HIV/AIDSPhase 1NCT04035759
Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy
A Phase 1 study testing APPEAL in people with HIV/AIDS, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- APPEAL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 26 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Health Sciences University
Brooklyn, New York, 11231
About this study
Official title: 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.
Read the 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
- Being tested
- APPEAL
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APPEALBehavioural
Three-session, individually administered program, with sessions spaced monthly. Optional weekly contacts with participants to support engagement in program exercises/activities.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: APPEAL |
| Standard of care | No intervention | Participants receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment approaches
The percentage of eligible individuals consented and randomized
Measured: 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
Measured: Baseline to 3 months
Acceptability of intervention
The percentage of individuals in the intervention condition who complete all three sessions
Measured: 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
Measured: 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).
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.
Measured: Baseline, 3 months, 6 months
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Drug Abuse Screening Test (DAST 10)
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.
Measured: Baseline, 3 months, 6 months
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Perceived Stress Scale (PSS4)
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.
Measured: Baseline, 3 months, 6 months
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Coping Strategies Inventory, Short Form (CSISF)
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.
Measured: Baseline, 3 months, 6 months
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Revised Life Orientation Test (LOT-R)
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.
Measured: Baseline, 3 months, 6 months
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Patient Health Questionnaire-8 item (PHQ8)
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.
Measured: 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)
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.
Measured: Baseline, 3 months, 6 months
Frequency of endorsement of stressful life events utilizing a modification of the Crisis in Family Systems (CRYSIS)
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.
Measured: Baseline, 3 months, 6 months
Self-reported values of percent adherence
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%
Measured: Baseline, 3 months, 6 months
Self-reported adherence with medication taking instructions
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
Measured: Baseline, 3 months, 6 months
Self-reported adherence missed doses of medication
Single item asking number of days in the past 30 days that participant missed at least one dose of medication
Measured: Baseline, 3 months, 6 months
Feasibility of electronic medication adherence
Proportion of participants who utilize Wisepill throughout study participation
Measured: Baseline through 6 months
HIV RNA viral load
Chart review will be conducted to assess HIV RNA viral load
Measured: Baseline through 6 months
Retention in care
Chart review will be conducted to assess kept and missed study visits
Measured: Baseline through six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start16 Oct 2019
- Primary completion26 Apr 2021
- Study completion26 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Tracey Wilson, State University of New York - Downstate Medical Center
- Investigators
- Tracey Wilson, PhD, Principal investigator, SUNY Downstate Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035759
- Sponsor's protocol ID
- 1259781
- Other IDs
- R21NR018348
- Status last verified
- Oct 2021
- First submitted
- 23 Jul 2019
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
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.
PubMed 32833478
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy (Project APPEAL)
- ClinicalTrials.gov ID
- NCT04035759
- Acronym / sponsor ID
- 1259781
- Conditions
- HIV/AIDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 26 Apr 2021 (actual)
- Study completion
- 26 Apr 2021 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APPEAL Program | Experimental | Behavioral: APPEALParticipants 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. |
| Standard of care | No intervention | –Participants receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APPEALThree-session, individually administered program, with sessions spaced monthly. Optional weekly contacts with participants to support engagement in program exercises/activities. | Behavioural | APPEAL Program |
Primary outcome
Feasibility of recruitment approaches
Time frame: Baseline to 6 months
The percentage of eligible individuals consented and randomized
Feasibility of retention methods
Time frame: Baseline to 3 months
The percentage of enrolled individuals who complete baseline, three-month, and six-month self-report evaluation measures
Acceptability of intervention
Time frame: Baseline to 6 months
The percentage of individuals in the intervention condition who complete all three sessions
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
14 secondary outcomes
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
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
Measurement properties (range, missingness, reliability) and mean scores with standard deviations for the Perceived Stress Scale (PSS4)
Time frame: 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
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
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
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
Frequency of endorsement of stressful life events utilizing a modification of the Crisis in Family Systems (CRYSIS)
Time frame: Baseline, 3 months, 6 months
Self-reported values of percent adherence
Time frame: Baseline, 3 months, 6 months
Self-reported adherence with medication taking instructions
Time frame: Baseline, 3 months, 6 months
Self-reported adherence missed doses of medication
Time frame: Baseline, 3 months, 6 months
Feasibility of electronic medication adherence
Time frame: Baseline through 6 months
HIV RNA viral load
Time frame: Baseline through 6 months
Retention in care
Time frame: Baseline through six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 32833478Wilson 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.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracey Wilson, PhD principal investigator
SUNY Downstate Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APPEAL in people with HIV/AIDS, run by State University of New York - Downstate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment approaches (time frame: Baseline to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.