Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A
1 other identifier
observational
225
1 country
1
Brief Summary
The target population for this project will be men-who-have-sex-with-men (MSM) at high risk of HIV acquisition
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 27, 2017
CompletedFirst Posted
Study publicly available on registry
April 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedApril 5, 2018
April 1, 2018
2.6 years
March 27, 2017
April 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
PrEP acceptability using a PrEP knowledge and acceptability questionnaire.
Measure the degree of acceptance of PrEP in the study subjects
One visit
PrEP knowledge using a PrEP knowledge and acceptability questionnaire.
Measure the level of education of the study subjects in the topic of PrEP using a questionnaire.
One visit
Study Arms (1)
Part A - high risk MSM
Part A will consist of a descriptive analysis of the acceptability and knowledge on the topic of PrEP of the individuals that undergo routine HIV testing and counseling in study facilities or through outreach activities. Part A will be focused only on high risk MSM. For this part of the study, 225 high risk will be interviewed to understand the knowledge and acceptability of PrEP in this population in Puerto Rico.
Interventions
This questionnaire consists of 187 items and evaluates socio-demographic variables, sex conducts, PrEP knowledge and PrEP acceptability.
Eligibility Criteria
225 high risk men who have sex with men, HIV- subjects, 21 years or older , will be enrolled in Part A
You may qualify if:
- age 21 years or older
- understand and sign the informed consent form and willing to participate in the study
- male or transgender female
- has one of the following risk factors:
- a high risk MSM as defined by:
- having unprotected sexual intercourse with at least two male partners in the past 6 months, or
- diagnosed with an STI in the past 6 months.
You may not qualify if:
- Subjects with any of the following will not be considered for enrollment in Part A:
- Age younger than 21 years old
- Unable or unwilling to provide an informed consent
- Female gender at birth
- Do not meet the high risk criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)
San Juan, PR, 00928, Puerto Rico
Biospecimen
Dried Blood Spots are obtained at 2 time points for participants in part B in order to assess adequate drug levels are retained for bulk shipping for processing at collaborating lab.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vivian Tamayo-Agrait, MD
787-753-9443
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 27, 2017
First Posted
April 17, 2017
Study Start
November 1, 2016
Primary Completion
June 1, 2019
Study Completion
November 1, 2019
Last Updated
April 5, 2018
Record last verified: 2018-04