HIVCRUSHNCT02183909
Connecting Resources for Urban Sexual Health
A study testing Testing and linkage to care for Y/MSM, Engagement and retention for HIV-positive Y/MSM in care and Engagement and retention for HIV-negative Y/MSM in sexual health services in people with HIV and Sexually Transmitted Infections, run by University of California, San Francisco at 1 site in United States.
Trial summary
The overall goal of the CRUSH project is to enhance and extend a response to the local HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions across the continuum of HIV prevention and care, targeting individuals and communities most vulnerable to HIV. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Infections
- What is being tested?
- Testing and linkage to care for Y/MSM, Engagement and retention for HIV-positive Y/MSM in care and Engagement and retention for HIV-negative Y/MSM in sexual health services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 378 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men between the ages of 18-29 who are ever sexually active with men;
- Transgender females (M2F) between the ages of 18-29 who are sexually active with men; Transgender males (F2M) between the ages of 18-29 who are sexually active with men; and
- Any HIV-negative person aged 18-29, male or female, who has at least one known HIV positive (i.e. serodiscordant) sexual partner.
Who cannot join
- None.
- For the PEP substudy the inclusion criterion is at least one episode in the 72 hours prior to presentation of unprotected receptive anal intercourse with a partner known or suspected to be HIV positive and the following are the substudy exclusion criteria:
- Known kidney disease
- Dipstick proteinuria >1+
- eGFR < 70 ml/min/1.73m2
- Known metabolic bone disease
- Signs or symptoms of acute HIV infection
- Concomitant use of nephrotoxic drug or medication contraindicated with Stribild®
Trial locations and contacts
1 site in 1 country.
About this study
The overall goal of the CRUSH project is to enhance and extend a response to the local HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions across the continuum of HIV prevention and care, targeting individuals and communities most vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of California San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and several key community-based organizations, are engaging in a participatory partnership to enhance and implement HIV services which target the East Bay's highest risk population- young men who have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to evaluate a combination of program approaches to address the sexual health care needs of young gay men of color and their sexual partners by enhancing the current program activities of the Downtown Youth Clinic (DYC).
We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC services structure in two ways. We intend to expand HIV testing, and linkage to and retention in care for youth who test HIV positive, providing them with intensive risk-reduction counseling and antiretroviral treatment, and thereby ultimately reducing the risk of further HIV transmission. And we intend for the first time to offer a comprehensive combination package of preventive services to HIV-negative youth, including routine accesses to HIV/STI screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).
The CRUSH Project will also have a substudy that will enroll HIV-negative participants who are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability of a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual acquisition of HIV-1 in Y/MSM of color.
Read the detailed description
The CRUSH Project (Connecting Resources for Urban Sexual Health) is a demonstration project at Alta Bates Summit Medical Center's East Bay AIDS Center (EBAC) and Downtown Youth Clinic (DYC) offering interventions aimed at reducing HIV-1 incidence among young MSM of color in the East Bay region. CRUSH has two major components:
- Providing enhanced testing and linkage to care (TLC+) for HIV positives, aimed at increasing the proportion of HIV positive Y/MSM who are in care, virologically suppressed, and receiving intensive risk reduction counseling.
- Providing comprehensive sexual health services to high risk HIV-negatives, including but not limited to the provision of PrEP and PEP when clinically appropriate.
In addition, the CRUSH Project will offer a substudy of CRUSH, and will enroll HIV negative CRUSH participants who are eligible to receive PEP. Stribild® is a single-tablet, four-drug, once-daily complete regimen that is FDA-approved for the treatment of HIV-1 infection in treatment-naïve HIV-infected adults with estimated glomerular filtration rate ≥70ml/min/1.73m2. Because of limited data, no antiretroviral drug or combination of drugs has been approved for PEP. Current PEP guidelines generally call for using a 28-day course of a 3-drug regimen that has been approved for the treatment of HIV-1 infection
- Conditions
- HIV, Sexually Transmitted Infections
- Being tested
- Testing and linkage to care for Y/MSM, Engagement and retention for HIV-positive Y/MSM in care, Engagement and retention for HIV-negative Y/MSM in sexual health services, Stribild PEP Substudy
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing and linkage to care for Y/MSMOther
Implementation of strategies to enhance testing and linkage to care of Y/MSM, including social network testing and a youth outreach corps working with existing and new community partner agencies.
Engagement and retention for HIV-positive Y/MSM in careBehavioural
Optimizing current HIV care and treatment services at DYC by implementing a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.
