Pre-Exposure ProphylaxisPrEPTECH2NCT04902820
PrEPTECH Phase 2 Study of a PrEP Telehealth Intervention
A study testing PrEPTECH website and Online PrEP resource list in people with Pre-Exposure Prophylaxis and HIV, run by ETR Associates at 1 site in United States.
Trial summary
PrEPTECH Phase 2 is a 2-arm randomized controlled trial to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender men and transgender women who have sex with men over six months. Read more about this study
- Who is it for?
- Ages 15 to 27 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pre-Exposure Prophylaxis, HIV, Telemedicine
- What is being tested?
- PrEPTECH website and Online PrEP resource list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2022to 30 Jun 2023
- 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 15 to 27 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Live in the San Francisco Bay Area, CA (the 9-counties of Alameda, Contra Costa, Marin, Napa, San Mateo, Santa Clara, Solano, Sonoma, and San Francisco); Los Angeles County, CA; Miami-Dade County, FL; or Broward County, FL.
- Qualify for PrEP by virtue of self-reporting being diagnosed with a sexually transmitted infection (including chlamydia, genital herpes, gonorrhea, syphilis, genital warts, HPV, trichomoniasis, and other less common STIs) in the past six months or self-reporting unprotected anal intercourse in the past 90 days.
- Report having sex with men
- Either: Identify as a cisgender male and age 15-17 (in California only; minors in Broward or Miami-Dade Counties will not be eligible) OR identify as a cisgender male and age 18-27 OR identify as a transgender woman (or assigned male at birth and identify as a woman) and age 18-27
Who cannot join
- Must not have taken PrEP in the past 30 days
- Ever been diagnosed with HIV, hepatitis B, kidney disease, liver disease, or bone disease.
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PrEPTECH Phase 2 Study: Randomized-Controlled Trial of a Telehealth Intervention Delivering PrEP to Young Men Who Have Sex With Men and Transgender Women
PrEPTECH Phase 2 is a 2-arm randomized controlled trial to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender men and transgender women who have sex with men over six months. Participants (N = 400) will be randomized equally into one of two study conditions, treatment with a telehealth intervention called PrEPTECH or a control condition consisting of treatment as usual plus access to a listing of online and local PrEP resources, and assessed via surveys at baseline and at 90 and 180 days after baseline. Randomization of participants will be stratified by participant sub-group (adult men who have sex with men, adolescent men who have sex with men, and transgender women).
The baseline and follow-up assessments will include questions on demographic characteristics, measures related to our primary and secondary outcomes, and psychosocial measures. The primary outcomes measure is self-reported PrEP initiation at 3-month post enrollment, the percentage of participants reporting having taken at least one dose of PrEP medication by that time point. In addition, usage data and medical data will be collected and analyzed.
Read the detailed description
A 2-arm randomized controlled trial will be conducted to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender gay or bisexual men and transgender women over six months. PrEPTECH 2 is a follow-up to a pilot study of PrEPTECH undertaken in 25 adult men who have sex with men aged 18-25 years from the San Francisco Bay Area. In the pilot, PrEPTECH reached underserved populations, providing access to a pre-exposure prophylaxis (PrEP) regimen through a convenient telehealth system. The digital PrEPTECH 1 program provided digital PrEP education and resources to users, facilitated PrEP initiation and maintenance, simplified appointments needed to begin and maintain PrEP regimens through telemedicine appointments with physicians, eliminated the need for direct in-person follow-up with medical providers, provided a gay and bisexual male preferred telehealth method for accessing PrEP, offered personalized messaging to increase adherence and motivation for PrEP regimens, bypassed stigma and cost barriers for PrEP uptake in young men who have sex with men, and decreased the time required of clinicians managing PrEP patients. This follow-up study will extend our understanding of the PrEPTECH intervention and its capacity to increase PrEP uptake, adherence and maintenance, extending the populations served to include adolescent MSM ages 15-17 and transgender women.
In this phase 2 study, participants (N = 400) will be randomized equally into one of two study conditions, treatment with the PrEPTECH telehealth intervention or a control condition. Randomization of participants will be stratified by participant sub-group (adult men who have sex with men, adolescent men who have sex with men, and transgender women). Those in the treatment arm will have access to PrEPTECH for six months. PrEPTECH features includes a platform for connecting the participant with a prescribing physician providing free PrEP care, optional email or text message reminders, free home lab testing, and a supply of free PrEP (a 6 month supply for adolescent and transgender gender women participants and a 1 month supply for all other participants). Those in the control arm will be provided with a list of online resources about PrEP and how to locate and pay for PrEP care and contact information for a professional PrEP navigator at a local community-based organization partnering with the study. Participants will complete brief online surveys at baseline and at 90- and 180-days following baseline.
