HIV/AIDSPhase 4NCT03120494
Evaluating the Feasibility and Acceptability of Implementing a PrEP Program in PR-CoNCRA (San Juan, Puerto Rico)- Part B
A Phase 4 study testing Emtricitabine and Tenofovir in people with HIV/AIDS, run by Puerto Rico Community Network for Clinical Research on AIDS at 1 site in Puerto Rico.
Trial summary
75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well as routine medical evaluations during one year. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Emtricitabine and Tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Nov 2016to Nov 2019
- Phase
- Phase 4
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a male, female or transgender female age 21 or older
- Subject provides written informed consent.
- Subject provides written authorization for use and disclosure of protected health information (PHI).
- Subject has one of the following risk factors:
- male, female or transgender female or female sexual partner of an HIV-infected individual, ideally who is not virologically suppressed
- high risk MSM as defined by: having unprotected sexual intercourse with at least two male partner in the last 6 months, or
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- diagnosed with an STI in the past 6 months
- Baseline eCrCl of ≥60 ml/min (calculated using the CKD-EPI formula)
- Negative Hepatitis B serology
- No medical contraindications to the use of PrEP
- Confirmed HIV negative by 5th generation (AB/antigen) HIV test
Who cannot join
- younger than 21 years of age
- unable to provide consent
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- Positive pregnancy test: Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week prior to study entry. Pregnancy testing will also be performed in enrolled female participants prior to any study procedures being performed
- Baseline eCrCl <60 ml/min
- Positive Hepatitis B serology to avoid potential flares upon product discontinuation
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- Any medical contraindication to the use of PrEP or any other conditions deemed by the study investigator to exclude the subject's participation in the study
- HIV infected
- Signs and symptoms of acute HIV infection
- For sero-discordant couples: upon review of HIV positive partner's chart, evidence of resistance to any of the components of the study drug.
- Illness or other condition that, in the opinion of the PI, may interfere with study participation at the time of enrollment.
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
75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.
Read the detailed description
75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.
All subjects will have a total of at least 8 study visits during which routine assessment are performed for patients on Truvada for PrEP. Apart from offering routine medical care, a baseline questionnaire that includes socio-demographic variables, PrEP knowledge and acceptability and sexual conducts will be offered. At the 6 months visit, an abbreviated sexual conducts questionnaire will be offered.
- Conditions
- HIV/AIDS
- Being tested
- Emtricitabine and Tenofovir
- Keywords
- HIV prevention, high risk MSM, sero-discordant couples, 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.
Emtricitabine and TenofovirDrug
Also called Truvada
All subjects will be provided study drug for use daily for one year.
| Study group | Role | What they receive |
|---|---|---|
| Subjects at risk of HIV | Experimental | 25 high risk MSM and 50 negative partners in a sero-discordant couple will be recruited and emtricitabine and tenofovir (Truvada) for PrEP will be provided, per guidelines, for one year Receives: Drug: Emtricitabine and Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in care
Retention to follow up clinical visits based on completed and missed visits
Measured: 12 months
Treatment adherence
Determine adherence to study drug based on pill count and died blood spots (DBS)
Measured: 12 months
PrEP knowledge
Measure the level of education of the study subjects in the topic of PrEP using a questionnaire
Measured: 12 months
Secondary outcomes (4)
Study drug safety
Determine safety of study drug based on AE reports related to treatment
Measured: 12 months
Study drug safety
Determine safety of study drug based on safety laboratories monitoring, reported as percentage of participants with abnormal laboratory values
Measured: 12 months
HIV sero-prevalence
Determine the sero-prevalence of the study subjects receiving PrEP based on the number of study subjects diagnosed with HIV during study duration.
Measured: 12 months
Changes in sexual risk behaviors
Measure changes from baseline sexual risk behaviors after initiating use of study drug, specifically frequency of unprotected sexual intercourse according to sexual behaviors questionnaire.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive same treatment with study drug
- Masking
- None (open label)
- Enrolment
- 75 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
- Sponsor
- Investigators
- Vivian M Tamayo-Agrait, MD, Principal investigator, PR-CoNCRA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120494
- Sponsor's protocol ID
- Puerto Rico PrEP study- Part B
- Status last verified
- Apr 2017
- First submitted
- 11 Apr 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 B
- ClinicalTrials.gov ID
- NCT03120494
- Acronym / sponsor ID
- Puerto Rico PrEP study- Part B
- Conditions
- HIV/AIDS
- Keywords
- HIV prevention, high risk MSM, sero-discordant couples, PrEP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 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
- 19 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.
75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.
Detailed description
75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.
All subjects will have a total of at least 8 study visits during which routine assessment are performed for patients on Truvada for PrEP. Apart from offering routine medical care, a baseline questionnaire that includes socio-demographic variables, PrEP knowledge and acceptability and sexual conducts will be offered. At the 6 months visit, an abbreviated sexual conducts questionnaire will be offered.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive same treatment with study drug
| Arm | Type | Receives |
|---|---|---|
| Subjects at risk of HIV | Experimental | Drug: Emtricitabine and Tenofovir25 high risk MSM and 50 negative partners in a sero-discordant couple will be recruited and emtricitabine and tenofovir (Truvada) for PrEP will be provided, per guidelines, for one year |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is a male, female or transgender female age 21 or older
- Subject provides written informed consent.
- Subject provides written authorization for use and disclosure of protected health information (PHI).
- Subject has one of the following risk factors:
- Baseline eCrCl of ≥60 ml/min (calculated using the CKD-EPI formula)
Key exclusion criteria (11 listed)
- younger than 21 years of age
- unable to provide consent
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
- Positive pregnancy test: Women of childbearing potential must have a negative serum or urine pregnancy test within 1 week prior to study entry. Pregnancy testing will also be performed in enrolled female participants prior to any study procedures being performed
- Baseline eCrCl <60 ml/min
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 |
|---|---|---|
| Emtricitabine and TenofovirAlso: TruvadaAll subjects will be provided study drug for use daily for one year. | Drug | Subjects at risk of HIV |
Primary outcome
Retention in care
Time frame: 12 months
Retention to follow up clinical visits based on completed and missed visits
Treatment adherence
Time frame: 12 months
Determine adherence to study drug based on pill count and died blood spots (DBS)
PrEP knowledge
Time frame: 12 months
Measure the level of education of the study subjects in the topic of PrEP using a questionnaire
4 secondary outcomes
Study drug safety
Time frame: 12 months
Study drug safety
Time frame: 12 months
HIV sero-prevalence
Time frame: 12 months
Changes in sexual risk behaviors
Time frame: 12 months
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: No
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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 M Tamayo-Agrait, MD principal investigator
PR-CoNCRA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Emtricitabine and Tenofovir in people with 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 11 inclusion and 11 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Retention in care (time frame: 12 months). The study lists 3 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.