HIV InfectionsPhase 2NCT01061762
Adherence Intervention for People With Low-literacy
A Phase 2 study testing Stick To It, Standard medication adherence counseling and Health Counseling in people with HIV Infections, run by University of Connecticut at 1 site in United States.
Trial summary
Consistent adherence to antiretroviral therapy is necessary for treatment success. People with poor health literacy skills experience considerable difficulty adhering to their medications. 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?
- Stick To It, Standard medication adherence counseling and Health Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2013
- 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
- 18 years or older,
- HIV positive,
- receiving antiretroviral medications, and
- score below cut-off on a standard health literacy test.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southeast HIV/AIDS Research and Evaluation Project
Atlanta, Georgia, 30308
About this study
Official title: HIV Treatment Adherence Intervention for People With Poor Literacy Skills
Consistent adherence to antiretroviral therapy is necessary for treatment success. People with poor health literacy skills experience considerable difficulty adhering to their medications. Effective strategies for improving adherence in patients with poor health literacy must be tailored to achieve optimal adherence and therefore viral suppression. This proposal requests support to conduct a randomized clinical trial of a theory-based HIV treatment adherence intervention tailored for people with low-literacy skills.
Read the detailed description
Adherence to antiretroviral medications is necessary to achieve sufficient HIV suppression and nonadherence can lead to the development of treatment resistant genetic variants of HIV. Research has demonstrated that people living with HIV/AIDS who have low-levels of health literacy experience greater treatment non-adherence than their higher-literacy counterparts. Interventions are urgently needed to improve treatment adherence in people with poor literacy skills. This application proposes to test a theory based behavioral intervention for improving HIV treatment adherence in people living with HIV/AIDS who have low-literacy skills. Grounded in the Information - Motivation - Behavioral Skills (IMB) model of health behavior change, the experimental intervention has been tailored for people with low-levels of health literacy and has been pilot tested in preliminary intervention development research. The intervention is delivered in three one-on-one counseling sessions and one maintenance-focused booster session. The intervention will be conducted in a community care setting in Atlanta. Men and women will be recruited from a AIDS services and infectious disease clinics throughout the Atlanta metropolitan area. Following screening, informed consent and baseline assessments participants will be randomly assigned to receive one of three conditions: (a) Theory-based literacy tailored treatment adherence intervention; (b) standard of care non-tailored time-matched adherence counseling intervention; (c) noncontaminating time-matched attention control intervention. Participants will be followed for 12-months observation. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence, self-report and objective medication adherence, and viral load. The study will test the hypothesis that a theory-based HIV treatment adherence intervention that is tailored for people with low-literacy will improve HIV treatment adherence and health relative to the standard and attention control conditions. The study will also examine the influence of IMB theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to address treatment adherence among people with poor literacy skills. If shown effective, the intervention model will be ready for immediate dissemination to clinical and community adherence enhancement services for people living with HIV-AIDS.
- Conditions
- HIV Infections
- Being tested
- Stick To It, Standard medication adherence counseling, Health Counseling
- Keywords
- Treatment adherence, Low literacy skills, HIV treatment
- 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.
Stick To ItBehavioural
3-counseling session adherence intervention tailored for people with poor literacy skills
Standard medication adherence counselingBehavioural
3 counseling sessions for adherence improvement derived from standard behavioral approaches.
Health CounselingBehavioural
3-session of health improvement counseling to serve as an attention control.
| Study group | Role | What they receive |
|---|---|---|
| Low Literacy Adherence Counseling | Experimental | 3-counseling sessions for medication adherence improvement tailored for people with poor literacy Receives: Behavioral: Stick To It |
| Standard Adherence Counseling | Active comparator | 3 counseling sessions for adherence improvement derived from standard behavioral approaches. Receives: Behavioral: Standard medication adherence counseling |
| Health Counseling Comparison | Active comparator | 3-sessions of health improvement counseling. Receives: Behavioral: Health Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unannounced Phone Based Pill Counts for Medication Adherence
Measured: Baseline, monthly for 12 months
Secondary outcomes (1)
Theoretical Constructs derived from the Information-Motivation-Behavioral Skills Model assessed by psychometric scales of AIDS knowledge, behavioral intentions, adherence self-efficacy, adherence strategies/skills
Measured: Baseline, 3, 6, and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startFeb 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Seth Kalichman, University of Connecticut
- Investigators
- Seth C Kalichman, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061762
- Sponsor's protocol ID
- H07-266
- Other IDs
- R01MH082633-01
- Status last verified
- Jun 2013
- First submitted
- 1 Feb 2010
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Treatment Adherence Intervention for People With Poor Literacy Skills
- ClinicalTrials.gov ID
- NCT01061762
- Acronym / sponsor ID
- H07-266
- Conditions
- HIV Infections
- Keywords
- Treatment adherence, Low literacy skills, HIV treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 3 Feb 2010 (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.
