HIV InfectionNCT02411630
Factors Affecting PrEP Adherence
An observational study of HIV Infection, run by University of North Carolina, Chapel Hill at 12 sites in United States.
Trial summary
The purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS). Read more about this study
- Who is it for?
- Ages 15 to 22 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Emtricitabine/tenofovir disoproxil
- Type of treatment
- Pill or oral medicine
- How many people
- 167 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2013to Jun 2015
- 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 15 to 22 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Participants in this study will be HIV-1 uninfected YMSM, including transgender women, ages 15 through 22 years, inclusive at the time of consent into the parent protocol, currently enrolled in ATN 110 or ATN 113 and prescribed FTC/TDF (Truvada®) for PrEP.
Who may be able to join
- Concurrent enrollment in ATN 110 or ATN 113 and prescribed FTC/TDF (Emtricitabine/Tenofovir disoproxil fumarate (Truvada®)) for PrEP;
- Ability to understand written and spoken English; and
- Willing and able to provide written informed consent.
Who cannot join
- Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent; and
- Intoxicated or under the influence of alcohol or other substances at the time of consent.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Children's Hospital of Denver
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21287
Fenway Institute
Boston, Massachusetts, 02215
Stroger Hospital of Cook County
Chicago, Illinois, 60612
Wayne State University-Children's Hospital of Michigan
Detroit, Michigan, 48201
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030
Children's Hopsital of Los Angeles
Los Angeles, California, 90027
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105
University of Miami School of Medicine
Miami, Florida, 33101
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Structural and Partnership Factors Affecting Adherence to Pre-exposure Prophylaxis (PREP)Among Young Men Who Have Sex With Men
The purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS). In this study, the iQS will be tested on HIV-negative young men who have sex with men (YMSM) who are taking PrEP as part of another study, either ATN 110 or ATN 113.
Read the detailed description
Among Men who have Sex with Men (MSM) in the U.S., Human Immunodeficiency Virus (HIV) incidence has remained highest in those less than 30 years of age, demonstrating the need for new ways to prevent HIV in Young Men who have Sex with Men (YMSM). Pre-exposure Prophylaxis or PrEP is the use of a daily medication to prevent HIV infection. In order for PrEP to work the pills must be taken, so adherence is a very important part of PrEP. Efforts to accurately assess adherence to PrEP have been hindered because participants do not always accurately report adherence and the flawed methods that have been used to measure adherence. In previous studies it has been shown that participants over-report adherence when compared to drug concentration levels in blood. Although drug-levels can be used to monitor adherence, the cost can be prohibitive and specimens may be difficult to collect in real-time. This means that better and more accurate assessments of PrEP adherence from self-reports are needed in order for PrEP to achieve wide-spread use.
This longitudinal pilot sub-study of ATN 110 and ATN 113 (Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States) aims to assess how structural (physical settings) and partnership factors affect adherence of YMSM to PrEP. This study will compare levels of adherence reported in the Interactive Questionnaire System (iQS) to those collected in ATN 110 or ATN 113 by Audio Computer Assisted Self Interview (ACASI), Wisepill, and drug concentration levels in blood and hair. The iQS will be administered at study entry and week 24 visits. PrEP, Emtricitabine/Tenofovir disoproxil fumarate (Truvada®), will be administered as part of the ATN 110 and ATN 113 protocols. Study drug will not be administered as part of this study, ATN 123.
- Conditions
- HIV Infection
- Being tested
- Emtricitabine/tenofovir disoproxil
- Keywords
- PrEP, HIV Prevention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emtricitabine/tenofovir disoproxilDrug
Also called Truvada®, FTC/TFV
ATN 123 participants will not be administered Emtricitabine /Tenofovir disoproxil fumarate (Truvada®) as part of the ATN 123 study, but as part of the parent studies, ATN 110 or ATN 113. In order to be eligible for ATN 123, all participants must be co-enrolled in ATN 110 or ATN 113.