Engagement and retention for HIV-negative Y/MSM in sexual health servicesOther
Offering a highly effective combination HIV prevention strategy, including PrEP; warm-hand offs for high-risk negatives, nPEP; risk reduction counseling; frequent HIV and STI testing, including testing a highly sensitive method of detecting early HIV infection; and youth-focused programming.
Stribild PEP SubstudyDrug
A substudy of 28 days of once-daily Stribild® initiated within 72 hours of a high risk sexual exposure for HIV post-exposure prophylaxis (PEP).
| Study group | Role | What they receive |
|---|---|---|
| Study intervention | Experimental | Not described Receives: Other: Testing and linkage to care for Y/MSM; Behavioral: Engagement and retention for HIV-positive Y/MSM in care; Other: Engagement and retention for HIV-negative Y/MSM in sexual health services; Drug: Stribild PEP Substudy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
Expanding the investigators currently successful HIV testing strategy-collaborations and systems of referral of new cases of HIV from existing partners-so that referrals are also received for high risk negatives to receive sexual health services. Implementing two new strategies: social network testing and a youth outreach corps working with partner agencies; it is hypothesized that social network testing will increase the proportion of positive test results.
Measured: 1 year
The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care
Optimizing current HIV care and treatment services at DYC by adding three new components: a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.
Measured: 1 year
The Proportion of HIV-uninfected YMSM Participants Who Are Retained, Receive Sexually Transmitted Infection (STI) Testing, and Receive Non-occupational Post-exposure-prophylaxis (nPEP) and/or PrEP
Integrating sexual health services for HIV-uninfected young MSM of color into an HIV care setting, including PrEP, warm-hand offs for high risk negatives, nPEP, risk reduction counseling, frequent HIV and STI testing, and youth-focused programming.
Measured: 1 year
Substudy Primary Outcome: The Tolerability and Acceptability of a 28 Day Course of Stribild® Given as Post-exposure Prophylaxis (PEP) to Prevent Sexual Acquisition of HIV-1
Regimen completion at 28 days.
Measured: 4 Weeks
Secondary outcomes (8)
Substudy Secondary Outcome: The Renal Safety of Stribild® PEP
Change from week 1 to week 4 in serum creatinine.
Measured: 1 Week and 4 Weeks
Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR
To Assess the Renal Safety of Stribild® PEP. Change from 1 Week to 4 Weeks in estimated glomerular filtration rate (eGFR), which measures how well the kidneys are filtering waste and toxins from the blood.
Measured: 1 Week and 4 Weeks
Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP
Markers of proximal tubulopathy (glycosuria, proteinuria > 1+).
Measured: 4 Weeks
Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP
HIV-1 seroconversion.
Measured: 4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Self-reported adherence.
Measured: 4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Reported reasons for non-adherence
Measured: 4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Changes from baseline in quality of life.
Measured: 4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Early cessation of regimen.
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startMay 2013
- Primary completionMar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Burack, MD, Principal investigator, East Bay AIDS Center (EBAC)Robert Grant, MD, MPH, Principal investigator, Gladstone InstitutesJanet Myers, PhD, Principal investigator, UCSF Center for AIDS Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183909
- Sponsor's protocol ID
- EI12-EBACA-003
- Acronym
- CRUSH
- Status last verified
- Nov 2024
- First submitted
- 6 May 2014
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
PubMed 21091279Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
PubMed 22784037Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT; TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012 Aug 2;367(5):423-34. doi: 10.1056/NEJMoa1110711. Epub 2012 Jul 11.
PubMed 22784038
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting Resources for Urban Sexual Health
- ClinicalTrials.gov ID
- NCT02183909
- Acronym / sponsor ID
- CRUSH / EI12-EBACA-003
- Conditions
- HIV, Sexually Transmitted Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Posted 12 Dec 2024
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 the CRUSH project is to enhance and extend a response to the local HIV/AIDS epidemic in Alameda County with a set of innovative, evidence-based interventions across the continuum of HIV prevention and care, targeting individuals and communities most vulnerable to HIV. The East Bay AIDS Center, in partnership with the University of California San Francisco's Center for AIDS Prevention Studies, the Gladstone Institutes, and several key community-based organizations, are engaging in a participatory partnership to enhance and implement HIV services which target the East Bay's highest risk population- young men who have sex with men (Y/MSM). Specifically, the CRUSH Project is designed to evaluate a combination of program approaches to address the sexual health care needs of young gay men of color and their sexual partners by enhancing the current program activities of the Downtown Youth Clinic (DYC).
