MSMNCT02611362
A Multilevel Gaming Intervention for Persons on PrEP
A study testing IMB Gaming Intervention in people with MSM and PrEP, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This study will develop and test a novel, smartphone based gaming intervention to improve adherence to medication to prevent HIV (known as Pre-exposure Prophylaxis, PrEP) and to decrease HIV risk behaviors among men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- IMB Gaming Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- Receiving prophylactic antiretroviral treatment
- Not enrolled in another PrEP related study
- Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
This study will develop and test a novel, smartphone based gaming intervention to improve adherence to medication to prevent HIV (known as Pre-exposure Prophylaxis, PrEP) and to decrease HIV risk behaviors among men who have sex with men (MSM). In the intervention, participants will engage with an immersive app/game on their iPhone. While gaming, participants will gain information about their health, improve motivation for PrEP and medical appointment adherence, and practice healthy behaviors. If the intervention is found to be effective, it can be tested in a larger study and then disseminated to other people taking PrEP.
Read the detailed description
The use of antiretroviral medications to reduce the risk of acquiring HIV infection (Pre-exposure Prophylaxis, PrEP) is an efficacious and promising new prevention strategy. In published studies, failure of PrEP was associated with poor adherence and low plasma drug levels. This indicates that optimal PrEP treatment will require behavioral interventions to promote adherence. Averting increases in risk behavior will also be essential for maintaining PrEP's protective effects. Interventions will need to address on-going HIV risk behavior and be relevant for persons using PrEP (e.g. young adult MSM). Borrowing from recent literature in HIV prevention and treatment adherence, interventions that utilize intuitive easy to use technologies with motivational components show promise for behavior change and dissemination.
This study will examine an interactive smartphone based app/game that is immersive and appealing. This novel, but intuitive multi-level technology will measure PrEP adherence, promote engagement in treatment and safe sexual behavior. The smartphone app/game will be developed to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about PrEP treatment and HIV), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners, condom self efficacy). In-depth interviews with young adults on PrEP and an open trial of the intervention will inform the development of the intervention and procedures. A small randomized controlled pilot study among 50 participants on PrEP will examine the preliminary efficacy of the intervention (IMB informed app/game). It is hypothesized that, compared to subjects in the control group, participants in the IMB Gaming Intervention will show: improved adherence to PrEP, higher blood ARV levels, decreased HIV risk behaviors, and improved self efficacy and attitudes for PrEP treatment adherence.
The specific aims are:
- To create an engaging and absorbing smartphone based app/game with content consistent with the Information-Motivation-Behavioral Skills (IMB) model to measure and improve PrEP treatment adherence and safer sex behaviors, and to receive feedback on the game's utility and acceptability from in-depth interviews with MSM (estimated mean age 27).
- To conduct an open trial of the IMB Gaming Intervention with MSM to obtain further qualitative and quantitative information on its acceptability, and feasibility. These data will be used to modify the approach and technology as needed.
- To evaluate, in a 24 week randomized controlled pilot study (n=50), the preliminary efficacy of the IMB Gaming Intervention compared to a time, attention, and technology matched group. Investigators will examine the impact of the IMB Gaming Intervention in improving treatment adherence (measured by clinic visits attended, self-report) and biological measures (ARV levels). Investigators will also examine the impact on HIV risk behaviors.
- Being tested
- IMB Gaming Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB Gaming InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Subjects in the intervention group will each receive a smartphone with a data service plan as the active arm. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic. Receives: Behavioral: IMB Gaming Intervention |
| Comparison | No intervention | This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Report of PrEP Adherence
Self-report measure of adherence in the past 7 days categorized as "optimal" (0-3 missed doses in the past 7 days) versus "suboptimal" (4-7 missed doses in the past 7 days).
Measured: 24 weeks
ARV (TFV-DP) Levels
Intracellular TFV-DP will be measured in red blood cells using dried blood spots. TFV-DP levels provide a measure of long-term adherence over the preceding month (like hemoglobin A1C). The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average (e.g. 7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average).
