Targeting HIV Retention and Improved Viral Load Through Engagement ('THRIVE')

NCT04481373 | Completed Results

• 2 other identifiers: H-474445R34MH122294
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Many people with HIV infection are not consistently engaged in outpatient HIV care, and avoidance, stigma and denial contribute to poor engagement in HIV care. This project will develop and pilot test a new intervention, "THRIVE," for hospitalized persons who are out of HIV care and endorse avoidance, to improve how well they stay in outpatient HIV care after discharge. If successfully developed, the intervention will undergo large scale testing in later studies and could improve the health of persons with HIV infection and help end the HIV epidemic in the United States.

Conditions

Human Immunodeficiency Virus; Depression; Anxiety

Keywords

Acceptance and Commitment Therapy; HIV; depression; anxiety; distress; avoidance

Outcome Measures

Primary Outcomes (4)

• Acceptability of Enrollment and Randomization: Eligible But Declined Participation

  The number of eligible PWH who agree and decline to participate, and reasons for declining;

  6 months

• Acceptability of Enrollment and Randomization: Completion Sessions

  Completion of at least 3 out of 4 intervention sessions in the THRIVE group

  6 months

• Acceptability of the Intervention: 6 Month Follow-up

  The completion of participant 6-month follow-up assessments

  6 months

• Acceptability of the Intervention

  Mean duration of contact for participants who completed all four sessions

  6 months

Secondary Outcomes (2)

• Viral Load Improvement

  6 months

• Number of Patients Who Are Retained in HIV Care

  6 months

Other Outcomes (7)

• Internalized AIDS-Related Stigma Scale (IARSS)

  6 months

• Depression Anxiety and Stress Scale (DASS-21).

  6 months

• Alcohol Use Disorders Identification Test (AUDIT)

  6 months

Study Arms (2)

THRIVE

EXPERIMENTAL

Acceptance and Commitment Therapy plus Education about HIV A master's level mental health professional will provide the 4-5 hour intervention for out-of-care PWH during a hospitalization. There are two important components to the intervention: Acceptance and Commitment Therapy (ACT) content, targeting avoidance with acceptance-based coping and active engagement in values-based living, and HIV education.

Behavioral: THRIVE

Treatment as Usual

OTHER

Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.

Other: Treatment as Usual

Interventions

THRIVE BEHAVIORAL

The ACT components (3-3.5 hours) will focus on clarifying patient values and goals and identifying obstacles that may be getting in the way of living a rich life. Short-and long-term effects of avoidance will be discussed (e.g., avoidance reduces immediate contact with distressing experiences and provides short-term relief but leads to greater dysfunction in long run). Patients will be taught acceptance, mindfulness, and perspective taking to help patient cope with difficult emotions and thoughts that may interfere with living a values-driven life. Individuals will also be encouraged to examine the costs of stigmatization on their life (e.g. avoidance of medical care, sense of isolation). Education will include medical information about HIV, services available at the clinic, and health needs related to comorbidities. This content to be delivered in 30 minutes.

Also known as: Acceptance and Commitment Therapy plus Education

THRIVE

Treatment as Usual OTHER

Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized at Ben Taub Hospital, Houston, TX;
• at least 18 years of age;
• able to speak English or Spanish;
• HIV infected;
• able to provide informed consent and participate in the study (patients who are temporarily unable to participate will be followed and approached for enrollment if and when they are cognitively and physically capable of consenting and participating);
• HIV VL\>1000 c/mL;
• never in care or currently out of HIV care, defined as not meeting the 'visit constancy' measure (≥1 completed HIV primary care visit at Thomas Street Health Center (TSHC), Houston, TX, in each of the three 4-month intervals preceding admission); or ≥2 "no shows" to HIV primary care visits at TSHC in the last year.
• endorse one of two avoidance coping statements with the highest factor loadings on the Avoidant Coping Subscale from the Coping with HIV/AIDS scale

You may not qualify if:

• intending to use a source of HIV primary care other than TSHC after discharge, because their outcomes cannot be evaluated;
• in the opinion of the primary medical team caring for the patient, likely to be discharged to an institutional setting, die in the hospital or enter hospice;
• incarcerated or expected to be discharged to prison or jail;
• enrolled in another research study with prospective follow-up;
• pregnant, since pregnant women receive additional efforts to be linked and retained in care;
• admitted with acute psychosis which would preclude informed consent or meaningful participation with the intervention.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of Iowa: collaborator
• Brown University: collaborator
• University of Texas: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Ben Taub Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Dindo L, Moitra E, Roddy MK, Ratcliff C, Markham C, Giordano T. Development and Initial Feasibility of a Hospital-Based Acceptance and Commitment Therapy Intervention to Improve Retention in Care for Out-of-Care Persons with HIV: Lessons Learned from an Open Pilot Trial. J Clin Med. 2022 May 17;11(10):2827. doi: 10.3390/jcm11102827.

  PMID: 35628955 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression; Anxiety Disorders

Interventions

Nicotine; Educational Status; Therapeutics

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Thomas Giordano
• Organization: Baylor College of Medicine

tpg@bcm.edu

7137988918

Study Officials

• Lilian Dindo, Ph.D

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Thomas Giordano, M.D., M.P.H.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 22, 2020
• Study Start: March 3, 2021
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Locations

US (1)