HIV InfectionsPhase 2NCT01061021
HIV Prevention Intervention for People Living With HIV/AIDS
A Phase 2 study testing In The Mix and Information Support Group in people with HIV Infections, run by University of Connecticut at 1 site in United States.
Trial summary
HIV prevention interventions are needed to assist people living with HIV/AIDS to adhere to their medications and not transmit the virus to others. This study is testing a behavioral intervention designed to address both medication adherence and risk reduction in people living with HIV/AIDS. 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?
- In The Mix and Information Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Aug 2010
- 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
- Age 18 years or older,
- Tested HIV positive,
- Able to provide informed consent.
Who cannot join
- Significant cognitive impairment.
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/Risk Reduction Integrated
HIV prevention interventions are needed to assist people living with HIV/AIDS to adhere to their medications and not transmit the virus to others. This study is testing a behavioral intervention designed to address both medication adherence and risk reduction in people living with HIV/AIDS. It is hypothesized that the experimental behavioral intervention will show improved medication adherence and safer sexual behaviors compared to a comparison group.
Read the detailed description
Non-adherence to antiretroviral medications can lead to the development of treatment resistant genetic variants of HIV which can then be transmitted to sexual risk partners. Interventions are urgently needed to reduce the risk of HIV treatment resistance and the risks of transmitting HIV. This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk behaviors in people living with HIV-AIDS. Grounded in behavioral theory, the experimental intervention will be delivered in a mixed format model with five group sessions preceded by and followed by one individual counseling session conducted by community-based group facilitators. The intervention will be conducted at an AIDS service organization in Atlanta. Men and women will be recruited from a variety of AIDS services and infectious disease clinics. Following informed consent and baseline assessments participants will be randomly assigned to receive either the (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched sexual risk reduction intervention, or (c) a time matched non-contaminating comparison intervention. Participants will be followed over the course of a 9-month observation period. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence and HIV transmission risks and risk reduction, medication adherence, sexual transmission risk behaviors, viral load, and CD4 cell counts. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will improve HIV treatment adherence, reduce HIV transmission risk behaviors, and improve health as indexed by viral load and CD4 cell counts. The study will also examine the influence of theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model derived from a single, unified theory of health behavior. If shown effective, the intervention model will be ready for immediate dissemination to community services for people living with HIV-AIDS.
- Conditions
- HIV Infections
- Being tested
- In The Mix, Information Support Group
- Keywords
- HIV prevention, Treatment adherence, Treatment for Prevention
- 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.
In The MixBehavioural
Five small group + 2 individual counseling intervention designed to addresses HIV transmission risk behavior and HIV treatment adherence in men and women living with HIV/AIDS.
Information Support GroupBehavioural
Five small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Intervention | Experimental | Five small group + 2 individual counseling behavioral intervention to simultaneously address HIV transmission risk reduction and HIV treatment adherence in men and women living with HIV/AIDS. Receives: Behavioral: In The Mix |
| Comparison Group | Active comparator | Five small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement. Receives: Behavioral: Information Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized Interview or Sexual Transmission Risk Behavior
Measured: Baseline, 3, 6 and 9 months
Unannounced Phone Based Pill Counts for Medication Adherence
Measured: Baseline, 3, 6, 9 months
Secondary outcomes (1)
Infectiousness Beliefs
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 posted2 Feb 2010 (estimated)
- Study startMar 2005
- Primary completionOct 2009
- Study completionAug 2010
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
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Seth C Kalichman, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061021
- Sponsor's protocol ID
- H06-113
- Other IDs
- R01MH071164-04
- Status last verified
- Nov 2010
- First submitted
- 1 Feb 2010
- Last updated
- 17 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Treatment Adherence/Risk Reduction Integrated
- ClinicalTrials.gov ID
- NCT01061021
- Acronym / sponsor ID
- H06-113
- Conditions
- HIV Infections
- Keywords
- HIV prevention, Treatment adherence, Treatment for Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 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.
HIV prevention interventions are needed to assist people living with HIV/AIDS to adhere to their medications and not transmit the virus to others. This study is testing a behavioral intervention designed to address both medication adherence and risk reduction in people living with HIV/AIDS. It is hypothesized that the experimental behavioral intervention will show improved medication adherence and safer sexual behaviors compared to a comparison group.
Detailed description
Non-adherence to antiretroviral medications can lead to the development of treatment resistant genetic variants of HIV which can then be transmitted to sexual risk partners. Interventions are urgently needed to reduce the risk of HIV treatment resistance and the risks of transmitting HIV. This application proposes to test a theory-based behavioral intervention to simultaneously improve HIV treatment adherence and reduce HIV transmission risk behaviors in people living with HIV-AIDS. Grounded in behavioral theory, the experimental intervention will be delivered in a mixed format model with five group sessions preceded by and followed by one individual counseling session conducted by community-based group facilitators. The intervention will be conducted at an AIDS service organization in Atlanta. Men and women will be recruited from a variety of AIDS services and infectious disease clinics. Following informed consent and baseline assessments participants will be randomly assigned to receive either the (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched sexual risk reduction intervention, or (c) a time matched non-contaminating comparison intervention. Participants will be followed over the course of a 9-month observation period. Assessments will include measures of information, motivation, and behavioral skills pertaining to HIV treatment adherence and HIV transmission risks and risk reduction, medication adherence, sexual transmission risk behaviors, viral load, and CD4 cell counts. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will improve HIV treatment adherence, reduce HIV transmission risk behaviors, and improve health as indexed by viral load and CD4 cell counts. The study will also examine the influence of theoretical constructs on intervention outcomes. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model derived from a single, unified theory of health behavior. If shown effective, the intervention model will be ready for immediate dissemination to community 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Intervention | Experimental | Behavioral: In The MixFive small group + 2 individual counseling behavioral intervention to simultaneously address HIV transmission risk reduction and HIV treatment adherence in men and women living with HIV/AIDS. |
| Comparison Group | Active comparator | Behavioral: Information Support GroupFive small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older,
- Tested HIV positive,
- Able to provide informed consent.
Key exclusion criteria (1 listed)
- Significant cognitive impairment.
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 |
|---|---|---|
| In The MixFive small group + 2 individual counseling intervention designed to addresses HIV transmission risk behavior and HIV treatment adherence in men and women living with HIV/AIDS. | Behavioural | Integrated Intervention |
| Information Support GroupFive small group + 2 individual counseling session intervention that serves as an attention control group. Content included stress reduction, nutrition, and exercise for health improvement. | Behavioural | Comparison Group |
Primary outcome
Computerized Interview or Sexual Transmission Risk Behavior
Time frame: Baseline, 3, 6 and 9 months
Unannounced Phone Based Pill Counts for Medication Adherence
Time frame: Baseline, 3, 6, 9 months
1 secondary outcome
Infectiousness Beliefs
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 Nov 2010.
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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.
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 In The Mix and Information Support Group 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 3 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 17 Nov 2010. 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?
Computerized Interview or Sexual Transmission Risk Behavior (time frame: Baseline, 3, 6 and 9 months). 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 17 Nov 2010.