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Antibody Mediated Prevention (AMP) Study(NY-1)
June 1, Length: 2-6 Months
Location: New York, NY
is a phase 2b study to evaluate the safety and efficacy of VRC01 broadly neutralizing monoclonal antibody in reducing acquisition of HIV-1 infection. The study will enroll 2700 HIV-1–uninfected men who have sex with men (MSM) and transgender persons (TG) who have sex with men or TG, aged 18-50 years, in North America, South America and Switzerland.
The AMP (Antibody Mediated Prevention) study is a multicenter, randomized, controlled, double blind trial. Participants will be randomly assigned to receive either one of two dosing concentrations of the VRC01 or a placebo control. Participants will be followed for 21 months of scheduled clinic visits; total estimated study duration is 59 months. Data are collected from participants by research counselors and study clinicians at study visits which occur monthly for a total of 26 scheduled visits over a period of 21 months.
, a phase 2b/3 double blind safety and efficacy study of injectable Cabotegravir compared to daily oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), for pre-exposure prophylaxis in HIV-uninfected cisgender men and transgender women who have sex with men.
The purpose of this study is to evaluate the safety and efficacy of the injectable agent, Cabotegravir (CAB LA), for pre-exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).
This is a multi-site, double blind, two-arm, randomized (1:1), controlled non-inferiority trial of the efficacy of CAB LA (long acting) compared to daily oral Tenofovir Disoproxil Fumarate (TDF/Emtricitabine (FTC) for HIV prevention, the study is conducted in the Americas, Asia and South Africa. The target population is HIV-uninfected MSM and TGW at risk for acquiring HIV infection, ages 18 and older. The study size is approximately 4500, with 2250 per arm. The duration of the study is approximately 4.5 years total, with individual participants being followed between 1.5 years (for the last enrolling participants) to 4.5 years (for the earliest enrolling participants).
Scope of Work:
The student will work closely with the study team to support data management and community outreach activities, including but not limited to the following:
- Conduct data monitoring and quality assurance on data collected for the study, including:
- Review study case report forms, surveys, and source documents for completeness and issue queries to research staff
- Review eligibility criteria of screened study participants for enrollment, including review of eligibility case report forms, source documents and informed consent forms
- Assist with submission of study forms to the statistical and data management center
- Assist with prompt review of all data queries and their immediate resolution.
- Identify problem areas with data collection, report findings to the project’s leadership, and develop appropriate corrective measures with input from the team
- Help the study team prepare IRB submissions and updates as needed
- Assist in summarizing data and preparation of presentations for scientific meetings
- Participate in community outreach activities
- Perform informal presentations about the studies conducted at Harlem Prevention Center at support groups or community-based organizations with the community outreach team
- Attend outreach fairs and events as well as health symposiums related to the studies’ target population with the community outreach team
- Attend weekly staff meetings to discuss progress of the studies involved and research related issues
- Other duties as assigned by the Site Coordinator, and Investigators
- Current CUMC student
- Excellent oral/written communication, interpersonal, organizational, and computer skills
- Flexible, open-minded, and able to easily adapt to new challenges
- Experience working with research and data management