Managing Medications (MM2)
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ClinicalTrials.gov Identifier: NCT00222716 |
Recruitment Status
:
Completed
First Posted
: September 22, 2005
Last Update Posted
: June 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Behavioral: Problem solving counseling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 349 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Improving Adherence to Antiretroviral Therapy |
Study Start Date : | January 2004 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Structured
Behavioral Intervention: Structured counseling behavioral intervention focused on problem solving.
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Behavioral: Problem solving counseling
Telephone nurse counseling behavioral intervention focused on problem solving.
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No Intervention: Usual Care
Control arm
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Experimental: Inidividualized
Behavioral Intervention: Individualized nurse counseling behavioral intervention focused on problem-solving
|
Behavioral: Problem solving counseling
Telephone nurse counseling behavioral intervention focused on problem solving.
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- Medication adherence as measured by electronic event monitors [ Time Frame: 12 weeks ]MEMS data using AARDEX medication monitoring caps, percent daily dose correct.
- Morisky Medication Adherence Scaler [ Time Frame: 12 weeks ]9 item Morisky self report measure on medication adherence

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222716
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15261 |
Principal Investigator: | Judith A Erlen, PHD | University of Pittsburgh | |
Study Director: | Lisa K Tamres, MS | University of Pittsburgh School of Nursing |
Responsible Party: | Judith Erlen, Professor, University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00222716 History of Changes |
Other Study ID Numbers: |
2R01NR004749 ( U.S. NIH Grant/Contract ) |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | June 26, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | 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. |
Keywords provided by Judith Erlen, University of Pittsburgh:
Treatment adherence HIV Self-efficacy Treatment Experienced |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |