HIV Clinical Trial
— FACEOfficial title:
Palliative Care in People Living With HIV/AIDS: Integrating Into Standard of Care
Verified date | March 2019 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Our goal is to advance palliative care with persons living with AIDS (PLWA) or life-limiting
co-morbidities to decrease suffering and increase quality of life (QOL). Left without advance
care planning (ACP) for end-of-life decision, miscommunication and disagreements may result
in families being charged with neglect or court battles over treatment choices, unmet care or
delivery of unnecessary or unwanted care, and non-relative caregivers being dismissed (e.g.
gay partners). We hope to increase families' understandings of their family member's wishes
for end-of-life care to decrease conflict through the FAmily-CEntered Advance (FACE) Care
Planning intervention. We will also study communication, quality of life, and spiritual
struggle. Families will be randomized into either the Control (N=96 families) or the FACE
Intervention (n=192 dyads). FACE families will meet with a trained/certified researcher for
two 60-minute sessions scheduled one week apart: Session 1: The Respecting Choices
Interview®; and Session 2: Completion of The Five Wishes©. Control families will also meet
with a researcher for two 60-minute sessions scheduled one week apart: Session 1:
Developmental History; and Session 2: Nutrition and Exercise. Questionnaires will be
administered five times, Baseline and at 3, 6, 12 and 18 month post-intervention, for an
average of 2 years.
AIM 1. To determine the efficacy of FACE on congruence in treatment preferences between PLWA
and their surrogates over time, and the effect of the pattern of congruence development
trajectory on healthcare utilization (i.e., distal outcomes: number of hospitalizations,
dialysis, ER visits).
Hypothesis A: Development of congruence may not be homogeneous and FACE may influence the
pattern of congruence development.
Hypothesis B: Different patterns of congruence development may have different effects on
health care utilization.
Hypothesis C: Compared to Controls, FACE participants will better maintain congruence over
time.
AIM 2. To determine the efficacy of FACE on key components of QOL for PLWA. Hypothesis: FACE
participants will increase or better maintain psychosocial QOL compared to Controls.
AIM 3. To minimize health disparities in ACP between Blacks and non Blacks and identify
factors associated with disparities.
Hypothesis: Blacks in the FACE intervention will complete advance directives at a rate
comparable to non Blacks, and at significantly greater rates compared to Controls.
Status | Completed |
Enrollment | 444 |
Est. completion date | March 28, 2017 |
Est. primary completion date | March 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Patient Inclusion Criteria: - HIV positive outpatients or inpatients with detectable viral load (>200 copies) twice in the past 1 year period OR CD4 count <200 OR with a co-morbidity that may significantly limit life expectancy, including malignancy, cirrhosis, cardiomyopathy, etc. - Patients with AIDS receiving dialysis, inpatients or outpatients - Patients not in the Intensive Care Unit (ICU) - Age 21 years or older - All ethnic groups - Male or female - Knows his/her HIV status - English speaking - Absence of active psychosis or homicidal or suicidal ideation, determined at baseline screening by a trained research assistant as assessed by questions from a structured questionnaire - Absence of HIV dementia, determined at screening using the HIV Dementia Scale cut off score of <10 - No evidence of developmental delay - Consent from surrogate - Consent from persons living with AIDS (PLWA) aged 21 or older Surrogate Decision-maker inclusion criteria: - Selected by patient - Age 18 or older - Willingness to discuss problems related to HIV and End Of Life (EOL) - Absence of active psychosis, homicidal ideation, or suicidal ideation determined at baseline screening by trained RA - Absence of HIV dementia, determined at screening using the HIV Dementia Scale cut off score of <10 - English speaking - Consent to participate - Knows HIV status of patient Patient Exclusion Criteria: - Patients in the ICU - Age under 21 years old - Patient unaware of HIV status - Active psychosis or homicidal or suicidal ideation, determined at baseline screening by a trained research assistant as assessed by questions from a structured questionnaire - Presence fo HIV Dementia at baseline - Developmental delay - Unable to find willing consented surrogate Surrogate Decision-maker Exclusion Criteria: - Surrogate under age of 18 years old - Unwilling to discuss problems related to HIV and EOL - Active psychosis or homicidal or suicidal ideation, determined at baseline screening by a trained research assistant as assessed by questions from a structured questionnaire - Not an English speaker - Unwilling to consent to participate and does not know HIV status of patient |
