HIV/AIDSiSTAMPNCT04219878
Implementation of Rapid HIV Self-Testing Among MSM Project
A study testing Know@Home and Self-test Kit in people with HIV/AIDS, run by Emory University at 1 site in United States.
Trial summary
This study will use online materials and strategies to recruit 3600 Black and Hispanic men who have sex with men (MSM) and transgender women (TGW) to participate in a study evaluating the effectiveness of the Know@Home mobile app compared to control condition with respect to linkage of participants to appropriate… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Know@Home and Self-test Kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,195 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2020to 15 Jan 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black/African-American race or Hispanic/Latino ethnicity
- Male sex at birth
- Currently identify as male
- Reported anal sex with at least one man in the past 12 months
- Aged 18 or over
- Has an Android or Apple mobile phone with currently active service
Show all 17Show fewer
- Currently resides in a study state: North Carolina, South Carolina, Georgia, Alabama, Mississippi, Florida, Louisiana, California, Nevada, Texas, New York
- Willing to download a study participation management mobile app
- Willing to provide valid contact information so that study HIV testing kits and other materials (condoms, lubricants, STI testing kits) can be mailed to participants.
- Successful completion of baseline survey
- Male sex at birth
- Currently identify as transgender woman or female
- Aged 18 or over
- Has an Android or Apple mobile smartphone with currently active service
- Currently resides in a study state: North Carolina, South Carolina, Georgia, Alabama, Mississippi, Florida, Louisiana, California, Nevada, Texas, New York
- Willing to provide valid contact information so that study HIV testing kits and other materials (condoms, lubricants, STI testing kits) can be mailed to participants
- Successful completion of baseline survey
Who cannot join
- Currently participating in another HIV prevention research study or program
- Has a bleeding disorder preventing use of dried blood spot testing
- Has previously participated in an HIV vaccine study.
- Currently taking PrEP for HIV prevention
- Self-reports living with HIV
- Has plans to move out of a study state during the study period (4 months)
Show all 12Show fewer
- Currently participating in another HIV prevention clinical trial or intervention
- Has a bleeding disorder preventing use of dried blood spot testing
- Has previously participated in an HIV vaccine study
- Currently taking PrEP for HIV prevention
- Self-reports living with HIV
- Has plans to move out of a study state during the study period (4 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Engaging African American and Hispanic/Latino MSM for HIV Testing and Prevention Services Through Technology
This study will use online materials and strategies to recruit 3600 Black and Hispanic men who have sex with men (MSM) and transgender women (TGW) to participate in a study evaluating the effectiveness of the Know@Home mobile app compared to control condition with respect to linkage of participants to appropriate services, as well as cost-effectiveness outcomes.
Read the detailed description
To evaluate the effectiveness of mailing out rapid HIV home-testing kits and additional testing promotion components among African-American or black and Hispanic or Latino gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW), the study "Implementation of Rapid HIV Self-Testing among MSM Project", known as iSTAMP, is being conducted in 11 US states. This study is interested in the most cost-effective ways to recruit people at high risk for HIV infection. The researchers want to study a sample of 3600 adult MSM and TGW who are not known to be living with HIV; 1800 black/African-American and 1800 Hispanic/Latino participants will be enrolled.
All participants will be mailed two rapid HIV self-test kits upon randomization. All participants, regardless of study arm, will also complete a follow-up survey at the end of a 4-month follow-up period. At the end of the 4-month follow-up period, participants will be mailed a dried blood spot (DBS) collection kit for research purposes, as well as another rapid HIV self-test kit for immediate testing. Participants in each of the arms will have access to videoconferencing-delivered prevention counseling, and all participants, regardless of assigned arm, will be contacted if they report seroconversion and/or a preliminary positive test during the study period for active linkage to care.