The only intervention for ATN 123 is the administration of the Interactive Questionnaire System (iQS), which is a new method to collect data on adherence. It will be utilized to collect adherence data across a variety of devices (i.e., computer/laptop, smartphone, tablet, etc.). Accuracy of this method will be determined; preference for this mode of data collection compared to other methods for adherence reporting used in the parent studies will be assessed.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Questionnaire System (iQS) | An Interactive Questionnaire System (iQS) will be administered twice. First at study entry (ATN 110/113 week 24 visit) and second at week 24 (ATN 110/113 week 48 visit). The questionnaire will assess adherence as well as how structural (physical settings) and partnership factors affect adherence of YMSM to PrEP with FTC/TDF (Truvada®). Receives: Drug: Emtricitabine/tenofovir disoproxil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire
To assess preference of the iQS as a way to measure adherence to Pre-Exposure Prophylaxis (PrEP) in PrEP clinical trials, completion rates; pattern of skipped or incomplete responses by variables will be analyzed.
Measured: Week 0
Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire
To assess preference of the iQS as a way to measure adherence to Pre-Exposure Prophylaxis (PrEP) in PrEP clinical trials, completion rates; pattern of skipped or incomplete responses by variables will be analyzed.
Measured: Week 24
Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill
Preference for the iQS method compared to the ACASI and Wisepill will be assessed as reported by participants.
Measured: Week 0
Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill
Preference for the iQS method compared to the ACASI and Wisepill will be assessed as reported by participants.
Measured: Week 24
Adherence to Pre-Exposure Prophylaxis (PrEP) Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI)
Self reports in iQS, Wisepill, and ACASI will be compared to measured drug concentration levels in blood and hair. The iQS is administered as part of this study (ATN 123). The ACASI, Wisepill and drug concentration levels in blood and hair are collected as part of the parent studies (ATN 110 or ATN 113)
Measured: Week 0
Adherence to Pre-Exposure Prophylaxis (PrEP)Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI)
Self reports in iQS, Wisepill, and ACASI will be compared to measured drug concentration levels in blood and hair. The iQS is administered as part of this study (ATN 123). The ACASI, Wisepill and drug concentration levels in blood and hair are collected as part of the parent studies (ATN 110 or ATN 113)
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies 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
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Pamina M Gorbach, MHS, DrPH, Study chair, University of California, Los AngelesMichelle Lally, MD, MSc, Study chair, Alpert Medical School, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411630
- Sponsor's protocol ID
- ATN 123
- Status last verified
- Dec 2016
- First submitted
- 23 Jan 2014
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Partnership Factors Affecting Adherence to Pre-exposure Prophylaxis (PREP)Among Young Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT02411630
- Acronym / sponsor ID
- ATN 123
- Conditions
- HIV Infection
- Keywords
- PrEP, HIV Prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Apr 2015 (estimated)
- 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 purpose of this study is to test a new way to take a questionnaire that asks about adherence (whether the person is taking the medicine correctly). This new questionnaire is called Interactive Questionnaire System (iQS). In this study, the iQS will be tested on HIV-negative young men who have sex with men (YMSM) who are taking PrEP as part of another study, either ATN 110 or ATN 113.
Detailed description
Among Men who have Sex with Men (MSM) in the U.S., Human Immunodeficiency Virus (HIV) incidence has remained highest in those less than 30 years of age, demonstrating the need for new ways to prevent HIV in Young Men who have Sex with Men (YMSM). Pre-exposure Prophylaxis or PrEP is the use of a daily medication to prevent HIV infection. In order for PrEP to work the pills must be taken, so adherence is a very important part of PrEP. Efforts to accurately assess adherence to PrEP have been hindered because participants do not always accurately report adherence and the flawed methods that have been used to measure adherence. In previous studies it has been shown that participants over-report adherence when compared to drug concentration levels in blood. Although drug-levels can be used to monitor adherence, the cost can be prohibitive and specimens may be difficult to collect in real-time. This means that better and more accurate assessments of PrEP adherence from self-reports are needed in order for PrEP to achieve wide-spread use.
