Adherence, PatientPCANCT03442192
A Comparative Effectiveness Demonstration Project for Linkage and Retention in PrEP Care for Men Who Have Sex With Men
A study testing PrEP Care Anywhere Services in people with Adherence, Patient, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to learn more about the differences in engaging, recruiting, linking and adhering to pre-exposure prophylaxis (PrEP) services for men who have sex with other men at risk for HIV in Baltimore City. In 2012, the U.S. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adherence, Patient
- What is being tested?
- PrEP Care Anywhere Services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2018to 31 Dec 2021
- Phase
- Interventional
- 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 18 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older who are HIV-negative and meeting CDC risk criteria
- Persons self-identifying as Black/African American, Latino or other men of color up to 20% Caucasian
- Men who report unprotected sex with another male partner in preceding twelve months
- Expressed interest in seeking HIV PrEP clinical services
- Willing to participate in study-related procedures, including baseline and study visits every three months
- Willing and able (i.e., access to internet connectivity) to participate in virtual PrEP model through EPIC, polycom platform
- Insured with plan that is accepted by Johns Hopkins (study team will conduct monthly tracking of insurance plans accepted by the Bartlett Specialty Care Clinic)
- Willing to receive PrEP care at Johns Hopkins
Who cannot join
- Under 18 years of age
- Unable to read, write or speak English
- For medical reasons, are unable to receive TDF/FTC for PrEP (including HIV- positive persons)
- Participating in another PrEP clinical trial or HIV vaccination study
- Not insured with a plan that is accepted at Johns Hopkins
- Not willing or able (i.e. access to internet connectivity) to participate in virtual PrEP model
- Not willing to receive PrEP care at Johns Hopkins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Effectiveness Demonstration Project for Linkage and Retention in PrEP Care for Men Who Have Sex With Men (PCA)
This research is being done to learn more about the differences in engaging, recruiting, linking and adhering to pre-exposure prophylaxis (PrEP) services for men who have sex with other men at risk for HIV in Baltimore City.
In 2012, the U.S. Food and Drug Administration (FDA) approved the use of Truvada as pre-exposure prophylaxis (PrEP) to help prevent HIV infection. In the intervention, a virtual, PrEP Care Anywhere Telemedicine approach supported by virtual peer-navigator will be compared to standard clinic-based PrEP services with face-to-face peer navigation. The study will evaluate whether PrEP Care Anywhere, which is more patient-centered, will improve adherence and retention in PrEP care.
Read the detailed description
According to the Centers for Disease Control and Prevention (CDC), the estimated lifetime risk for HIV is 1 in 2 for Black men who have sex with men (MSM) and 1 in 4 for Latino MSM. In 2012, the U.S. Food and Drug Administration approved the use of Truvada as pre-exposure prophylaxis (PrEP) to help prevent HIV infection. However, PrEP uptake and adherence among MSM of color in particular remains low. Part of the challenge of increasing PrEP uptake and adherence among MSM of color is related to a historical lack of ethnic and sexual minority engagement in health care systems, perceptions of racism and negativity, and inequities in treatment.
In order to engage, recruit, link, and retain MSM at substantial risk of HIV infection, this study proposes a randomized controlled pilot trial among 100 HIV-negative MSM of color (50 per arm) in Baltimore City to determine differences in engagement, retention and adherence to Truvada along with PrEP services. In the intervention, a virtual, PrEP Care Anywhere Telemedicine approach supported by virtual peer-navigator will be compared to standard clinic-based PrEP services with face-to-face peer navigation. The study will evaluate whether PrEP Care Anywhere, as a more client-centered approach, will improve adherence and retention.
