Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy

State University of New York - Downstate Medical Center

Status and phase: Completed; Phase 1

Conditions: HIV/AIDS

Treatments: Behavioral: APPEAL

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04035759

R21NR018348 (U.S. NIH Grant/Contract)

1259781

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

APPEAL Program

Experimental group

Description:

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.

Treatment:

Behavioral: APPEAL

Standard of care

No Intervention group

Description:

Participants receive standard of care.