HIV/AIDSNCT01752777
Behavioral Intervention to Enhance HIV Test/Treat
A study testing Infectiousness Risk Reduction and General Health Improvement in people with HIV/AIDS, run by University of Connecticut at 1 site in United States.
Trial summary
Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study will test a theory-based behavioral intervention to reduce HIV infectiousness by simultaneously improving HIV treatment adherence and… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Infectiousness Risk Reduction and General Health Improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2012to 1 Feb 2018
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older
- HIV positive
- Sexually active in the previous Month
- Active substance use
Who cannot join
- None
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
Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study will test a theory-based behavioral intervention to reduce HIV infectiousness by simultaneously improving HIV treatment adherence and reducing sexually transmitted co-infections in people living with HIV-AIDS who use alcohol and other drugs. The intervention is delivered in a single office-based counseling session followed by 4 cell phone delivered counseling sessions in a model that will be ready for immediate dissemination to case management and clinical services for people living with HIV/AIDS in resource constrained settings.
Read the detailed description
Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). Scalable interventions are urgently needed to sustain low infectiousness by improving HIV treatment adherence and reducing risks for 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 who use alcohol and other drugs. Grounded in Conflict Theory of Decision Making, the intervention will be delivered in a mixed format, with one office-based counseling session followed by four cell phone delivered counseling sessions. The intervention will be conducted in Atlanta and surrounding impoverished areas. Men (n = 250) and women (n = 250) receiving HIV treatment will be recruited from AIDS services and infectious disease clinics. Following informed consent and baseline assessments, participants will be randomly assigned to either an (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched non-contaminating attention control condition. Participants will be followed for 12-months using office-based computerized interviews, unannounced pill counts, and medical chart abstraction. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will reduce HIV transmission risk behaviors, improve HIV treatment adherence, reduce viral load and prevent new STI. The study will also examine the influence of theoretical constructs and structural barriers on intervention outcomes. Factors that predict relapse to non-adherence and risk behaviors in relation to changes in viral load and STI over the 12-month follow-up period will also be a focal point of the study. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model for substance using HIV positive men and women. If shown effective, the intervention model will be ready for immediate dissemination to community and clinical services for people living with HIV/AIDS.
- Conditions
- HIV/AIDS
- Being tested
- Infectiousness Risk Reduction, General Health Improvement
- Keywords
- HIV/AIDS, HIV infectiousness, Medication adherence, Sexual risks reduction
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infectiousness Risk ReductionBehavioural
Behavioral counseling conducted in one office session followed by 4 cell-phone-based sessions. Counseling is based on models of behavioral self-management and cognitive decision making with the primary aim to increase antiretroviral adherence, engagement in HIV care, and reduction of sexual risk behaviors for HIV transmission.
General Health ImprovementBehavioural
Educational counseling to help link participants to social serves and health related strategies.
| Study group | Role | What they receive |
|---|---|---|
| Infectiousness Risk Reduction | Experimental | Behavioral counseling conducted in one office session followed by 4 cell-phone-based sessions. Counseling is based on models of behavioral self-management and cognitive decision making with the primary aim to increase antiretroviral adherence, engagement in HIV care, and reduction of sexual risk behaviors for HIV transmission. Receives: Behavioral: Infectiousness Risk Reduction |
| General Health Improvement | Sham comparator | Participants in this condition receive education conducted in one office session followed by 4 cell-phone-based sessions. The education sessions focus on raising awareness of health services and health improvement strategies. Receives: Behavioral: General Health Improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV RNA Viral Load
HIV RNA viral load determined by blood plasma PCR
Measured: 12 month
Secondary outcomes (1)
Sexual Transmission Risk Behaviors
Sexual behaviors that create risks for HIV transmission and protective actions against transmission risks
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study start1 Feb 2012
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Kalichman, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752777
- Sponsor's protocol ID
- H11-159
- Status last verified
- May 2018
- First submitted
- 16 Dec 2012
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention to Enhance HIV Test/Treat
- ClinicalTrials.gov ID
- NCT01752777
- Acronym / sponsor ID
- H11-159
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, HIV infectiousness, Medication adherence, Sexual risks reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 19 Dec 2012 (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.
Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). The proposed study will test a theory-based behavioral intervention to reduce HIV infectiousness by simultaneously improving HIV treatment adherence and reducing sexually transmitted co-infections in people living with HIV-AIDS who use alcohol and other drugs. The intervention is delivered in a single office-based counseling session followed by 4 cell phone delivered counseling sessions in a model that will be ready for immediate dissemination to case management and clinical services for people living with HIV/AIDS in resource constrained settings.
Detailed description
Prevention strategies that aim to test and treat people for HIV infection are undermined by HIV treatment non-adherence and sexually transmitted co-infections (STI). Scalable interventions are urgently needed to sustain low infectiousness by improving HIV treatment adherence and reducing risks for 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 who use alcohol and other drugs. Grounded in Conflict Theory of Decision Making, the intervention will be delivered in a mixed format, with one office-based counseling session followed by four cell phone delivered counseling sessions. The intervention will be conducted in Atlanta and surrounding impoverished areas. Men (n = 250) and women (n = 250) receiving HIV treatment will be recruited from AIDS services and infectious disease clinics. Following informed consent and baseline assessments, participants will be randomly assigned to either an (a) integrated HIV treatment adherence - risk reduction intervention or (b) a time-matched non-contaminating attention control condition. Participants will be followed for 12-months using office-based computerized interviews, unannounced pill counts, and medical chart abstraction. The study will test the hypothesis that a unified, integrated theory-based HIV treatment and risk reduction intervention will reduce HIV transmission risk behaviors, improve HIV treatment adherence, reduce viral load and prevent new STI. The study will also examine the influence of theoretical constructs and structural barriers on intervention outcomes. Factors that predict relapse to non-adherence and risk behaviors in relation to changes in viral load and STI over the 12-month follow-up period will also be a focal point of the study. The intervention under investigation will be among the first to simultaneously address treatment adherence and risk behavior in an integrated model for substance using HIV positive men and women. If shown effective, the intervention model will be ready for immediate dissemination to community and clinical services for people living with HIV/AIDS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infectiousness Risk Reduction | Experimental | Behavioral: Infectiousness Risk ReductionBehavioral counseling conducted in one office session followed by 4 cell-phone-based sessions. Counseling is based on models of behavioral self-management and cognitive decision making with the primary aim to increase antiretroviral adherence, engagement in HIV care, and reduction of sexual risk behaviors for HIV transmission. |
| General Health Improvement | Sham comparator | Behavioral: General Health ImprovementParticipants in this condition receive education conducted in one office session followed by 4 cell-phone-based sessions. The education sessions focus on raising awareness of health services and health improvement strategies. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 and older
- HIV positive
- Sexually active in the previous Month
- Active substance use
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 |
|---|---|---|
| Infectiousness Risk ReductionBehavioral counseling conducted in one office session followed by 4 cell-phone-based sessions. Counseling is based on models of behavioral self-management and cognitive decision making with the primary aim to increase antiretroviral adherence, engagement in HIV care, and reduction of sexual risk behaviors for HIV transmission. | Behavioural | Infectiousness Risk Reduction |
| General Health ImprovementEducational counseling to help link participants to social serves and health related strategies. | Behavioural | General Health Improvement |
Primary outcome
HIV RNA Viral Load
Time frame: 12 month
HIV RNA viral load determined by blood plasma PCR
1 secondary outcome
Sexual Transmission Risk Behaviors
Time frame: 3 month
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 9 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infectiousness Risk Reduction and General Health Improvement in people with HIV/AIDS, 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 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 9 May 2018. 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. Some participants in this study may receive a placebo. 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?
HIV RNA Viral Load (time frame: 12 month). 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 9 May 2018.