HIV/AIDSBCUNCT02421159
Hybrid STTR Intervention for Heterosexuals: Anonymous Testing and Confidential Care Linkage
A study testing Seek and Test Phase and Treat and Retain Phase in people with HIV/AIDS, run by New York University at 1 site in United States.
Trial summary
The Brooklyn Community United (BCU) study is a supplement to the main research study titled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#: 11-01257). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Seek and Test Phase and Treat and Retain Phase
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Dec 2016
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- sexually active (vaginal, anal) with at least one partner of the opposite sex within the previous year;
- reside in the 7 zip code central Brooklyn HRA (initial seeds only; peers may reside in the larger 19 zip code HRA);
- comprehend English or Spanish;
- HIV negative or unknown HIV status (initial seeds only; peers may be 'known positives');
- willing to try to recruit peers;
Who cannot join
- actively psychotic based on valid screening instrument;
- participant in the past NHBS studies with HHR (called HET1, 2, 3);
- enrolled already in the supplement study (RDS-ASTN), VBS or RDS-CTTN in the main study
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University College of Nursing
New York, New York, 10003
About this study
The Brooklyn Community United (BCU) study is a supplement to the main research study titled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation (CTTN-RDS)).
HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7% in HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%, 35.14% of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with HIV in the VBS sample.
Read more
The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central Brooklyn.
The supplement study hypotheses are:
(H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience.
(H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN.
(H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase.
(H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%), all of whom will be HIV infected, will be linked to care within 3 months.
Read the detailed description
The Brooklyn Community United (BCU) study is a supplement to the main research study to seek, test, treat and retain heterosexuals at high risk for HIV. The main research study is entitled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project or BCAP (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling and Confidential Two-Session Testing with Navigation).
We have studied HHR in New York City as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. Building on the NHBS work, we are currently in our third year of the main study (R01DA032083, R#: 11-01257), the primary aim of which is to compare the efficacy of a peer-driven intervention that uses a respondent-driven sampling strategy ("RDS-CTTN") and venue-based sampling (VBS) with respect to identifying previously undiagnosed HIV infection. The main study is located in central Brooklyn, a high-risk area (HRA) with elevated rates of poverty, high heterosexual HIV prevalence, and where a generalized HIV epidemic may be said to exist.
To date, RDS-CTTN and VBS have enrolled approximately 45% of their samples (RDS-CTTN 1338/3000; VBS 174/400). Participants in both samples evidence high rates of risk factors (substance use, incarceration, homelessness, unemployment). As hypothesized, PDI/RDS is reaching a population with higher rates of risk factors, and lower rates of HIV testing compared to VBS. Almost all in RDS-CTTN and VBS had been tested at least once previously (> 86%), but fewer than half have been tested in the past year. Among those with lifetime testing, data suggest testing is infrequent with a median of 2.5 tests per ten years of adulthood. Interestingly, almost all of those who enroll in RDS-CTTN and VBS elected to test for HIV (> 90%), with no difference in HIV testing acceptance rates between those who tested previously and first-time testers. This suggests that those who enroll in the study, although they have known barriers to HIV testing and a range of risk factors for adverse outcomes, are open to confidential HIV testing. These findings support the promise of the RDS-CTTN approach, but preliminary studies also signal the need to reach those with the greatest fears of and barriers to HIV testing who will not engage in confidential testing.
With approximately 45% of the sample enrolled, HIV prevalence in the RDS-CTTN sample is 3.45% (37/1071); 35.14% of these are newly diagnosed (13/37). Rates of newly diagnosed HIV infection may continue to increase as recruitment chains reach deeper into hidden and more vulnerable components of networks. In VBS, 1.89% is newly diagnosed with HIV (3/159). Yet these HIV prevalence rates are lower than those found in two previous heterosexual cycles of NHBS in the local area: 7% in HET1 and 12.3% in HET2 spurring our interest in additional innovative strategies to seek out those with undiagnosed HIV.
Despite its high acceptability among enrolled participants and preliminary evidence of efficacy, the two-session RDS-CTTN approach may be less successful in enrolling those in the HRA who would decline confidential HIV testing in a formal setting or have poor access to such testing. The RDS-CTTN intervention may not be optimal for reaching those with the greatest psychosocial barriers to regular HIV testing, who may for a number of reasons have high rates of undiagnosed HIV, or individuals, particularly women, with multiple job and family responsibilities who may not have time for a two-session intervention. (Indeed women are under-represented in both RDS-CTTN [~ 40%] and VBS [~30%].) It is possible to test participants for HIV in a first encounter, aswe do in VBS and as other studies have done. In the supplement study, we build on lessons learned from themain study in progress and the literature to address this concern.