Measured: 24 weeks
Average Number of Days on PrEP Per Week
The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average in the past month (e.g. 7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average).
Measured: 24 weeks
Secondary outcomes (2)
HIV Knowledge at 24 Weeks
The HIV Knowledge Scale assesses knowledge about issues such as risks for HIV, using 5 items with "true," "false," or "do not know" response options. Total scores range from 0 to 5. Higher scores indicate greater knowledge.
Measured: 24 weeks
Motivational Readiness for Adherence at 24 Weeks
Rollnick's Readiness Ruler will be used to assess motivation for adherence to medication and medical visits. Respondents rate how ready they are to take PrEP as prescribed on a scale from 1 (not ready) to 10 (ready to be consistent or already consistent) each month.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (144)Papers the sponsor has linked to this study.
- Other trials for MSMStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Whiteley, Rhode Island Hospital
- Investigators
- Laura Whiteley, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02611362
- Sponsor's protocol ID
- 1R34MH104068
- Status last verified
- Dec 2020
- First submitted
- 3 Nov 2015
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Underhill K, Operario D, Skeer M, Mimiaga M, Mayer K. Packaging PrEP to Prevent HIV: An Integrated Framework to Plan for Pre-Exposure Prophylaxis Implementation in Clinical Practice. J Acquir Immune Defic Syndr. 2010 Sep;55(1):8-13. doi: 10.1097/qai.0b013e3181e8efe4.
PubMed 21423876Padian NS, Buve A, Balkus J, Serwadda D, Cates W Jr. Biomedical interventions to prevent HIV infection: evidence, challenges, and way forward. Lancet. 2008 Aug 16;372(9638):585-99. doi: 10.1016/S0140-6736(08)60885-5. Epub 2008 Aug 5.
PubMed 18687456UNAIDS. Global Facts & Figures. Geneva, Switzerland: Joint United Nations Programme on HIV/ AIDS; 2012.
Szekeres G, Coates TJ. Policy and practice implications of HIV pre-exposure prophylaxis (PrEP) in the United States. Los Angeles, CA: UCLA Program in Global Health, AIDS Policy Development Center; 2006.
Paxton LA, Hope T, Jaffe HW. Pre-exposure prophylaxis for HIV infection: what if it works? Lancet. 2007 Jul 7;370(9581):89-93. doi: 10.1016/S0140-6736(07)61053-8. No abstract available.
PubMed 17617276Abdool Karim SS. Antiretroviral chemoprophylaxis for the prevention of HIV infection: future implementation challenges. HIV Therapy. 2009; 3(1):3-6.
CDC. Pre-exposure prophylaxis (PrEP) for HIV prevention: planning for potential implementation in the U.S. Atlanta, GA: 2009
Rotheram-Borus MJ, Swendeman D, Chovnick G. The past, present, and future of HIV prevention: integrating behavioral, biomedical, and structural intervention strategies for the next generation of HIV prevention. Annu Rev Clin Psychol. 2009;5:143-67. doi: 10.1146/annurev.clinpsy.032408.153530.
PubMed 19327028Liu AY, Grant RM, Buchbinder SP. Preexposure prophylaxis for HIV: unproven promise and potential pitfalls. JAMA. 2006 Aug 16;296(7):863-5. doi: 10.1001/jama.296.7.863. No abstract available.
PubMed 16905792Mayer KH, Wheeler DP, Bekker LG, Grinsztejn B, Remien RH, Sandfort TG, Beyrer C. Overcoming biological, behavioral, and structural vulnerabilities: new directions in research to decrease HIV transmission in men who have sex with men. J Acquir Immune Defic Syndr. 2013 Jul;63 Suppl 2(0 2):S161-7. doi: 10.1097/QAI.0b013e318298700e.
