HIV Clinical Trial
Official title:
Longitudinal Pediatric Palliative Care: Quality of Life & Spiritual Struggle
Our goal is to advance palliative care to adolescents and their families. We hope our study will decrease suffering (psychological, spiritual, physical) and increase quality of life (QOL). Left unprepared for end-of-life decisions, miscommunication and disagreements may result in families being charged with neglect or court battles over treatment choices. FAmily CEntered (FACE) Advance Care Planning helps prepare adolescents with HIV/AIDS and their families for future medical decisions. We hope to increase families' understanding of their teens' wishes for end-of-life care and to decrease conflict. We will also study communication and spiritual struggle Families will be randomized into the either the Control (N=65 families) or FACE Intervention (N=65 families). FACE families will meet with a trained/certified researcher for three 60- to 90-minute sessions scheduled one week apart: Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2: The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control families will also meet with a researcher for three 60-to 90-minute sessions scheduled one week apart: Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Nutrition. Questionnaires will be administered five times, when first seen, at 3, 6, 12 and 18 months from the time of Session 3. Hypothesis 1: Compared to an active control, FACE will relieve psychological suffering by 1) increasing congruence in treatment preferences between teens with AIDS and their surrogates, 2) decreasing decisional conflict regarding EOL decision making for future medical treatment in adolescents with AIDS; 3) increasing quality communication about EOL care in adolescent/legal guardian or surrogate dyads; 4) and maximizing QOL. Hypothesis 2: In addition to the direct effects, FACE will also indirectly affect QOL through dimensions of threat appraisal. Hypothesis 3: FACE will have stronger effects on the QOL measures among patients who have less spiritual struggle. Hypothesis 4: Spiritual struggle has both direct and indirect effects on hospitalization/dialysis use. FACE will also affect hospitalization/dialysis use indirectly through threat appraisal and HAART adherence.
Our goal is to advance palliative care with children and their families aimed at relieving suffering (psychological, spiritual, physical) and maximizing quality of life. Left unprepared for end-of-life decisions, miscommunication and disagreements may result in families being charged with neglect, court battles and even legislative intervention. We propose building on our R34, evidence based model, the Family Centered (FACE) Advance Care Planning intervention, to test our full theoretical model examining the putative mediators and moderators, and spiritual struggle (negative religious coping) with a sicker group and adolescents with AIDS in an adequately powered randomized, clinical, 2-arm, controlled trial. FACE is a culturally sensitive and developmentally appropriate, manualized family intervention based on transactional stress and coping theory, which prepares adolescents with HIV/AIDS and their families for end-of-life decision-making through problem solving. Theoretically, threat appraisal is related to Lazarus' concept of primary appraisal, particularly the way in which an event threatens the child's goals or values. Spiritual struggle (negative religious coping) may be a source of distress, causing disparities in palliative care and outcomes. We will test the efficacy of the FACE intervention for increasing communication and congruence in end-of-life treatment preferences between teens with AIDS and their surrogates, and determine if increased congruence can be maintained over time. We will also examine the impact of the FACE intervention on decisional conflict, quality of communication, and patient quality of life. We will also evaluate hypothesized mediators (threat appraisal, HAART adherence) and moderator (spiritual struggle) of study outcomes, including hospitalizations. We will recruit from hospital-based clinics and randomize 130 adolescent/surrogate dyads (N=260 subjects) to either Control (N=65 dyads) or FACE Intervention (N=65 dyads). Participants with HIV dementia, severe depression, suicidality or homicidality or in foster care will not be allowed to participate. Three 60- to 90-minute sessions will be conducted with a certified interviewer at weekly intervals: FACE: Session 1: Lyon Advance Care Planning Survey© - Adolescent and Surrogate Versions: Session 2: The Respecting Choices Interview® Session 3: Completion of The Five Wishes©. Control will also be administered in a family group format to control for time, attention, and Hawthorn effects: Session 1: Developmental History, Session 2: Safety Tips, and Session 3: Safety Tips. Standardized self-report measures will be administered at baseline, immediate post intervention (3 month), and 6, 12 and 18 month post intervention. Generalized estimating equation (GEE) will assess outcomes. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06162897 -
Case Management Dyad
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Adherence to Anti- Retroviral Therapy (ART) Among People Living With Human Immunodeficiency Virus (HIV)
|
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 |