Instacare - Rapid ART Initiation Among Persons With HIV and Out of Care

NCT04240691 | Completed DMC

• 1 other identifier: 191875
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate two ways to help people re-engage with healthcare. The first is to assess if providing HIV treatment on the first visit (or within 1 week) can help people re-engage with care and ultimately stay in care after 24 and 48 weeks. It will also assess the success of starting treatment immediately by measuring the HIV virus in people's bloodstream after 24 and 48 weeks. The second part of this study is to assess a new behavioral treatment called 60-Minutes-for-Health which aims to help people identify and overcome barriers to HIV care, to help with motivation maintaining in care, to help cope with negative feelings about HIV, and to help increase self-reliance in seeking healthcare amid other things that are happening in your life.

Conditions

Hiv; HIV Infections

Outcome Measures

Primary Outcomes (2)

• Viral Suppression

  HIV VL ≤50 at week 24

  Week 24

• Retention in Care

  Two clinical care visits between enrollment and week 24 at least 90 days apart

  Week 24

Secondary Outcomes (5)

• ART Initiation

  Week 4

• Viral Suppression

  Week 48

• Retention in care

  Week 48

• Genotypic susceptibility score comparison

  Week 24 and 48

• Rapid ART acceptability

  Week 4-8

Study Arms (2)

60-Minutes-For-Health

60-Minutes-for Health: this is a psychological intervention which seeks to correct factors underlying decisions to delay or avoid HIV care and strengthen abilities to overcome HIV care utilization barriers. This is achieved through assistance identifying and reducing misinformation guiding HIV care attendance decisions; enhancing motivation to maintain HIV care via personal health goals; building skills for coping with negative feelings related to living with HIV; and increasing self-efficacy for navigating structural barriers and maintaining HIV care amidst competing priorities.

Behavioral: 60-Minutes-For-Health

Time-and-Attention Control Session

60 Minute diet \& nutrition control session

Other: Time-and-Attention Control Session

Interventions

60-Minutes-For-Health BEHAVIORAL

Refer to description under Groups

60-Minutes-For-Health

Time-and-Attention Control Session OTHER

Refer to description under Groups

Time-and-Attention Control Session

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Potential subjects from UCSD Owen Clinic that fulfill the entry criteria will be contacted and offered an appointment for study recruitment 2. Subjects identified in the UCSD emergency department HIV screening program will be contacted and offered an appointment for study recruitment 3. San Diego Public Health Department (SDPHD) has implemented routine evaluations of their local HIV surveillance data in conjunction with other data to identify PWH who may be OOC33. This Data to Care program results in the evaluation of \~ 250 new cases per year in San Diego (\~20-21 PWH-OOC a month), many of whom are found to be viremic and out-of-care. Once located, SDPHD will offer immediate transportation vouchers (Lyft) to and from the AVRC to expedite study enrollment and rapid ART start.

You may qualify if:

• years of age or older;
• Documented HIV infection status (or rapid HIV will be repeated);
• Out-of-care defined as not seen in HIV provider clinic for ≥6 months AND not receiving ART for ≥1 month (by self-report);
• Available for follow-up according to schedule of evaluations.

You may not qualify if:

• Co-morbid condition(s) that in the opinion of the investigator could limit the participant's ability to comply with the visit schedule or safely initiate rapid ART (e.g. psychiatric comorbidities or suspected central nervous system opportunistic infection);
• Prior ART regimens that in the opinion of the investigator precludes selection of a treatment option likely to result in virologic suppression (e.g. documented treatment failure on INSTI based regimen and multiple prior NRTI, NNRTI and PI regimens or documented resistance mutations likely to result in treatment failure)

Sponsors & Collaborators

• University of California, San Diego: lead
• Gilead Sciences: collaborator

Study Sites (2)

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, 92103, United States

Location

UC San Diego Owen Clinic

San Diego, California, 92103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stored Samples Containing DNA: blood and cells containing genetic materials will be stored. The blood and cells will be identified only be an identification number. However, there is an inherent risk of inadvertent disclosure of identity because DNA can be used to identify an individual.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Susan Little, MD

  UC San Diego AntiViral Research Center (AVRC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 27, 2020
• Study Start: May 20, 2020
• Primary Completion: September 1, 2022
• Study Completion: April 5, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

US (2)