Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-07 @ 3:04 AM
Study NCT ID:
NCT03120494
Status:
UNKNOWN
Last Update Posted:
2018-04-05
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B
Sponsor:
Puerto Rico Community Network for Clinical Research on AIDS
Organization:
Study Overview
Official Title:
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: