HIVHTH2-MOSTNCT02801747
Using MOST to Optimize an HIV Care Continuum Intervention for Vulnerable Populations
A study testing Heart to Heart2 (HTH2) in people with HIV, run by New York University at 1 site in United States.
Trial summary
The present study targets the large population of persons living with HIV/AIDS (PLHA) in the U.S. who are both insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), who are mainly African American/Black and Latino. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Heart to Heart2 (HTH2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 512 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 15 Jul 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African American/Black or Latino/Hispanic race/ethnicity
- HIV diagnosed for at least 6 months (HIV status confirmed with medical documentation)
- Has not taken antiretroviral therapy (ART) in the past 6 weeks (the period of time assessed by hair assay, and a reasonable period of time not on ART for the present study)
- Sub-optimal engagement in HIV care (assessed from the medical record, defined as less than 1 visit in every 4-mo. period in the past year [two of them at least 90 days apart], pro-rated for those diagnosed less than a year ago) or > 2 missed visits (without prior cancellation) in the past year
- Reside in the New York City (NYC) metropolitan area
- Not planning to leave the NYC metropolitan area in next year
Show all 11Show fewer
- Not actively psychotic based on screening instrument
- Not a participant in the preliminary pilot HTH R34 study
- Able to conduct research activities in English or Spanish
- Willing to provide hair sample (if possible), blood samples (to assess CD4, VL), and Medical Report Form ([MRF]; to assess health care attendance) at screening
- Willing to participate in a Core intervention session and be randomly assigned to 1-5 intervention components.
Who cannot join
- NONE SEE ABOVE
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Silver School of Social Work
New York, New York, 10003
About this study
The present study targets the large population of persons living with HIV/AIDS (PLHA) in the U.S. who are both insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), who are mainly African American/Black and Latino. NIH has emphasized the urgent need for new research approaches to advance intervention science, and the proposed project employs a new, potent, and innovative research methodology, the Multiphase Optimization STrategy (MOST), a framework for developing highly efficacious, efficient, scalable, and cost-effective interventions. The proposed study has the highest public health significance: it addresses a vulnerable population of PLHA, including the critically important subpopulations of men who have sex with men (MSM) and substance users; will develop an efficient and cost effective intervention to increase engagement along the HIV care continuum for these vulnerable groups; and addresses two areas highlighted in the August 2015 notice on research priorities from the NIH Office of AIDS Research (NOT-OD-15-137), namely, engaging PLHA in prevention/treatment services, and reducing HIV/AIDS-related racial/ethnic disparities.
Read the detailed description
More than half of persons living with HIV/AIDS (PLHA) in the U.S. are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans and Latinos. In the proposed project, two experienced and productive behavioral scientists will employ a potent and innovative research methodology, the Multiphase Optimization STrategy (MOST), to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials (RCTs) are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. The investigators propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American and Latino PLHA not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. This efficiency and cost-effectiveness are critical in a time of constrained resources, and will also increase the intervention's future scalability. NIH has signaled its interest in MOST, and this is the first study to apply it in the field of adult HIV treatment. A similar set of multi-level factors impede both HIV care and ART initiation for African American and Latino PLHA, primary among them individual (e.g., substance use, distrust, fear), social (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, the study will evaluate 5 distinct intervention components (i.e., Motivational Interviewing sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study. Study aims are: 1) using a highly efficient experimental design, identify which of 5 components contribute meaningfully to improvement in viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American and Latino PLHA (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N=512). This highly innovative and significant study, which addresses a high-priority research area (NIH NOT-OD-15-137), will produce an HIV care continuum intervention for the nation's most vulnerable PLHA, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability.
- Conditions
- HIV
- Being tested
- Heart to Heart2 (HTH2)
- Keywords
- HIV care continuum, antiretroviral therapy, engagement in HIV care, Multiphase Optimization Strategy (MOST)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart to Heart2 (HTH2)Behavioural
The present study uses a fractional factorial design to evaluate the efficacy of five distinct culturally appropriate intervention components on the primary outcome, HIV viral suppression.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Receives a core intervention session and the navigation intervention component (long duration; that is, up to 6 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 2 | Experimental | Receives a core intervention session, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 3 | Experimental | Receives a core intervention session, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 4 | Experimental | Receives a core intervention session, the peer mentorship component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 5 | Experimental | Receives a core intervention session, the pre-adherence preparation component, and the navigation intervention component (short duration, that is, up to 3 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 6 | Experimental | Receives a core intervention session, the pre-adherence preparation component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 7 | Experimental | Receives a core intervention session, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (long duration, that is, up to 6 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 8 | Experimental | Receives a core intervention session, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 9 | Experimental | Receives a core intervention session, the Motivational Interviewing sessions component, and the navigation intervention component (short duration, that is, up to 3 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 10 | Experimental | Receives a core intervention session, the Motivational Interviewing sessions component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 11 | Experimental | Receives a core intervention session, the Motivational Interviewing sessions component, the peer mentorship component, and the navigation intervention component (long duration, that is, up to 6 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 12 | Experimental | Receives a core intervention session, the Motivational Interviewing sessions component, the peer mentorship component, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 13 | Experimental | Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, and the navigation intervention component (long duration, that is, up to 6 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 14 | Experimental | Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 15 | Experimental | Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
| Condition 16 | Experimental | Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the peer mentorship component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months). Receives: Behavioral: Heart to Heart2 (HTH2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HIV viral suppression
Blood will be drawn and viral load will be assessed via laboratory report (Bioreference Lab, HIV-1,RNA,PCR,ULTRA). Participants will not have viral suppression at baseline. Change in viral suppression, that is, whether viral suppression has been achieved, will be coded as present if viral load levels are < 20 ppml. Viral suppression will be assessed at both FU periods. Participants may achieve this primary endpoint, or not, at one or both FU periods.