- Conditions
- HIV/AIDS
- Being tested
- Know@Home, Self-test Kit
- Keywords
- Sexually transmitted infections, Behavioral intervention, Public health, HIV preexposure prophylaxis (PrEP)
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Know@HomeBehavioural
Participants randomly assigned to the Know@Home arm will access the features of Know@Home by downloading the app or accessing the website. The contents were developed to serve as a comprehensive mobile HIV prevention platform for MSM or TGW, with HIV prevention and care information and links to resources. This intervention arm provides an toolkit that allows users to access information about prevention services as their needs change. Participants will have access to Know@Home for the study period. The Know@Home arm will offer participants the opportunity to order free condoms and lubricant as well as an at-home sexually transmitted infection (STI) testing kit.
Self-test KitOther
Also called OraQuick® In-Home HIV Test
All participants will be shipped two at-home HIV self-tests. They will also receive a link to a previously-produced video that fully describes the specimen collection process, pointing out common errors and providing tips for successful collection. Participants will interact with study staff through phone, email, or text. Information to schedule a video HIV testing and counseling session with study staff will be made available to participants in all arms via a website, email, and/or text.
| Study group | Role | What they receive |
|---|---|---|
| Know@Home App or Website and Test Kit | Active comparator | Participants in this study arm will have access to Know@Home, a mobile HIV prevention app or website and will receive mail-out HIV self-testing kits. Receives: Behavioral: Know@Home; Other: Self-test Kit |
| Mail-Out Testing Kit Only | Active comparator | Participants in this study arm will receive mail-out HIV self-testing kits. Receives: Other: Self-test Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants initiating HIV treatment
Effectiveness of the interventions will be assessed by linkage of participants to HIV treatment.
Measured: Up to Month 4
Number of participants initiating PrEP treatment
Effectiveness of the interventions will be assessed by linkage of participants to PrEP treatment.
Measured: Up to Month 4
Number of participants testing for STIs
Effectiveness of the interventions will be assessed by linkage of participants to STI testing.
Measured: Up to Month 4
Number of participants engaging in HIV prevention services
Effectiveness of the interventions will be assessed by linkage of participants to HIV prevention services.
Measured: Up to Month 4
Number of participants engaging in HIV social services
Effectiveness of the interventions will be assessed by linkage of participants to HIV social services.
Measured: Up to Month 4
Cost of different online venues for study enrollment
Enrollment in the study defined as completion of the baseline survey and downloading of the study app. The cost (in US dollars) to enroll participants (online banner advertisement placement, study staff time to manage enrollment, validating participant eligibility, monitoring and evaluation of enrollment data) will be compared between the study arms.
Measured: Baseline
Cost of different online venues for HIV test results returned
The cost (in US dollars) of HIV tests returned within 1 month of enrollment will be compared between the study arms. The costs involved with having HIV tests returned include:
- Online banner advertisement placement
- Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data
- HIV test kits
- Shipping for HIV test kits
- Staff/personnel time to manage mailing/return of test kits
- Other general and administrative time, office supplies, equipment, rents, utilities
Measured: Month 1
Cost of different online venues for identifying new HIV diagnoses
The cost (in US dollars) of identifying established HIV infections will be compared between the study arms. The costs involved with identifying established HIV infections include:
- Online banner advertisement placement
- Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data
- HIV test kits
- Shipping for HIV test kits
- Staff/personnel time to manage mailing/return of test kits
- Study staff time to manage monitoring and evaluation of HIV test result data
- Study staff time to provide phone counseling to those with established infections
- Other general and administrative time, office supplies, equipment, rents, utilities
Measured: Month 1
Secondary outcomes (6)
Cost of linkage to HIV counseling
The cost (in US dollars) of linking participants testing positive for HIV to HIV counseling will be compared between the study arms, including:
- Study staff time spent contacting participants
- Study staff time for intervention maintenance (e.g., app management)
