SUNY Downstate Health Sciences University
Brooklyn, New York, 11231, United States
NCT Number: NCT04035759
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 1
Brooklyn, New York, 11231, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Three-session, individually administered program, with sessions spaced monthly. Optional weekly contacts with participants to support engagement in program exercises/activities.
Time frame: Baseline to 6 months
The percentage of eligible individuals consented and randomized
Time frame: Baseline to 3 months
The percentage of enrolled individuals who complete baseline, three-month, and six-month self-report evaluation measures
Time frame: Baseline to 6 months
The percentage of individuals in the intervention condition who complete all three sessions
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
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.
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.
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.
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.
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.
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.
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.
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.
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%
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
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
Time frame: Baseline through 6 months
Proportion of participants who utilize Wisepill throughout study participation
Time frame: Baseline through 6 months
Chart review will be conducted to assess HIV RNA viral load
Time frame: Baseline through six months
Chart review will be conducted to assess kept and missed study visits
State University of New York - Downstate Medical Center
Other
Positive Affect Promotion to Empower Optimal Adherence to HIV Therapy (Project APPEAL)
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.
Published trials that share one or more normalized conditions with this study.
NCT05609513
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Kampala, Uganda
View Trial DetailsNCT06739915
Acquired Immunodeficiency Syndrome, Actinomycetales Infections
Soweto, Gauteng, South Africa
View Trial DetailsNCT04446611
Acquired Immunodeficiency Syndrome, Antenatal Care
East London, Eastern Cape, South Africa
View Trial DetailsNCT05121064
Acquired Immunodeficiency Syndrome, Alcohol-Related Disorders
Lusaka, Zambia
View Trial Details