PubMed 23764630Paltiel AD, Freedberg KA, Scott CA, Schackman BR, Losina E, Wang B, Seage GR 3rd, Sloan CE, Sax PE, Walensky RP. HIV preexposure prophylaxis in the United States: impact on lifetime infection risk, clinical outcomes, and cost-effectiveness. Clin Infect Dis. 2009 Mar 15;48(6):806-15. doi: 10.1086/597095.
PubMed 19193111Abbas UL, Anderson RM, Mellors JW. Potential impact of antiretroviral chemoprophylaxis on HIV-1 transmission in resource-limited settings. PLoS One. 2007 Sep 19;2(9):e875. doi: 10.1371/journal.pone.0000875.
PubMed 17878928Desai K, Sansom SL, Ackers ML, Stewart SR, Hall HI, Hu DJ, Sanders R, Scotton CR, Soorapanth S, Boily MC, Garnett GP, McElroy PD. Modeling the impact of HIV chemoprophylaxis strategies among men who have sex with men in the United States: HIV infections prevented and cost-effectiveness. AIDS. 2008 Sep 12;22(14):1829-39. doi: 10.1097/QAD.0b013e32830e00f5.
PubMed 18753932Golub SA, Kowalczyk W, Weinberger CL, Parsons JT. Preexposure prophylaxis and predicted condom use among high-risk men who have sex with men. J Acquir Immune Defic Syndr. 2010 Aug;54(5):548-55. doi: 10.1097/QAI.0b013e3181e19a54.
PubMed 20512046Amico KR, Mansoor LE, Corneli A, Torjesen K, van der Straten A. Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. AIDS Behav. 2013 Jul;17(6):2143-55. doi: 10.1007/s10461-013-0429-9.
PubMed 23435697
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Gaming Intervention for Persons on PrEP
- ClinicalTrials.gov ID
- NCT02611362
- Acronym / sponsor ID
- 1R34MH104068
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will develop and test a novel, smartphone based gaming intervention to improve adherence to medication to prevent HIV (known as Pre-exposure Prophylaxis, PrEP) and to decrease HIV risk behaviors among men who have sex with men (MSM). In the intervention, participants will engage with an immersive app/game on their iPhone. While gaming, participants will gain information about their health, improve motivation for PrEP and medical appointment adherence, and practice healthy behaviors. If the intervention is found to be effective, it can be tested in a larger study and then disseminated to other people taking PrEP.
Detailed description
The use of antiretroviral medications to reduce the risk of acquiring HIV infection (Pre-exposure Prophylaxis, PrEP) is an efficacious and promising new prevention strategy. In published studies, failure of PrEP was associated with poor adherence and low plasma drug levels. This indicates that optimal PrEP treatment will require behavioral interventions to promote adherence. Averting increases in risk behavior will also be essential for maintaining PrEP's protective effects. Interventions will need to address on-going HIV risk behavior and be relevant for persons using PrEP (e.g. young adult MSM). Borrowing from recent literature in HIV prevention and treatment adherence, interventions that utilize intuitive easy to use technologies with motivational components show promise for behavior change and dissemination.
This study will examine an interactive smartphone based app/game that is immersive and appealing. This novel, but intuitive multi-level technology will measure PrEP adherence, promote engagement in treatment and safe sexual behavior. The smartphone app/game will be developed to include content consistent with the Information-Motivation-Behavioral Skills (IMB) Model. While gaming, participants will experience absorbing action-oriented adventures that increase information about their health (e.g. knowledge about PrEP treatment and HIV), improve motivation (e.g. action-figures experience health benefits of adherence), and build skills (e.g. utilize clinicians as partners, condom self efficacy). In-depth interviews with young adults on PrEP and an open trial of the intervention will inform the development of the intervention and procedures. A small randomized controlled pilot study among 50 participants on PrEP will examine the preliminary efficacy of the intervention (IMB informed app/game). It is hypothesized that, compared to subjects in the control group, participants in the IMB Gaming Intervention will show: improved adherence to PrEP, higher blood ARV levels, decreased HIV risk behaviors, and improved self efficacy and attitudes for PrEP treatment adherence.