The specific aims of the Randomized Controlled Trial (RCT) pilot are:
- To explore differences in linkage, engagement (uptake) and retention in PrEP services between traditional clinic-based PrEP services compared to the PrEP Care Anywhere (i.e., virtual) approach
Secondary Objectives
- To describe engagement with the smartphone application, PrEP me, in the PrEP Care Anywhere arm
- To evaluate the feasibility and scalability of the intervention package by measuring the number of peer intervention contacts (e.g., text message, email, phone, in person, mobile app chats) per participant over 12 months
- To evaluate biological markers of adherence among a subset of HIV-negative participants and all participants who seroconvert
- To evaluate agreement in self-reported daily adherence (app-based reporting) to standard quarterly clinic-based self-report and to correlate self-reported adherence with biomarkers of adherence including peripheral blood mononuclear cells (PBMC) and plasma levels of tenofovir disoproxil fumarate (TDF) in a subset of participants
- To compare longitudinal changes in sexual risk behavior, health care utilization, intimate partner violence, stigma, substance use and mental health between the two study arms over 12 months by administering questionnaires at baseline, month 1 and quarterly visits
- To assess feasibility and acceptability of virtual self-testing for HIV and sexually transmitted infections
- To compare the experience of and satisfaction with linkage to and engagement in ongoing HIV prevention services among participants by conducting and analyzing exit interviews
- Conditions
- Adherence, Patient
- Being tested
- PrEP Care Anywhere Services
- Keywords
- PrEP, virtual, adherence, retention
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Care Anywhere ServicesOther
PrEP Virtual Clinic Visits. PrEP clinical care will follow guidelines as established by the CDC for PrEP clinical evaluation and follow-up. Appointments will be set up in the same process as any practice visit and require the same clinical documentation and billing requirements, but will have a separate clinic designation for the visit type. At any time during the study, a patient can request a face-to-face visit with the provider. The provider may also request a face-to-face visit based on patient presentation and/or laboratory results.
The typical visit options will include:
- On demand peer interim visits- participants can text, chat (via PrEPme app) or call to access an on demand virtual support visit with a peer Case Manager (CM).
- HIV and Sexually Transmitted Infection (STI) at Home Self-Testing
| Study group | Role | What they receive |
|---|---|---|
| PrEP Care Anywhere Services | Other | The PrEP Care Anywhere intervention adapts peer PrEP case management for virtual delivery and provides clinical services through a tele-health program, delivered by the same clinic providers. After an initial face-to-face intake clinical evaluation within the clinic, will then receive the remaining PrEP clinical evaluations via telemedicine using the HIPPA compliant polycom platform. Case management interventions will be conducted virtually via the PrEPme application, telephone consultation, text, or email. Receives: Other: PrEP Care Anywhere Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Uptake
Primary outcome 1 will examine PrEP uptake at Month 1, among those not already taking PrEP at baseline, defined as Tenofovir (TFV) levels of 35.5 ng/mL or greater, using students T-test
Measured: 1 month
Secondary outcomes (1)
PrEP Adherence
Adherence at Month 12, defined as persistent TFV levels of 35.5 ng/mL between the arms will be evaluated by Cox Proportional Hazard models
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 posted22 Feb 2018
- Study start30 Jul 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: COVID erupted and change in policy making all visits throughout hospital telemedicine
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Changed from randomization to provide PrEP Care Anywhere approach to everyone enrolled to determine differences in engagement, retention and adherence.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Jason E Farley, PhD, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442192
- Sponsor's protocol ID
- IRB00132612
- Acronym
- PCA
- Status last verified
- Dec 2022
- First submitted
- 16 Feb 2018
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirby T, Thornber-Dunwell M. Uptake of PrEP for HIV slow among MSM. Lancet. 2014 Feb 1;383(9915):399-400. doi: 10.1016/s0140-6736(14)60137-9. No abstract available.
PubMed 24494225Arnold EA, Rebchook GM, Kegeles SM. 'Triply cursed': racism, homophobia and HIV-related stigma are barriers to regular HIV testing, treatment adherence and disclosure among young Black gay men. Cult Health Sex. 2014 Jun;16(6):710-22. doi: 10.1080/13691058.2014.905706. Epub 2014 May 2.
