HIV-1-infection
Conditions
Brief summary
This is a pilot study to assess the feasibility, acceptability, and preliminary effectiveness of pre-exposure prophylaxis (PrEP)smart among cisgender sexual minority males (SMM) taking on-demand PrEP over a 6-month period. Upon project completion, the investigators will have developed a highly innovative tool to support men who have sex with men (MSM) using on-demand PrEP ready for testing in a larger efficacy trial
Detailed description
This study is designed to enroll a diverse population of English-speaking cisgender sexual minority males (SMM) in the United States. The study team will enroll up to 60 participants who are taking or are interested in taking on-demand pre-exposure prophylaxis (PrEP). Participants will be randomized 2:1 to receive (intervention arm) or not receive (control arm) the PrEPsmart app at enrollment. Participants will complete follow-up visits at 3 and 6 months. Participants newly starting 2-1-1 PrEP will be seen at the Bridge HIV clinic (prescribed group), while those already on PrEP may be seen at the clinic or complete visits virtually (non-prescribed group). Although no restrictions are put on the racial/ethnic make-up of the study participants, the site will strive to enroll at least 50% African American or Latino SMM into this study. The study will also strive to enroll at least 30% of participants who are newly starting or restarting 2-1-1 PrEP. Upon project completion, the study team will have developed a highly innovative tool to support men who have sex with men (MSM) using on-demand PrEP ready for testing in a larger efficacy trial.
Interventions
DEVICEPrEPsmart mobile app
The PrEPsmart mobile app is an innovative and comprehensive app to support sexual minority men (SMM) using on-demand pre-exposure prophylaxis (PrEP) or daily PrEP. The PrEPsmart app consists of the following components: 1. PrEP 211 dosing/sex diary and reminders 2. Feedback on PrEP protection levels 3. Quick tips 4. Bi-directional secure messaging
DRUGTruvada
Combination medication used in Human immunodeficiency virus (HIV) prevention, it blocks virus pathways to infection.
Sponsors
Gilead Sciences
Public Health Foundation Enterprises, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants will be randomized in a 2:1 ratio to the intervention (N=40) or control (N=20) conditions, using randomly-permuted blocks of randomly selected sizes 2 and 4, stratified by PrEP status (prescribed, non-prescribed). The randomization scheme will be generated and archived by the study statistician and implemented in RedCap.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older * Cisgender-male who reports sex with persons assigned male at birth * Willing and able to provide written informed consent * HIV-uninfected by negative 4th generation HIV test during screening (prescribed group) * Documentation of negative HIV test within the last 3 months by outside laboratory OR evidence of PrEP prescription within the last 6 months based on medical records or pharmacy/provider communication * Owns an iOS or Android mobile phone with a camera and has private access to the internet * Able to understand, read, and speak English * Able to attend study visits at a local research site in San Francisco (Bridge HIV) (prescribed and non-prescribed groups) or virtual visits via a HIPAA-compliant teleconferencing platform (non-prescribed group) * Interested in starting or currently taking on-demand PrEP with TDF/FTC * Report having anal sex at least once a month and expecting to maintain at least this frequency of anal sex during study participation by self-report * Creatinine clearance ≥60 mL/min based on testing done during screening (prescribed group) * Have PrEP clinical and laboratory monitoring by another provider or clinic by self-report (non-prescribed group) * No contraindications to TDF/FTC use * No evidence of chronic HBV infection based on testing done during screening (prescribed group) * Willing to self-collect urine samples weekly
Exclusion criteria
* Repeatedly reactive HIV test at screening or enrollment or self-reported reactive HIV test (prescribed group) * Signs or symptoms of acute HIV infection at screening or enrollment * Currently enrolled in another PrEP intervention study. * Unable to commit to study participation for the duration of the study * Any medical, psychiatric, or social condition or other responsibilities that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the PrEPsmart mobile app | 6 months | Acceptability will be measured using the Client Satisfaction Questionnaire (CSQ-8) adapted for use in PrEPsmart pilot. The study team will also assess interest in future use of the app at study completion. |
| Usability of the PrEPsmart mobile app | 6 months | Usability will be measured using the System Usability Scale (SUS) adapted for use in PrEPsmart pilot. A score \>50 (out of 100) on the SUS indicates the app is acceptable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To compare PrEP coverage of sex acts as measured by weekly urine tenofovir test strips among SMM in the PrEPsmart vs. control arms | 6 months | PrEP coverage will be primarily defined as self-reported sex acts in which the participant reported at least one pill taken within 24 hours before sex and one pill taken within 24 hours after sex, as defined in the Ipergay study. Additionally, the study team will conduct an analysis in which weekly PrEP dosing is confirmed by having a detectable TFV urine test within 7 days of reported sex. |
| To compare switching of PrEP regimens among SMM in the PrEPsmart vs. control arms | 6 months | The proportion of participants who switch from on-demand PrEP to daily PrEP (or another regimen, e.g. injectable PrEP) will be calculated and compared between arms using chi-square tests. |
| To compare rates of PrEP discontinuation among SMM in the PrEPsmart vs. control arm | 6 months | PrEP discontinuation and retention rates will be calculated, with 95% binomial confidence intervals, and compared between arms using log-binomial models. The study team will also estimate and compare time to discontinuation using Kaplan Meier methods and the log-rank test, accounting for censoring by end of study or dropout. |
| Elicit feedback on areas for improvement for PrEPsmart to guide further app refinement | 6 months | Ideas for improvement of PrEPsmart elicited through exit interviews will be tabulated, discussed with the protocol team, and prioritized for development. |
Countries
United States
Contacts
Primary ContactJuwann Moss
Outcome results
None listed