Participants will be recruited using a variety of methods, including through digital advertising on social media platforms and online dating/hook-up web sites and posting to community listservs, web sites offering resources on finding PrEP, and forums; community-based organizations partnering, that will assist with recruitment through social media and other online communication and in-person advertising with palm cards and flyers.
Randomization. Stratified randomization will be used to allocate participants. Participants will be stratified by study site and participant sub-group, ensuring that half of participants in each study site will be allocated to the PrEPTECH condition and half to the control condition and that the participants in each of the three study populations (adult YMSM, minors, and transgender women) will also be allocated equally to each of the two conditions.
Implementation. After randomization participants in the treatment group, will be granted access to the online PrEPTECH intervention, which includes a panel that sets-up text-message or email medication reminders, information about the intervention and PrEP, and a panel that guides the participant through the process of getting on PrEP: from ordering home lab testing, to completing a telehealth appointment with a study doctor, to ordering PrEP medication home delivery through an online pharmacy. Those in the control group will exclusively have access to a static web page offering links to online resources and information about local PrEP navigation resources available to them.
Data Collection. Participants will be surveyed at three time points: 1) prior to randomization (baseline) 2) 3 months (90 days) after enrollment 4) and 6 months (180 days) after enrollment. Surveys will be created on Qualtrics, hosted on the PrEPTECH web site, and taken online. All survey data will be transferred to SPSS for survey analysis. Data will also be collected through the app on usage of the web site. Additional study data will come from the lab tests collected prior to the first prescription being administered (hepatitis B, HIV, creatinine, serum creatinine and syphilis, gonorrhea, and chlamydia test) and roughly 90 days later (HIV, syphilis, gonorrhea and chlamydia).
- Conditions
- Pre-Exposure Prophylaxis, HIV, Telemedicine
- Being tested
- PrEPTECH website, Online PrEP resource list
- Keywords
- Randomized Controlled Trial, Online systems, Sexual and Gender Minorities, Transgender Persons, Adolescent, Sexual health
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPTECH websiteOther
The intervention is a web site delivering access to PrEP telehealth. The platform provides access to laboratory testing for PrEP eligibility delivered to a participant's home, telehealth care and PrEP prescriptions for those eligible delivered asynchronously through an online form for all adult participants and through telephone appointments for adolescent participants, and a mail-order pharmacy for PrEP. Additionally, free PrEP medication will be provided through the intervention. Transgender female and adolescent cisgender male participants will receive free PrEP medication (emtricitabine [200 mg]/tenofovir disoproxil fumarate [300 mg]) for the duration of their participation in the study, while adult cisgender male participants will receive a free 30-day supply of PrEP and subsequently have to pay for PrEP medication through insurance, patient assistance programs, or out of pocket.
Online PrEP resource listOther
Participants will receive access to an online list of web-based resources about PrEP and how to locate and pay for PrEP care and contact information for a professional PrEP navigator at a local community-based organization partnering with the study.
| Study group | Role | What they receive |
|---|---|---|
| PrEPTECH intervention recipients | Experimental | The intervention is a web site delivering access to PrEP telehealth. The platform provides access to laboratory testing for PrEP eligibility delivered to a participant's home, telehealth care and PrEP prescriptions for those eligible delivered asynchronously through an online form for all adult participants and through telephone appointments for adolescent participants, and a mail-order pharmacy for PrEP. Additionally, free PrEP medication will be provided through the intervention. Transgender female and adolescent cisgender male participants will receive free PrEP medication (emtricitabine [200 mg]/tenofovir disoproxil fumarate [300 mg]) for the duration of their participation in the study, while adult cisgender male participants will receive a free 30-day supply of PrEP and subsequently have to pay for PrEP medication through insurance, patient assistance programs, or out of pocket. Receives: Other: PrEPTECH website |
| Control resource-list only recipients | Active comparator | Participants will receive access to an online list of web-based resources about PrEP and how to locate and pay for PrEP care and contact information for a professional PrEP navigator at a local community-based organization partnering with the study. Receives: Other: Online PrEP resource list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported PrEP initiation
Percentage of participants reporting having taken at least one dose of PrEP medication at any point during the intervention period
Measured: 3 months post enrollment
Secondary outcomes (14)
Self-reported PrEP initiation
Percentage of participants reporting having taken at least one dose of PrEP medication at any point during the intervention period
Measured: 6 months post enrollment
Self-reported PrEP persistence
Percentage of participants reporting having taken at least one dose of PrEP medication during both the first and second 90-day periods of the intervention.