PubMed 24784224Cahill S, Taylor SW, Elsesser SA, Mena L, Hickson D, Mayer KH. Stigma, medical mistrust, and perceived racism may affect PrEP awareness and uptake in black compared to white gay and bisexual men in Jackson, Mississippi and Boston, Massachusetts. AIDS Care. 2017 Nov;29(11):1351-1358. doi: 10.1080/09540121.2017.1300633. Epub 2017 Mar 12.
PubMed 28286983Freeman R, Gwadz MV, Silverman E, Kutnick A, Leonard NR, Ritchie AS, Reed J, Martinez BY. Critical race theory as a tool for understanding poor engagement along the HIV care continuum among African American/Black and Hispanic persons living with HIV in the United States: a qualitative exploration. Int J Equity Health. 2017 Mar 24;16(1):54. doi: 10.1186/s12939-017-0549-3.
PubMed 28340589Beck C, McSweeney JC, Richards KC, Roberson PK, Tsai PF, Souder E. Challenges in tailored intervention research. Nurs Outlook. 2010 Mar-Apr;58(2):104-10. doi: 10.1016/j.outlook.2009.10.004.
PubMed 20362779Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, Salata R, Soto-Torres L, Patterson K, Minnis AM, Gandham S, Gomez K, Richardson BA, Bumpus NN. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One. 2013;8(1):e55013. doi: 10.1371/journal.pone.0055013. Epub 2013 Jan 30.
PubMed 23383037DiFrancesco R, Rosenkranz SL, Taylor CR, Pande PG, Siminski SM, Jenny RW, Morse GD. Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories. Ther Drug Monit. 2013 Oct;35(5):631-42. doi: 10.1097/FTD.0b013e31828f5088.
PubMed 24052065Hendrix CW, Andrade A, Bumpus NN, Kashuba AD, Marzinke MA, Moore A, Anderson PL, Bushman LR, Fuchs EJ, Wiggins I, Radebaugh C, Prince HA, Bakshi RP, Wang R, Richardson P, Shieh E, McKinstry L, Li X, Donnell D, Elharrar V, Mayer KH, Patterson KB. Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retroviruses. 2016 Jan;32(1):32-43. doi: 10.1089/AID.2015.0182. Epub 2015 Oct 15.
PubMed 26414912Liu AY, Yang Q, Huang Y, Bacchetti P, Anderson PL, Jin C, Goggin K, Stojanovski K, Grant R, Buchbinder SP, Greenblatt RM, Gandhi M. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP). PLoS One. 2014 Jan 8;9(1):e83736. doi: 10.1371/journal.pone.0083736. eCollection 2014.
PubMed 24421901Castro FG, Barrera M Jr, Martinez CR Jr. The cultural adaptation of prevention interventions: resolving tensions between fidelity and fit. Prev Sci. 2004 Mar;5(1):41-5. doi: 10.1023/b:prev.0000013980.12412.cd.
PubMed 15058911Montgomery MC, Oldenburg CE, Nunn AS, Mena L, Anderson P, Liegler T, Mayer KH, Patel R, Almonte A, Chan PA. Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting. PLoS One. 2016 Jun 22;11(6):e0157742. doi: 10.1371/journal.pone.0157742. eCollection 2016.
PubMed 27333000Zheng JH, Rower C, McAllister K, Castillo-Mancilla J, Klein B, Meditz A, Guida LA, Kiser JJ, Bushman LR, Anderson PL. Application of an intracellular assay for determination of tenofovir-diphosphate and emtricitabine-triphosphate from erythrocytes using dried blood spots. J Pharm Biomed Anal. 2016 Apr 15;122:16-20. doi: 10.1016/j.jpba.2016.01.038. Epub 2016 Jan 21.
PubMed 26829517Whetten K, Reif S, Swartz M, Stevens R, Ostermann J, Hanisch L, Eron JJ Jr. A brief mental health and substance abuse screener for persons with HIV. AIDS Patient Care STDS. 2005 Feb;19(2):89-99. doi: 10.1089/apc.2005.19.89.