The specific aims are:
- To create an engaging and absorbing smartphone based app/game with content consistent with the Information-Motivation-Behavioral Skills (IMB) model to measure and improve PrEP treatment adherence and safer sex behaviors, and to receive feedback on the game's utility and acceptability from in-depth interviews with MSM (estimated mean age 27).
- To conduct an open trial of the IMB Gaming Intervention with MSM to obtain further qualitative and quantitative information on its acceptability, and feasibility. These data will be used to modify the approach and technology as needed.
- To evaluate, in a 24 week randomized controlled pilot study (n=50), the preliminary efficacy of the IMB Gaming Intervention compared to a time, attention, and technology matched group. Investigators will examine the impact of the IMB Gaming Intervention in improving treatment adherence (measured by clinic visits attended, self-report) and biological measures (ARV levels). Investigators will also examine the impact on HIV risk behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: IMB Gaming InterventionSubjects in the intervention group will each receive a smartphone with a data service plan as the active arm. The IMB Gaming Intervention is designed to improve information, motivation, and skills about adherence and HIV preventative behaviors throughout play. The mission of Viral Combat is: kill virus and build strength through taking medicine, learning HIV prevention information, and engaging with healthy characters in order to improve motivation and build skills. Participants will get a game graphic with a supportive message such as "Missing you: Get in the Game" to their phones. Throughout the gaming intervention subjects will continue routine clinical care visits and HIV testing in the PrEP clinic. |
| Comparison | No intervention | –This condition will be matched with the IMB Gaming Intervention for appeal, time and attention. Subjects in COMP will each receive smartphones with the same data service plan as the active arm. Smartphones given to participants in COMP will have a stylistically similar non-PrEP, non-IMB game designed by Mission Critical Studios (Dr. Nano X: Incredible Voyage Inside The Body, http://www.youtube.com/watch?v=lyHzSZFzU1Q ). This is the same game that Viral Combat is being adapted from. Therefore, the iPhone game in COMP will have a look and feel that is very similar to our intervention game but without IMB, PrEP, and HIV prevention related content. Similar to the Intervention group, participants will have routine clinical care visits in the PrEP clinic (or more frequently if needed for urgent care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- Receiving prophylactic antiretroviral treatment
- Not enrolled in another PrEP related study
- Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.
Key exclusion criteria (1 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 |
|---|---|---|
| IMB Gaming Intervention | Behavioural | Intervention |
Primary outcome
Self-Report of PrEP Adherence
Time frame: 24 weeks
Self-report measure of adherence in the past 7 days categorized as "optimal" (0-3 missed doses in the past 7 days) versus "suboptimal" (4-7 missed doses in the past 7 days).
ARV (TFV-DP) Levels
Time frame: 24 weeks
Intracellular TFV-DP will be measured in red blood cells using dried blood spots. TFV-DP levels provide a measure of long-term adherence over the preceding month (like hemoglobin A1C). The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average (e.g. 7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average).
Average Number of Days on PrEP Per Week
Time frame: 24 weeks
The level of intracellular TFV-DP can be used to estimate how many doses/week the participant is taking on average in the past month (e.g. 7/wk on average, 4-7/wk on average, 2-4/wk on average, <2/wk on average).
2 secondary outcomes
HIV Knowledge at 24 Weeks
Time frame: 24 weeks
Motivational Readiness for Adherence at 24 Weeks
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21423876Underhill K, Operario D, Skeer M, Mimiaga M, Mayer K. Packaging PrEP to Prevent HIV: An Integrated Framework to Plan for Pre-Exposure Prophylaxis Implementation in Clinical Practice. J Acquir Immune Defic Syndr. 2010 Sep;55(1):8-13. doi: 10.1097/qai.0b013e3181e8efe4.
