HIV InfectionsMM2NCT00222716
Managing Medications
A study testing Problem solving counseling in people with HIV Infections, run by University of Pittsburgh at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Problem solving counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Improving Adherence to Antiretroviral Therapy
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).
Read the detailed description
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). The secondary aims address the relationship between adherence and quality of life (QOL), and between adherence and clinical response. The exploratory aims focus on examining the effect of self-efficacy on the relationship between the intervention and adherence, the effect of adherence on the relationship between self-efficacy and outcomes (clinical response and quality of life), as well as the effects of symptoms, alcohol and/or drug use, chronic interpersonal problems, mood, social support, optimism, perceived burden of medication regimen, perceived stigma, purpose in life, co-morbidity, personality, literacy, and intimate partner abuse on self-efficacy, and psychometric analyses of the instruments. The sample of 300 (plus 51 dropouts) PWHIV who are taking antiretroviral therapy and without cognitive dysfunction will be randomly assigned to one of two treatment arms. Those individuals who are deemed to be 100% adherers (approximately 25-50) will be assigned to the control group, but will be followed separately as a natural history substudy and interviewed. Data will be collected at baseline, post-treatment, post-maintenance, post-booster, and 18 months. Electronic event monitors, diaries, the Self-reported Medication-taking Scale, and the ACTG Adherence Follow-up Questionnaire will be used to assess adherence. The Digit Vigilance Test will be used to assess the effect of sustained attention on adherence. QOL will be measured using the MOS-HIV, the Satisfaction with Life Scale, and the Perception of Illness Visual Analogue Scale. Clinical response will be assessed using viral load, CD4 T-cell count, AIDS defining conditions, and hospitalizations. Variables influencing self-efficacy (measured with an investigator-developed Self-efficacy Scale) will be examined: symptoms ( CRCD Symptom Checklist), alcohol and/or drug use (AUDIT), chronic interpersonal problems (IIP), social support (Interpersonal Support Evaluation List), optimism (Life Orientation Test), anxiety (Beck Anxiety Inventory) and Beck Depression Inventory II), perceived burden of regimen (visual analog scales), perceived stigma (Perceived Stigma of HIV Scale), purpose in life (Purpose in Life Scale), co-morbidity (CRCD Co-Morbidity Scale), personality characteristics (NEO-FFI), health literacy (Test of Functional Health Literacy in Adults), knowledge about HIV medication adherence (HIV Medication Adherence Knowledge), and intimate partner abuse (Abuse Assessment Screen). A repeated measures model with planned comparisons will be used to test the hypotheses for the primary aim. Structural equation modeling will be used to examine the relationships identified in the secondary and exploratory aims. PWHIV who adhere to their therapy may live longer, require fewer hospitalizations, and have an improved QOL.
- Conditions
- HIV Infections
- Being tested
- Problem solving counseling
- Keywords
- Treatment adherence, HIV, Self-efficacy, Treatment Experienced
- Medical subject headings
- HIV Infections, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem solving counselingBehavioural
Telephone nurse counseling behavioral intervention focused on problem solving.
| Study group | Role | What they receive |
|---|---|---|
| Structured | Experimental | Behavioral Intervention: Structured counseling behavioral intervention focused on problem solving. Receives: Behavioral: Problem solving counseling |
| Usual Care | No intervention | Control arm |
| Inidividualized | Experimental | Behavioral Intervention: Individualized nurse counseling behavioral intervention focused on problem-solving Receives: Behavioral: Problem solving counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence as measured by electronic event monitors
MEMS data using AARDEX medication monitoring caps, percent daily dose correct.
