HIVProyecto PACToNCT01792752
Enhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico
A study testing Enhanced HIV Care Access and Retention Intervention, HIV Testing Campaign and Treatment Re-engagement Campaign in people with HIV and AIDS, run by Columbia University at 2 sites in Puerto Rico.
Trial summary
The overall goal of this project is to implement and evaluate a community-level, structured approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, AIDS, Substance Abuse
- What is being tested?
- Enhanced HIV Care Access and Retention Intervention, HIV Testing Campaign and Treatment Re-engagement Campaign
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,082 participants
- Where
- 2 sitesPuerto Rico
- Study dates
- 20 Dec 2013to Jul 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 18 years of age or older
- report having injected drugs (opioid or stimulants) at least once in the past 30 days
- provide written informed consent
- HIV Care Cohort
- be 18 years of age or older
- test HIV-seropositive through rapid testing (confirmed with Western Blot or immunofluorescence assay)
Show all 27Show fewer
- report having injected drugs more than once per week for the past 30 days
- self-report that they have not been in HIV care for the past 6 months
- agree to have their blood drawn for CD4 and HIV plasma RNA testing
- live in one of the San Juan neighborhoods targeted for intervention
- provide basic contact information for follow-up
- sign a HIPAA Authorization/medical record release form
- provide written informed consent
- Assessment Cohort
- be 18 years of age or older
- test HIV-seropositive through rapid testing (confirmed with Western Blot or immunofluorescence assay)
- report having injected drugs more than once per week for the past 30 days
- self-report that they have not been in HIV care for the past 6 months
- agree to have their blood drawn for CD4 and HIV plasma RNA testing
- live in one of the San Juan neighborhoods targeted for intervention
- provide basic contact information for follow-up
- sign a HIPAA Authorization/medical record release form
- provide written informed consent
- Exclusion Criteria (for all study components mentioned above):
- do not meet any one or more of the above-described inclusion criteria
- have significant cognitive or developmental impairment to the extent that they are unable to provide informed consent
- are terminated via Site PI decision
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Puerto Rico2 sites
Puerto Rico Department of Health
Rio Piedras, 00922
Iniciativa Comunitaria de Investigacion, Inc.
San Juan, 00918
About this study
The overall goal of this project is to implement and evaluate a community-level, structured approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico. The "Enhanced HIV Care Access and Retention Intervention" will: 1) identify drug users living with HIV who either do not know their HIV status and/or are not engaged in HIV care; 2) provide direct HIV care services through a mobile health van; and 3) support identified HIV-infected drug users with patient navigators to enhance their ability to engage in HIV care and substance abuse treatment, to initiate antiretroviral therapy, and maintain adherence to their treatment regimens. The structural enhanced care approach will be evaluated through a randomized roll-out design, a refinement of the stepped-wedge design. The community-level success of the intervention will be assessed by evaluating virologic suppression (primary biological outcome), increased attendance to HIV care visits, uptake of antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn from each of the neighborhoods included in the intervention. The investigators will also evaluate the implementation process and cost of the enhanced care approach including implications for cost-effectiveness, feasibility of expansion, and sustainability.
Read the detailed description
Recent scientific advances demonstrate that for people living with HIV, antiretroviral therapy (ART) is the most effective strategy to improve immune function, reduce morbidity, improve quality of life, prolong survival, and prevent HIV transmission. Translating this knowledge into practice, however, requires prompt diagnosis and linkage to care, entry into care with timely ART initiation, and engagement in care, support for ART adherence, and retention to promote durable viral suppression. Addressing failures in this cascade of care, often referred to as the "Seek, Test, Treat, and Retain (STTR)" paradigm, has become a major part of the National HIV/AIDS strategy in the United States. To date, much of the research and discussion surrounding this strategy has focused on expanding HIV testing to improve the early identification of new cases. There has been less attention focused on linkage to, engagement in, and retention in care. Specifically, little attention has focused on identifying HIV-positive individuals who, despite being aware of their diagnosis, have never been in HIV care, are intermittent users of care, or have dropped out of care.
