HIVNCT01559805
Intervention to Improve Engagement in Care Among Newly Diagnosed HIV-positive Men
A study testing Positive Choices and Personalized Cognitive Counseling in people with HIV and Patient Compliance, run by Columbia University at 4 sites in United States.
Trial summary
The study involves delivering one of two interventions - either Promoting Action Towards Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men (MSM) who have recently been diagnosed with HIV and assessing whether participants who received PATH achieve greater suppression of HIV… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV, Patient Compliance
- What is being tested?
- Positive Choices and Personalized Cognitive Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2012to 14 Dec 2021
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receiving an HIV diagnosis within the previous 12 months
- entry into HIV primary care
- residence in the greater New York metropolitan area
- aged 18 or older
- provision of written informed consent
Who cannot join
- -demonstrating cognitive impairment, acute psychosis, or suicidal intent or plans
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Yale University
New Haven, Connecticut, 06511
Callen-Lorde Community Health Center
New York, New York, 10011
Harlem United Community AIDS Center, Inc.
New York, New York, 10027
Mailman School of Public Health, Columbia University
New York, New York, 10032
About this study
Official title: Efficacy Trial of a Brief Health Enhancement Intervention for Newly Diagnosed Men
The study involves delivering one of two interventions - either Promoting Action Towards Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men (MSM) who have recently been diagnosed with HIV and assessing whether participants who received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of care and adherence to treatment, and engage in less sexual HIV transmission risk behavior than participants who received PCC.
- PATH consists of two preliminary sessions plus "booster" sessions after 1, 3, and 6 months.
- Personalized Cognitive Counseling consists of one session.
Participants will complete assessments before participating in their intervention (i.e., at "baseline") and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be measured at approximately 6 and 12 months following baseline.
Read the detailed description
Objectives:
The investigators will conduct a randomized controlled trial to test the efficacy of Promoting Action Towards Health (PATH), a brief health-enhancement and risk reduction intervention targeting newly HIV diagnosed men who have sex with men (MSM).
Specific Aims:
The investigators will establish the efficacy of PATH. The following hypotheses will be tested: Participants in the experimental condition will (1) achieve significantly greater suppression of HIV viral load; (2) demonstrate greater uptake of care and adherence to treatment; and (3) engage in less sexual HIV transmission risk behavior across the study duration than participants in the comparison condition.
Procedures:
440 newly HIV diagnosed (within 12 months) men will be randomly assigned to either: (1) the PATH experimental condition, or (2) the PCC comparison condition and followed for one year. HIV counselors will be trained to deliver the interventions within each condition. Assessments will be conducted at baseline, 3, 6, 9 and 12 months.
Significance:
Given increases in HIV incidence among MSM, advances in HIV treatment, and the demonstrated efficacy of early treatment in preventing HIV transmission, there is a critical need for effective interventions that can increase engagement and retention of MSM in care and reduce sexual HIV transmission risk behavior. PATH can be seamlessly integrated into medical care and translated into a sustainable model of care for newly diagnosed MSM to meet the urgent need for care programs that identify, treat, and prevent HIV infections.
- Conditions
- HIV, Patient Compliance
- Being tested
- Positive Choices, Personalized Cognitive Counseling
- Keywords
- HIV, Viral Load, Risk, Patient Compliance, Homosexuality, Male, Anti-Retroviral Agents
- Medical subject headings
- Patient Compliance, Homosexuality, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive ChoicesBehavioural
A two-session, individually-focused intervention focusing on engagement in care, disclosure decision-making, and sexual risk reduction, with booster sessions after 1, 3 and 6 months.
Personalized Cognitive CounselingBehavioural
A one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI.
| Study group | Role | What they receive |
|---|---|---|
| Positive Choices | Experimental | A two-session, individually-focused intervention focusing on engagement in care, disclosure decision-making, and sexual risk reduction, with booster sessions after 1, 3 and 6 months. Receives: Behavioral: Positive Choices |
| Personalized Cognitive Counseling | Active comparator | A one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI. Receives: Behavioral: Personalized Cognitive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
Measured: 12 months
Secondary outcomes (3)
Sexual HIV transmission risk behavior
Timeline Followback Method (Sobell et al., 1996) for Transmission Risk Behavior, Risk Reduction Behavioral Intentions (Fisher, 1992), HIV Serostatus Disclosure (Kalichman, 2001) \& HIV Disclosure or Nondisclosure (Serovich \& Mosack, 2003), Risk Reduction Self-Efficacy (Kalichman, 2001), Risk Reduction Skill Enactment (Kalichman, 2001), Compulsive Sexual Behavior Inventory (Minor et al., 2007), Sexual Sensation Seeking (Kalichman \& Rompa, 1995)
Measured: Baseline, post (3 months), 6, 9, and 12 months
Care and treatment uptake/adherence
- Medical Chart/Self-report to assess Treatment Utilization
- HIV Treatment and Risk-Related Knowledge (Kalichman, 2000)
Measured: Baseline, post (3 months), 6, 9, and 12 months
Viral load
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startNov 2012
- Primary completion6 Nov 2017
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Patrick A Wilson, PhD, Principal investigator, Columbia UniversityNathan B Hansen, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559805
- Sponsor's protocol ID
- AAAJ3106
- Other IDs
- R01MH097651
- Status last verified
- Jan 2022
- First submitted
- 16 Mar 2012
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sikkema KJ, Hansen NB, Kochman A, Santos J, Watt MH, Wilson PA, Delorenzo A, Laudato J, Mayer G. THE DEVELOPMENT AND FEASIBILITY OF A BRIEF RISK REDUCTION INTERVENTION FOR NEWLY HIV-DIAGNOSED MEN WHO HAVE SEX WITH MEN. J Community Psychol. 2011 Aug 1;39(6):717-732. doi: 10.1002/jcop.20463.