PubMed 15716640Wilson IB, Fowler FJ Jr, Cosenza CA, Michaud J, Bentkover J, Rana A, Kogelman L, Rogers WH. Cognitive and field testing of a new set of medication adherence self-report items for HIV care. AIDS Behav. 2014 Dec;18(12):2349-58. doi: 10.1007/s10461-013-0610-1.
PubMed 24077970
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Effectiveness Demonstration Project for Linkage and Retention in PrEP Care for Men Who Have Sex With Men (PCA)
- ClinicalTrials.gov ID
- NCT03442192
- Acronym / sponsor ID
- PCA / IRB00132612
- Conditions
- Adherence, Patient
- Keywords
- PrEP, virtual, adherence, retention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID erupted and change in policy making all visits throughout hospital telemedicine
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Feb 2018 (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.
This research is being done to learn more about the differences in engaging, recruiting, linking and adhering to pre-exposure prophylaxis (PrEP) services for men who have sex with other men at risk for HIV in Baltimore City.
In 2012, the U.S. Food and Drug Administration (FDA) approved the use of Truvada as pre-exposure prophylaxis (PrEP) to help prevent HIV infection. In the intervention, a virtual, PrEP Care Anywhere Telemedicine approach supported by virtual peer-navigator will be compared to standard clinic-based PrEP services with face-to-face peer navigation. The study will evaluate whether PrEP Care Anywhere, which is more patient-centered, will improve adherence and retention in PrEP care.
Detailed description
According to the Centers for Disease Control and Prevention (CDC), the estimated lifetime risk for HIV is 1 in 2 for Black men who have sex with men (MSM) and 1 in 4 for Latino MSM. In 2012, the U.S. Food and Drug Administration approved the use of Truvada as pre-exposure prophylaxis (PrEP) to help prevent HIV infection. However, PrEP uptake and adherence among MSM of color in particular remains low. Part of the challenge of increasing PrEP uptake and adherence among MSM of color is related to a historical lack of ethnic and sexual minority engagement in health care systems, perceptions of racism and negativity, and inequities in treatment.
In order to engage, recruit, link, and retain MSM at substantial risk of HIV infection, this study proposes a randomized controlled pilot trial among 100 HIV-negative MSM of color (50 per arm) in Baltimore City to determine differences in engagement, retention and adherence to Truvada along with PrEP services. In the intervention, a virtual, PrEP Care Anywhere Telemedicine approach supported by virtual peer-navigator will be compared to standard clinic-based PrEP services with face-to-face peer navigation. The study will evaluate whether PrEP Care Anywhere, as a more client-centered approach, will improve adherence and retention.
The specific aims of the Randomized Controlled Trial (RCT) pilot are:
- To explore differences in linkage, engagement (uptake) and retention in PrEP services between traditional clinic-based PrEP services compared to the PrEP Care Anywhere (i.e., virtual) approach
Secondary Objectives
- To describe engagement with the smartphone application, PrEP me, in the PrEP Care Anywhere arm
- To evaluate the feasibility and scalability of the intervention package by measuring the number of peer intervention contacts (e.g., text message, email, phone, in person, mobile app chats) per participant over 12 months
- To evaluate biological markers of adherence among a subset of HIV-negative participants and all participants who seroconvert
- To evaluate agreement in self-reported daily adherence (app-based reporting) to standard quarterly clinic-based self-report and to correlate self-reported adherence with biomarkers of adherence including peripheral blood mononuclear cells (PBMC) and plasma levels of tenofovir disoproxil fumarate (TDF) in a subset of participants
- To compare longitudinal changes in sexual risk behavior, health care utilization, intimate partner violence, stigma, substance use and mental health between the two study arms over 12 months by administering questionnaires at baseline, month 1 and quarterly visits
- To assess feasibility and acceptability of virtual self-testing for HIV and sexually transmitted infections
- To compare the experience of and satisfaction with linkage to and engagement in ongoing HIV prevention services among participants by conducting and analyzing exit interviews
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Changed from randomization to provide PrEP Care Anywhere approach to everyone enrolled to determine differences in engagement, retention and adherence.
