Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy

NCT04035759 | Completed Phase 1

• 2 other identifiers: 1259781R21NR018348
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (4)

• Feasibility of recruitment approaches

  The percentage of eligible individuals consented and randomized

  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

  Baseline to 3 months

• Acceptability of intervention

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

  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

  Baseline, 3 months, 6 months

Secondary Outcomes (14)

• Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Modified Differential Emotions Scale (MDES).

  Baseline, 3 months, 6 months

• Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Drug Abuse Screening Test (DAST 10)

  Baseline, 3 months, 6 months

• Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Perceived Stress Scale (PSS4)

  Baseline, 3 months, 6 months

• Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Coping Strategies Inventory, Short Form (CSISF)

  Baseline, 3 months, 6 months

• Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Revised Life Orientation Test (LOT-R)

  Baseline, 3 months, 6 months

Study Arms (2)

APPEAL Program

EXPERIMENTAL

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.

Behavioral: APPEAL

Standard of care

NO INTERVENTION

Participants receive standard of care.

Interventions

APPEAL BEHAVIORAL

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

APPEAL Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Downstate Medical Center: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

SUNY Downstate Health Sciences University

Brooklyn, New York, 11231, United States

Location

Related Publications (1)

• 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.

  PMID: 32833478 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tracey Wilson, PhD

  SUNY Downstate Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Community Health Sciences

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 29, 2019
• Study Start: October 16, 2019
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available upon completion of publication of outcomes paper associated with the study. Data will be made available for three years following publication.
• Access Criteria: Principal Investigator wil grant permission upon request

Locations

US (1)