HIV TestingNCT02834572
Using Technology to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options
A study testing All About Me in people with HIV Testing, run by New York Blood Center at 1 site in United States.
Trial summary
Young Black men who have sex with men (MSM) and transwomen in the US are affected by HIV at severely disproportionate rates. A key component of HIV prevention for communities at risk is diagnosing HIV infections through regular HIV testing. Read more about this study
- Who is it for?
- Ages 16 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Testing
- What is being tested?
- All About Me
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Dec 2017
- 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 16 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- male at birth;
- self-identify as Black, African American, Caribbean Black, African Black or multiethnic Black;
- able to read and respond in English;
- between 16-29 years of age;
- known to be HIV-infected;
- insertive or receptive anal intercourse with a man or transwoman in the last 12 months;
- reside in the New York City metropolitan area
Who cannot join
- enrolled in any other HIV research study involving HIV testing
- participant in an HIV vaccine trial
- currently taking pre-exposure prophylaxis
Trial locations and contacts
1 site in 1 country.
About this study
Young Black men who have sex with men (MSM) and transwomen in the US are affected by HIV at severely disproportionate rates. A key component of HIV prevention for communities at risk is diagnosing HIV infections through regular HIV testing. A significant proportion of young Black MSM and transwomen have not tested in the prior year. This research study seeks to address low HIV testing rates among young Black MSM and transwomen by testing a brief Internet-based HIV testing intervention optimized for mobile devices. The intervention takes advantage of the variety of HIV testing options now available, including the HIV self testing, couples-based HIV counseling and testing and traditional clinic-based testing and will provide men and transwomen with a tailored recommendation of their optimal HIV testing approach. The investigators are conducting a pilot randomized study among young Black MSM and transwomen followed for 6 months to estimate the intervention's potential efficacy in increasing HIV testing.
Read the detailed description
We are conducting a pilot study among 240 young Black MSM and transgender women randomized to the Intervention Arm (assessment and algorithm to deliver a tailored recommendation) or Control (assessment and standard HIV testing information) and followed for 6 months to estimate the intervention's potential efficacy in increasing HIV testing. After informed consent, participants are asked to provide contact information on the locator form. Then, participants complete a brief quantitative assessment including basic demographics, HIV testing history and other factors related to HIV testing. All participants, regardless of study arm, then receive information about each HIV testing method including how the tests are conducted (blood, oral sample), and availability of counseling and support. Participants then are randomized into 1 of the 2 study arms. A computer program will randomly assign each participant using randomly ordered block sizes of 4 and 6 and stratified by age (16-23, 24-29 years) to balance groups.
Participants assigned to the Intervention Arm will complete a brief quantitative assessment lasting approximately 2-3 minutes to assess those factors associated with HIV testing and thus are needed to complete the algorithm. They then receive the results of the HIV testing algorithm, presented as their personalized HIV testing approach. All participants will receive information on resources in New York City to test by all of these methods. The control participants are provided with the above information about each testing approach but without a recommended approach.
- Conditions
- HIV Testing
- Being tested
- All About Me, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All About MeBehavioural
Assessment and algorithm to determine recommended HIV testing approach
ControlBehavioural
HIV testing information
| Study group | Role | What they receive |
|---|---|---|
| All About Me | Experimental | assessment and algorithm to provide participants with a tailored recommendation of their optimal HIV testing approach Receives: Behavioral: All About Me |
| Control | Active comparator | HIV testing information Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting having an HIV test as assessed by questionnaire
Self-reported HIV test in the prior 3 months assessed by questionnaire
Measured: 3 months
Secondary outcomes (4)
Number of participants who are aware of HIV self-testing and couples based voluntary counseling and testing as assessed by questionnaire
Self-reported awareness of HIV self-testing and couples based voluntary counseling and testing assessed by questionnaire
Measured: 3 months
Number of intervention participants recommended a self-test who use a self-test as assessed by questionnaire
Self-reported use of self test among those recommended a self test - Intervention participants only
Measured: 3 months
Number of intervention participants recommended testing at a clinic who test at a clinic as assessed by questionnaire
Self-reported use of testing at a clinic among those recommended to test at a clinic - Intervention participants
Measured: 3 months
Number of intervention participants recommended couples testing who test using couples testing as assessed by questionnaire
Self-reported use of couples testing among those recommended to test using couples testing - Intervention only
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: PI (Koblin) at different institution
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 HIV TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Blood Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beryl Koblin, PhD, Principal investigator, NY Blood Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02834572
- Sponsor's protocol ID
- 473699-41
- Status last verified
- Apr 2026
- First submitted
- 23 May 2016
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Frye V, Nandi V, Hirshfield S, Chiasson MA, Wilton L, Usher D, Hoover DR, Koblin BA. Brief Report: Randomized Controlled Trial of an Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options in New York City (All About Me). J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):31-36. doi: 10.1097/QAI.0000000000002223.
