Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A

HIV/AIDS Clinical Trial

Official title:

Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03116932
• Other study ID #: Puerto Rico PrEP Study-Part A
• Status: Enrolling by invitation
• First received: March 27, 2017
• Last updated: April 4, 2018
• Start date: November 2016
• Est. completion date: November 2019

Study information

• Verified date: April 2018
• Source: Puerto Rico Community Network for Clinical Research on AIDS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The target population for this project will be men-who-have-sex-with-men (MSM) at high risk of HIV acquisition

Description:

225 high risk MSM will be interviewed to understand the knowledge and acceptability of pre-exposure prophylaxis (PrEP) in this population in Puerto Rico. A 187 item questionnaire will administered which will evaluate socio-demographic information, sexual conducts, PrEP knowledge and PrEP acceptability.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 225
• Est. completion date: November 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years and older

Eligibility

INCLUSION CRITERIA;

Study subjects who meet the following inclusion criteria will be considered for enrollment for Part A:

1. age 21 years or older

2. understand and sign the informed consent form and willing to participate in the study

3. male or transgender female

4. 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.

PART A - EXCLUSION CRITERIA:

Subjects with any of the following will not be considered for enrollment in Part A:

1. Age younger than 21 years old

2. Unable or unwilling to provide an informed consent

3. Female gender at birth

4. Do not meet the high risk criteria

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

Behavioral:
• PrEP knowledge and acceptability questionnaire
This questionnaire consists of 187 items and evaluates socio-demographic variables, sex conducts, PrEP knowledge and PrEP acceptability.

Locations

Country	Name	City	State
Puerto Rico	Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)	San Juan

Sponsors (2)

Lead Sponsor	Collaborator
Puerto Rico Community Network for Clinical Research on AIDS	Gilead Sciences

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PrEP acceptability using a PrEP knowledge and acceptability questionnaire.	Measure the degree of acceptance of PrEP in the study subjects	One visit
Primary	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