Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05474313
Other study ID # 21-35533
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 8, 2022
Est. completion date December 2023

Study information

Verified date September 2022
Source Public Health Foundation Enterprises, Inc.
Contact Kenneth Coleman, MA
Phone 628-217-7443
Email kenneth.coleman@sfdph.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The PrEP 3D randomized controlled trial (RCT) will study the effectiveness of the PrEP-3D app compared to standard of care for starting pre-exposure prophylaxis (PrEP), continuing PrEP, and adherence to PrEP.


Description:

The investigators will be testing a pharmacist-led model of PrEP delivery combined with mobile app-based PrEP support developed by the investigator's team to improve PrEP initiation and persistence. Alto Pharmacy is a full-service online pharmacy already using mobile and web apps to communicate with patients, providers, laboratories, and insurers to provide timely medication delivery. Alto can provide PrEP prescriptions, order laboratory tests, and perform clinical referrals through a collaborative practice agreement (CPA) with SFDPH that allows transfer of these responsibilities. The investigators have integrated online tools with Alto Pharmacy's technology platform to create PrEP-3D: Digital Diary and Delivery, combining a tailored online support tool with the personalized service of a community pharmacy and the convenience of medication delivery. By removing the requirement for initiation and quarterly visits with a primary care physician for PrEP, the PrEP-3D model will expand access to PrEP visits (including for persons who choose not to go to their primary care provider for PrEP) and reduce burden on the health care system.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years or older - Assigned male at birth 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 - Owns a smartphone and has private access to the internet - Able to understand, read, and speak English or Spanish - Lives in California - Self-reported evidence of being at-risk for HIV acquisition, including at least one of the following in the past 6 months: - = 1 episode of anal/vaginal sex with a male or transgender female partner; - Diagnosed with a bacterial sexually transmitted infection (STI). - Interested in taking daily TDF/FTC or TAF/FTC PrEP - Willing and able to receive PrEP prescriptions through Alto Pharmacy (e.g., no specific pharmacy required by health plan, such as Kaiser HMO) - Creatinine clearance >30 mL/min - No contraindications to TDF/FTC or TAF/FTC use Exclusion Criteria: - Repeatedly reactive HIV test at screening or enrollment - Signs or symptoms of acute HIV infection at screening or enrollment - Currently enrolled in another HIV 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PrEP-3D package
A package of support tools for accessing, adhering to, and monitoring PrEP use, including Alto Pharmacy delivery services, PrEP-3D mobile app, and home laboratory testing.
Standard of Care
Participants are given local standard of care navigation for initiation of PrEP

Locations

Country Name City State
United States Alto Pharmacy San Francisco California
United States Bridge HIV, San Francisco Department of Public Health San Francisco California

Sponsors (3)

Lead Sponsor Collaborator
Public Health Foundation Enterprises, Inc. Alto Pharmacy, San Francisco Department of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effectiveness of PREP-3D on PREP use Measurement of PrEP adherence using dried blood spot measurements of tenofovir-diphosphate (TFV-DP) levels greater than or equal to 700 fmol/punch 12 months
See also
  Status Clinical Trial Phase
Completed NCT03411577 - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program N/A
Active, not recruiting NCT03112369 - Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use N/A
Not yet recruiting NCT03642314 - HIV Self-testing in Implementation PrEP Study N/A
Completed NCT01810315 - Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity Phase 1
Completed NCT00984971 - Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet Phase 1
Completed NCT00142935 - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1 N/A
Active, not recruiting NCT03255915 - PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study) Early Phase 1
Completed NCT05037513 - Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky N/A
Recruiting NCT05087680 - An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South N/A
Recruiting NCT05804461 - Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico N/A
Completed NCT03148171 - Project WERK (Wellness Encouragement Respect Kinship) N/A
Completed NCT04791007 - OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults Early Phase 1
Recruiting NCT05412433 - Clinic-based HIV Identification and Prevention Project Using Electronic Resources N/A
Active, not recruiting NCT03977181 - The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms N/A
Recruiting NCT05165745 - Stick2PrEP Cisgender Women and Trans Individuals N/A
Completed NCT03719053 - Single Dose Truvada Study Phase 1
Recruiting NCT03856580 - Long-acting Biomedical HIV Prevention in Transgender Women N/A
Completed NCT02750540 - Optimization of a Tenofovir Enema for HIV Prevention Phase 1
Completed NCT01386294 - Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection Phase 3
Completed NCT00993811 - The Shang Ring: A Novel Male Circumcision Device for HIV Prevention Phase 1