HIV/AIDSNCT03116932
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A
An observational study of HIV/AIDS, run by Puerto Rico Community Network for Clinical Research on AIDS at 1 site in Puerto Rico.
Trial summary
The target population for this project will be men-who-have-sex-with-men (MSM) at high risk of HIV acquisition Read more about this study
- Who is it for?
- Ages 21 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- PrEP knowledge and acceptability questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 225 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Nov 2016to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 225 high risk men who have sex with men, HIV- subjects, 21 years or older , will be enrolled in Part A
Who may be able to join
- Study subjects who meet the following inclusion criteria will be considered for enrollment for Part A:
- 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:
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- 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:
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA)
San Juan, PR, 00928
About this study
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.
- Conditions
- HIV/AIDS
- Being tested
- PrEP knowledge and acceptability questionnaire
- Keywords
- HIV prevention, high risk MSM, PrEP
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP knowledge and acceptability questionnaireBehavioural
This questionnaire consists of 187 items and evaluates socio-demographic variables, sex conducts, PrEP knowledge and PrEP acceptability.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PrEP knowledge and acceptability questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP acceptability using a PrEP knowledge and acceptability questionnaire.
Measure the degree of acceptance of PrEP in the study subjects
Measured: 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.
Measured: One visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study startNov 2016
- Primary completionJun 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Puerto Rico Community Network for Clinical Research on AIDS
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Principal investigator, Vivian Tamayo-Agrait, MD, Puerto Rico Community Network for Clinical Research on AIDS
- Investigators
- Vivian Tamayo-Agrait, MD, Principal investigator, 787-753-9443
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116932
- Sponsor's protocol ID
- Puerto Rico PrEP Study-Part A
- Status last verified
- Apr 2018
- First submitted
- 27 Mar 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part A
- ClinicalTrials.gov ID
- NCT03116932
- Acronym / sponsor ID
- Puerto Rico PrEP Study-Part A
- Conditions
- HIV/AIDS
- Keywords
- HIV prevention, high risk MSM, PrEP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Puerto Rico Community Network for Clinical Research on AIDSUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Nov 2016 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The target population for this project will be men-who-have-sex-with-men (MSM) at high risk of HIV acquisition
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Part A - high risk MSM | – | Behavioral: PrEP knowledge and acceptability questionnairePart 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 225 high risk men who have sex with men, HIV- subjects, 21 years or older , will be enrolled in Part A
Key inclusion criteria (14 listed)
- Study subjects who meet the following inclusion criteria will be considered for enrollment for Part A:
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrEP knowledge and acceptability questionnaireThis questionnaire consists of 187 items and evaluates socio-demographic variables, sex conducts, PrEP knowledge and PrEP acceptability. | Behavioural | Part A - high risk MSM |
Primary outcome
PrEP acceptability using a PrEP knowledge and acceptability questionnaire.
Time frame: One visit
Measure the degree of acceptance of PrEP in the study subjects
PrEP knowledge using a PrEP knowledge and acceptability questionnaire.
Time frame: One visit
Measure the level of education of the study subjects in the topic of PrEP using a questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian Tamayo-Agrait, MD principal investigator
787-753-9443
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Puerto Rico Community Network for Clinical Research on AIDS at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP acceptability using a PrEP knowledge and acceptability questionnaire. (time frame: One visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018; AzTrials last refreshed its copy on 27 Oct 2026.