Country | Name | City | State |
---|---|---|---|
United States | Children's National Medical Center | Washington | District of Columbia |
United States | George Washington University | Washington | District of Columbia |
United States | Georgetown University Hospital | Washington | District of Columbia |
United States | Institute for Clinical Research, Inc. (Affiliated with Department of Veterans Affairs Medical Center of Washington, DC) | Washington | District of Columbia |
United States | MedStar Health Research Institute/Washington Hospital Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's National Research Institute | George Washington University, Georgetown University, Medstar Health Research Institute, VA Medical Center |
United States,
Curtin KB, Cheng YI, Wang J, Scott RK, Squires L, Benator DA, Lyon ME; Palliative Care Consortiums. Quality of life of persons living with HIV and congruence with surrogate decision-makers. Qual Life Res. 2019 Jan;28(1):47-56. doi: 10.1007/s11136-018-2002 — View Citation
Grill KB, Wang J, Cheng YI, Lyon ME. (2020, January 30). The role of religiousness and spirituality in health-related quality of life of persons living with HIV: A latent class analysis. Psychology of Religion and Spirituality. Advance online publication.
Kimmel AL, Wang J, Scott RK, Briggs L, Lyon ME. FAmily CEntered (FACE) advance care planning: Study design and methods for a patient-centered communication and decision-making intervention for patients with HIV/AIDS and their surrogate decision-makers. Co — View Citation
Lyon ME, Squires L, D'Angelo LJ, Benator D, Scott RK, Greenberg IH, Tanjutco P, Turner MM, Weixel TE, Cheng YI, Wang J. FAmily-CEntered (FACE) Advance Care Planning Among African-American and Non-African-American Adults Living With HIV in Washington, DC: — View Citation
Lyon ME, Squires L, Scott RK, Benator D, Briggs L, Greenberg I, D'Angelo LJ, Cheng YI, Wang J. Effect of FAmily CEntered (FACE®) Advance Care Planning on Longitudinal Congruence in End-of-Life Treatment Preferences: A Randomized Clinical Trial. AIDS Behav — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | HIV Dementia Scale | Rapid screener to identify HIV dementia, which is an exclusion criteria. However, once enrolled in the study we will track changes in status over time, per the longitudinal nature of this study. | Screen for eligibility at Baseline, 3, 6, 12 and 18 months post intervention | |
Other | Psychological Interview | Questions to screen for homicidality and psychosis | Baseline to screen to determine eligibility | |
Other | Patient Health Questionnaire (PHQ-9) | Patients or surrogates who present with severe depression or suicidality are excluded from this study. However, once enrolled levels of depressive symptoms will be monitored over the course of this longitudinal study. | Baseline screening to determine if eligible for participation, then at 3, 6, 12 and 18 month post-intervention follow-up | |
Other | Medication Adherence Self Report Inventory (MASRI) | Validated self-report measure of medication adherence, using the Visual Analogue Scale for estimated adherence in the past month. Measured multiple times as part of this longitudinal study. | Baseline and 3, 6, 12 and 18 month follow-up | |
Other | Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Assesses the construct of spiritual functioning, specifically subscales for Forgiveness, Values and Believes will be used for study purposes. | Baseline and 3, 6, 12 and 18-month post intervention | |
Other | Brief Religious Coping Questionnaire (Brief RCOPE) | Assesses positive and negative religious coping methods. Study will use 14-item version. | Baseline and 3, 6, 12 and 18-month post-intervention | |
