75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.
75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention. All subjects will have a total of at least 8 study visits during which routine assessment are performed for patients on Truvada for PrEP. Apart from offering routine medical care, a baseline questionnaire that includes socio-demographic variables, PrEP knowledge and acceptability and sexual conducts will be offered. At the 6 months visit, an abbreviated sexual conducts questionnaire will be offered.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
75
All subjects will be provided study drug for use daily for one year.
Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)
San Juan, PR, Puerto Rico
Retention in care
Retention to follow up clinical visits based on completed and missed visits
Time frame: 12 months
Treatment adherence
Determine adherence to study drug based on pill count and died blood spots (DBS)
Time frame: 12 months
PrEP knowledge
Measure the level of education of the study subjects in the topic of PrEP using a questionnaire
Time frame: 12 months
Study drug safety
Determine safety of study drug based on AE reports related to treatment
Time frame: 12 months
Study drug safety
Determine safety of study drug based on safety laboratories monitoring, reported as percentage of participants with abnormal laboratory values
Time frame: 12 months
HIV sero-prevalence
Determine the sero-prevalence of the study subjects receiving PrEP based on the number of study subjects diagnosed with HIV during study duration.
Time frame: 12 months
Changes in sexual risk behaviors
Measure changes from baseline sexual risk behaviors after initiating use of study drug, specifically frequency of unprotected sexual intercourse according to sexual behaviors questionnaire.
Time frame: 12 months
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