HIV-infected injection drug users (IDUs) are a particularly difficult subpopulation to link to and retain in HIV care. They face a myriad of challenges that can impede retention in care including substance use disorders (both alcohol and drugs), mental health problems and poverty-related issues such as unstable housing and food insecurity. If IDUs adhere to their treatment regimens, however, studies have demonstrated they realize similar survival benefits from antiretroviral therapy as persons without a history of injection drug use. In contrast to the majority of communities in the U.S., in Puerto Rico, drug use, particularly injection drug use, continues to fuel a fast-growing HIV epidemic. Puerto Rico has an estimated incidence rate of 45 HIV cases per 100,000 population, twice the rate for the 50 U.S. states, and almost 40% of new infections are associated with injection drug use. In contrast, only 12% of new infections in the 50 U.S. states are among IDUs.
The overall goal of this project is to implement and evaluate a community-level, structured enhanced approach, the Enhanced HIV Care Access and Retention Intervention, for substance users in San Juan, Puerto Rico. It will bring HIV care directly to five San Juan zones in which a high proportion of HIV-infected substance users reside. The significance of the study is threefold.f care, or have dropped out of care.
- Conditions
- HIV, AIDS, Substance Abuse
- Being tested
- Enhanced HIV Care Access and Retention Intervention, HIV Testing Campaign, Treatment Re-engagement Campaign, Patient Navigator Linkage to Care and Substance Abuse Treatment Team, Mobile Care Clinic
- Keywords
- HIV/AIDS, Drug Users, Puerto Rico
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders, Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced HIV Care Access and Retention InterventionBehavioural
Through the Enhanced HIV Care Access and Retention Intervention, the five neighborhoods will receive the 4 components of the intervention: 1) HIV Testing Campaign; 2) Treatment Re-engagement Campaign; 3) Patient Navigator Linkage to Care and Substance Abuse Treatment Team; and 4) Mobile Care Clinic. In addition to these intervention components, study participants will receive screening and access to treatment for other physical and mental co-morbidities, general primary health care, and social/psychosocial services addressing unstable housing, food insecurity, interpersonal violence, legal issues. All HIV-positive IDUs identified either through the HIV Testing Campaign or the Treatment Re-engagement Campaign will be enrolled in the HIV Care Cohort. The HIV Care Cohort will be comprised of the HIV-positive injectors who are receiving direct services in the Mobile Care Clinic. The 4 intervention components are detailed below:
HIV Testing CampaignBehavioural
When the intervention is initiated in a neighborhood, HIV rapid testing will begin and continue in a particular neighborhood from the time that the neighborhood's intervention begins until the end of the study period. Anyone testing HIV positive will be seen and counseled by a member of the Patient Navigator Team.
Treatment Re-engagement CampaignBehavioural
Simultaneously with the introduction of the HIV Testing Campaign, a patient navigator team will approach HIV-positive IDUs identified as not having seen their HIV care provider in the last 6 months. In addition, known HIV-positive IDUs within the designated neighborhoods will be approached for service enrollment and meet with a patient navigator.
Patient Navigator Linkage to Care and Substance Abuse Treatment TeamBehavioural
The patient navigator team will provide informational support to the HIV-positive injectors, motivate them to attend HIV care visits and engage in substance abuse treatment, encourage their use of and adherence to antiretroviral therapies, and work with them to overcome any barriers to attendance at HIV care visits and substance abuse treatment. All clients of the patient navigator will become part of the HIV Care Cohort; they will have been identified either in the HIV Testing Campaign or the Treatment Re-Engagement Campaign.