Other | Satisfaction Scale | Process measure developed in pilot study to assess satisfaction. | Immediately following Session 1 and Session 2, week 2 and week 3 of the study | |
Other | Longitudinal Satisfaction Questionnaire | Process measure to assess longitudinal satisfaction with future decision making. | 3, 6, 12 and 18 month post-intervention | |
Other | Medical Chart Abstraction | Mode of transmission, Cluster of Differentiation 4 (CD4) count, viral load, hospitalization, emergency room visit or dialysis since last study visit. | Baseline and 3, 6, 12 and 18 month post intervention | |
Other | Threat Appraisal Scale (TAS) | Threat Appraisal Scale (TAS)is a questionnaire administered to the adolescent during baseline assessment only. This measure will retrospectively estimate the adolescent's threat appraisal of cancer when adolescent learned of cancer diagnosis. Test-retest reliability for this measure ranges from .68 in younger children to .93 in older children. TAS scores are found to demonstrate a high degree of agreement with children's open-ended descriptions of negative life events, indicating adequate convergent validity of this measure. Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal, particularly to the way in which the event threatens the child's commitments, goals, or values. Higher threat appraisals should lead to negative arousal and coping and to increased psychological symptoms. | Baseline, 3, 6, 12 and 18 month post-intervention | |
Primary | Statement of Treatment Preferences | Measured by the Statement of Treatment Preferences. This measure was adapted using experts and community advisory board. It is a tool to express values and goals related to future medical decisions regarding frequently occurring situations specific to HIV/AIDS.Multiple Time Frames are needed as the Primary Outcome measure is going to report a change over time, per Aim 1: "to sustain congruence in treatment preferences between PLWA and their surrogate over time" compared to controls. | Baseline and 3, 6, 12, 18 month post-intervention | |
Secondary | Lyon Advance Care Planning Survey (Patient and Surrogate Version) | A 31-item instrument that assesses palliative care needs of PLWA of Black and non Black PLWA in DC metropolitan area | at baseline | |
Secondary | Palliative Care Outcome Scale (POS) | This scale is a valid and reliable measure of patient's current health, social and psychological status.We are conducting a longitudinal study and therefore looking at multiple time frames for change in palliative care over time. | Baseline, and 3, 6, 12 and 18 month post-intervention | |
Secondary | Medical Outcomes Study-HIV (MOS-HIV) | Measures HIV specific Health Related Quality of Life; general health perceptions; pain; physical, role, cognitive and social functioning; mental health; energy/fatigue; health distress and quality of life. This is a longitudinal study requiring multiple time frames so we can report change in quality of life over time, related to HIV specific symptoms. | Baseline, and 3, 6, 12 and 18 month post-intervention |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06162897 -
Case Management Dyad
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT02528773 -
Efficacy of ART to Interrupt HIV Transmission Networks
|
||
Recruiting |
NCT05454839 -
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
|
||
Recruiting |
NCT05322629 -
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
|
N/A | |
Completed |
NCT02579135 -
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
|
N/A | |
Active, not recruiting |
NCT01790373 -
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
|
N/A | |
Not yet recruiting |
NCT06044792 -
The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
|
||
Completed |
NCT04039217 -
Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM
|
Phase 4 | |
Active, not recruiting |
NCT04519970 -
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
|
N/A | |
Completed |
NCT04124536 -
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
|
N/A | |
Recruiting |
NCT05599581 -
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT02758093 -
Speed of Processing Training in Adults With HIV
|
N/A | |
Completed |
NCT02500446 -
Dolutegravir Impact on Residual Replication
|
Phase 4 | |
Completed |
NCT03805451 -
Life Steps for PrEP for Youth
|
N/A | |
Active, not recruiting |
NCT03902431 -
Translating the ABCS Into HIV Care
|
N/A | |
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 |