Abstract
Background:
In the United States, young men who have sex with men (YMSM) of color represent a high number of new human immunodeficiency virus (HIV) diagnoses annually. HIV pre-exposure prophylaxis (PrEP) is effective and acceptable to YMSM of color, yet PrEP uptake is low in those communities due to barriers including stigma, cost, adherence concerns, and medical distrust. A telehealth-based approach to PrEP initiation may be a solution to those barriers. This pilot study investigates one such intervention called PrEPTECH.
Methods:
We enrolled 25 HIV-uninfected YMSM, aged 18–25 years, from the San Francisco Bay Area into a 180-day longitudinal study between November 2016 and May 2017. Participants received cost-free PrEP services via telehealth (e.g., telemedicine visits, home delivery of Truvada® and sexually transmitted infection [STI] testing kits), except for two laboratory visits. Online survey assessments querying PrEPTECH features and experiences were administered to participants at 90- and 180-days.
Results:
Eighty-four percent of participants were YMSM of color. Among the 21 who completed the study, 11 of the 16 who wanted to continue PrEP were transitioned to sustainable PrEP providers. At least 75% felt that PrEPTECH was confidential, fast, convenient, and easy to use. Less than 15% personally experienced PrEP stigma during the study. The median time to PrEP initiation was 46 days. STI positivity was 20% and 19% at baseline and 90-days respectively. No HIV infections were detected.
Conclusions:
Telehealth programs like PrEPTECH increase PrEP access for YMSM of color by eliminating barriers inherent in traditional clinic-based models.
Keywords: telehealth, HIV, pre-exposure prophylaxis (PrEP), young MSM of color
INTRODUCTION
In the United States, men who have sex with men (MSM) accounted for two-thirds of the approximate forty thousand new human immunodeficiency virus (HIV) diagnoses in 2016; of those, 72% were non-white.1 Among those new HIV diagnoses in non-white MSM, about 30% were 15 to 24 years old.1 Those numbers emphasize the importance of HIV prevention efforts, like pre-exposure prophylaxis (PrEP), that reach young men who have sex with men (YMSM) of color.
Barriers to PrEP initiation among YMSM of color include cost, access, the need for regular clinic visits, stigma, daily adherence, side effect concerns, and medical distrust.2–7 Interventions to increase PrEP access among YMSM of color are lacking; telehealth-based approaches can potentially fill that gap and circumvent those barriers.
The U.S. Health Resources and Services Administration defines telehealth as “the use of electronic information and telecommunications technologies to support long-distance clinical health care, patient and professional health-related education, public health and health administration”.8 Telehealth has been implemented in multiple fields including HIV care and prevention.9,10 Telehealth-based HIV prevention services are acceptable and may actually be preferred by YMSM of color.11–13
Few telehealth-based PrEP providers exist. Examples of for-profit, commercially-available entities are Nurx (nurx.com) and PlushCare (plushcare.com). Public, state-funded telehealth PrEP programs include the Washington’s Gay City Health Project14 in Seattle and Iowa’s TelePrEP program (prepiowa.org/teleprep); prior to this study, none existed in California.
This pilot study investigated the feasibility of PrEPTECH, an intervention that uses telehealth to initiate and deliver PrEP medication, as well as promote PrEP adherence.
METHODS
Recruitment
Participants were recruited through convenience sampling; the study was advertised on Grindr, posters and flyers at gay venues in the San Francisco Bay area, and through word of mouth. The advertisements were designed and marketed to YMSM of color with a goal of recruiting >60% racial/ethnic minority (i.e., not self-identifying as non-Hispanic/White) participants. Participants were incentivized with gift cards: $25 at baseline and 90-days, and $35 at 180-days.
Materials
Study website
The mobile-friendly study website (preptechyth.org) used a secure HIPAA-compliant Paubox© (San Francisco, CA) server and DLP encryption web portal. A multidisciplinary team from Youth+Tech+Health developed the website prototype using an evidence-based, youth-centered approach. Six YMSM of color formed the Community Advisory Board that provided input during the development and usability-testing phase, and determined community acceptability and feasibility. The final website features included a GPS laboratory locator, automated medication and sexually transmitted infection (STI) kit delivery, customizable daily PrEP reminders via text message and/or e-mail, and automated appointment reminders.
Procedures
Data was collected at baseline, 30-, 90-, and 180-days. All procedures were streamlined via telehealth except for two laboratory visits.