Anonymous testing is available in state and local health departments, in cases of occupational exposure, through home test/self-test technologies, and research studies including our local NHBS studies with HHR. There is some evidence to suggest individuals who test anonymously do so earlier in the course of their HIV disease than those who engage in confidential testing. Additionally, anonymous testing may be useful for and/or preferred by individuals from marginalized populations. As Kegeles and colleagues have found, many who seek anonymous HIV-antibody testing would avoid it under other circumstances, and anonymous testing may be preferred among those who suspect they are infected, and by bisexual individuals, and those who fear stigma and discrimination. Thus, a brief, anonymous HIV testing effort may appeal to and engage HHR who face barriers to confidential HIV testing.
While anonymous testing may be an effective and/or efficient strategy in the 'seek' phase of STTR, in the majority of studies and testing programs it does not address the vital step of linkage to care. Although anonymous testing tends to yield individuals earlier in their HIV disease, those who test anonymously are more likely to experience delays entering care, because anonymous testing sites and programs do not typically have the resources to engage individuals into linkage programs and are not co-located with medical care. For example, in a study of characteristics of the HIV testing encounter and linkage to care, Reed (2009) found that 36% of those testing anonymously did not enter care within three months of diagnosis, compared with 26% of those testing confidentially.
The supplement study hypotheses are:
(H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience.
(H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN.
(H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase.
(H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%), all of whom will be HIV infected, will be linked to care within 3 months.
- Conditions
- HIV/AIDS
- Being tested
- Seek and Test Phase, Treat and Retain Phase
- Keywords
- HIV/AIDS, vulnerable populations, heterosexuals at high risk, peer-driven intervention, tailored intervention, African-American, Latino/Hispanic, Seek, test, treat, and retain (STTR), Brooklyn
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seek and Test PhaseBehavioural
The primary endpoint for this phase is the proportion of newly identified HIV infections of the RDS-ASTN intervention. Components for eligible and willing participants are a computerized baseline interview, counseling session, blood draw for HIV testing, HIV pre-test counseling, use of blood samples for clinical lab tests if found to be HIV infected, semi-structured interviews (if selected), the opportunity to recruit peers for the study, and the post-test counseling session.
Treat and Retain PhaseBehavioural
The primary endpoints for this phase are: proportion linked to care within three months and time to the HIV care appointment. Participants with HIV infection who are interested in participating will be enrolled in this phase and navigated to HIV primary care over three months. Components are the locator form, patient navigation and support contacts, medical report form, follow-up contacts to update locator information, semi-structured interviews, follow-up interview, and blood draw for clinical lab testing.
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of newly diagnosed HIV infections
Measured: 1 week post-baseline
Secondary outcomes (2)
proportion linked to care
Measured: 3 months post-baseline
time to the HIV care appointment
Measured: 3 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by New York 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Marya Gwadz, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421159
- Sponsor's protocol ID
- 14-00963
- Acronym
- BCU
- Status last verified
- Mar 2017
- First submitted
- 15 Apr 2015
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gwadz M, Cleland CM, Leonard NR, Kutnick A, Ritchie AS, Banfield A, Hagan H, Perlman DC, McCright-Gill T, Sherpa D, Martinez BY; BCAP Collaborative Research Team. Hybrid STTR intervention for heterosexuals using anonymous HIV testing and confidential linkage to care: a single arm exploratory trial using respondent-driven sampling. BMC Public Health. 2015 Nov 16;15:1133. doi: 10.1186/s12889-015-2451-5.
PubMed 26572865
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
- Hybrid STTR Intervention for Heterosexuals: Anonymous Testing and Confidential Care Linkage
- ClinicalTrials.gov ID
- NCT02421159
- Acronym / sponsor ID
- BCU / 14-00963
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, vulnerable populations, heterosexuals at high risk, peer-driven intervention, tailored intervention, African-American, Latino/Hispanic, Seek, test, treat, and retain (STTR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Apr 2015 (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 Brooklyn Community United (BCU) study is a supplement to the main research study titled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project (BCAP) (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling (VBS) and Confidential Two-Session Testing with Navigation (CTTN-RDS)).
