure: Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Drug Abuse Screening Test (DAST 10)
timeFrame: Baseline, 3 months, 6 months
measure: Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Perceived Stress Scale (PSS4)
timeFrame: Baseline, 3 months, 6 months
measure: Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Coping Strategies Inventory, Short Form (CSISF)
timeFrame: Baseline, 3 months, 6 months
measure: Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Revised Life Orientation Test (LOT-R)
timeFrame: Baseline, 3 months, 6 months
measure: Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Patient Health Questionnaire-8 item (PHQ8)
timeFrame: Baseline, 3 months, 6 months
measure: Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Alcohol Use Disorders Identification Test - Concise (AUDIT-C)
timeFrame: Baseline, 3 months, 6 months
measure: Frequency of endorsement of stressful life events utilizing a modification of the Crisis in Family Systems (CRYSIS)
timeFrame: Baseline, 3 months, 6 months
measure: Self-reported values of percent adherence
timeFrame: Baseline, 3 months, 6 months
measure: Self-reported adherence with medication taking instructions
timeFrame: Baseline, 3 months, 6 months
measure: Self-reported adherence missed doses of medication
timeFrame: Baseline, 3 months, 6 months
measure: Feasibility of electronic medication adherence
timeFrame: Baseline through 6 months
measure: HIV RNA viral load
timeFrame: Baseline through 6 months
measure: Retention in care
timeFrame: Baseline through six months
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Health Sciences University
state: New York
Study officials:
affiliation: SUNY Downstate Health Sciences University
name: Tracey Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson TE, Massiah C, Radigan R, DeHovitz J, Govindarajulu US, Holman S, Melendez M, Yusuff J, Taylor T. The positive affect, promoting Positive Engagement, and Adherence for Life (APPEAL) feasibility trial: Design and rationale. Health Psychol. 2020 Sep;39(9):767-775. doi: 10.1037/hea0000880.