| Arm | Type | Receives |
|---|---|---|
| PrEP Care Anywhere Services | Other | Other: PrEP Care Anywhere ServicesThe PrEP Care Anywhere intervention adapts peer PrEP case management for virtual delivery and provides clinical services through a tele-health program, delivered by the same clinic providers. After an initial face-to-face intake clinical evaluation within the clinic, will then receive the remaining PrEP clinical evaluations via telemedicine using the HIPPA compliant polycom platform. Case management interventions will be conducted virtually via the PrEPme application, telephone consultation, text, or email. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older who are HIV-negative and meeting CDC risk criteria
- Persons self-identifying as Black/African American, Latino or other men of color up to 20% Caucasian
- Men who report unprotected sex with another male partner in preceding twelve months
- Expressed interest in seeking HIV PrEP clinical services
- Willing to participate in study-related procedures, including baseline and study visits every three months
Key exclusion criteria (7 listed)
- Under 18 years of age
- Unable to read, write or speak English
- For medical reasons, are unable to receive TDF/FTC for PrEP (including HIV- positive persons)
- Participating in another PrEP clinical trial or HIV vaccination study
- Not insured with a plan that is accepted at Johns Hopkins
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 Care Anywhere ServicesPrEP Virtual Clinic Visits. PrEP clinical care will follow guidelines as established by the CDC for PrEP clinical evaluation and follow-up. Appointments will be set up in the same process as any practice visit and require the same clinical documentation and billing requirements, but will have a separate clinic designation for the visit type. At any time during the study, a patient can request a face-to-face visit with the provider. The provider may also request a face-to-face visit based on patient presentation and/or laboratory results. The typical visit options will include: * On demand peer interim visits- participants can text, chat (via PrEPme app) or call to access an on demand virtual support visit with a peer Case Manager (CM). * HIV and Sexually Transmitted Infection (STI) at Home Self-Testing | Other | PrEP Care Anywhere Services |
Primary outcome
PrEP Uptake
Time frame: 1 month
Primary outcome 1 will examine PrEP uptake at Month 1, among those not already taking PrEP at baseline, defined as Tenofovir (TFV) levels of 35.5 ng/mL or greater, using students T-test
1 secondary outcome
PrEP Adherence
Time frame: 12 months
Results and safety
The study was stopped early (reason given: COVID erupted and change in policy making all visits throughout hospital telemedicine). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 24494225Kirby T, Thornber-Dunwell M. Uptake of PrEP for HIV slow among MSM. Lancet. 2014 Feb 1;383(9915):399-400. doi: 10.1016/s0140-6736(14)60137-9. No abstract available.
- Background: PubMed 24784224Arnold EA, Rebchook GM, Kegeles SM. 'Triply cursed': racism, homophobia and HIV-related stigma are barriers to regular HIV testing, treatment adherence and disclosure among young Black gay men. Cult Health Sex. 2014 Jun;16(6):710-22. doi: 10.1080/13691058.2014.905706. Epub 2014 May 2.
- Background: PubMed 28286983Cahill S, Taylor SW, Elsesser SA, Mena L, Hickson D, Mayer KH. Stigma, medical mistrust, and perceived racism may affect PrEP awareness and uptake in black compared to white gay and bisexual men in Jackson, Mississippi and Boston, Massachusetts. AIDS Care. 2017 Nov;29(11):1351-1358. doi: 10.1080/09540121.2017.1300633. Epub 2017 Mar 12.
- Background: PubMed 28340589Freeman R, Gwadz MV, Silverman E, Kutnick A, Leonard NR, Ritchie AS, Reed J, Martinez BY. Critical race theory as a tool for understanding poor engagement along the HIV care continuum among African American/Black and Hispanic persons living with HIV in the United States: a qualitative exploration. Int J Equity Health. 2017 Mar 24;16(1):54. doi: 10.1186/s12939-017-0549-3.