HIV prevalence rates in two previous heterosexual cycles of NHBS in the local area are: 7% in HET1 and 12.3% in HET2. The main study, BCAP, found lower prevalence rates of 3.45%, 35.14% of which were newly diagnosed in the RDS-CTTN sample and 1.89% newly diagnosed with HIV in the VBS sample.
The primary aim of the Brooklyn Community United (BCU) study is to seek out individuals with undiagnosed HIV using a streamlined RDS-CTTN approach, and anonymous HIV Testing in Central Brooklyn.
The supplement study hypotheses are:
(H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience.
(H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN.
(H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase.
(H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%), all of whom will be HIV infected, will be linked to care within 3 months.
Detailed description
The Brooklyn Community United (BCU) study is a supplement to the main research study to seek, test, treat and retain heterosexuals at high risk for HIV. The main research study is entitled "Peer Driven Intervention to Seek, Test, \& Treat Heterosexuals at High Risk for HIV." The main study's field name is Brooklyn Community Action Project or BCAP (R01DA032083, R#: 11-01257). The main study is testing two approaches to seeking out undiagnosed HIV infection (Venue-based Sampling and Confidential Two-Session Testing with Navigation).
We have studied HHR in New York City as part of the CDC's National HIV Behavioral Surveillance (NHBS) studies. Building on the NHBS work, we are currently in our third year of the main study (R01DA032083, R#: 11-01257), the primary aim of which is to compare the efficacy of a peer-driven intervention that uses a respondent-driven sampling strategy ("RDS-CTTN") and venue-based sampling (VBS) with respect to identifying previously undiagnosed HIV infection. The main study is located in central Brooklyn, a high-risk area (HRA) with elevated rates of poverty, high heterosexual HIV prevalence, and where a generalized HIV epidemic may be said to exist.
To date, RDS-CTTN and VBS have enrolled approximately 45% of their samples (RDS-CTTN 1338/3000; VBS 174/400). Participants in both samples evidence high rates of risk factors (substance use, incarceration, homelessness, unemployment). As hypothesized, PDI/RDS is reaching a population with higher rates of risk factors, and lower rates of HIV testing compared to VBS. Almost all in RDS-CTTN and VBS had been tested at least once previously (> 86%), but fewer than half have been tested in the past year. Among those with lifetime testing, data suggest testing is infrequent with a median of 2.5 tests per ten years of adulthood. Interestingly, almost all of those who enroll in RDS-CTTN and VBS elected to test for HIV (> 90%), with no difference in HIV testing acceptance rates between those who tested previously and first-time testers. This suggests that those who enroll in the study, although they have known barriers to HIV testing and a range of risk factors for adverse outcomes, are open to confidential HIV testing. These findings support the promise of the RDS-CTTN approach, but preliminary studies also signal the need to reach those with the greatest fears of and barriers to HIV testing who will not engage in confidential testing.
With approximately 45% of the sample enrolled, HIV prevalence in the RDS-CTTN sample is 3.45% (37/1071); 35.14% of these are newly diagnosed (13/37). Rates of newly diagnosed HIV infection may continue to increase as recruitment chains reach deeper into hidden and more vulnerable components of networks. In VBS, 1.89% is newly diagnosed with HIV (3/159). Yet these HIV prevalence rates are lower than those found in two previous heterosexual cycles of NHBS in the local area: 7% in HET1 and 12.3% in HET2 spurring our interest in additional innovative strategies to seek out those with undiagnosed HIV.
Despite its high acceptability among enrolled participants and preliminary evidence of efficacy, the two-session RDS-CTTN approach may be less successful in enrolling those in the HRA who would decline confidential HIV testing in a formal setting or have poor access to such testing. The RDS-CTTN intervention may not be optimal for reaching those with the greatest psychosocial barriers to regular HIV testing, who may for a number of reasons have high rates of undiagnosed HIV, or individuals, particularly women, with multiple job and family responsibilities who may not have time for a two-session intervention. (Indeed women are under-represented in both RDS-CTTN [~ 40%] and VBS [~30%].) It is possible to test participants for HIV in a first encounter, aswe do in VBS and as other studies have done. In the supplement study, we build on lessons learned from themain study in progress and the literature to address this concern.