Measured: Assessed at 4 month follow up (FU), 12 month FU
Secondary outcomes (3)
Absolute HIV viral load (log10)
Blood will be drawn and viral load will be assessed via laboratory report (Bioreference Lab, HIV-1,RNA,PCR,ULTRA).
Measured: Assessed at baseline, 4 month follow up (FU), 12 month FU
Adherence to antiretroviral therapy
Hair samples will be tested for average adherence to antiretroviral therapy
Measured: 4 month follow up (FU), 8 month FU, 12 month FU
Engagement in HIV primary care
Assessed with a Medical Report Form completed by the health care provider. "Engagement in HIV care" is operationalized as 3 visits a year (two of them at least 90 days apart) and < 2 missed visits/year
Measured: 4 month follow up (FU), 12 month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start20 Mar 2017
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- Penn State University, Binghamton University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02801747
- Sponsor's protocol ID
- i15-01480
- Acronym
- HTH2-MOST
- Status last verified
- Jul 2022
- First submitted
- 8 Jun 2016
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strayhorn JC, Cleland CM, Vanness DJ, Wilton L, Gwadz M, Collins LM. Using decision analysis for intervention value efficiency to select optimized interventions in the multiphase optimization strategy. Health Psychol. 2024 Feb;43(2):89-100. doi: 10.1037/hea0001318. Epub 2023 Aug 3.
PubMed 37535575Gwadz MV, Collins LM, Cleland CM, Leonard NR, Wilton L, Gandhi M, Scott Braithwaite R, Perlman DC, Kutnick A, Ritchie AS. Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol. BMC Public Health. 2017 May 4;17(1):383. doi: 10.1186/s12889-017-4279-7.
PubMed 28472928
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using MOST to Optimize an HIV Care Continuum Intervention for Vulnerable Populations
- ClinicalTrials.gov ID
- NCT02801747
- Acronym / sponsor ID
- HTH2-MOST / i15-01480
- Conditions
- HIV
- Keywords
- HIV care continuum, antiretroviral therapy, engagement in HIV care, Multiphase Optimization Strategy (MOST)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- Penn State University, Binghamton University
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 16 Jun 2016 (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 present study targets the large population of persons living with HIV/AIDS (PLHA) in the U.S. who are both insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), who are mainly African American/Black and Latino. NIH has emphasized the urgent need for new research approaches to advance intervention science, and the proposed project employs a new, potent, and innovative research methodology, the Multiphase Optimization STrategy (MOST), a framework for developing highly efficacious, efficient, scalable, and cost-effective interventions. The proposed study has the highest public health significance: it addresses a vulnerable population of PLHA, including the critically important subpopulations of men who have sex with men (MSM) and substance users; will develop an efficient and cost effective intervention to increase engagement along the HIV care continuum for these vulnerable groups; and addresses two areas highlighted in the August 2015 notice on research priorities from the NIH Office of AIDS Research (NOT-OD-15-137), namely, engaging PLHA in prevention/treatment services, and reducing HIV/AIDS-related racial/ethnic disparities.
