Modified Directly Observed Therapy for Improving Antiretroviral Therapy Adherence in People With HIV

NCT00339092 | Completed

• 1 other identifier: R01MH064388
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of a modified directly observed therapy program in increasing antiretroviral therapy adherence in poor, HIV-infected residents of urban communities.

Conditions

HIV Infections

Keywords

HIV; ART

Outcome Measures

Primary Outcomes (1)

• CD4 and Viral Load

  Measured at baseline and Months 3, 6, and 9

Secondary Outcomes (1)

• Adherence

  Measured monthly for 9 months

Study Arms (2)

Treatment

EXPERIMENTAL

Participants who receive storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals

Behavioral: Modified Directly Observed Therapy

Control

ACTIVE COMPARATOR

Participants who receive standard care

Behavioral: Standard Care

Interventions

Modified Directly Observed Therapy BEHAVIORAL

Treatment includes storefront modified directly observed therapy (MDOT) of prescribed antiretrovirals. Participants in the MDOT program will report to the study site each morning for 3 months, Monday through Friday, to take their HIV medication and any other medications prescribed by their primary care doctors. At the end of 3 months, participants will no longer attend the study site for medication assistance. Participants will then attend Action Point, a county program that helps participants adhere to taking medication, for an additional 3 months.

Also known as: MDOT

Treatment

Standard Care BEHAVIORAL

Participants assigned to standard care will report to the study site once a month for 9 months, but will not receive any assistance with taking HIV medications. Information about medication adherence, housing, income, use of health services, drug use, sexual practices, and mental health services will be collected at each visit.

Control

Eligibility Criteria

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

You may qualify if:

• HIV infected
• Severely immunosuppressed (HIV viral load of greater than 400 copies/ml)
• Does not consistently take prescribed ARV
• Currently prescribed HIV medications or prescribed to start taking HIV medications

You may not qualify if:

• Currently participating in any other adherence program or intervention study

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCSF Market Street Study Site

San Francisco, California, 94102, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

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; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• David R. Bangsberg, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: January 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: April 19, 2013

Record last verified: 2013-04

Locations

US (1)