Mobile Care ClinicBehavioural
Participants who choose to receive services in the study mobile HIV care clinic will receive an initial appointment and the patient navigator will ensure that the client attends it. At the initial visit, clients will have a medical history taken, be examined and have blood drawn to measure CD4 and viral load. The mobile care clinic doctor will also prescribe medications for the client at the subsequent visit which will be scheduled as soon as lab results are available and interpreted, approximately one week later. The mobile HIV care clinic van will provide health services to the general IDU population within each intervention neighborhood to avoid any stigmatization of the HIV positive clients.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced HIV Care Access and Retention Intervention | Experimental | Through the Enhanced HIV Care Access and Retention Intervention, the five neighborhoods will receive the 4 components of the intervention: 1) HIV Testing Campaign; 2) Treatment Re-engagement Campaign; 3) Patient Navigator Linkage to Care and Substance Abuse Treatment Team; and 4) Mobile Care Clinic. The neighborhoods will receive the intervention at different times throughout the study period, but once the intervention is initiated in a neighborhood it will continue being implemented in that neighborhood until the end of the study period. Receives: Behavioral: Enhanced HIV Care Access and Retention Intervention; Behavioral: HIV Testing Campaign; Behavioral: Treatment Re-engagement Campaign; Behavioral: Patient Navigator Linkage to Care and Substance Abuse Treatment Team; Behavioral: Mobile Care Clinic |
| Control / Neighborhood(s) not receiving the intervention | No intervention | The neighborhood(s) not receiving the intervention will act as a control while the intervention is initiated and implemented in other neighborhoods. All neighborhoods will receive the intervention but at different times throughout the study period. Once the intervention is initiated in a neighborhood, that neighborhood will continue receiving the intervention until the end of the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Virologic Suppression
Assessment of success of the intervention will be measured by testing whether there is a significant change in virologic suppression associated with the intervention.
Measured: Every 6 months for up to 36 months
Secondary outcomes (6)
Increasing HIV care visit attendance
Measured: Every 6 months for up to 36 months
Uptake of antiretroviral therapy
Measured: Every 6 months for up to 36 months
Adherence to HIV treatment regimens
Measured: Every 6 months for up to 36 months
Decreasing substance use
Measured: Every 6 months for up to 36 months
Consistency of enrollment in the intervention and receipt of intervention services across neighborhoods over time
Measured: 36 months
Cost of delivering the intervention and of other medical services received
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study start20 Dec 2013
- Primary completionAug 2020
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,082 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico, Iniciativa Comunitaria de Investigacion, Puerto Rico Department of Health, University of Miami, Weill Medical College of Cornell University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Lisa Metsch, Columbia University
- Investigators
- Lisa Metsch, Ph.D., Principal investigator, Columbia UniversityJorge Santana, M.D., Principal investigator, University of Puerto Rico Medical Sciences CampusSandra Miranda De Leon, M.P.H., Principal investigator, Puerto Rico Department of HealthDaniel Feaster, Ph.D., Principal investigator, University of MiamiBruce Schackman, Ph.D., Principal investigator, Joan & Sanford I. Weill Medical College of Cornell UniversityGlenda Davila, M.D., Principal investigator, Iniciativa Comunitaria de Investigacion, Inc.Lauren K. Gooden, Ph.D, Study director, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792752
- Sponsor's protocol ID
- AAAK8805
- Other IDs
- 1R01DA035280-01
- Acronym
- Proyecto PACTo
- Status last verified
- Mar 2022
- First submitted
- 8 Feb 2013
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Access to HIV Care for Drug Users in San Juan, Puerto Rico
- ClinicalTrials.gov ID
- NCT01792752
- Acronym / sponsor ID
- Proyecto PACTo / AAAK8805
- Conditions
- HIV, AIDS, Substance Abuse
- Keywords
- HIV/AIDS, Drug Users, Puerto Rico
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,082 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- University of Puerto Rico, Iniciativa Comunitaria de Investigacion, Puerto Rico Department of Health, University of Miami, Weill Medical College of Cornell University, National Institute on Drug Abuse (NIDA)
- Study start
- 20 Dec 2013 (actual)
- Primary completion
- Aug 2020 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 15 Feb 2013 (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 overall goal of this project is to implement and evaluate a community-level, structured approach to enhance HIV care access and retention for drug users in San Juan, Puerto Rico. The "Enhanced HIV Care Access and Retention Intervention" will: 1) identify drug users living with HIV who either do not know their HIV status and/or are not engaged in HIV care; 2) provide direct HIV care services through a mobile health van; and 3) support identified HIV-infected drug users with patient navigators to enhance their ability to engage in HIV care and substance abuse treatment, to initiate antiretroviral therapy, and maintain adherence to their treatment regimens. The structural enhanced care approach will be evaluated through a randomized roll-out design, a refinement of the stepped-wedge design. The community-level success of the intervention will be assessed by evaluating virologic suppression (primary biological outcome), increased attendance to HIV care visits, uptake of antiretroviral therapy, adherence to HIV treatment regimens, and decreased substance use (as secondary behavioral outcomes) in an independent cohort of HIV-positive individuals drawn from each of the neighborhoods included in the intervention. The investigators will also evaluate the implementation process and cost of the enhanced care approach including implications for cost-effectiveness, feasibility of expansion, and sustainability.