Measured: 3 months post enrollment and 6 months post enrollment
Self-reported PrEP adherence, continuous (3 months)
Excluding participants taking event-based PrEP, the count of doses of PrEP taken in the past 30 days.
Measured: 3 months post enrollment
Self-reported PrEP adherence, continuous (6 months)
Excluding participants taking event-based PrEP, the count of doses of PrEP taken in the past 30 days.
Measured: 6 months post enrollment
Self-reported PrEP adherence, categorical (3 months)
Excluding participants taking event-based PrEP, the percentage of participants who reported taking a dose of PrEP medication at least 4 days per week "All of the last 4 weeks (4 out of 4 weeks)" or "Most of the last 4 weeks (3 out of 4 weeks)"
Measured: 3 months
Self-reported PrEP adherence, categorical (6 months)
Excluding participants taking event-based PrEP, the percentage of participants who reported taking a dose of PrEP medication at least 4 days per week "All of the last 4 weeks (4 out of 4 weeks)" or "Most of the last 4 weeks (3 out of 4 weeks)"
Measured: 6 months
PrEP coverage at 3 months post-enrollment
Number of instances of vaginal or anal sex in which there was no protection from event-driven PrEP (defined as taking PrEP between 2 and 24 hours ahead of the sex act(s) and 2 more doses 24 and 48 hours after the first dose) or continuous PrEP (defined as taking a minimum of 4 doses of PrEP within a week of the sex act(s)), past 30 days
Measured: 3 months post enrollment
PrEP coverage at 6 months post-enrollment
Number of instances of vaginal or anal sex in which there was no protection from event-driven PrEP (defined as taking PrEP between 2 and 24 hours ahead of the sex act(s) and 2 more doses 24 and 48 hours after the first dose) or continuous PrEP (defined as taking a minimum of 4 doses of PrEP within a week of the sex act(s)), past 30 days
Measured: 6 months post enrollment
Self-reported PrEP medication prescription, self-reported
Percentage of participants reporting having received a PrEP prescription at any point during the intervention period
Measured: 3-months post enrollment and 6 months post enrollment
PrEP medication prescription, observed
Based on study records, percentage of participants who were issued a PrEP prescription through the study electronic health record at any point during the study period, amongst eligible intervention arm participants
Measured: 3-months post enrollment and 6 months post enrollment
System Usability Scale
Among intervention arm participants, score on the scale ranging from 0 to 40, the sum of scores on 10 items, with higher scores indicating better usability, a better outcome.
Measured: 6 months post enrollment
Reported likelihood of recommending PrEPTECH
Among intervention arm participants, percentage of participants reporting they "definitely" or "probably" would recommend PrEPTECH to a friend who wanted to start PrEP.
Measured: 6 months post enrollment
Reported interest in continuing in PrEPTECH beyond the study period
Among intervention arm participants, percentage of participants who would "definitely" or "probably" want to continue using PrEPTECH if given the chance to at the end of the intervention.
Measured: 6 months post enrollment
Transition to community care
Percentage of participants who are in the control group or opt to transition to community PrEP care during the course of the intervention who received a PrEP prescription in the past 90 days at 6-month post-enrollment
Measured: 6 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start12 Feb 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre-Exposure ProphylaxisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm randomized controlled trial with a one-to-one allocation ratio. Randomization will be stratified by sub-group (adult men who have sex with men ages 18-27 \[n = 320\], adult transgender women ages 18-27 \[n = 40\], and adolescent men who have sex with men ages 15-17 \[n = 40\]).