- Background: PubMed 18687456Padian NS, Buve A, Balkus J, Serwadda D, Cates W Jr. Biomedical interventions to prevent HIV infection: evidence, challenges, and way forward. Lancet. 2008 Aug 16;372(9638):585-99. doi: 10.1016/S0140-6736(08)60885-5. Epub 2008 Aug 5.
- BackgroundUNAIDS. Global Facts & Figures. Geneva, Switzerland: Joint United Nations Programme on HIV/ AIDS; 2012.
- BackgroundSzekeres G, Coates TJ. Policy and practice implications of HIV pre-exposure prophylaxis (PrEP) in the United States. Los Angeles, CA: UCLA Program in Global Health, AIDS Policy Development Center; 2006.
- Background: PubMed 17617276Paxton LA, Hope T, Jaffe HW. Pre-exposure prophylaxis for HIV infection: what if it works? Lancet. 2007 Jul 7;370(9581):89-93. doi: 10.1016/S0140-6736(07)61053-8. No abstract available.
- BackgroundAbdool Karim SS. Antiretroviral chemoprophylaxis for the prevention of HIV infection: future implementation challenges. HIV Therapy. 2009; 3(1):3-6.
- BackgroundCDC. Pre-exposure prophylaxis (PrEP) for HIV prevention: planning for potential implementation in the U.S. Atlanta, GA: 2009
- Background: PubMed 19327028Rotheram-Borus MJ, Swendeman D, Chovnick G. The past, present, and future of HIV prevention: integrating behavioral, biomedical, and structural intervention strategies for the next generation of HIV prevention. Annu Rev Clin Psychol. 2009;5:143-67. doi: 10.1146/annurev.clinpsy.032408.153530.
- Background: PubMed 16905792Liu AY, Grant RM, Buchbinder SP. Preexposure prophylaxis for HIV: unproven promise and potential pitfalls. JAMA. 2006 Aug 16;296(7):863-5. doi: 10.1001/jama.296.7.863. No abstract available.
- Background: PubMed 23764630Mayer KH, Wheeler DP, Bekker LG, Grinsztejn B, Remien RH, Sandfort TG, Beyrer C. Overcoming biological, behavioral, and structural vulnerabilities: new directions in research to decrease HIV transmission in men who have sex with men. J Acquir Immune Defic Syndr. 2013 Jul;63 Suppl 2(0 2):S161-7. doi: 10.1097/QAI.0b013e318298700e.
- Background: PubMed 19193111Paltiel AD, Freedberg KA, Scott CA, Schackman BR, Losina E, Wang B, Seage GR 3rd, Sloan CE, Sax PE, Walensky RP. HIV preexposure prophylaxis in the United States: impact on lifetime infection risk, clinical outcomes, and cost-effectiveness. Clin Infect Dis. 2009 Mar 15;48(6):806-15. doi: 10.1086/597095.
- Background: PubMed 17878928Abbas UL, Anderson RM, Mellors JW. Potential impact of antiretroviral chemoprophylaxis on HIV-1 transmission in resource-limited settings. PLoS One. 2007 Sep 19;2(9):e875. doi: 10.1371/journal.pone.0000875.
Related trials for MSM
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Behavioral Intervention for PrEP Service Utilization Among Chinese MSM: A HAPA and CEI Integrated Model
HIV, PrEP
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.
Laura Whiteley, MD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMB Gaming Intervention in people with MSM and PrEP, run by Rhode Island Hospital at 1 site 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 4 inclusion and 1 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 12 Jan 2021. 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 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?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-Report of PrEP Adherence (time frame: 24 weeks). 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?
On the ClinicalTrials.gov record for NCT02611362, which also lists 144 linked publications.
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 12 Jan 2021; AzTrials last refreshed its copy on 28 Oct 2026.