Detailed description
Recent scientific advances demonstrate that for people living with HIV, antiretroviral therapy (ART) is the most effective strategy to improve immune function, reduce morbidity, improve quality of life, prolong survival, and prevent HIV transmission. Translating this knowledge into practice, however, requires prompt diagnosis and linkage to care, entry into care with timely ART initiation, and engagement in care, support for ART adherence, and retention to promote durable viral suppression. Addressing failures in this cascade of care, often referred to as the "Seek, Test, Treat, and Retain (STTR)" paradigm, has become a major part of the National HIV/AIDS strategy in the United States. To date, much of the research and discussion surrounding this strategy has focused on expanding HIV testing to improve the early identification of new cases. There has been less attention focused on linkage to, engagement in, and retention in care. Specifically, little attention has focused on identifying HIV-positive individuals who, despite being aware of their diagnosis, have never been in HIV care, are intermittent users of care, or have dropped out of care.
HIV-infected injection drug users (IDUs) are a particularly difficult subpopulation to link to and retain in HIV care. They face a myriad of challenges that can impede retention in care including substance use disorders (both alcohol and drugs), mental health problems and poverty-related issues such as unstable housing and food insecurity. If IDUs adhere to their treatment regimens, however, studies have demonstrated they realize similar survival benefits from antiretroviral therapy as persons without a history of injection drug use. In contrast to the majority of communities in the U.S., in Puerto Rico, drug use, particularly injection drug use, continues to fuel a fast-growing HIV epidemic. Puerto Rico has an estimated incidence rate of 45 HIV cases per 100,000 population, twice the rate for the 50 U.S. states, and almost 40% of new infections are associated with injection drug use. In contrast, only 12% of new infections in the 50 U.S. states are among IDUs.
The overall goal of this project is to implement and evaluate a community-level, structured enhanced approach, the Enhanced HIV Care Access and Retention Intervention, for substance users in San Juan, Puerto Rico. It will bring HIV care directly to five San Juan zones in which a high proportion of HIV-infected substance users reside. The significance of the study is threefold.f care, or have dropped out of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced HIV Care Access and Retention Intervention | Experimental | Behavioral: Enhanced HIV Care Access and Retention Intervention, Behavioral: HIV Testing Campaign, Behavioral: Treatment Re-engagement Campaign, Behavioral: Patient Navigator Linkage to Care and Substance Abuse Treatment Team, Behavioral: Mobile Care ClinicThrough the Enhanced HIV Care Access and Retention Intervention, the five neighborhoods will receive the 4 components of the intervention: 1) HIV Testing Campaign; 2) Treatment Re-engagement Campaign; 3) Patient Navigator Linkage to Care and Substance Abuse Treatment Team; and 4) Mobile Care Clinic. The neighborhoods will receive the intervention at different times throughout the study period, but once the intervention is initiated in a neighborhood it will continue being implemented in that neighborhood until the end of the study period. |
| Control / Neighborhood(s) not receiving the intervention | No intervention | –The neighborhood(s) not receiving the intervention will act as a control while the intervention is initiated and implemented in other neighborhoods. All neighborhoods will receive the intervention but at different times throughout the study period. Once the intervention is initiated in a neighborhood, that neighborhood will continue receiving the intervention until the end of the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- be 18 years of age or older
- report having injected drugs (opioid or stimulants) at least once in the past 30 days
- provide written informed consent
- HIV Care Cohort
- be 18 years of age or older