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- ETR Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Braun, DrPH, MPH, Principal investigator, ETR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902820
- Sponsor's protocol ID
- PrEPTECH2
- Acronym
- PrEPTECH2
- Status last verified
- Sep 2023
- First submitted
- 14 Apr 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Refugio ON, Kimble MM, Silva CL, Lykens JE, Bannister C, Klausner JD. Brief Report: PrEPTECH: A Telehealth-Based Initiation Program for HIV Pre-exposure Prophylaxis in Young Men of Color Who Have Sex With Men. A Pilot Study of Feasibility. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):40-45. doi: 10.1097/QAI.0000000000001873.
PubMed 30272632Erenrich RK, Braun RA, Torres-Mendoza DM, Stevenson OL, Doan TP, Klausner JD. Effectiveness of PrEPTECH: Findings From a 180-Day Randomized Controlled Trial of a Pre-Exposure Prophylaxis Telehealth Intervention. J Acquir Immune Defic Syndr. 2024 Apr 15;95(5):463-469. doi: 10.1097/QAI.0000000000003375. Epub 2024 Mar 11.
PubMed 38133600Braun RA, Erenrich RK, Coyle KK, Doan TP, Klausner JD. Effectiveness, Acceptability, and Feasibility of a Telehealth HIV Pre-Exposure Prophylaxis Care Intervention Among Young Cisgender Men and Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 15;12:e47932. doi: 10.2196/47932.
PubMed 37713244
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEPTECH Phase 2 Study: Randomized-Controlled Trial of a Telehealth Intervention Delivering PrEP to Young Men Who Have Sex With Men and Transgender Women
- ClinicalTrials.gov ID
- NCT04902820
- Acronym / sponsor ID
- PrEPTECH2 / PrEPTECH2
- Conditions
- Pre-Exposure Prophylaxis, HIV, Telemedicine
- Keywords
- Randomized Controlled Trial, Online systems, Sexual and Gender Minorities, Transgender Persons, Adolescent, Sexual health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- ETR AssociatesUniversity, hospital or other
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 May 2021 (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.
PrEPTECH Phase 2 is a 2-arm randomized controlled trial to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender men and transgender women who have sex with men over six months. Participants (N = 400) will be randomized equally into one of two study conditions, treatment with a telehealth intervention called PrEPTECH or a control condition consisting of treatment as usual plus access to a listing of online and local PrEP resources, and assessed via surveys at baseline and at 90 and 180 days after baseline. Randomization of participants will be stratified by participant sub-group (adult men who have sex with men, adolescent men who have sex with men, and transgender women).
The baseline and follow-up assessments will include questions on demographic characteristics, measures related to our primary and secondary outcomes, and psychosocial measures. The primary outcomes measure is self-reported PrEP initiation at 3-month post enrollment, the percentage of participants reporting having taken at least one dose of PrEP medication by that time point. In addition, usage data and medical data will be collected and analyzed.
Detailed description
A 2-arm randomized controlled trial will be conducted to assess the effectiveness of a telehealth intervention in increasing PrEP uptake among cisgender gay or bisexual men and transgender women over six months. PrEPTECH 2 is a follow-up to a pilot study of PrEPTECH undertaken in 25 adult men who have sex with men aged 18-25 years from the San Francisco Bay Area. In the pilot, PrEPTECH reached underserved populations, providing access to a pre-exposure prophylaxis (PrEP) regimen through a convenient telehealth system. The digital PrEPTECH 1 program provided digital PrEP education and resources to users, facilitated PrEP initiation and maintenance, simplified appointments needed to begin and maintain PrEP regimens through telemedicine appointments with physicians, eliminated the need for direct in-person follow-up with medical providers, provided a gay and bisexual male preferred telehealth method for accessing PrEP, offered personalized messaging to increase adherence and motivation for PrEP regimens, bypassed stigma and cost barriers for PrEP uptake in young men who have sex with men, and decreased the time required of clinicians managing PrEP patients. This follow-up study will extend our understanding of the PrEPTECH intervention and its capacity to increase PrEP uptake, adherence and maintenance, extending the populations served to include adolescent MSM ages 15-17 and transgender women.
In this phase 2 study, participants (N = 400) will be randomized equally into one of two study conditions, treatment with the PrEPTECH telehealth intervention or a control condition. Randomization of participants will be stratified by participant sub-group (adult men who have sex with men, adolescent men who have sex with men, and transgender women). Those in the treatment arm will have access to PrEPTECH for six months. PrEPTECH features includes a platform for connecting the participant with a prescribing physician providing free PrEP care, optional email or text message reminders, free home lab testing, and a supply of free PrEP (a 6 month supply for adolescent and transgender gender women participants and a 1 month supply for all other participants). Those in the control arm will be provided with a list of online resources about PrEP and how to locate and pay for PrEP care and contact information for a professional PrEP navigator at a local community-based organization partnering with the study. Participants will complete brief online surveys at baseline and at 90- and 180-days following baseline.