Enrollment
Twenty-five participants were enrolled between November 2016 and May 2017. Any visitor of the website was able to create a password-protected account and complete the online inclusion criteria screening survey. The inclusion criteria were the following: cisgender MSM, 18–25 years old, HIV-uninfected, San Francisco Bay Area county resident, English-speaking, smartphone access, and not taking Truvada®. Written consent was obtained remotely upon meeting inclusion criteria and successfully completing an online PrEP knowledge quiz.
STI testing
Following consent, an STI kit from Quest Diagnostics™ was home-delivered by mail to participants at baseline and 90-days. The kit contained swabs and instructions for self-collection of pharyngeal and rectal specimens for Neisseria gonorrhea (NG) and Chlamydia trachomatis (CT) testing.
Laboratory visits
Electronic lab orders with the participants’ information were sent to Quest Diagnostics™. Participants were mailed a corresponding receipt to bring to a Quest™ laboratory along with the completed STI kit. STI specimens were analyzed using the APTIMA® COMBO2 Assay (Hologic Inc., San Diego, CA). Blood was drawn for additional tests including: 4th generation HIV-1/2 antigen and antibody testing, rapid plasma reagin with reflex fluorescent treponemal antibody absorption testing for Treponema pallidum, Hepatitis B surface antigen (at baseline only), and creatinine. Those with positive lab results for medical contraindications to Truvada® were excluded from the study. Labs were repeated at 90-days to determine continuing PrEP eligibility.
PrEP medication
After PrEP contraindications were ruled out, a free 3-month supply of Truvada® was home-delivered to each participant at baseline and 90-days.
Telehealth visits
An infectious diseases physician conducted telehealth visits via telephone at baseline, 30-, 90-, and 180-days to review lab results and gather information regarding medical history, sexual behaviors, and PrEP adherence. Counseling was provided for incident STIs, as well as treatment referral and verification.
Feedback surveys
At 90- and 180-days, participants completed an online feedback survey. Using a 5-point Likert scale, participants assessed: helpfulness of PrEPTECH features; confidentiality; ease of use; convenience of PrEPTECH; and trust in the study team. The survey also queried PrEP adherence and stigma.
Locating a post-study PrEP source
During the final month of each participant’s study period, the study coordinators followed case management best practices and navigated participants to a local, free or low-cost PrEP source using pleaseprepme.org and community organization referrals.
Data analysis
Data and descriptive analyses were conducted using an excel spreadsheet. Frequencies and percentages were reported for categorical and ordinal variables. Medians and ranges were reported for discrete variables.
Human subjects
Human subjects review was performed by the Quorum Review© (Seattle, WA) and University of California Los Angeles institutional review boards.
RESULTS
Enrollment and retention
Figure 1 illustrates the outcomes of the 401 individuals who created an online PrEPTECH account, including the 25 enrolled participants.
Figure 1.
Flow chart tracking the outcomes of all individuals who created an online PrEPTECH account between November 2016 and May 2016, including the 25 participants enrolled into the PrEPTECH pilot study.
Participant characteristics and laboratory results
Participant demographics, medical and sexual history, and lab results are displayed in Table 1.
Table 1.
Baseline demographics, baseline medical and sexual history, and baseline and 90-day sexually transmitted infection results of the 25 participants enrolled in the PrEPTECH study.
| Baseline demographics | n (%) or median (range) | ||
|---|---|---|---|
| Age in years | 22 (18, 25) | ||
| Race/ethnicity | |||
| Hispanic or Latino | 10 (40%) | ||
| Asian or Pacific Islander | 8 (32%) | ||
| Non-Hispanic/White or Caucasian | 4 (16%) | ||
| Black or African-American | 2 (8%) | ||
| Middle Eastern | 1 (4%) | ||
| County of residence | |||
| San Francisco | 13 (52%) | ||
| Alameda | 6 (24%) | ||
| Contra Costa | 4 (16%) | ||
| Santa Clara | 2 (8%) | ||
| Health insurance status | |||
| Insured | 20 (80%) | ||
| Not insured | 1 (4%) | ||
| Dropped from study prior to obtaining status | 4 (16%) | ||
| Source of study referral | |||
| Grindr advertisement | 14 (56%) | ||
| Word of mouth | 6 (24%) | ||
| Poster/Flyer | 3 (12%) | ||
| Internet search | 1 (4%) | ||
| Not specified | 1 (4%) | ||
| Reasons for wanting to initiate PrEP through PrEPTECH* | |||
| Extra protection/”safer” sex | 17 (68%) | ||
| Multiple sex partners | 4 (16%) | ||
| Other reason+ | 4 (16%) | ||
| PrEP not covered by insurance or no insurance | 2 (8%) | ||
| Baseline medical and sexual history | n/N (%) | ||
| Diagnosed medical condition(s) | 7/25 (28%) | ||
| Diagnosed psychiatric condition(s) | 4/25 (16%) | ||
| Taking prescribed medication(s) | 7/25 (28%) | ||
| Current substance abuse | 0/25 (0%) | ||
| Male sex partners only | 21/25 (84%) | ||
| Engaged in condomless receptive anal sex in the past 30 days | 5/25 (20%) | ||
| History of sexually transmitted infection (STI) | 8/25 (32%) | ||
| STI positivity | Baseline n/N (%) |
90-Days n/N (%) |
|
| HIV | 0/25 (0%) | 0/21 (0%) | |
| Any bacterial STI | 5/25 (20%) | 4/21 (19.0%) | |
| Syphilis** | 3/25(12%) | 2/21 (9.5%) | |
| Rectal NG/CT | 2/24 (8.4%) | 3/20 (15.0%) | |
| Pharyngeal NG/CT | 0/23 (0%) | 0/21 (0%) | |
| Hepatitis B++ | 0/25 (0%) | -- | |
Participants were able to report or choose multiple responses so frequencies may not sum to N.
