CClinicalTrials.gg
Status unknownNCT03116932Updated Apr 5, 2018

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

An observational study in HIV/AIDS, sponsored by Puerto Rico Community Network for Clinical Research on AIDS. Status unknown at 1 site in Puerto Rico. Open to male participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.

Sponsored by Puerto Rico Community Network for Clinical Research on AIDS · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
225
Ages
21 Years and older
Sex
Male
01

Study summary

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

Read the 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.

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Conditions studied

  • HIV/AIDS

Keywords

  • HIV prevention, high risk MSM, PrEP
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In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 225 is close to the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Puerto Rico Community Network for Clinical Research on AIDS is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes
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

Eligibility criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
225 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Groups and cohorts

  • 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

Interventions

  • BehavioralPrEP knowledge and acceptability questionnaire

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

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What researchers measure

Primary outcomes

  1. PrEP acceptability using a PrEP knowledge and acceptability questionnaire.

    Measure the degree of acceptance of PrEP in the study subjects

    Time frame: One visit

  2. 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.

    Time frame: One visit

07

Study locations

1 site
  • Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)
    San Juan, 00928, Puerto Rico
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03116932
Lead sponsor
Puerto Rico Community Network for Clinical Research on AIDS
Collaborators
Gilead Sciences
Responsible party
Vivian Tamayo-Agrait, MD (Principal Investigator, Puerto Rico Community Network for Clinical Research on AIDS) — Principal investigator
First posted
Apr 17, 2017
Start date
Nov 2016
Primary completion
Jun 2019 (estimated)
Completion
Nov 2019 (estimated)
Last update
Apr 5, 2018

Study contacts

Vivian Tamayo-Agrait, MD
principal investigator · 787-753-9443

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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