PubMed 31809359Koblin B, Hirshfield S, Chiasson MA, Wilton L, Usher D, Nandi V, Hoover DR, Frye V. Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options (All About Me): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 19;6(12):e254. doi: 10.2196/resprot.8856.
PubMed 29258976
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Technology to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options
- ClinicalTrials.gov ID
- NCT02834572
- Acronym / sponsor ID
- 473699-41
- Conditions
- HIV Testing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI (Koblin) at different institution
- Enrolment
- 236 participants (actual)
- Lead sponsor
- New York Blood CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 15 Jul 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.
Young Black men who have sex with men (MSM) and transwomen in the US are affected by HIV at severely disproportionate rates. A key component of HIV prevention for communities at risk is diagnosing HIV infections through regular HIV testing. A significant proportion of young Black MSM and transwomen have not tested in the prior year. This research study seeks to address low HIV testing rates among young Black MSM and transwomen by testing a brief Internet-based HIV testing intervention optimized for mobile devices. The intervention takes advantage of the variety of HIV testing options now available, including the HIV self testing, couples-based HIV counseling and testing and traditional clinic-based testing and will provide men and transwomen with a tailored recommendation of their optimal HIV testing approach. The investigators are conducting a pilot randomized study among young Black MSM and transwomen followed for 6 months to estimate the intervention's potential efficacy in increasing HIV testing.
Detailed description
We are conducting a pilot study among 240 young Black MSM and transgender women randomized to the Intervention Arm (assessment and algorithm to deliver a tailored recommendation) or Control (assessment and standard HIV testing information) and followed for 6 months to estimate the intervention's potential efficacy in increasing HIV testing. After informed consent, participants are asked to provide contact information on the locator form. Then, participants complete a brief quantitative assessment including basic demographics, HIV testing history and other factors related to HIV testing. All participants, regardless of study arm, then receive information about each HIV testing method including how the tests are conducted (blood, oral sample), and availability of counseling and support. Participants then are randomized into 1 of the 2 study arms. A computer program will randomly assign each participant using randomly ordered block sizes of 4 and 6 and stratified by age (16-23, 24-29 years) to balance groups.
Participants assigned to the Intervention Arm will complete a brief quantitative assessment lasting approximately 2-3 minutes to assess those factors associated with HIV testing and thus are needed to complete the algorithm. They then receive the results of the HIV testing algorithm, presented as their personalized HIV testing approach. All participants will receive information on resources in New York City to test by all of these methods. The control participants are provided with the above information about each testing approach but without a recommended approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| All About Me | Experimental | Behavioral: All About Meassessment and algorithm to provide participants with a tailored recommendation of their optimal HIV testing approach |
| Control | Active comparator | Behavioral: ControlHIV testing information |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- male at birth;
- self-identify as Black, African American, Caribbean Black, African Black or multiethnic Black;
- able to read and respond in English;
- between 16-29 years of age;
- known to be HIV-infected;
Key exclusion criteria (3 listed)
- enrolled in any other HIV research study involving HIV testing
- participant in an HIV vaccine trial
- currently taking pre-exposure prophylaxis
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 |
|---|---|---|
| All About MeAssessment and algorithm to determine recommended HIV testing approach | Behavioural | All About Me |
| ControlHIV testing information | Behavioural | Control |
Primary outcome
Number of participants reporting having an HIV test as assessed by questionnaire
Time frame: 3 months
Self-reported HIV test in the prior 3 months assessed by questionnaire
4 secondary outcomes
Number of participants who are aware of HIV self-testing and couples based voluntary counseling and testing as assessed by questionnaire
Time frame: 3 months
Number of intervention participants recommended a self-test who use a self-test as assessed by questionnaire
Time frame: 3 months
Number of intervention participants recommended testing at a clinic who test at a clinic as assessed by questionnaire
Time frame: 3 months
Number of intervention participants recommended couples testing who test using couples testing as assessed by questionnaire
Time frame: 3 months
Results and safety
The study was stopped early (reason given: PI (Koblin) at different institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 31809359Frye V, Nandi V, Hirshfield S, Chiasson MA, Wilton L, Usher D, Hoover DR, Koblin BA. Brief Report: Randomized Controlled Trial of an Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options in New York City (All About Me). J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):31-36. doi: 10.1097/QAI.0000000000002223.
- Derived from this study: PubMed 29258976Koblin B, Hirshfield S, Chiasson MA, Wilton L, Usher D, Nandi V, Hoover DR, Frye V. Intervention to Match Young Black Men and Transwomen Who Have Sex With Men or Transwomen to HIV Testing Options (All About Me): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 19;6(12):e254. doi: 10.2196/resprot.8856.
- Individual participant dataSharing planned: Undecided
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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.
Beryl Koblin, PhD principal investigator
NY Blood Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All About Me in people with HIV Testing, run by New York Blood Center 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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Apr 2026. 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 was stopped early (reason given: PI (Koblin) at different institution). Results are not available in the source record.
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 reporting having an HIV test as assessed by questionnaire (time frame: 3 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 NCT02834572, 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 8 Apr 2026.