Human Immunodeficiency Virus I InfectionNCT01304186
An Automated, Tailored Information Application for Medication Health Literacy
A study testing Tailored Information in people with Human Immunodeficiency Virus I Infection, run by Nova Southeastern University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the acceptability and efficacy of a computer-based tailored information application designed to promote health literacy in persons treated for HIV infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus I Infection
- What is being tested?
- Tailored Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jun 2012
- 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
- Aged 18 years or older
- Currently treated with at least one medication for HIV infection
- No change in target medication anticipated in the next two months
- Able to participate in the study intervention in English
Who cannot join
- Psychiatric or cognitive disorder of severity sufficient to make the potential participant unable to provide informed consent.
- Not able to participate in the intervention using English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ziff Health Clinics, Nova Southeastern University
Fort Lauderdale, Florida, 33328
About this study
The purpose of this study is to evaluate the acceptability and efficacy of a computer-based tailored information application designed to promote health literacy in persons treated for HIV infection. The study hypothesis is that the application will be acceptable and usable for persons treated for HIV infection, and will improve their levels of adherence to antiretroviral medication treatment.
Read the detailed description
Health literacy is a critically important problem in improving the effectiveness of health care interventions. Patient behaviors essential to the successful treatment of HIV infection, such as high levels of medication adherence, may depend on patients understanding how to take medication, how to solve medication-related problems, and how to cope with medication side effects. An approach that has shown promise in promoting behavior change in HIV+ persons is the Information-Motivation-Behavior Skills (IMB) model. The intervention proposed in this application will implement a health literacy intervention based in part on insights about behavior change drawn from studies of this model. The purpose of the proposed research is to implement this intervention via a computer-based and automated tailored information application. Participants will first complete an automated computer-administered self interview (ACASI) that will assess medication knowledge, disease knowledge likely to be related to motivation, and problem solving skills. Results of this assessment will feed forward to an automated training application that provides individually-tailored training on these topics. This computer-based program will provide training, test understanding, and if necessary reteach and retest. It will also provide printed information for participants to take home to provide ongoing prompts. This study will comprise two phases. In the first, the program will be developed and tested with potential users to assess its usability and detect problems with the wording of materials. In the second phase, participants' health literacy and cognitive status will be evaluated, their adherence to a medication for HIV infection will be assessed using electronic monitoring, and the effects of the program on their adherence will be tested.
- Conditions
- Human Immunodeficiency Virus I Infection
- Being tested
- Tailored Information
- Keywords
- Health literacy, HIV, Medication Adherence, IMB Model
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored InformationBehavioural
Also called Health literacy
The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Information | Experimental | Participants in this arm receive the computer-based tailored information application that focuses on improving health literacy related to treatment of HIV infection. Receives: Behavioral: Tailored Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence is assessed using electronic monitoring of pill bottle openings via the Medication Event Monitoring System (MEMS) for the month before and the month after participants engage in the study intervention.
Measured: Four weeks after intervention
Secondary outcomes (4)
Participant self-efficacy
Measured: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Mood
Measured: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Elements of the Information, Motivation, and Behavioral Skills Model
A self-report questionnaire asking participants about their knowledge, motivation, and behavioral skills with respect to HIV infection and its treatment.
Measured: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Intervention acceptability and usability
A questionnaire assessing elements of the Technology Acceptance Model is administered immediately after completing the intervention and four weeks after its completion.
Measured: Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2011
- Study completionJun 2012
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 Human Immunodeficiency Virus I InfectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Raymond L Ownby, MD, PhD, Principal investigator, Nova Southeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304186
- Sponsor's protocol ID
- R21MH086491
- Other IDs
- R21MH086491
- Status last verified
- Feb 2013
- First submitted
- 18 Feb 2011
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ownby RL, Waldrop-Valverde D, Caballero J, Jacobs RJ. Baseline medication adherence and response to an electronically delivered health literacy intervention targeting adherence. Neurobehav HIV Med. 2012 Oct 18;4:113-121. doi: 10.2147/NBHIV.S36549.
PubMed 23293544Ownby RL, Waldrop-Valverde D, Hardigan P, Caballero J, Jacobs R, Acevedo A. Development and validation of a brief computer-administered HIV-Related Health Literacy Scale (HIV-HL). AIDS Behav. 2013 Feb;17(2):710-8. doi: 10.1007/s10461-012-0301-3.
PubMed 22961499Ownby RL, Waldrop-Valverde D, Jacobs RJ, Acevedo A, Caballero J. Cost effectiveness of a computer-delivered intervention to improve HIV medication adherence. BMC Med Inform Decis Mak. 2013 Feb 28;13:29. doi: 10.1186/1472-6947-13-29.