Participants will be recruited using a variety of methods, including through digital advertising on social media platforms and online dating/hook-up web sites and posting to community listservs, web sites offering resources on finding PrEP, and forums; community-based organizations partnering, that will assist with recruitment through social media and other online communication and in-person advertising with palm cards and flyers.
Randomization. Stratified randomization will be used to allocate participants. Participants will be stratified by study site and participant sub-group, ensuring that half of participants in each study site will be allocated to the PrEPTECH condition and half to the control condition and that the participants in each of the three study populations (adult YMSM, minors, and transgender women) will also be allocated equally to each of the two conditions.
Implementation. After randomization participants in the treatment group, will be granted access to the online PrEPTECH intervention, which includes a panel that sets-up text-message or email medication reminders, information about the intervention and PrEP, and a panel that guides the participant through the process of getting on PrEP: from ordering home lab testing, to completing a telehealth appointment with a study doctor, to ordering PrEP medication home delivery through an online pharmacy. Those in the control group will exclusively have access to a static web page offering links to online resources and information about local PrEP navigation resources available to them.
Data Collection. Participants will be surveyed at three time points: 1) prior to randomization (baseline) 2) 3 months (90 days) after enrollment 4) and 6 months (180 days) after enrollment. Surveys will be created on Qualtrics, hosted on the PrEPTECH web site, and taken online. All survey data will be transferred to SPSS for survey analysis. Data will also be collected through the app on usage of the web site. Additional study data will come from the lab tests collected prior to the first prescription being administered (hepatitis B, HIV, creatinine, serum creatinine and syphilis, gonorrhea, and chlamydia test) and roughly 90 days later (HIV, syphilis, gonorrhea and chlamydia).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm randomized controlled trial with a one-to-one allocation ratio. Randomization will be stratified by sub-group (adult men who have sex with men ages 18-27 [n = 320], adult transgender women ages 18-27 [n = 40], and adolescent men who have sex with men ages 15-17 [n = 40]).
| Arm | Type | Receives |
|---|---|---|
| PrEPTECH intervention recipients | Experimental | Other: PrEPTECH websiteThe intervention is a web site delivering access to PrEP telehealth. The platform provides access to laboratory testing for PrEP eligibility delivered to a participant's home, telehealth care and PrEP prescriptions for those eligible delivered asynchronously through an online form for all adult participants and through telephone appointments for adolescent participants, and a mail-order pharmacy for PrEP. Additionally, free PrEP medication will be provided through the intervention. Transgender female and adolescent cisgender male participants will receive free PrEP medication (emtricitabine [200 mg]/tenofovir disoproxil fumarate [300 mg]) for the duration of their participation in the study, while adult cisgender male participants will receive a free 30-day supply of PrEP and subsequently have to pay for PrEP medication through insurance, patient assistance programs, or out of pocket. |
| Control resource-list only recipients | Active comparator | Other: Online PrEP resource listParticipants will receive access to an online list of web-based resources about PrEP and how to locate and pay for PrEP care and contact information for a professional PrEP navigator at a local community-based organization partnering with the study. |
Who may qualify
- Ages
- 15 to 27 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Live in the San Francisco Bay Area, CA (the 9-counties of Alameda, Contra Costa, Marin, Napa, San Mateo, Santa Clara, Solano, Sonoma, and San Francisco); Los Angeles County, CA; Miami-Dade County, FL; or Broward County, FL.
- Qualify for PrEP by virtue of self-reporting being diagnosed with a sexually transmitted infection (including chlamydia, genital herpes, gonorrhea, syphilis, genital warts, HPV, trichomoniasis, and other less common STIs) in the past six months or self-reporting unprotected anal intercourse in the past 90 days.
- Report having sex with men
- Either: Identify as a cisgender male and age 15-17 (in California only; minors in Broward or Miami-Dade Counties will not be eligible) OR identify as a cisgender male and age 18-27 OR identify as a transgender woman (or assigned male at birth and identify as a woman) and age 18-27
Key exclusion criteria (3 listed)
- Must not have taken PrEP in the past 30 days
- Ever been diagnosed with HIV, hepatitis B, kidney disease, liver disease, or bone disease.