n=1 for each of the following reasons: current primary care doctor is not helpful/does not want to discuss PrEP, curious about PrEP, recommended by clinic, to help with study.
Syphilis positivity at baseline was defined as a positive rapid plasma reagin (RPR) test with a confirmatory positive fluorescent treponemal antibody absorption test and no history of syphilis; for 90-day syphilis positivity, same definition as baseline or previously confirmed syphilis with a four-fold increase in RPR titer.
Hepatitis B positivity was defined as detectable Hepatitis B surface antigen.
NG = Neisseria gonorrhea.
CT = Chlamydia trachomatis.
History of STI = syphilis, NG, CT, and/or herpes.
Any bacterial STI = positive syphilis, NG, and/or CT.
Experiences with PrEPTECH
At least two-thirds of participants agreed that they felt uncomfortable going to a doctor’s office/clinic for PrEP at 90-days (66.7%) and 180-days (72.2%). The majority (≥85%) agreed that PrEPTECH is a better way for gay/bisexual men to get PrEP at 90- and 180-days. At least 88% reported that PrEPTECH was very or extremely easy to use at 90- and 180-days. All participants reported that PrEPTECH was very or extremely fast and convenient compared to other forms of getting on PrEP at 90- and 180-days. More than three-quarters of participants felt that PrEPTECH was very or extremely confidential and agreed that they would still use PrEPTECH even if the services were not free at 90- and 180-days. When asked how much they trusted the PrEPTECH team at 90- and 180-days, the vast majority (≥85%) responded with “extremely” or “very”.
PrEP stigma
About half had heard of others being stigmatized for taking PrEP; 52.4% (11/21) at 90-days and 50% (9/18) at 180-days. In comparison, only a minority personally experienced PrEP stigma, 14.3% (3/21) by 90-days and 10.5% (2/19) by 180-days. Among those who experienced stigma, two indicated that the gay community was a source. Healthcare providers, family, friends, and strangers were each cited as other sources by another participant.
Time to PrEP initiation
The median number of total days from completing the online eligibility survey to the first shipment of Truvada® was 46 days (range 21 to 133).
DISCUSSION
We created and implemented a novel telehealth program to help YMSM of color initiate PrEP, with the goal of identifying a sustainable PrEP provider to which they could transition to after the study.
Participants
PrEPTECH served YMSM of color from the San Francisco Bay area, exceeding its goal of recruiting >60% racial/ethnic minority participants. The majority were Latino or Asian/Pacific Islander, however, only 8% of participants were Black/African-American; a percentage that reflects the San Francisco Bay area population.15 At baseline, most participants reported high-risk sexual behaviors, were relatively healthy, and would not otherwise have to regularly seek medical care. For those with little to no opportunity to discuss PrEP with their physicians, the burden is placed on the patient to seek PrEP; this is one PrEP barrier for YMSM.
Barriers mitigated by PrEPTECH
Cost and access
PrEPTECH successfully functioned as an initiation program that temporarily provided free PrEP services. The majority of our participants had health insurance, which was found to be associated with PrEP use in previous studies.16 Those who are uninsured may not know where or how to access affordable PrEP. Even if insured, otherwise healthy YMSM may not know how to navigate their insurance, discover if their insurance covers PrEP, and if so, how to identify and ask providers who are willing to prescribe it—this is where PrEPTECH intervened.