PubMed 23446180
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Automated, Tailored Information Application for Medication Health Literacy
- ClinicalTrials.gov ID
- NCT01304186
- Acronym / sponsor ID
- R21MH086491
- Conditions
- Human Immunodeficiency Virus I Infection
- Keywords
- Health literacy, HIV, Medication Adherence, IMB Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Feb 2011 (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 study is to evaluate the acceptability and efficacy of a computer-based tailored information application designed to promote health literacy in persons treated for HIV infection. The study hypothesis is that the application will be acceptable and usable for persons treated for HIV infection, and will improve their levels of adherence to antiretroviral medication treatment.
Detailed description
Health literacy is a critically important problem in improving the effectiveness of health care interventions. Patient behaviors essential to the successful treatment of HIV infection, such as high levels of medication adherence, may depend on patients understanding how to take medication, how to solve medication-related problems, and how to cope with medication side effects. An approach that has shown promise in promoting behavior change in HIV+ persons is the Information-Motivation-Behavior Skills (IMB) model. The intervention proposed in this application will implement a health literacy intervention based in part on insights about behavior change drawn from studies of this model. The purpose of the proposed research is to implement this intervention via a computer-based and automated tailored information application. Participants will first complete an automated computer-administered self interview (ACASI) that will assess medication knowledge, disease knowledge likely to be related to motivation, and problem solving skills. Results of this assessment will feed forward to an automated training application that provides individually-tailored training on these topics. This computer-based program will provide training, test understanding, and if necessary reteach and retest. It will also provide printed information for participants to take home to provide ongoing prompts. This study will comprise two phases. In the first, the program will be developed and tested with potential users to assess its usability and detect problems with the wording of materials. In the second phase, participants' health literacy and cognitive status will be evaluated, their adherence to a medication for HIV infection will be assessed using electronic monitoring, and the effects of the program on their adherence will be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tailored Information | Experimental | Behavioral: Tailored InformationParticipants in this arm receive the computer-based tailored information application that focuses on improving health literacy related to treatment of HIV infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Currently treated with at least one medication for HIV infection
- No change in target medication anticipated in the next two months
- Able to participate in the study intervention in English
Key exclusion criteria (2 listed)
- Psychiatric or cognitive disorder of severity sufficient to make the potential participant unable to provide informed consent.
- Not able to participate in the intervention using English.
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 |
|---|---|---|
| Tailored InformationAlso: Health literacyThe intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion. | Behavioural | Tailored Information |
Primary outcome
Medication adherence
Time frame: Four weeks after intervention
Medication adherence is assessed using electronic monitoring of pill bottle openings via the Medication Event Monitoring System (MEMS) for the month before and the month after participants engage in the study intervention.
4 secondary outcomes
Participant self-efficacy
Time frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Mood
Time frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Elements of the Information, Motivation, and Behavioral Skills Model
Time frame: Immediately after completing the intervention (average time: 15 minutes) and four weeks after the intervention
Intervention acceptability and usability
Time frame: Immediately after the intervention (average time: 15 minutes) and four weeks after the intervention
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 1 Mar 2013.
- Results publication: PubMed 23293544Ownby RL, Waldrop-Valverde D, Caballero J, Jacobs RJ. Baseline medication adherence and response to an electronically delivered health literacy intervention targeting adherence. Neurobehav HIV Med. 2012 Oct 18;4:113-121. doi: 10.2147/NBHIV.S36549.
- Results publication: PubMed 22961499Ownby RL, Waldrop-Valverde D, Hardigan P, Caballero J, Jacobs R, Acevedo A. Development and validation of a brief computer-administered HIV-Related Health Literacy Scale (HIV-HL). AIDS Behav. 2013 Feb;17(2):710-8. doi: 10.1007/s10461-012-0301-3.
- Derived from this study: PubMed 23446180Ownby RL, Waldrop-Valverde D, Jacobs RJ, Acevedo A, Caballero J. Cost effectiveness of a computer-delivered intervention to improve HIV medication adherence. BMC Med Inform Decis Mak. 2013 Feb 28;13:29. doi: 10.1186/1472-6947-13-29.
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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.
Raymond L Ownby, MD, PhD principal investigator
Nova Southeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Information in people with Human Immunodeficiency Virus I Infection, run by Nova Southeastern University 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 4 inclusion and 2 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 1 Mar 2013. 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 (time frame: Four weeks after intervention). 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 NCT01304186, 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 1 Mar 2013; AzTrials last refreshed its copy on 7 Nov 2026.