- Not meeting inclusion criteria
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 |
|---|---|---|
| PrEPTECH websiteThe intervention is a web site delivering access to PrEP telehealth. The platform provides access to laboratory testing for PrEP eligibility delivered to a participant's home, telehealth care and PrEP prescriptions for those eligible delivered asynchronously through an online form for all adult participants and through telephone appointments for adolescent participants, and a mail-order pharmacy for PrEP. Additionally, free PrEP medication will be provided through the intervention. Transgender female and adolescent cisgender male participants will receive free PrEP medication (emtricitabine [200 mg]/tenofovir disoproxil fumarate [300 mg]) for the duration of their participation in the study, while adult cisgender male participants will receive a free 30-day supply of PrEP and subsequently have to pay for PrEP medication through insurance, patient assistance programs, or out of pocket. | Other | PrEPTECH intervention recipients |
| Online PrEP resource listParticipants will receive access to an online list of web-based resources about PrEP and how to locate and pay for PrEP care and contact information for a professional PrEP navigator at a local community-based organization partnering with the study. | Other | Control resource-list only recipients |
Primary outcome
Self-reported PrEP initiation
Time frame: 3 months post enrollment
Percentage of participants reporting having taken at least one dose of PrEP medication at any point during the intervention period
14 secondary outcomes
Self-reported PrEP initiation
Time frame: 6 months post enrollment
Self-reported PrEP persistence
Time frame: 3 months post enrollment and 6 months post enrollment
Self-reported PrEP adherence, continuous (3 months)
Time frame: 3 months post enrollment
Self-reported PrEP adherence, continuous (6 months)
Time frame: 6 months post enrollment
Self-reported PrEP adherence, categorical (3 months)
Time frame: 3 months
Self-reported PrEP adherence, categorical (6 months)
Time frame: 6 months
PrEP coverage at 3 months post-enrollment
Time frame: 3 months post enrollment
PrEP coverage at 6 months post-enrollment
Time frame: 6 months post enrollment
Self-reported PrEP medication prescription, self-reported
Time frame: 3-months post enrollment and 6 months post enrollment
PrEP medication prescription, observed
Time frame: 3-months post enrollment and 6 months post enrollment
System Usability Scale
Time frame: 6 months post enrollment
Reported likelihood of recommending PrEPTECH
Time frame: 6 months post enrollment
Reported interest in continuing in PrEPTECH beyond the study period
Time frame: 6 months post enrollment
Transition to community care
Time frame: 6 months post enrollment
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 11 Sep 2023.
- Background: PubMed 30272632Refugio ON, Kimble MM, Silva CL, Lykens JE, Bannister C, Klausner JD. Brief Report: PrEPTECH: A Telehealth-Based Initiation Program for HIV Pre-exposure Prophylaxis in Young Men of Color Who Have Sex With Men. A Pilot Study of Feasibility. J Acquir Immune Defic Syndr. 2019 Jan 1;80(1):40-45. doi: 10.1097/QAI.0000000000001873.
- Derived from this study: PubMed 38133600Erenrich RK, Braun RA, Torres-Mendoza DM, Stevenson OL, Doan TP, Klausner JD. Effectiveness of PrEPTECH: Findings From a 180-Day Randomized Controlled Trial of a Pre-Exposure Prophylaxis Telehealth Intervention. J Acquir Immune Defic Syndr. 2024 Apr 15;95(5):463-469. doi: 10.1097/QAI.0000000000003375. Epub 2024 Mar 11.
- Derived from this study: PubMed 37713244Braun RA, Erenrich RK, Coyle KK, Doan TP, Klausner JD. Effectiveness, Acceptability, and Feasibility of a Telehealth HIV Pre-Exposure Prophylaxis Care Intervention Among Young Cisgender Men and Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Sep 15;12:e47932. doi: 10.2196/47932.
- 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.
Rebecca Braun, DrPH, MPH principal investigator
ETR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEPTECH website and Online PrEP resource list in people with Pre-Exposure Prophylaxis and HIV, run by ETR Associates 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 3 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 11 Sep 2023. 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 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?
Self-reported PrEP initiation (time frame: 3 months post enrollment). 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 NCT04902820, which also lists 3 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 11 Sep 2023.