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Enhanced HIV Care Access and Retention InterventionThrough the Enhanced HIV Care Access and Retention Intervention, the five neighborhoods will receive the 4 components of the intervention: 1) HIV Testing Campaign; 2) Treatment Re-engagement Campaign; 3) Patient Navigator Linkage to Care and Substance Abuse Treatment Team; and 4) Mobile Care Clinic. In addition to these intervention components, study participants will receive screening and access to treatment for other physical and mental co-morbidities, general primary health care, and social/psychosocial services addressing unstable housing, food insecurity, interpersonal violence, legal issues. All HIV-positive IDUs identified either through the HIV Testing Campaign or the Treatment Re-engagement Campaign will be enrolled in the HIV Care Cohort. The HIV Care Cohort will be comprised of the HIV-positive injectors who are receiving direct services in the Mobile Care Clinic. The 4 intervention components are detailed below: | Behavioural | Enhanced HIV Care Access and Retention Intervention |
| HIV Testing CampaignWhen the intervention is initiated in a neighborhood, HIV rapid testing will begin and continue in a particular neighborhood from the time that the neighborhood's intervention begins until the end of the study period. Anyone testing HIV positive will be seen and counseled by a member of the Patient Navigator Team. | Behavioural | Enhanced HIV Care Access and Retention Intervention |
| Treatment Re-engagement CampaignSimultaneously with the introduction of the HIV Testing Campaign, a patient navigator team will approach HIV-positive IDUs identified as not having seen their HIV care provider in the last 6 months. In addition, known HIV-positive IDUs within the designated neighborhoods will be approached for service enrollment and meet with a patient navigator. | Behavioural | Enhanced HIV Care Access and Retention Intervention |
| Patient Navigator Linkage to Care and Substance Abuse Treatment TeamThe patient navigator team will provide informational support to the HIV-positive injectors, motivate them to attend HIV care visits and engage in substance abuse treatment, encourage their use of and adherence to antiretroviral therapies, and work with them to overcome any barriers to attendance at HIV care visits and substance abuse treatment. All clients of the patient navigator will become part of the HIV Care Cohort; they will have been identified either in the HIV Testing Campaign or the Treatment Re-Engagement Campaign. | Behavioural | Enhanced HIV Care Access and Retention Intervention |
| Mobile Care ClinicParticipants who choose to receive services in the study mobile HIV care clinic will receive an initial appointment and the patient navigator will ensure that the client attends it. At the initial visit, clients will have a medical history taken, be examined and have blood drawn to measure CD4 and viral load. The mobile care clinic doctor will also prescribe medications for the client at the subsequent visit which will be scheduled as soon as lab results are available and interpreted, approximately one week later. The mobile HIV care clinic van will provide health services to the general IDU population within each intervention neighborhood to avoid any stigmatization of the HIV positive clients. | Behavioural | Enhanced HIV Care Access and Retention Intervention |
Primary outcome
HIV Virologic Suppression
Time frame: Every 6 months for up to 36 months
Assessment of success of the intervention will be measured by testing whether there is a significant change in virologic suppression associated with the intervention.
6 secondary outcomes
Increasing HIV care visit attendance
Time frame: Every 6 months for up to 36 months
Uptake of antiretroviral therapy
Time frame: Every 6 months for up to 36 months
Adherence to HIV treatment regimens
Time frame: Every 6 months for up to 36 months
Decreasing substance use
Time frame: Every 6 months for up to 36 months
Consistency of enrollment in the intervention and receipt of intervention services across neighborhoods over time
Time frame: 36 months
Cost of delivering the intervention and of other medical services received
Time frame: 36 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 28 Mar 2022.
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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.
Lisa Metsch, Ph.D. principal investigator
Columbia University
Jorge Santana, M.D. principal investigator
University of Puerto Rico Medical Sciences Campus
Sandra Miranda De Leon, M.P.H. principal investigator
Puerto Rico Department of Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced HIV Care Access and Retention Intervention, HIV Testing Campaign and Treatment Re-engagement Campaign in people with HIV and AIDS, run by Columbia University at 2 sites in Puerto Rico.
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 27 inclusion and 0 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 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Puerto Rico. 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?
HIV Virologic Suppression (time frame: Every 6 months for up to 36 months). 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 28 Mar 2022.