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Completed

NCT Number: NCT04035759

Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APPEAL

Behavioral

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

Primary outcomes

  1. Feasibility of recruitment approaches

    Time frame: Baseline to 6 months

    The percentage of eligible individuals consented and randomized

  2. 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

  3. Acceptability of intervention

    Time frame: Baseline to 6 months

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

  4. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Frequency of endorsement of stressful life events utilizing a modification of the Crisis in Family Systems (CRYSIS)

    Time frame: Baseline, 3 months, 6 months

    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.

  9. Self-reported values of percent adherence

    Time frame: Baseline, 3 months, 6 months

    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%

  10. Self-reported adherence with medication taking instructions

    Time frame: Baseline, 3 months, 6 months

    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

  11. Self-reported adherence missed doses of medication

    Time frame: Baseline, 3 months, 6 months

    Single item asking number of days in the past 30 days that participant missed at least one dose of medication

  12. Feasibility of electronic medication adherence

    Time frame: Baseline through 6 months

    Proportion of participants who utilize Wisepill throughout study participation

  13. HIV RNA viral load

    Time frame: Baseline through 6 months

    Chart review will be conducted to assess HIV RNA viral load

  14. Retention in care

    Time frame: Baseline through six months

    Chart review will be conducted to assess kept and missed study visits

Sponsors and collaborators

Lead sponsor

State University of New York - Downstate Medical Center

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy (Project APPEAL)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2019
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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