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

NCT ID: NCT04240691

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2024-04-05

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.

Detailed Description

The human immunodeficiency virus (HIV) continues to cause significant illness and death in the USA despite availability of effective treatment. People who are aware of their HIV status, but who are out of care and not on medications, are therefore at risk of developing HIV related health problems. In addition, people with HIV who are out of care are at greater risk of transmitting HIV compared to people on HIV treatment with suppressed levels of virus in plasma. To date, there are no interventions that have been shown to successfully link this "out of care" population back into care and successfully maintain viral suppression.

This study will test a strategy of providing immediate HIV therapy drugs, linkage to care, and a randomized intervention (60-minutes for health or diet and nutrition session). The goal of the study is to demonstrate that the 60-Minutes-for-Health intervention improves the rate of viral suppression at 24 weeks.

The use of rapid antiretroviral therapy (rapid ART), defined as the initiation of ART within 7 days of HIV diagnosis, has been associated with improved rates of linkage to care, retention in care and virological suppression after 1 year among persons newly diagnoses with HIV. In addition, the behavioral intervention, "60-Minutes-for-Health", was shown in a pilot study to improve retention in care among PWH-OOC. We aim to undertake a study to evaluate the feasibility of providing rapid-ART to people who are aware of their HIV status, but have been out of care at the time they re-engage in care. In addition, study participants will be randomized to either the "60-Minutes-for-Health" intervention or a 60 minute diet and nutrition control session.

Conditions

Hiv; HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

60-Minutes-For-Health

Intervention Type: BEHAVIORAL

Refer to description under Groups

Time-and-Attention Control Session

60 Minute diet \& nutrition control session

Time-and-Attention Control Session

Intervention Type: OTHER

Refer to description under Groups

Interventions

60-Minutes-For-Health

Refer to description under Groups

Intervention Type: BEHAVIORAL

Time-and-Attention Control Session

Refer to description under Groups

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Susan Little, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Little, MD

Role: PRINCIPAL_INVESTIGATOR

UC San Diego AntiViral Research Center (AVRC)

Locations

UC San Diego AntiViral Research Center (AVRC)

San Diego, California, United States

UC San Diego Owen Clinic

San Diego, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

191875

Identifier Type: -

Identifier Source: org_study_id