Measured: 12 weeks
Secondary outcomes (1)
Morisky Medication Adherence Scaler
9 item Morisky self report measure on medication adherence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Judith Erlen, University of Pittsburgh
- Investigators
- Judith A Erlen, PHD, Principal investigator, University of PittsburghLisa K Tamres, MS, Study director, University of Pittsburgh School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222716
- Sponsor's protocol ID
- 2R01NR004749
- Acronym
- MM2
- Status last verified
- Jun 2017
- First submitted
- 14 Sep 2005
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 35274279
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence to Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00222716
- Acronym / sponsor ID
- MM2 / 2R01NR004749
- Conditions
- HIV Infections
- Keywords
- Treatment adherence, HIV, Self-efficacy, Treatment Experienced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Jan 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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). The secondary aims address the relationship between adherence and quality of life (QOL), and between adherence and clinical response. The exploratory aims focus on examining the effect of self-efficacy on the relationship between the intervention and adherence, the effect of adherence on the relationship between self-efficacy and outcomes (clinical response and quality of life), as well as the effects of symptoms, alcohol and/or drug use, chronic interpersonal problems, mood, social support, optimism, perceived burden of medication regimen, perceived stigma, purpose in life, co-morbidity, personality, literacy, and intimate partner abuse on self-efficacy, and psychometric analyses of the instruments. The sample of 300 (plus 51 dropouts) PWHIV who are taking antiretroviral therapy and without cognitive dysfunction will be randomly assigned to one of two treatment arms. Those individuals who are deemed to be 100% adherers (approximately 25-50) will be assigned to the control group, but will be followed separately as a natural history substudy and interviewed. Data will be collected at baseline, post-treatment, post-maintenance, post-booster, and 18 months. Electronic event monitors, diaries, the Self-reported Medication-taking Scale, and the ACTG Adherence Follow-up Questionnaire will be used to assess adherence. The Digit Vigilance Test will be used to assess the effect of sustained attention on adherence. QOL will be measured using the MOS-HIV, the Satisfaction with Life Scale, and the Perception of Illness Visual Analogue Scale. Clinical response will be assessed using viral load, CD4 T-cell count, AIDS defining conditions, and hospitalizations. Variables influencing self-efficacy (measured with an investigator-developed Self-efficacy Scale) will be examined: symptoms ( CRCD Symptom Checklist), alcohol and/or drug use (AUDIT), chronic interpersonal problems (IIP), social support (Interpersonal Support Evaluation List), optimism (Life Orientation Test), anxiety (Beck Anxiety Inventory) and Beck Depression Inventory II), perceived burden of regimen (visual analog scales), perceived stigma (Perceived Stigma of HIV Scale), purpose in life (Purpose in Life Scale), co-morbidity (CRCD Co-Morbidity Scale), personality characteristics (NEO-FFI), health literacy (Test of Functional Health Literacy in Adults), knowledge about HIV medication adherence (HIV Medication Adherence Knowledge), and intimate partner abuse (Abuse Assessment Screen). A repeated measures model with planned comparisons will be used to test the hypotheses for the primary aim. Structural equation modeling will be used to examine the relationships identified in the secondary and exploratory aims. PWHIV who adhere to their therapy may live longer, require fewer hospitalizations, and have an improved QOL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structured | Experimental | Behavioral: Problem solving counselingBehavioral Intervention: Structured counseling behavioral intervention focused on problem solving. |
| Usual Care | No intervention | –Control arm |
| Inidividualized | Experimental | Behavioral: Problem solving counselingBehavioral Intervention: Individualized nurse counseling behavioral intervention focused on problem-solving |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem solving counselingTelephone nurse counseling behavioral intervention focused on problem solving. | Behavioural | Inidividualized, Structured |
Primary outcome
Medication adherence as measured by electronic event monitors
Time frame: 12 weeks
MEMS data using AARDEX medication monitoring caps, percent daily dose correct.
1 secondary outcome
Morisky Medication Adherence Scaler
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
- Derived from this study: PubMed 35274279Butler 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith A Erlen, PHD principal investigator
University of Pittsburgh
Lisa K Tamres, MS study director
University of Pittsburgh School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem solving counseling in people with HIV Infections, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication adherence as measured by electronic event monitors (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222716, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2017.