Detailed description
More than half of persons living with HIV/AIDS (PLHA) in the U.S. are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans and Latinos. In the proposed project, two experienced and productive behavioral scientists will employ a potent and innovative research methodology, the Multiphase Optimization STrategy (MOST), to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials (RCTs) are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. The investigators propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American and Latino PLHA not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. This efficiency and cost-effectiveness are critical in a time of constrained resources, and will also increase the intervention's future scalability. NIH has signaled its interest in MOST, and this is the first study to apply it in the field of adult HIV treatment. A similar set of multi-level factors impede both HIV care and ART initiation for African American and Latino PLHA, primary among them individual (e.g., substance use, distrust, fear), social (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, the study will evaluate 5 distinct intervention components (i.e., Motivational Interviewing sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study. Study aims are: 1) using a highly efficient experimental design, identify which of 5 components contribute meaningfully to improvement in viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American and Latino PLHA (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N=512). This highly innovative and significant study, which addresses a high-priority research area (NIH NOT-OD-15-137), will produce an HIV care continuum intervention for the nation's most vulnerable PLHA, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session and the navigation intervention component (long duration; that is, up to 6 months). |
| Condition 2 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months). |
| Condition 3 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months). |
| Condition 4 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the peer mentorship component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months). |
| Condition 5 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the pre-adherence preparation component, and the navigation intervention component (short duration, that is, up to 3 months). |
| Condition 6 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the pre-adherence preparation component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months). |
| Condition 7 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (long duration, that is, up to 6 months). |
| Condition 8 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months). |
| Condition 9 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the Motivational Interviewing sessions component, and the navigation intervention component (short duration, that is, up to 3 months). |
| Condition 10 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the Motivational Interviewing sessions component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months). |
| Condition 11 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the Motivational Interviewing sessions component, the peer mentorship component, and the navigation intervention component (long duration, that is, up to 6 months). |
| Condition 12 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the Motivational Interviewing sessions component, the peer mentorship component, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months). |
| Condition 13 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, and the navigation intervention component (long duration, that is, up to 6 months). |
| Condition 14 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the focused support group component, and the navigation intervention component (short duration, that is, up to 3 months). |
| Condition 15 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the peer mentorship component, and the navigation intervention component (short duration, that is, up to 3 months). |
| Condition 16 | Experimental | Behavioral: Heart to Heart2 (HTH2)Receives a core intervention session, the Motivational Interviewing sessions component, the pre-adherence preparation component, the peer mentorship component, the focused support group component, and the navigation intervention component (long duration, that is, up to 6 months). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- African American/Black or Latino/Hispanic race/ethnicity
- HIV diagnosed for at least 6 months (HIV status confirmed with medical documentation)
- Has not taken antiretroviral therapy (ART) in the past 6 weeks (the period of time assessed by hair assay, and a reasonable period of time not on ART for the present study)
- Sub-optimal engagement in HIV care (assessed from the medical record, defined as less than 1 visit in every 4-mo. period in the past year [two of them at least 90 days apart], pro-rated for those diagnosed less than a year ago) or > 2 missed visits (without prior cancellation) in the past year
- Reside in the New York City (NYC) metropolitan area
Key exclusion criteria (1 listed)
- NONE SEE ABOVE
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 |
|---|---|---|
| Heart to Heart2 (HTH2)The present study uses a fractional factorial design to evaluate the efficacy of five distinct culturally appropriate intervention components on the primary outcome, HIV viral suppression. | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9 |
Primary outcome
Change in HIV viral suppression
Time frame: Assessed at 4 month follow up (FU), 12 month FU
Blood will be drawn and viral load will be assessed via laboratory report (Bioreference Lab, HIV-1,RNA,PCR,ULTRA). Participants will not have viral suppression at baseline. Change in viral suppression, that is, whether viral suppression has been achieved, will be coded as present if viral load levels are < 20 ppml. Viral suppression will be assessed at both FU periods. Participants may achieve this primary endpoint, or not, at one or both FU periods.
3 secondary outcomes
Absolute HIV viral load (log10)
Time frame: Assessed at baseline, 4 month follow up (FU), 12 month FU
Adherence to antiretroviral therapy
Time frame: 4 month follow up (FU), 8 month FU, 12 month FU
Engagement in HIV primary care
Time frame: 4 month follow up (FU), 12 month FU
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 3 Nov 2022.
- Derived from this study: PubMed 37535575Strayhorn JC, Cleland CM, Vanness DJ, Wilton L, Gwadz M, Collins LM. Using decision analysis for intervention value efficiency to select optimized interventions in the multiphase optimization strategy. Health Psychol. 2024 Feb;43(2):89-100. doi: 10.1037/hea0001318. Epub 2023 Aug 3.
- Derived from this study: PubMed 28472928Gwadz MV, Collins LM, Cleland CM, Leonard NR, Wilton L, Gandhi M, Scott Braithwaite R, Perlman DC, Kutnick A, Ritchie AS. Using the multiphase optimization strategy (MOST) to optimize an HIV care continuum intervention for vulnerable populations: a study protocol. BMC Public Health. 2017 May 4;17(1):383. doi: 10.1186/s12889-017-4279-7.
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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 Heart to Heart2 (HTH2) in people with HIV, run by New York University 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 11 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 3 Nov 2022. 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?
Change in HIV viral suppression (time frame: Assessed at 4 month follow up (FU), 12 month FU). 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 NCT02801747, which also lists 2 linked publications.
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 3 Nov 2022.