Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy

State University of New York - Downstate Medical Center20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

HIV/AIDS

Interventions

APPEALBEHAVIORAL

Three-session, individually administered program, with sessions spaced monthly. Optional weekly contacts with participants to support engagement in program exercises/activities.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

SUNY Downstate Health Sciences University

Brooklyn, New York, United States

Outcomes

Primary Outcomes

Feasibility of recruitment approaches

The percentage of eligible individuals consented and randomized

Time frame: Baseline to 6 months

Feasibility of retention methods

The percentage of enrolled individuals who complete baseline, three-month, and six-month self-report evaluation measures

Time frame: Baseline to 3 months

Acceptability of intervention

The percentage of individuals in the intervention condition who complete all three sessions

Time frame: Baseline to 6 months

Changes in the proposed mechanistic target of positive and negative emotions, assessed using the Positive and Negative Affect Scale (PANAS)

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