Anonymous testing is available in state and local health departments, in cases of occupational exposure, through home test/self-test technologies, and research studies including our local NHBS studies with HHR. There is some evidence to suggest individuals who test anonymously do so earlier in the course of their HIV disease than those who engage in confidential testing. Additionally, anonymous testing may be useful for and/or preferred by individuals from marginalized populations. As Kegeles and colleagues have found, many who seek anonymous HIV-antibody testing would avoid it under other circumstances, and anonymous testing may be preferred among those who suspect they are infected, and by bisexual individuals, and those who fear stigma and discrimination. Thus, a brief, anonymous HIV testing effort may appeal to and engage HHR who face barriers to confidential HIV testing.
While anonymous testing may be an effective and/or efficient strategy in the 'seek' phase of STTR, in the majority of studies and testing programs it does not address the vital step of linkage to care. Although anonymous testing tends to yield individuals earlier in their HIV disease, those who test anonymously are more likely to experience delays entering care, because anonymous testing sites and programs do not typically have the resources to engage individuals into linkage programs and are not co-located with medical care. For example, in a study of characteristics of the HIV testing encounter and linkage to care, Reed (2009) found that 36% of those testing anonymously did not enter care within three months of diagnosis, compared with 26% of those testing confidentially.
The supplement study hypotheses are:
(H1): Compared with VBS and RDS-CTTN, and controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN participants will have less HIV testing experience.
(H2) Controlling for potential differences on key socio-demographic characteristics across the samples, RDS-ASTN will yield higher rates previously undiagnosed HIV compared with VBS and RDS-CTTN.
(H3): Most participants (> 70%) found to be HIV-infected in the RDS-ASTN intervention will engage in the Treat and Retain intervention phase.
(H4): Most participants in the Treat and Retain phase of the RDS-ASTN intervention (> 70%), all of whom will be HIV infected, will be linked to care within 3 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- sexually active (vaginal, anal) with at least one partner of the opposite sex within the previous year;
- reside in the 7 zip code central Brooklyn HRA (initial seeds only; peers may reside in the larger 19 zip code HRA);
- comprehend English or Spanish;
- HIV negative or unknown HIV status (initial seeds only; peers may be 'known positives');
- willing to try to recruit peers;
Key exclusion criteria (3 listed)
- actively psychotic based on valid screening instrument;
- participant in the past NHBS studies with HHR (called HET1, 2, 3);
- enrolled already in the supplement study (RDS-ASTN), VBS or RDS-CTTN in the main study
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 |
|---|---|---|
| Seek and Test PhaseThe primary endpoint for this phase is the proportion of newly identified HIV infections of the RDS-ASTN intervention. Components for eligible and willing participants are a computerized baseline interview, counseling session, blood draw for HIV testing, HIV pre-test counseling, use of blood samples for clinical lab tests if found to be HIV infected, semi-structured interviews (if selected), the opportunity to recruit peers for the study, and the post-test counseling session. | Behavioural | – |
| Treat and Retain PhaseThe primary endpoints for this phase are: proportion linked to care within three months and time to the HIV care appointment. Participants with HIV infection who are interested in participating will be enrolled in this phase and navigated to HIV primary care over three months. Components are the locator form, patient navigation and support contacts, medical report form, follow-up contacts to update locator information, semi-structured interviews, follow-up interview, and blood draw for clinical lab testing. | Behavioural | – |
Primary outcome
proportion of newly diagnosed HIV infections
Time frame: 1 week post-baseline
2 secondary outcomes
proportion linked to care
Time frame: 3 months post-baseline
time to the HIV care appointment
Time frame: 3 months post-baseline
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 26572865Gwadz M, Cleland CM, Leonard NR, Kutnick A, Ritchie AS, Banfield A, Hagan H, Perlman DC, McCright-Gill T, Sherpa D, Martinez BY; BCAP Collaborative Research Team. Hybrid STTR intervention for heterosexuals using anonymous HIV testing and confidential linkage to care: a single arm exploratory trial using respondent-driven sampling. BMC Public Health. 2015 Nov 16;15:1133. doi: 10.1186/s12889-015-2451-5.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Marya Gwadz, PhD principal investigator
New York 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 Seek and Test Phase and Treat and Retain Phase in people with HIV/AIDS, 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 5 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: 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?
proportion of newly diagnosed HIV infections (time frame: 1 week post-baseline). 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 NCT02421159, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.