Comparative Effectiveness of Brief HIV Care Counseling

NCT04180280 | Completed

• 1 other identifier: H14-184GDPH
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Retention in care and persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. Alcohol use is known to impede the health care and health outcomes of people living with HIV. The proposed comparative effectiveness study will evaluate the outcomes as well as the facilitators and barriers to implementing a theory-based alcohol counseling intervention that objectively monitors HIV treatment adherence with corrective feedback and increases care engagement delivered by cell phone in resource limited clinical settings.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Engagement in care

  Number of participants with clinical appointments attended.

  12-months

Secondary Outcomes (1)

• Medication adherence

  12-months

Study Arms (2)

Phone Delivered

ACTIVE COMPARATOR

Participants receive 5 sessions of phone-delivered behavioral counseling to improve HIV care.

Behavioral: Behavioral self-regulation Phone counseling to improve HIV care

Office Delivered

ACTIVE COMPARATOR

Participants receive 5 sessions of office-delivered behavioral counseling to improve HIV care.

Behavioral: Behavioral self-regulation Office counseling to improve HIV care

Interventions

Behavioral self-regulation Phone counseling to improve HIV care BEHAVIORAL

Participants receive 5 sessions of behavioral counseling to improve HIV care. Counseling is delivered using phone calls by a trained adherence and care engagement counselor.

Phone Delivered

Behavioral self-regulation Office counseling to improve HIV care BEHAVIORAL

Participants receive 5 sessions of behavioral counseling to improve HIV care. Counseling is delivered in clinical care offices s by a trained adherence and care

Office Delivered

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive Receiving clinical care New to care Or Returning to care or Not fully engaged in care

You may not qualify if:

• HIV Negative Not receiving HIV care

Sponsors & Collaborators

• University of Connecticut: lead
• Mercer University: collaborator

Study Sites (1)

Share Project

Atlanta, Georgia, 30308, United States

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Behavioral Counseling to Improve HIV Care

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: June 23, 2017
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

US (1)