Clinical Trials Directory

Trials / Completed

CompletedNCT04035759

Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy

Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy (Project APPEAL)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
20 (actual)
Sponsor
State University of New York - Downstate Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2019-10-16
Primary completion
2021-04-26
Completion
2021-04-26
First posted
2019-07-29
Last updated
2021-11-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04035759. Inclusion in this directory is not an endorsement.