HIV/AIDSPRIMENCT01032824
Self-Managing HIV and Chronic Disease
A study testing Individual Telephone Counseling Intervention, Group Arm and Book Arm in people with HIV/AIDS, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with HIV/AIDS and other… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Individual Telephone Counseling Intervention, Group Arm and Book Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Feb 2011
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 50 years or older
- HIV-positive serostatus
- currently prescribed antiretroviral medication
- antiretroviral nonadherence reported in past 30 days
- provision of oral informed consent
Who cannot join
- hearing problems that preclude participation in a telephone study
- presence of probable dementia or acute psychosis detectable by screening interview
Trial locations and contacts
1 site in 1 country.
United States1 site
Group Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Community-based Self-management of HIV and Chronic Disease
The purpose of this study is to conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with HIV/AIDS and other chronic conditions.
Read the detailed description
450 adult HIV+ patients aged 50 or older will be randomized to one of three arms. 150 will be assigned to receive a series of ten 30-minute phone calls every two weeks from a counselor. 150 will be assigned to an attention-matched comparison arm, and will receive 10 sessions in a didactic telephone group. 150 will be assigned to a information-matched control arm and will receive the book Living Well with HIV \& AIDS. Letters will be sent by AIDS Service Organizations inviting interested clients to call the study's 800 number to learn more about the study and to be screened for enrollment. Posters and brochures will also be posted in public areas of the ASOs. The individualized intervention combines problem-solving, with motivation and self-management. This trial will allow us to evaluate the effectiveness of a multi-component intervention on both specific HIV behavioral outcomes and non-disease-specific outcomes.
- Conditions
- HIV/AIDS
- Being tested
- Individual Telephone Counseling Intervention, Group Arm, Book Arm
- Keywords
- Complementary Therapies
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual Telephone Counseling InterventionBehavioural
Also called telephone counseling
10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention.
Group ArmOther
Also called Attention-matched comparison arm
10-session didactic telephone group
Book ArmOther
Also called Information-matched comparison arm
Book only.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Individual telephone counseling intervention. Receives: Behavioral: Individual Telephone Counseling Intervention |
| Group Arm | Other | Attention-matched comparison arm Receives: Other: Group Arm |
| Book Arm | Other | Information-matched control arm. Receives: Other: Book Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
antiretroviral (ART) adherence
Measured: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.
health-related quality of life (physical, mental health, and social function)
Measured: Baseline, 6, 9, 12 mo f/u
Secondary outcomes (3)
chronic disease treatment adherence
Measured: baseline, 6, 9 and 12 months f/u
Self-efficacy and readiness to change
Measured: baseline, 6, 9, 12 months f/u
perceived stress and depression
Measured: baseline, 6, 9, and 12 months f/u
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startOct 2007
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheryl L Catz, PhD, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032824
- Sponsor's protocol ID
- 5R01MH074380
- Acronym
- PRIME
- Status last verified
- Oct 2017
- First submitted
- 15 Dec 2009
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based Self-management of HIV and Chronic Disease
- ClinicalTrials.gov ID
- NCT01032824
- Acronym / sponsor ID
- PRIME / 5R01MH074380
- Conditions
- HIV/AIDS
- Keywords
- Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 16 Dec 2009 (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 conduct a randomized control trial of a behavioral intervention delivered by counselors via telephone to determine if this is an efficacious method for improving medication adherence and health-related quality of life for persons who are 50 and older and living with HIV/AIDS and other chronic conditions.
Detailed description
450 adult HIV+ patients aged 50 or older will be randomized to one of three arms. 150 will be assigned to receive a series of ten 30-minute phone calls every two weeks from a counselor. 150 will be assigned to an attention-matched comparison arm, and will receive 10 sessions in a didactic telephone group. 150 will be assigned to a information-matched control arm and will receive the book Living Well with HIV \& AIDS. Letters will be sent by AIDS Service Organizations inviting interested clients to call the study's 800 number to learn more about the study and to be screened for enrollment. Posters and brochures will also be posted in public areas of the ASOs. The individualized intervention combines problem-solving, with motivation and self-management. This trial will allow us to evaluate the effectiveness of a multi-component intervention on both specific HIV behavioral outcomes and non-disease-specific outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Individual Telephone Counseling InterventionIndividual telephone counseling intervention. |
| Group Arm | Other | Other: Group ArmAttention-matched comparison arm |
| Book Arm | Other | Other: Book ArmInformation-matched control arm. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age 50 years or older
- HIV-positive serostatus
- currently prescribed antiretroviral medication
- antiretroviral nonadherence reported in past 30 days
- provision of oral informed consent
Key exclusion criteria (2 listed)
- hearing problems that preclude participation in a telephone study
- presence of probable dementia or acute psychosis detectable by screening interview
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 |
|---|---|---|
| Individual Telephone Counseling InterventionAlso: telephone counseling10-session, 5-month HIV adherence and chronic disease self-management individual telephone counseling intervention. | Behavioural | Intervention |
| Group ArmAlso: Attention-matched comparison arm10-session didactic telephone group | Other | Group Arm |
| Book ArmAlso: Information-matched comparison armBook only. | Other | Book Arm |
Primary outcome
antiretroviral (ART) adherence
Time frame: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.
health-related quality of life (physical, mental health, and social function)
Time frame: Baseline, 6, 9, 12 mo f/u
3 secondary outcomes
chronic disease treatment adherence
Time frame: baseline, 6, 9 and 12 months f/u
Self-efficacy and readiness to change
Time frame: baseline, 6, 9, 12 months f/u
perceived stress and depression
Time frame: baseline, 6, 9, and 12 months f/u
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 13 Oct 2017.
Related trials for HIV/AIDS
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
Sheryl L Catz, PhD principal investigator
Group Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual Telephone Counseling Intervention, Group Arm and Book Arm in people with HIV/AIDS, run by Kaiser Permanente 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 5 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 13 Oct 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?
antiretroviral (ART) adherence (time frame: Pre-treatment Screening and Baseline, 6, 9, and 12 months f/u.). The study lists 2 primary outcomes in all. 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 13 Oct 2017.