- HIV counseling costs to the healthcare system
- Other general and administrative time, office supplies, equipment, rents, utilities
Measured: Month 4
Cost of linkage to HIV treatment
The cost (in US dollars) of linking participants testing positive for HIV to HIV treatment will be compared between the three study arms, including:
- Study staff time for intervention maintenance (e.g., app management)
- HIV treatment costs to the healthcare system
- Other general and administrative time, office supplies, equipment, rents, utilities
Measured: Month 4
Cost of linkage to PrEP counseling
The cost (in US dollars) of linking participants testing negative for HIV to PrEP counseling will be compared between the study arms, including:
- Study staff time contacting participants
- Study staff time for intervention maintenance (e.g., app management)
- PrEP counseling costs to the healthcare system
- Other general and administrative time, office supplies, equipment, rents, utilities
Measured: Month 4
Cost of linkage to PrEP uptake
The cost (in US dollars) of linking participants testing negative for HIV to initiate PrEP treatment will be compared between the study arms, including:
- Study staff time contacting participants
- Study staff time for intervention maintenance (e.g., app management)
- PrEP uptake costs to the healthcare system
- Other general and administrative time, office supplies, equipment, rents, utilities
Measured: Month 4
Cost of Sexually Transmitted Infection (STI) testing
The cost (in US dollars) of providing at-home STI testing be compared between the study arms, including:
- Cost of STI testing materials and shipping
- Laboratory STI testing
- Study staff time processing orders and contacting participants
- Study staff time for intervention maintenance (e.g., app management)
- STI testing costs to the healthcare system
- Other general and administrative time, office supplies, equipment, rents, utilities
Measured: Month 4
Cost of linkage to STI treatment
The cost (in US dollars) of providing treatment for STIs discovered through at-home STI testing be compared between the three study arms, including:
- Study staff time processing orders and contacting participants
- Study staff time for intervention maintenance (e.g., app management)
- STI treatment costs to the healthcare system
- Other general and administrative time, office supplies, equipment, rents, utilities
Measured: Month 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start17 Feb 2020
- Primary completion1 Sep 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Emory 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Patrick S Sullivan, Emory University
- Investigators
- Patrick Sullivan, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219878
- Sponsor's protocol ID
- IRB00099710
- Other IDs
- 1U01PS005181
- Acronym
- iSTAMP
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2020
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial will be available for sharing with other researchers, after deidentification. Some data may be provided as categorical variables.
Publications
Caldwell JA, Dana R, Lucas IL, Sullivan PS, Olansky E, Sullivan S, Hannah M, Sanchez T, Hightow-Weidman L, Sharma A. Adaptation of a Protocol to Evaluate Online Recruitment Strategies for Mailing HIV Self-Tests and Pilot an Intervention to Improve Linkage to HIV Prevention and Care Among Transgender Women: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 20;15:e75345. doi: 10.2196/75345.
PubMed 41719490MacGowan RJ, Chavez PR, Dana R, Hannah M, Raiford JL, Caldwell JA, Wall KM, Johnson JA, Sharma A, Hightow-Weidman L, Stephenson R, Sanchez T, Smith AJ, Sullivan S, Jones J, Sullivan PS. Efficacy of Internet Recruitment and HIV Self-Testing for Diagnosing HIV Infections Among Black and Hispanic/Latino MSM and Transgender Women in 11 US States, 2020-2021. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):133-141. doi: 10.1097/QAI.0000000000003476.
PubMed 39250647Dana R, Sullivan S, MacGowan RJ, Chavez PR, Wall KM, Sanchez TH, Stephenson R, Hightow-Weidman L, Johnson JA, Smith A, Sharma A, Jones J, Hannah M, Trigg M, Luo W, Caldwell J, Sullivan PS. Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial. JMIR Res Protoc. 2023 Jan 6;12:e43414. doi: 10.2196/43414.
PubMed 36607707
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging African American and Hispanic/Latino MSM for HIV Testing and Prevention Services Through Technology
- ClinicalTrials.gov ID
- NCT04219878
- Acronym / sponsor ID
- iSTAMP / IRB00099710
- Conditions
- HIV/AIDS
- Keywords
- Sexually transmitted infections, Behavioral intervention, Public health, HIV preexposure prophylaxis (PrEP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,195 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- 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.
