Table 1.
Ongoing and planned PrEP trials and demonstration projects, as of November 2014
| Trial/project | Sponsor/funder | Type/Category | Location | Population | Design/key questions | Status |
|---|---|---|---|---|---|---|
| The Demo Project | National Institute of Allergy and Infectious Diseases of the NIH | Demonstration Project | US (Miami, FL; San Francisco, CA; and Washington, DC) | MSM and transgender women | Assesses uptake, acceptability, safety and feasibility of once-daily TDF/FTC as PrEP in 600 MSM (300 in San Francisco; 200 in Miami; 100 in Washington) | Ongoing; expected completion date January 2015 |
| East Bay Consortium/CRUSH (Connecting Resources for Urban Sexual Health) | California HIV/AIDS Research Program of the University of California | Demonstration Project | US (East Bay, CA) | Young MSM of colour | Testing and linking young MSM of colour to sexual health services; enhance engagement and retention for HIV-positive young MSM of colour; and retain HIV-negative young MSM of colour in sexual health services, including PrEP | Ongoing; started in December 2012 |
| LAC PATH PrEP Demo Project | California HIV/AIDS Research Program of the University of California; LA County HIV & STD Program; Los Angeles Gay and Lesbian Center; OASIS Clinic; AIDS Project LA; UCLA | Demonstration Project | US (Los Angeles, CA) | MSM | Evaluates a customized prevention package that may include PrEP Enrolling 375 high-risk MSM and transgender women | Ongoing; expected completion date of May 2017 |
| California Collaborative Treatment Group Consortium/ALERT (Active Linkage, Engagement and Retention to Reduce HIV) | California HIV/AIDS Research Program of the University of California, San Diego County HIV, STD, and Hepatitis Branch and the Long Beach Health and Human Services Agency | Demonstration Project | US (Long Beach, Los Angeles and San Diego, CA) | MSM | Evaluates whether a text messaging-based adherence intervention can improve adherence to the PrEP medication. Enrolling 400 high-risk MSM randomized to receive daily TDF/FTC as PrEP | Ongoing; expected completion date October 2015 |
| SPARK Project NYC | HART and Callen-Lorde Community Health Center, funded by the National Institute on Alcohol Abuse and Alcoholism | Demonstration Project | US (New York) | MSM and transgender women | Evaluates a comprehensive prevention package that includes PrEP and examines social and behavioural factors associated with disparities in access to prevention and care services among gay, bisexual and other men who have sex with men that might impact PrEP implementation programs | Ongoing; started October 2013. Expected completion of July 2017 |
|
Project PrEPare (Adolescents 18–22)
Project PrEPare (Adolescents 15–17) |
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN); funded by NICHD, NIDA, NIMH | Open-Label Demonstration Project and Phase II Safety Study | US (Baltimore; Boston; Bronx, NY; Chicago; Washington, DC; Denver; Detroit; Houston; Los Angeles; Memphis; Miami; New Orleans; Philadelphia; Tampa) | MSM MSM |
Explores the safety, acceptability and feasibility of PrEP among young men who have sex with men (YMSM) who are at risk for HIV infection. Enrolling 300 HIV-uninfected YMSM | Ongoing, started November 2012; expected completion November 2015 Ongoing; expected completion March 2016 |
| HPTN 073 | HPTN; funded by NIAID/NIH | Open-Label Demonstration Project | US (Los Angeles, CA; Washington, DC; Chapel Hill, NC] | MSM | Assesses the initiation, acceptability, safety and feasibility of PrEP for Black MSM (BMSM); subset of participants will be recruited for qualitative interviews about PrEP facilitators and barriers. Enrolling a total of 225 participants | Ongoing; started July 2013 |
| CDC Foundation Demonstration Project | Funding pending | Demonstration Project | US | MSM and heterosexual women | Proposed to evaluate real-world PrEP use in MSM and heterosexual women at risk of HIV infection in health clinic settings, potentially in 1200 participants | Start date pending funding |
| iPrEx OLE | Sponsored/funded by DAIDS/NIH, through a grant to the Gladstone Institutes. | Open-label extension | Brazil, Peru, Ecuador, South Africa, Thailand, US | MSM | Continuation of the iPrEx study designed to provide additional information about the safety of PrEP and the behaviour of people taking PrEP over a longer term | Completed. Results announced July 2014 |
Source: Donaldson E, Grant D and Warren M. Ongoing and Planned US PrEP Trials and Demonstration Projects. Available from: www.avac.org/prevention-option/prep/usdemoprojects [cited 2014 Dec 1].