HIVPhase 2NCT00264823
Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)
A Phase 2 study testing Use of Memory Aids to take medications in people with HIV and Mental Illness, run by National Institute of Nursing Research (NINR) at 1 site in United States.
Trial summary
The purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Mental Illness
- What is being tested?
- Use of Memory Aids to take medications
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to May 2008
- Phase
- Phase 2
- 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
- Diagnosis of serious mental illness; HIV positive
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Mental Health Services and Policy Research
Philadelphia, Pennsylvania, 19104
About this study
Official title: Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)
The purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans.
Read the detailed description
There is concern that HIV positive SMI persons may be a greater risk for poor treatment adherence, increasing risk for poorer outcomes and development of treatment resistance virus, and also placing others at greater risk. Involvement of advance practice nurses has been previously shown to improve outcomes for persons with HIV/AIDS.
- Conditions
- HIV, Mental Illness
- Being tested
- Use of Memory Aids to take medications
- Keywords
- HIV, Mental Illness
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Memory Aids to take medicationsBehavioural
Experimental participants will receive an integrated intervention tailored to the communication and comprehension of the individual, and will include memory aid devices, education regarding side effects and other treatment aspects, and active community outreach. For those who fail to adhere using the basic intervention, a treatment cascade that increases in intensity will be implemented. Using 80% adherence as a target, the cascade will include involvement of family and significant others in prompting participants through use of beepers, cellphones, and for those who still fall short of 80% adherence, directly observed therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Experimental | Experimental | Not described Receives: Behavioral: Use of Memory Aids to take medications |
| 2 - Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
How to best help people with serious mental illness follow HIV treatment regimens
Measured: baseline, 3, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startJun 2003
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nursing Research (NINR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Blank, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264823
- Sponsor's protocol ID
- 708134
- Other IDs
- 5R01NR008851-03
- Status last verified
- Oct 2008
- First submitted
- 9 Dec 2005
- Last updated
- 6 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dalseth N, Reed RS, Hennessy M, Eisenberg MM, Blank MB. Does Diagnosis Make a Difference? Estimating the Impact of an HIV Medication Adherence Intervention for Persons with Serious Mental Illness. AIDS Behav. 2018 Jan;22(1):265-275. doi: 10.1007/s10461-017-1795-5.
PubMed 28536741Wu ES, Rothbard A, Holtgrave DR, Blank MB. Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV. Community Ment Health J. 2016 May;52(4):439-45. doi: 10.1007/s10597-014-9788-6. Epub 2014 Dec 23.
PubMed 25535041Blank MB, Hennessy M, Eisenberg MM. Increasing quality of life and reducing HIV burden: the PATH+ intervention. AIDS Behav. 2014 Apr;18(4):716-25. doi: 10.1007/s10461-013-0606-x.
PubMed 24000053
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)
- ClinicalTrials.gov ID
- NCT00264823
- Acronym / sponsor ID
- 708134
- Conditions
- HIV, Mental Illness
- Keywords
- HIV, Mental Illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- National Institute of Nursing Research (NINR)US National Institutes of Health
- Study start
- Jun 2003
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Dec 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 purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans.
Detailed description
There is concern that HIV positive SMI persons may be a greater risk for poor treatment adherence, increasing risk for poorer outcomes and development of treatment resistance virus, and also placing others at greater risk. Involvement of advance practice nurses has been previously shown to improve outcomes for persons with HIV/AIDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Experimental | Experimental | Behavioral: Use of Memory Aids to take medications |
| 2 - Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of serious mental illness; HIV positive
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Use of Memory Aids to take medicationsExperimental participants will receive an integrated intervention tailored to the communication and comprehension of the individual, and will include memory aid devices, education regarding side effects and other treatment aspects, and active community outreach. For those who fail to adhere using the basic intervention, a treatment cascade that increases in intensity will be implemented. Using 80% adherence as a target, the cascade will include involvement of family and significant others in prompting participants through use of beepers, cellphones, and for those who still fall short of 80% adherence, directly observed therapy. | Behavioural | 1 - Experimental |
Primary outcome
How to best help people with serious mental illness follow HIV treatment regimens
Time frame: baseline, 3, 12 and 24 months
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 6 Oct 2008.
- Derived from this study: PubMed 28536741Dalseth N, Reed RS, Hennessy M, Eisenberg MM, Blank MB. Does Diagnosis Make a Difference? Estimating the Impact of an HIV Medication Adherence Intervention for Persons with Serious Mental Illness. AIDS Behav. 2018 Jan;22(1):265-275. doi: 10.1007/s10461-017-1795-5.
- Derived from this study: PubMed 25535041Wu ES, Rothbard A, Holtgrave DR, Blank MB. Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV. Community Ment Health J. 2016 May;52(4):439-45. doi: 10.1007/s10597-014-9788-6. Epub 2014 Dec 23.
- Derived from this study: PubMed 24000053Blank MB, Hennessy M, Eisenberg MM. Increasing quality of life and reducing HIV burden: the PATH+ intervention. AIDS Behav. 2014 Apr;18(4):716-25. doi: 10.1007/s10461-013-0606-x.
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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.
Michael Blank, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Use of Memory Aids to take medications in people with HIV and Mental Illness, run by National Institute of Nursing Research (NINR) 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 1 inclusion and 1 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 6 Oct 2008. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
How to best help people with serious mental illness follow HIV treatment regimens (time frame: baseline, 3, 12 and 24 months). 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 NCT00264823, which also lists 3 linked publications.
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 6 Oct 2008.