PubMed 22228917
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Trial of a Brief Health Enhancement Intervention for Newly Diagnosed Men
- ClinicalTrials.gov ID
- NCT01559805
- Acronym / sponsor ID
- AAAJ3106
- Conditions
- HIV, Patient Compliance
- Keywords
- HIV, Viral Load, Risk, Patient Compliance, Homosexuality, Male, Anti-Retroviral Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2012
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 21 Mar 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.
The study involves delivering one of two interventions - either Promoting Action Towards Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men (MSM) who have recently been diagnosed with HIV and assessing whether participants who received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of care and adherence to treatment, and engage in less sexual HIV transmission risk behavior than participants who received PCC.
- PATH consists of two preliminary sessions plus "booster" sessions after 1, 3, and 6 months.
- Personalized Cognitive Counseling consists of one session.
Participants will complete assessments before participating in their intervention (i.e., at "baseline") and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be measured at approximately 6 and 12 months following baseline.
Detailed description
Objectives:
The investigators will conduct a randomized controlled trial to test the efficacy of Promoting Action Towards Health (PATH), a brief health-enhancement and risk reduction intervention targeting newly HIV diagnosed men who have sex with men (MSM).
Specific Aims:
The investigators will establish the efficacy of PATH. The following hypotheses will be tested: Participants in the experimental condition will (1) achieve significantly greater suppression of HIV viral load; (2) demonstrate greater uptake of care and adherence to treatment; and (3) engage in less sexual HIV transmission risk behavior across the study duration than participants in the comparison condition.
Procedures:
440 newly HIV diagnosed (within 12 months) men will be randomly assigned to either: (1) the PATH experimental condition, or (2) the PCC comparison condition and followed for one year. HIV counselors will be trained to deliver the interventions within each condition. Assessments will be conducted at baseline, 3, 6, 9 and 12 months.
Significance:
Given increases in HIV incidence among MSM, advances in HIV treatment, and the demonstrated efficacy of early treatment in preventing HIV transmission, there is a critical need for effective interventions that can increase engagement and retention of MSM in care and reduce sexual HIV transmission risk behavior. PATH can be seamlessly integrated into medical care and translated into a sustainable model of care for newly diagnosed MSM to meet the urgent need for care programs that identify, treat, and prevent HIV infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Choices | Experimental | Behavioral: Positive ChoicesA two-session, individually-focused intervention focusing on engagement in care, disclosure decision-making, and sexual risk reduction, with booster sessions after 1, 3 and 6 months. |
| Personalized Cognitive Counseling | Active comparator | Behavioral: Personalized Cognitive CounselingA one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- receiving an HIV diagnosis within the previous 12 months
- entry into HIV primary care
- residence in the greater New York metropolitan area
- aged 18 or older
- provision of written informed consent
Key exclusion criteria (1 listed)
- -demonstrating cognitive impairment, acute psychosis, or suicidal intent or plans
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 |
|---|---|---|
| Positive ChoicesA two-session, individually-focused intervention focusing on engagement in care, disclosure decision-making, and sexual risk reduction, with booster sessions after 1, 3 and 6 months. | Behavioural | Positive Choices |
| Personalized Cognitive CounselingA one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI. | Behavioural | Personalized Cognitive Counseling |
Primary outcome
Viral load
Time frame: 12 months
3 secondary outcomes
Sexual HIV transmission risk behavior
Time frame: Baseline, post (3 months), 6, 9, and 12 months
Care and treatment uptake/adherence
Time frame: Baseline, post (3 months), 6, 9, and 12 months
Viral load
Time frame: 6 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 10 Jan 2022.
- Background: PubMed 22228917Sikkema KJ, Hansen NB, Kochman A, Santos J, Watt MH, Wilson PA, Delorenzo A, Laudato J, Mayer G. THE DEVELOPMENT AND FEASIBILITY OF A BRIEF RISK REDUCTION INTERVENTION FOR NEWLY HIV-DIAGNOSED MEN WHO HAVE SEX WITH MEN. J Community Psychol. 2011 Aug 1;39(6):717-732. doi: 10.1002/jcop.20463.
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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.
Patrick A Wilson, PhD principal investigator
Columbia University
Nathan B Hansen, PhD principal investigator
Yale University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Choices and Personalized Cognitive Counseling in people with HIV and Patient Compliance, run by Columbia University at 4 sites 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 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 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Viral load (time frame: 12 months). 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 NCT01559805, which also lists 1 linked publication.
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 10 Jan 2022.