- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04035759
Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy
October 25, 2021 updated by: Tracey Wilson, State University of New York - Downstate Medical Center
Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy (Project APPEAL)
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Brooklyn, New York, United States, 11231
- SUNY Downstate Health Sciences University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Three-session, individually administered program, with sessions spaced monthly.
Optional weekly contacts with participants to support engagement in program exercises/activities.
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No Intervention: Standard of care
Participants receive standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of recruitment approaches
Time Frame: Baseline to 6 months
|
The percentage of eligible individuals consented and randomized
|
Baseline to 6 months
|
Feasibility of retention methods
Time Frame: Baseline to 3 months
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The percentage of enrolled individuals who complete baseline, three-month, and six-month self-report evaluation measures
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Baseline to 3 months
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Acceptability of intervention
Time Frame: Baseline to 6 months
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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)
Time Frame: Baseline, 3 months, 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Modified Differential Emotions Scale (MDES).
Time Frame: Baseline, 3 months, 6 months
|
The MDES is a 20 item measure which assesses emotions utilizing 5 response options for each question, ranging in value from 0 to 4. MDES includes two 10-item subscales: positive affect and negative affect.
Positive affect and negative affect items are summed separately, and each is divided by 10, with each subscale ranging from 0 to 4. Higher score for each subscale indicate greater frequency of experiencing positive or negative emotions.
|
Baseline, 3 months, 6 months
|
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Drug Abuse Screening Test (DAST 10)
Time Frame: Baseline, 3 months, 6 months
|
The DAST 10 is a 10 item screen for drug abuse.
It includes 10 items, each response with a 0 or 1. Items are summed, with a range of responses from 0 to 10. Higher scores indicate greater negative consequences of drug abuse.
|
Baseline, 3 months, 6 months
|
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Perceived Stress Scale (PSS4)
Time Frame: Baseline, 3 months, 6 months
|
The PSS4 measures perceived stress.
Each of the 4 items has five possible response options, ranging from 0 to 4. The resulting summed scale can range from 0 to 16, with higher scores indicating greater stress.
|
Baseline, 3 months, 6 months
|
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Coping Strategies Inventory, Short Form (CSISF)
Time Frame: Baseline, 3 months, 6 months
|
The CSISF is a 16 item scale assessing approaches to coping with stressors.
Each of the items has 5 potential response options, ranging from 1 to 5, and items are grouped into four 4-item subscales.
Items within each subscale are summed, resulting in a subscale range from 4 to 20.
Higher scores on each of the subscales, focused on 1) Problem-Focused Engagement, (2) Problem-Focused Disengagement, (3) Emotion-Focused Engagement, and (4) Emotion-Focused Disengagement, indicates greater frequency of use of that particular coping strategy.
|
Baseline, 3 months, 6 months
|
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Revised Life Orientation Test (LOT-R)
Time Frame: Baseline, 3 months, 6 months
|
The LOT-R is a 6-item measure of generalized optimism versus pessimism.
For each of the items there are 5 response options ranging from 0 to 4. Items are summed with a scale range of 0 to 24, and with higher scores indicating greater optimism.
|
Baseline, 3 months, 6 months
|
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Patient Health Questionnaire-8 item (PHQ8)
Time Frame: Baseline, 3 months, 6 months
|
The PHQ8 is an 8-item measure assessing burden of depression symptoms.
Each item has 4 response options ranging from 0 to 3; items are summed with a resulting scale range of 0 to 24.
Higher scores suggest greater risk for depression.
|
Baseline, 3 months, 6 months
|
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Alcohol Use Disorders Identification Test - Concise (AUDIT-C)
Time Frame: Baseline, 3 months, 6 months
|
The AUDIT-C is a 3-item measure assessing risk for alcohol use disorder.
Each item has 4 response options ranging from 0 to 4, and items are summed with a resulting range from 0 to 12.
In men, a score of 4 or more is considered positive for an alcohol use disorder; in women, a score of 3 or more is considered positive.
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Baseline, 3 months, 6 months
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Frequency of endorsement of stressful life events utilizing a modification of the Crisis in Family Systems (CRYSIS)
Time Frame: Baseline, 3 months, 6 months
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An adapted version of the CRISYS checklist is being utilized, based on formative feedback on the scale.
The adapted measure lists thirty-four events, with a 0 indicating no experience and a 1 indicating an experience.
The checklist can range from 0 to 34 possible events.
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Baseline, 3 months, 6 months
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Self-reported values of percent adherence
Time Frame: Baseline, 3 months, 6 months
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Single item asking over past 30 days how often medication was taken as prescribed.
Four response options available: 100%, 95-99% 75-94%, less than 75%
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Baseline, 3 months, 6 months
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Self-reported adherence with medication taking instructions
Time Frame: Baseline, 3 months, 6 months
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Single item asking over past 30 days how good of a job did participant do at take medication in the way that they are supposed to.
Six response options available: Very poor, poor, fair, good, very good, excellent
|
Baseline, 3 months, 6 months
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Self-reported adherence missed doses of medication
Time Frame: Baseline, 3 months, 6 months
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Single item asking number of days in the past 30 days that participant missed at least one dose of medication
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Baseline, 3 months, 6 months
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Feasibility of electronic medication adherence
Time Frame: Baseline through 6 months
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Proportion of participants who utilize Wisepill throughout study participation
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Baseline through 6 months
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HIV RNA viral load
Time Frame: Baseline through 6 months
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Chart review will be conducted to assess HIV RNA viral load
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Baseline through 6 months
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Retention in care
Time Frame: Baseline through six months
|
Chart review will be conducted to assess kept and missed study visits
|
Baseline through six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tracey Wilson, PhD, SUNY Downstate Health Sciences University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 16, 2019
Primary Completion (Actual)
April 26, 2021
Study Completion (Actual)
April 26, 2021
Study Registration Dates
First Submitted
July 23, 2019
First Submitted That Met QC Criteria
July 24, 2019
First Posted (Actual)
July 29, 2019
Study Record Updates
Last Update Posted (Actual)
November 1, 2021
Last Update Submitted That Met QC Criteria
October 25, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- 1259781
- R21NR018348 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Raw, de-identified data and codebook related to primary outcomes will be made available on Open Science Framework.
Wilson, T. (2019, July 21). Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy. Retrieved from osf.io/s7ve9
IPD Sharing 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.
IPD Sharing Access Criteria
Principal Investigator wil grant permission upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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