This longitudinal pilot sub-study of ATN 110 and ATN 113 (Project PrEPare - An Open Label Demonstration Project and Phase II Safety Study of Pre-Exposure Prophylaxis Use Among Young Men Who Have Sex With Men (YMSM) in the United States) aims to assess how structural (physical settings) and partnership factors affect adherence of YMSM to PrEP. This study will compare levels of adherence reported in the Interactive Questionnaire System (iQS) to those collected in ATN 110 or ATN 113 by Audio Computer Assisted Self Interview (ACASI), Wisepill, and drug concentration levels in blood and hair. The iQS will be administered at study entry and week 24 visits. PrEP, Emtricitabine/Tenofovir disoproxil fumarate (Truvada®), will be administered as part of the ATN 110 and ATN 113 protocols. Study drug will not be administered as part of this study, ATN 123.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interactive Questionnaire System (iQS) | – | Drug: Emtricitabine/tenofovir disoproxilAn Interactive Questionnaire System (iQS) will be administered twice. First at study entry (ATN 110/113 week 24 visit) and second at week 24 (ATN 110/113 week 48 visit). The questionnaire will assess adherence as well as how structural (physical settings) and partnership factors affect adherence of YMSM to PrEP with FTC/TDF (Truvada®). |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants in this study will be HIV-1 uninfected YMSM, including transgender women, ages 15 through 22 years, inclusive at the time of consent into the parent protocol, currently enrolled in ATN 110 or ATN 113 and prescribed FTC/TDF (Truvada®) for PrEP.
Key inclusion criteria (3 listed)
- Concurrent enrollment in ATN 110 or ATN 113 and prescribed FTC/TDF (Emtricitabine/Tenofovir disoproxil fumarate (Truvada®)) for PrEP;
- Ability to understand written and spoken English; and
- Willing and able to provide written informed consent.
Key exclusion criteria (2 listed)
- Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent; and
- Intoxicated or under the influence of alcohol or other substances at the time of consent.
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/tenofovir disoproxilAlso: Truvada®, FTC/TFVATN 123 participants will not be administered Emtricitabine /Tenofovir disoproxil fumarate (Truvada®) as part of the ATN 123 study, but as part of the parent studies, ATN 110 or ATN 113. In order to be eligible for ATN 123, all participants must be co-enrolled in ATN 110 or ATN 113. The only intervention for ATN 123 is the administration of the Interactive Questionnaire System (iQS), which is a new method to collect data on adherence. It will be utilized to collect adherence data across a variety of devices (i.e., computer/laptop, smartphone, tablet, etc.). Accuracy of this method will be determined; preference for this mode of data collection compared to other methods for adherence reporting used in the parent studies will be assessed. | Drug | Interactive Questionnaire System (iQS) |
Primary outcome
Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire
Time frame: Week 0
To assess preference of the iQS as a way to measure adherence to Pre-Exposure Prophylaxis (PrEP) in PrEP clinical trials, completion rates; pattern of skipped or incomplete responses by variables will be analyzed.
Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire
Time frame: Week 24
To assess preference of the iQS as a way to measure adherence to Pre-Exposure Prophylaxis (PrEP) in PrEP clinical trials, completion rates; pattern of skipped or incomplete responses by variables will be analyzed.
Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill
Time frame: Week 0
Preference for the iQS method compared to the ACASI and Wisepill will be assessed as reported by participants.
Preference for Interactive Questionnaire System (iQS) compared to Audio Computer Assisted Self Interview (ACASI) or Wisepill
Time frame: Week 24
Preference for the iQS method compared to the ACASI and Wisepill will be assessed as reported by participants.
Adherence to Pre-Exposure Prophylaxis (PrEP) Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI)
Time frame: Week 0
Self reports in iQS, Wisepill, and ACASI will be compared to measured drug concentration levels in blood and hair. The iQS is administered as part of this study (ATN 123). The ACASI, Wisepill and drug concentration levels in blood and hair are collected as part of the parent studies (ATN 110 or ATN 113)
Adherence to Pre-Exposure Prophylaxis (PrEP)Reports by Mode: Interactive Questionnaire System (iQS) vs. Wisepill vs. Audio Computer Assisted Self Interview (ACASI)
Time frame: Week 24
Self reports in iQS, Wisepill, and ACASI will be compared to measured drug concentration levels in blood and hair. The iQS is administered as part of this study (ATN 123). The ACASI, Wisepill and drug concentration levels in blood and hair are collected as part of the parent studies (ATN 110 or ATN 113)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
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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.
Pamina M Gorbach, MHS, DrPH study chair
University of California, Los Angeles
Michelle Lally, MD, MSc study chair
Alpert Medical School, Brown University
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by University of North Carolina, Chapel Hill at 12 sites in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Missing Data in the Interactive Questionnaire System (iQS) questionnaire (time frame: Week 0). The study lists 6 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 28 Feb 2017.