- Background: PubMed 20362779Beck C, McSweeney JC, Richards KC, Roberson PK, Tsai PF, Souder E. Challenges in tailored intervention research. Nurs Outlook. 2010 Mar-Apr;58(2):104-10. doi: 10.1016/j.outlook.2009.10.004.
- Background: PubMed 23383037Hendrix CW, Chen BA, Guddera V, Hoesley C, Justman J, Nakabiito C, Salata R, Soto-Torres L, Patterson K, Minnis AM, Gandham S, Gomez K, Richardson BA, Bumpus NN. MTN-001: randomized pharmacokinetic cross-over study comparing tenofovir vaginal gel and oral tablets in vaginal tissue and other compartments. PLoS One. 2013;8(1):e55013. doi: 10.1371/journal.pone.0055013. Epub 2013 Jan 30.
- Background: PubMed 24052065DiFrancesco R, Rosenkranz SL, Taylor CR, Pande PG, Siminski SM, Jenny RW, Morse GD. Clinical pharmacology quality assurance program: models for longitudinal analysis of antiretroviral proficiency testing for international laboratories. Ther Drug Monit. 2013 Oct;35(5):631-42. doi: 10.1097/FTD.0b013e31828f5088.
- Background: PubMed 26414912Hendrix CW, Andrade A, Bumpus NN, Kashuba AD, Marzinke MA, Moore A, Anderson PL, Bushman LR, Fuchs EJ, Wiggins I, Radebaugh C, Prince HA, Bakshi RP, Wang R, Richardson P, Shieh E, McKinstry L, Li X, Donnell D, Elharrar V, Mayer KH, Patterson KB. Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retroviruses. 2016 Jan;32(1):32-43. doi: 10.1089/AID.2015.0182. Epub 2015 Oct 15.
- Background: PubMed 24421901Liu AY, Yang Q, Huang Y, Bacchetti P, Anderson PL, Jin C, Goggin K, Stojanovski K, Grant R, Buchbinder SP, Greenblatt RM, Gandhi M. Strong relationship between oral dose and tenofovir hair levels in a randomized trial: hair as a potential adherence measure for pre-exposure prophylaxis (PrEP). PLoS One. 2014 Jan 8;9(1):e83736. doi: 10.1371/journal.pone.0083736. eCollection 2014.
- Background: PubMed 15058911Castro FG, Barrera M Jr, Martinez CR Jr. The cultural adaptation of prevention interventions: resolving tensions between fidelity and fit. Prev Sci. 2004 Mar;5(1):41-5. doi: 10.1023/b:prev.0000013980.12412.cd.
- Background: PubMed 27333000Montgomery MC, Oldenburg CE, Nunn AS, Mena L, Anderson P, Liegler T, Mayer KH, Patel R, Almonte A, Chan PA. Adherence to Pre-Exposure Prophylaxis for HIV Prevention in a Clinical Setting. PLoS One. 2016 Jun 22;11(6):e0157742. doi: 10.1371/journal.pone.0157742. eCollection 2016.
- Background: PubMed 26829517Zheng JH, Rower C, McAllister K, Castillo-Mancilla J, Klein B, Meditz A, Guida LA, Kiser JJ, Bushman LR, Anderson PL. Application of an intracellular assay for determination of tenofovir-diphosphate and emtricitabine-triphosphate from erythrocytes using dried blood spots. J Pharm Biomed Anal. 2016 Apr 15;122:16-20. doi: 10.1016/j.jpba.2016.01.038. Epub 2016 Jan 21.
- 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.
Jason E Farley, PhD principal investigator
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP Care Anywhere Services in people with Adherence, Patient, run by Johns Hopkins University 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 9 Dec 2022. 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?
The study was stopped early (reason given: COVID erupted and change in policy making all visits throughout hospital telemedicine). 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 Uptake (time frame: 1 month). 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 NCT03442192, which also lists 14 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 9 Dec 2022.