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Dear [Patient Name],
We are writing to tell you about a clinical study called EXTEND 4M. This study is investigating a potential new HIV prevention option (the “study drug”). Pre-exposure prophylaxis (PrEP) is medicine that helps prevent HIV. It is safe and highly effective when taken as prescribed. However, many people who might benefit from PrEP are not accessing it.
Only 15% of women who might benefit from PrEP are accessing it. Women need to know that PrEP is for them too. An important step is for more women to join studies like EXTEND 4M.
Sources:
cdc.gov
nih.gov
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Current PrEP options include a pill taken daily or an injection given every other month. EXTEND 4M is part of the effort to develop more options allowing for a reduced dosing frequency of every 4 months after starter doses. Having more options could lead to an increase in people accessing PrEP. That, in turn, may help reduce the number of new HIV cases each year.
The study drug has been given to adults in another study. However, it is not approved for use with the general public.
If you are eligible and choose to participate, you will have up to 33 scheduled study visits (including 10 phone visits). At 10 visits, you will receive study injections. The injections will be given by the study doctor or another healthcare provider. At all visits, the study doctor and team will check your health. Support may be available to help arrange travel to visits or reimburse you for some costs.
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You may be eligible to participate in the
EXTEND 4M study if you:
- Are 16 years of age or older,
- Had sex in the past 6 months, and
- Have not acquired HIV
You will also need to meet additional
requirements.
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If you want to learn more about the EXTEND 4M study, you can visit extend4mhivpreventstudy.com or contact the study team using the information below. They would be glad to talk with you about the study and answer any questions you may have. Thank you for taking some time to learn about this important research.
Sincerely,
The Extend-4M Team
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