This study will use online materials and strategies to recruit 3600 Black and Hispanic men who have sex with men (MSM) and transgender women (TGW) to participate in a study evaluating the effectiveness of the Know@Home mobile app compared to control condition with respect to linkage of participants to appropriate services, as well as cost-effectiveness outcomes.
Detailed description
To evaluate the effectiveness of mailing out rapid HIV home-testing kits and additional testing promotion components among African-American or black and Hispanic or Latino gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW), the study "Implementation of Rapid HIV Self-Testing among MSM Project", known as iSTAMP, is being conducted in 11 US states. This study is interested in the most cost-effective ways to recruit people at high risk for HIV infection. The researchers want to study a sample of 3600 adult MSM and TGW who are not known to be living with HIV; 1800 black/African-American and 1800 Hispanic/Latino participants will be enrolled.
All participants will be mailed two rapid HIV self-test kits upon randomization. All participants, regardless of study arm, will also complete a follow-up survey at the end of a 4-month follow-up period. At the end of the 4-month follow-up period, participants will be mailed a dried blood spot (DBS) collection kit for research purposes, as well as another rapid HIV self-test kit for immediate testing. Participants in each of the arms will have access to videoconferencing-delivered prevention counseling, and all participants, regardless of assigned arm, will be contacted if they report seroconversion and/or a preliminary positive test during the study period for active linkage to care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Know@Home App or Website and Test Kit | Active comparator | Behavioral: Know@Home, Other: Self-test KitParticipants in this study arm will have access to Know@Home, a mobile HIV prevention app or website and will receive mail-out HIV self-testing kits. |
| Mail-Out Testing Kit Only | Active comparator | Other: Self-test KitParticipants in this study arm will receive mail-out HIV self-testing kits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Black/African-American race or Hispanic/Latino ethnicity
- Male sex at birth
- Currently identify as male
- Reported anal sex with at least one man in the past 12 months
- Aged 18 or over
Key exclusion criteria (12 listed)
- Currently participating in another HIV prevention research study or program
- Has a bleeding disorder preventing use of dried blood spot testing
- Has previously participated in an HIV vaccine study.
- Currently taking PrEP for HIV prevention
- Self-reports living with HIV
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 |
|---|---|---|
| Know@HomeParticipants randomly assigned to the Know@Home arm will access the features of Know@Home by downloading the app or accessing the website. The contents were developed to serve as a comprehensive mobile HIV prevention platform for MSM or TGW, with HIV prevention and care information and links to resources. This intervention arm provides an toolkit that allows users to access information about prevention services as their needs change. Participants will have access to Know@Home for the study period. The Know@Home arm will offer participants the opportunity to order free condoms and lubricant as well as an at-home sexually transmitted infection (STI) testing kit. | Behavioural | Know@Home App or Website and Test Kit |
| Self-test KitAlso: OraQuick® In-Home HIV TestAll participants will be shipped two at-home HIV self-tests. They will also receive a link to a previously-produced video that fully describes the specimen collection process, pointing out common errors and providing tips for successful collection. Participants will interact with study staff through phone, email, or text. Information to schedule a video HIV testing and counseling session with study staff will be made available to participants in all arms via a website, email, and/or text. | Other | Know@Home App or Website and Test Kit, Mail-Out Testing Kit Only |
Primary outcome
Number of participants initiating HIV treatment
Time frame: Up to Month 4
Effectiveness of the interventions will be assessed by linkage of participants to HIV treatment.
Number of participants initiating PrEP treatment
Time frame: Up to Month 4
Effectiveness of the interventions will be assessed by linkage of participants to PrEP treatment.
Number of participants testing for STIs
Time frame: Up to Month 4
Effectiveness of the interventions will be assessed by linkage of participants to STI testing.
Number of participants engaging in HIV prevention services
Time frame: Up to Month 4
Effectiveness of the interventions will be assessed by linkage of participants to HIV prevention services.