We hypothesize that we can reduce the impact of HIV among Y/MSM by expanding the current DYC services structure in two ways. We intend to expand HIV testing, and linkage to and retention in care for youth who test HIV positive, providing them with intensive risk-reduction counseling and antiretroviral treatment, and thereby ultimately reducing the risk of further HIV transmission. And we intend for the first time to offer a comprehensive combination package of preventive services to HIV-negative youth, including routine accesses to HIV/STI screening and treatment, and access to HIV pre-exposure prophylaxis (PrEP).
The CRUSH Project will also have a substudy that will enroll HIV-negative participants who are eligible to receive PEP. The substudy will evaluate the tolerability and acceptability of a 28 day course of Stribild® given as post-exposure prophylaxis (PEP) to prevent sexual acquisition of HIV-1 in Y/MSM of color.
Detailed description
The CRUSH Project (Connecting Resources for Urban Sexual Health) is a demonstration project at Alta Bates Summit Medical Center's East Bay AIDS Center (EBAC) and Downtown Youth Clinic (DYC) offering interventions aimed at reducing HIV-1 incidence among young MSM of color in the East Bay region. CRUSH has two major components:
- Providing enhanced testing and linkage to care (TLC+) for HIV positives, aimed at increasing the proportion of HIV positive Y/MSM who are in care, virologically suppressed, and receiving intensive risk reduction counseling.
- Providing comprehensive sexual health services to high risk HIV-negatives, including but not limited to the provision of PrEP and PEP when clinically appropriate.
In addition, the CRUSH Project will offer a substudy of CRUSH, and will enroll HIV negative CRUSH participants who are eligible to receive PEP. Stribild® is a single-tablet, four-drug, once-daily complete regimen that is FDA-approved for the treatment of HIV-1 infection in treatment-naïve HIV-infected adults with estimated glomerular filtration rate ≥70ml/min/1.73m2. Because of limited data, no antiretroviral drug or combination of drugs has been approved for PEP. Current PEP guidelines generally call for using a 28-day course of a 3-drug regimen that has been approved for the treatment of HIV-1 infection
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study intervention | Experimental | Other: Testing and linkage to care for Y/MSM, Behavioral: Engagement and retention for HIV-positive Y/MSM in care, Other: Engagement and retention for HIV-negative Y/MSM in sexual health services, Drug: Stribild PEP Substudy |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Men between the ages of 18-29 who are ever sexually active with men;
- Transgender females (M2F) between the ages of 18-29 who are sexually active with men; Transgender males (F2M) between the ages of 18-29 who are sexually active with men; and
- Any HIV-negative person aged 18-29, male or female, who has at least one known HIV positive (i.e. serodiscordant) sexual partner.
Key exclusion criteria (8 listed)
- None.
- For the PEP substudy the inclusion criterion is at least one episode in the 72 hours prior to presentation of unprotected receptive anal intercourse with a partner known or suspected to be HIV positive and the following are the substudy exclusion criteria:
- Known kidney disease
- Dipstick proteinuria >1+
- eGFR < 70 ml/min/1.73m2
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 |
|---|---|---|
| Testing and linkage to care for Y/MSMImplementation of strategies to enhance testing and linkage to care of Y/MSM, including social network testing and a youth outreach corps working with existing and new community partner agencies. | Other | Study intervention |
| Engagement and retention for HIV-positive Y/MSM in careOptimizing current HIV care and treatment services at DYC by implementing a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff. | Behavioural | Study intervention |
| Engagement and retention for HIV-negative Y/MSM in sexual health servicesOffering a highly effective combination HIV prevention strategy, including PrEP; warm-hand offs for high-risk negatives, nPEP; risk reduction counseling; frequent HIV and STI testing, including testing a highly sensitive method of detecting early HIV infection; and youth-focused programming. | Other | Study intervention |
| Stribild PEP SubstudyA substudy of 28 days of once-daily Stribild® initiated within 72 hours of a high risk sexual exposure for HIV post-exposure prophylaxis (PEP). | Drug | Study intervention |
Primary outcome
The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment
Time frame: 1 year
Expanding the investigators currently successful HIV testing strategy-collaborations and systems of referral of new cases of HIV from existing partners-so that referrals are also received for high risk negatives to receive sexual health services. Implementing two new strategies: social network testing and a youth outreach corps working with partner agencies; it is hypothesized that social network testing will increase the proportion of positive test results.