Convenience and speed
The telehealth-based design allowed participants to bypass clinic and pharmacy visits. Having to regularly attend provider visits to start and continue using PrEP can be daunting for relatively healthy YMSM who may have unpredictable schedules and/or unreliable transportation. The majority agreed that PrEPTECH, compared to other methods of accessing PrEP, was easy to use, fast, and convenient. In an observational study conducted with 192 Black YMSM, the median time to PrEP initiation was 4 months using a traditional, clinic-based model.17 For our study, the median time to PrEP initiation was approximately 1.5 months, almost 2.5 months faster compared to the study by Rolle and colleagues. Getting high-risk YMSM of color quickly started on PrEP shortens the window of time for potential HIV transmission.
PrEP stigma
PrEP users face stigma from multiple sources, often stemming from assumptions of increased risk-taking behaviors while on PrEP.18,19 About half of our participants had heard about others experiencing PrEP stigma, which is a major barrier to PrEP access, especially if patients perceive that their providers are not willing to prescribe PrEP. More than half of the participants felt uncomfortable going to a doctor’s office or clinic for PrEP. PrEPTECH abated stigma by having a team that was knowledgeable about PrEP and health issues affecting YMSM. In addition, PrEPTECH secured the trust and preference of participants; a sentiment reflected in the high percentage agreeing that PrEPTECH was confidential, trustworthy, and preferred over other means of obtaining PrEP. The provider visits via telephone rather than videoconference allowed for more anonymity.
Limitations
Since this was intended as a pilot study of feasibility, we enrolled a small cohort of 25 participants, of which 4 were lost to follow-up. Participants were followed for only 6 months because this program was designed as a short-term PrEP initiation service.
Because participants were self-selected, they likely had some prior awareness of PrEP and degree of trust in its effectiveness. PrEPTECH does not address barriers to PrEP awareness among YMSM of color. Without interventions that promote PrEP awareness and education in that population, PrEPTECH may not be able to fully reach YMSM of color.
Participation bias cannot be ascertained since no data besides inclusion criteria was collected from the 376 individuals who created a PrEPTECH account but did not complete the successive steps necessary for enrollment.
Future directions
PrEPTECH provides unique services that differ from the few other telehealth-based PrEP programs, including customizable daily reminders and online education.14 The perceived utility and feasibility of each PrEPTECH feature should be ascertained to establish a framework for future telehealth PrEP interventions. A cost-analysis is needed to determine PrEPTECH’s cost-effectiveness if implemented on a larger scale, and if perhaps it can become a sustainable, fully telehealth-based PrEP provider. The total cost of starting PrEP for the first year—which includes medications, labs, and professional services—is upwards of 17,000 U.S. dollars.20 Theoretically, a telehealth-based PrEP program compared to one that is clinic-based would incur unique costs from website maintenance, online professional staff services, and the shipment and delivery of medication and STI kits, but could drastically cut costs for clinic space, staff salaries, and other operational needs.
Finally, insurance coverage determines the burden of cost on the PrEP user. Plans to enhance PrEPTECH by incorporating insurance services and referrals for financial assistance for PrEP are being developed. Since U.S. laws that govern telehealth practice vary by state, PrEPTECH may be expanded, but limited to states with similar telehealth laws as California. In California, only patient consent is required in order to receive PrEP via telehealth by a state-licensed provider, but an in-person physical examination is not mandatory.21 Furthermore, some payers may require video conferencing for physician reimbursement for telehealth services. However, we believe that telephone visits for low risk interventions like PrEP should be reimbursable.
Summary
This study demonstrated that a telehealth-based PrEP initiation program can reach YMSM of color, quickly and conveniently start users on PrEP, and transition participants to a sustainable PrEP provider. Larger studies are needed to corroborate our findings, particularly in areas with a higher proportion of YMSM of color, especially Black and Latino.
Acknowledgements
The authors of this manuscript have no conflicts of interest to disclose. This work was supported by Gilead Sciences, Inc., and the National Institutes of Health (grant numbers AI028697, P30MH058107).
This work was supported by Gilead Sciences, Inc., and the National Institutes of Health (grant numbers AI028697, P30MH058107).
Footnotes
Conflicts of Interest and Source of Funding: The authors of this manuscript have no conflicts of interest to disclose.
Contributor Information
Oliver N. Refugio, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA
Mabel M. Kimble, Division of Infectious Diseases, Department of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
Cara L. Silva, YTH (Youth + Tech + Health), San Francisco, CA, USA
James E. Lykens, San Francisco State University, Center for Research and Education on Gender and Sexuality, San Francisco, CA, USA
Christian Bannister, YTH (Youth + Tech + Health), San Francisco, CA, USA
Jeffrey D. Klausner, Division of Infectious Diseases, Department of Medicine, University of California Los Angeles, Los Angeles CA, USA
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