Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy

NCT ID: NCT04035759

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2021-04-26

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

APPEAL

Intervention Type: BEHAVIORAL

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

Standard of care

Participants receive standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

APPEAL

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Tracey Wilson

Professor, Community Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tracey Wilson, PhD

Role: PRINCIPAL_INVESTIGATOR

SUNY Downstate Health Sciences University

Locations

SUNY Downstate Health Sciences University

Brooklyn, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32833478 (View on PubMed)

Other Identifiers

R21NR018348

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1259781

Identifier Type: -

Identifier Source: org_study_id