HIV Clinic-Based Intervention to Improve ART Adherence and Prevent HIV Transmission

NCT02044484 | Completed

• 2 other identifiers: CDC-NCHHSTP-2468CDC
• Study Type: interventional
• Target: 2,794
• Locations: 1 country
• Sites: 6

Brief Summary

This research, co-sponsored by the Centers for Disease Control and Prevention and the National Institute of Mental health, is conducted at six HIV clinics in the U.S. The research examines the effect of a clinic-based multi-component intervention delivered to HIV patients when they attend clinic for primary care. The study tests the hypothesis that the intervention will improve the viral load status of patients and improve attendance for HIV primary care.

Conditions

HIV

Keywords

HIV; AIDS; Viral load; Primary care

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with suppressed HIV (≤ 200 copies/mL)

  At 9-month time point

• Percentage of patients without a gap in HIV primary care (without a gap > 6 months)

  From baseline to 9-month time point

Secondary Outcomes (2)

• Change across time in log10 viral load values

  From baseline to 9-month time point

• HIV primary care appointment adherence

  From baseline to 9-month time point

Study Arms (2)

Multi-component intervention

EXPERIMENTAL

Computer-based intervention (CBI) completed twice (separated by 2-4 months) among patients whose viral load exceeds 1000 copies/mL at time of enrollment. One-on-one counseling from a project Health Coach (three 1-hour sessions at the clinic and two follow-up phone calls at 1 and 3 months after last session). The counseling is offered to patients who do not show a 1-log reduction in their viral load after the first CBI or whose viral load remains above 200 copies/mL after two administrations of the CBI. Behavioral screening of patients at HIV primary care visits. Dissemination of palm cards with empowering messages at HIV primary care visits.

Behavioral: Multi-component intervention

Standard of care control

NO INTERVENTION

HIV patients will continue to receive existing standard of care practices at the clinic without receiving the multi-component intervention.

Interventions

Multi-component intervention BEHAVIORAL

The computer-based intervention (CBI) is offered to patients whose viral load exceeds 1000 copies/mL at enrollment. Counseling is offered to patients whose viral load does not drop 1-log after the first CBI or remains above 200 copies/mL after completing two CBIs. The behavioral screener will be conducted of all patients at primary care visits. The patient completes the screener before seeing the provider. Responses are given to their provider who can use it in clinical care of the patient. At primary care visits, all patients are given a palm card containing 1 of 15 empowering messages before they leave the clinic. Messages cover three domains: adhering to antiretroviral therapy, regular care, and safer sex.

Multi-component intervention

Eligibility Criteria

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

You may qualify if:

• All patients are eligible to receive behavioral screening and palm cards
• Patients with viral load exceeding 1000 copies/mL are eligible for the computer-based intervention and referral to counseling

You may not qualify if:

• Patients under the age of 18 (under 19 in Alabama) are not eligible for the computer-based intervention or referral to counseling because they cannot provide legal informed consent.

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (6)

1917 Clinic

Birmingham, Alabama, 35294, United States

Location

Owen Clinic

San Diego, California, 92103, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Thomas Street Health Center

Houston, Texas, 77009, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Stirratt MJ, Marks G, O'Daniels C, Cachay ER, Sullivan M, Mugavero MJ, Dhanireddy S, Rodriguez AE, Giordano TP. Characterising HIV transmission risk among US patients with HIV in care: a cross-sectional study of sexual risk behaviour among individuals with viral load above 1500 copies/mL. Sex Transm Infect. 2018 May;94(3):206-211. doi: 10.1136/sextrans-2017-053178. Epub 2017 Nov 2.

  PMID: 29097417 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

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

Study Officials

• Thomas P Giordano, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Margaret Sullivan, MD

  Boston University

  PRINCIPAL INVESTIGATOR

• Matthew Golden, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Edward Cachay, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Michael J Mugavero, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Allan E Rodriguez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: January 24, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2016
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (6)