Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B
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|ClinicalTrials.gov Identifier: NCT03120494|
Recruitment Status : Unknown
Verified April 2017 by Puerto Rico Community Network for Clinical Research on AIDS.
Recruitment status was: Enrolling by invitation
First Posted : April 19, 2017
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Drug: Emtricitabine and Tenofovir||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All subjects will receive same treatment with study drug|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B|
|Actual Study Start Date :||November 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: Subjects at risk of HIV
25 high risk MSM and 50 negative partners in a sero-discordant couple will be recruited and emtricitabine and tenofovir (Truvada) for PrEP will be provided, per guidelines, for one year
Drug: Emtricitabine and Tenofovir
All subjects will be provided study drug for use daily for one year.
Other Name: Truvada
- Retention in care [ Time Frame: 12 months ]Retention to follow up clinical visits based on completed and missed visits
- Treatment adherence [ Time Frame: 12 months ]Determine adherence to study drug based on pill count and died blood spots (DBS)
- PrEP knowledge [ Time Frame: 12 months ]Measure the level of education of the study subjects in the topic of PrEP using a questionnaire
- Study drug safety [ Time Frame: 12 months ]Determine safety of study drug based on AE reports related to treatment
- Study drug safety [ Time Frame: 12 months ]Determine safety of study drug based on safety laboratories monitoring, reported as percentage of participants with abnormal laboratory values
- HIV sero-prevalence [ Time Frame: 12 months ]Determine the sero-prevalence of the study subjects receiving PrEP based on the number of study subjects diagnosed with HIV during study duration.
- Changes in sexual risk behaviors [ Time Frame: 12 months ]Measure changes from baseline sexual risk behaviors after initiating use of study drug, specifically frequency of unprotected sexual intercourse according to sexual behaviors questionnaire.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03120494
|Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)|
|San Juan, Puerto Rico, 00928|
|Principal Investigator:||Vivian M Tamayo-Agrait, MD||PR-CoNCRA|