The Proportion of HIV-positive Enrolled YMSM Who Are Retained, on Therapy, and Who Have Achieved Viral Suppression Within One Year of Entering Care
Time frame: 1 year
Optimizing current HIV care and treatment services at DYC by adding three new components: a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.
The Proportion of HIV-uninfected YMSM Participants Who Are Retained, Receive Sexually Transmitted Infection (STI) Testing, and Receive Non-occupational Post-exposure-prophylaxis (nPEP) and/or PrEP
Time frame: 1 year
Integrating sexual health services for HIV-uninfected young MSM of color into an HIV care setting, including PrEP, warm-hand offs for high risk negatives, nPEP, risk reduction counseling, frequent HIV and STI testing, and youth-focused programming.
Substudy Primary Outcome: The Tolerability and Acceptability of a 28 Day Course of Stribild® Given as Post-exposure Prophylaxis (PEP) to Prevent Sexual Acquisition of HIV-1
Time frame: 4 Weeks
Regimen completion at 28 days.
8 secondary outcomes
Substudy Secondary Outcome: The Renal Safety of Stribild® PEP
Time frame: 1 Week and 4 Weeks
Substudy Secondary Outcome: Change From 1 Week to 4 Weeks in eGFR
Time frame: 1 Week and 4 Weeks
Substudy Secondary Outcome: To Assess the Renal Safety of Stribild® PEP
Time frame: 4 Weeks
Substudy Secondary Outcome: To Document Any HIV-1 Seroconversions Occurring While on Stribild® PEP
Time frame: 4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Time frame: 4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Time frame: 4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Time frame: 4 Weeks
Substudy Secondary Outcome: To Assess Adherence to Stribild® PEP
Time frame: 4 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21091279Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, Goicochea P, Casapia M, Guanira-Carranza JV, Ramirez-Cardich ME, Montoya-Herrera O, Fernandez T, Veloso VG, Buchbinder SP, Chariyalertsak S, Schechter M, Bekker LG, Mayer KH, Kallas EG, Amico KR, Mulligan K, Bushman LR, Hance RJ, Ganoza C, Defechereux P, Postle B, Wang F, McConnell JJ, Zheng JH, Lee J, Rooney JF, Jaffe HS, Martinez AI, Burns DN, Glidden DV; iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.
- Background: PubMed 22784037Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, Tappero JW, Bukusi EA, Cohen CR, Katabira E, Ronald A, Tumwesigye E, Were E, Fife KH, Kiarie J, Farquhar C, John-Stewart G, Kakia A, Odoyo J, Mucunguzi A, Nakku-Joloba E, Twesigye R, Ngure K, Apaka C, Tamooh H, Gabona F, Mujugira A, Panteleeff D, Thomas KK, Kidoguchi L, Krows M, Revall J, Morrison S, Haugen H, Emmanuel-Ogier M, Ondrejcek L, Coombs RW, Frenkel L, Hendrix C, Bumpus NN, Bangsberg D, Haberer JE, Stevens WS, Lingappa JR, Celum C; Partners PrEP Study Team. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012 Aug 2;367(5):399-410. doi: 10.1056/NEJMoa1108524. Epub 2012 Jul 11.
- Background: PubMed 22784038Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, Henderson FL, Pathak SR, Soud FA, Chillag KL, Mutanhaurwa R, Chirwa LI, Kasonde M, Abebe D, Buliva E, Gvetadze RJ, Johnson S, Sukalac T, Thomas VT, Hart C, Johnson JA, Malotte CK, Hendrix CW, Brooks JT; TDF2 Study Group. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012 Aug 2;367(5):423-34. doi: 10.1056/NEJMoa1110711. Epub 2012 Jul 11.
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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.
Jeff Burack, MD principal investigator
East Bay AIDS Center (EBAC)
Robert Grant, MD, MPH principal investigator
Gladstone Institutes
Janet Myers, PhD principal investigator
UCSF Center for AIDS Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing and linkage to care for Y/MSM, Engagement and retention for HIV-positive Y/MSM in care and Engagement and retention for HIV-negative Y/MSM in sexual health services in people with HIV and Sexually Transmitted Infections, run by University of California, San Francisco 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 3 inclusion and 8 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 12 Dec 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?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Proportion of Young Men Who Have Sex With Men (YMSM) Who Test Positive for HIV at Enrollment (time frame: 1 year). The study lists 4 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 NCT02183909, 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 12 Dec 2024.