NCT00222716

Brief Summary

The primary aim of this study is to compare the effect of an individualized adherence intervention (TI) and a structured adherence intervention (TS) to usual care on adherence to antiretroviral therapy in persons infected with HIV (PWHIV).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

5.9 years

First QC Date

September 14, 2005

Last Update Submit

June 22, 2017

Conditions

HIV Infections

Keywords

Treatment adherenceHIVSelf-efficacyTreatment Experienced

Outcome Measures

Primary Outcomes (1)

  • Medication adherence as measured by electronic event monitors

    MEMS data using AARDEX medication monitoring caps, percent daily dose correct.

    12 weeks

Secondary Outcomes (1)

  • Morisky Medication Adherence Scaler

    12 weeks

Study Arms (3)

Structured

EXPERIMENTAL

Behavioral Intervention: Structured counseling behavioral intervention focused on problem solving.

Behavioral: Problem solving counseling

Usual Care

NO INTERVENTION

Control arm

Inidividualized

EXPERIMENTAL

Behavioral Intervention: Individualized nurse counseling behavioral intervention focused on problem-solving

Behavioral: Problem solving counseling

Interventions

Problem solving counselingBEHAVIORAL

Telephone nurse counseling behavioral intervention focused on problem solving.

InidividualizedStructured

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be able to give informed consent,
  • be 18 years or older,
  • be taking antiretroviral therapy,
  • be able to speak and understand English,
  • have a telephone or access to a telephone,
  • and be living in a private residence or apartment in the community as opposed to a personal care/nursing home.

You may not qualify if:

  • significant cognitive impairment,
  • blind
  • motor impairment of their upper extremities
  • if another person in their household was or is currently enrolled in the study
  • the HDS that we will use to screen for cognitive impairment cannot be used with individuals who have these physical problems
  • Those with a hearing impairment who do not have a modified telephone to enhance their hearing will be excluded since they are unable to participate in the telephone delivered interventions or data collection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • Butler KR, Harrell FR, Rahim-Williams B, Robinson JM, Zhang X, Gyamfi A, Erlen JA, Henderson WA. Symptoms and Comorbidities Differ Based on Race and Weight Status in Persons with HIV in the Northern United States: a Cross-Sectional Study. J Racial Ethn Health Disparities. 2023 Apr;10(2):826-833. doi: 10.1007/s40615-022-01271-0. Epub 2022 Mar 10.

    PMID: 35274279DERIVED

MeSH Terms

Conditions

HIV InfectionsTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHealth BehaviorBehavior

Study Officials

  • Judith A Erlen, PHD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

  • Lisa K Tamres, MS

    University of Pittsburgh School of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

January 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

There is not plan to share data specifically but the data has been shared with the Mach14 Collaborative. Entire data set has been shared with the Collaborative.

Locations

US(1)