Number of participants engaging in HIV social services
Time frame: Up to Month 4
Effectiveness of the interventions will be assessed by linkage of participants to HIV social services.
Cost of different online venues for study enrollment
Time frame: Baseline
Enrollment in the study defined as completion of the baseline survey and downloading of the study app. The cost (in US dollars) to enroll participants (online banner advertisement placement, study staff time to manage enrollment, validating participant eligibility, monitoring and evaluation of enrollment data) will be compared between the study arms.
Cost of different online venues for HIV test results returned
Time frame: Month 1
The cost (in US dollars) of HIV tests returned within 1 month of enrollment will be compared between the study arms. The costs involved with having HIV tests returned include: * Online banner advertisement placement * Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data * HIV test kits * Shipping for HIV test kits * Staff/personnel time to manage mailing/return of test kits * Other general and administrative time, office supplies, equipment, rents, utilities
Cost of different online venues for identifying new HIV diagnoses
Time frame: Month 1
The cost (in US dollars) of identifying established HIV infections will be compared between the study arms. The costs involved with identifying established HIV infections include: * Online banner advertisement placement * Study staff time managing enrollment, validating participant eligibility, monitoring and evaluation of enrollment data * HIV test kits * Shipping for HIV test kits * Staff/personnel time to manage mailing/return of test kits * Study staff time to manage monitoring and evaluation of HIV test result data * Study staff time to provide phone counseling to those with established infections * Other general and administrative time, office supplies, equipment, rents, utilities
6 secondary outcomes
Cost of linkage to HIV counseling
Time frame: Month 4
Cost of linkage to HIV treatment
Time frame: Month 4
Cost of linkage to PrEP counseling
Time frame: Month 4
Cost of linkage to PrEP uptake
Time frame: Month 4
Cost of Sexually Transmitted Infection (STI) testing
Time frame: Month 4
Cost of linkage to STI treatment
Time frame: Month 4
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 1 Feb 2024.
- Derived from this study: PubMed 41719490Caldwell JA, Dana R, Lucas IL, Sullivan PS, Olansky E, Sullivan S, Hannah M, Sanchez T, Hightow-Weidman L, Sharma A. Adaptation of a Protocol to Evaluate Online Recruitment Strategies for Mailing HIV Self-Tests and Pilot an Intervention to Improve Linkage to HIV Prevention and Care Among Transgender Women: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 20;15:e75345. doi: 10.2196/75345.
- Derived from this study: PubMed 39250647MacGowan RJ, Chavez PR, Dana R, Hannah M, Raiford JL, Caldwell JA, Wall KM, Johnson JA, Sharma A, Hightow-Weidman L, Stephenson R, Sanchez T, Smith AJ, Sullivan S, Jones J, Sullivan PS. Efficacy of Internet Recruitment and HIV Self-Testing for Diagnosing HIV Infections Among Black and Hispanic/Latino MSM and Transgender Women in 11 US States, 2020-2021. J Acquir Immune Defic Syndr. 2024 Oct 1;97(2):133-141. doi: 10.1097/QAI.0000000000003476.
- Derived from this study: PubMed 36607707Dana R, Sullivan S, MacGowan RJ, Chavez PR, Wall KM, Sanchez TH, Stephenson R, Hightow-Weidman L, Johnson JA, Smith A, Sharma A, Jones J, Hannah M, Trigg M, Luo W, Caldwell J, Sullivan PS. Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial. JMIR Res Protoc. 2023 Jan 6;12:e43414. doi: 10.2196/43414.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial will be available for sharing with other researchers, after deidentification. Some data may be provided as categorical variables.
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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 Sullivan, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Know@Home and Self-test Kit in people with HIV/AIDS, run by Emory 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 17 inclusion and 12 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 1 Feb 2024. 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?
Number of participants initiating HIV treatment (time frame: Up to Month 4). The study lists 8 primary outcomes in all. 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 NCT04219878, which also lists 3 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 1 Feb 2024.