Consistent adherence to antiretroviral therapy is necessary for treatment success. People with poor health literacy skills experience considerable difficulty adhering to their medications. Effective strategies for improving adherence in patients with poor health literacy must be tailored to achieve optimal adherence and therefore viral suppression. This proposal requests support to conduct a randomized clinical trial of a theory-based HIV treatment adherence intervention tailored for people with low-literacy skills.
Detailed description
Adherence to antiretroviral medications is necessary to achieve sufficient HIV suppression and nonadherence can lead to the development of treatment resistant genetic variants of HIV. Research has demonstrated that people living with HIV/AIDS who have low-levels of health literacy experience greater treatment non-adherence than their higher-literacy counterparts. Interventions are urgently needed to improve treatment adherence in people with poor literacy skills. This application proposes to test a theory based behavioral intervention for improving HIV treatment adherence in people living with HIV/AIDS who have low-literacy skills. Grounded in the Information - Motivation - Behavioral Skills (IMB) model of health behavior change, the experimental intervention has been tailored for people with low-levels of health literacy and has been pilot tested in preliminary intervention development research. The intervention is delivered in three one-on-one counseling sessions and one maintenance-focused booster session. The intervention will be conducted in a community care setting in Atlanta. Men and women will be recruited from a AIDS services and infectious disease clinics throughout the Atlanta metropolitan area. Following screening, informed consent and baseline assessments participants will be randomly assigned to receive one of three conditions: (a) Theory-based literacy tailored treatment adherence intervention; (b) standard of care non-tailored time-matched adherence counseling intervention; (c) noncontaminating time-matched attention control intervention. Participants will be followed for 12-months observation. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence, self-report and objective medication adherence, and viral load. The study will test the hypothesis that a theory-based HIV treatment adherence intervention that is tailored for people with low-literacy will improve HIV treatment adherence and health relative to the standard and attention control conditions. The study will also examine the influence of IMB theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to address treatment adherence among people with poor literacy skills. If shown effective, the intervention model will be ready for immediate dissemination to clinical and community adherence enhancement services for people living with HIV-AIDS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Literacy Adherence Counseling | Experimental | Behavioral: Stick To It3-counseling sessions for medication adherence improvement tailored for people with poor literacy |
| Standard Adherence Counseling | Active comparator | Behavioral: Standard medication adherence counseling3 counseling sessions for adherence improvement derived from standard behavioral approaches. |
| Health Counseling Comparison | Active comparator | Behavioral: Health Counseling3-sessions of health improvement counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older,
- HIV positive,
- receiving antiretroviral medications, and
- score below cut-off on a standard health literacy test.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Stick To It3-counseling session adherence intervention tailored for people with poor literacy skills | Behavioural | Low Literacy Adherence Counseling |
| Standard medication adherence counseling3 counseling sessions for adherence improvement derived from standard behavioral approaches. | Behavioural | Standard Adherence Counseling |
| Health Counseling3-session of health improvement counseling to serve as an attention control. | Behavioural | Health Counseling Comparison |
Primary outcome
Unannounced Phone Based Pill Counts for Medication Adherence
Time frame: Baseline, monthly for 12 months
1 secondary outcome
Theoretical Constructs derived from the Information-Motivation-Behavioral Skills Model assessed by psychometric scales of AIDS knowledge, behavioral intentions, adherence self-efficacy, adherence strategies/skills
Time frame: Baseline, 3, 6, and 9 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 17 Jun 2013.
Related trials for HIV Infections
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Enrolling by invitation
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
HIV Infections
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruitingPhase 4
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
HIV-1 Infection
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.
Seth C Kalichman, PhD principal investigator
University of Connecticut
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 Stick To It, Standard medication adherence counseling and Health Counseling in people with HIV Infections, run by University of Connecticut 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 0 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 17 Jun 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.
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?
Unannounced Phone Based Pill Counts for Medication Adherence (time frame: Baseline, monthly for 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2013.