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

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

Study Overview

• Status: Unknown
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: PrEP knowledge and acceptability questionnaire

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 225

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00928
    • Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

225 high risk men who have sex with men, HIV- subjects, 21 years or older , will be enrolled in Part A

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Puerto Rico Community Network for Clinical Research on AIDS
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Vivian Tamayo-Agrait, MD, 787-753-9443

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2016
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (ACTUAL): April 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 4, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: HIV prevention, high risk MSM, PrEP
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: Puerto Rico PrEP Study-Part A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes