HIV Prevention Clinical Trial
Official title:
Hybrid Evaluation of the Implementation and Effectiveness of Home-based HIV Pre-exposure Prophylaxis Monitoring in King County, Washington
The study's aim is to implement a home-based PrEP (HB-PrEP) monitoring system (self-collected blood and extragenital specimens at home and telehealth follow-up) into a large, urban sexual health clinic while also evaluating the program's clinical effectiveness. Study participants will self-collect blood specimens using Tasso devices, which are currently designated as FDA Class 2 exempt medical devices (similar to a medical lancet). This study will be integrated into King County's Ending the HIV Epidemic plan and generate data to inform refinement, adaptation and scale-up of future HB-PrEP programs. Specific research aims are to: 1. Conduct a hybrid randomized trial to compare the impact of a HB-PrEP program versus standard of care (routine in-clinic monitoring) on PrEP retention over time and use mixed-methods assessments to define the factors that influence HB-PrEP implementation. Hypothesis: HB-PrEP will increase PrEP retention rates by >10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits. 2. Perform a cost analysis of the HB-PrEP implementation strategy compared to standard care. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC. 3. Develop a qualitative tool to engage healthcare stakeholders and determine the wider scalability of HB-PrEP.
Pre-exposure prophylaxis (PrEP) is an established and effective method for HIV prevention, but lack of access to PrEP providers and the burden of quarterly monitoring visits remain barriers to PrEP uptake and retention, particularly for people of color and younger men who have sex with men (MSM). Home-based PrEP (HB-PrEP) monitoring could unburden medical systems and increase PrEP access, but whether this remote care option improves key clinical outcomes like PrEP retention is not known. The study's specific aims are to: - AIM 1: Evaluate the impact of HB-PrEP on PrEP retention and define the factors that influence HB-PrEP implementation. The investigators will conduct a type 1 hybrid randomized controlled trial comparing HB-PrEP as an implementation strategy (self-collected lab specimens from home and telehealth follow-up) to standard of care (SOC) at the Public Health-Seattle & King County (PHSKC) Sexual Health Clinic (SHC). The study's primary outcome will be effectiveness of the implementation strategy measured as the rate of retention in PrEP care. In secondary analyses, investigators will utilize mixed methods to assess reach (proportion of persons offered HB-PrEP who choose to use it), and examine individual-level barriers and facilitators (B&F) to PrEP retention (participant surveys and interviews) and system-level B&F to HB-PrEP implementation (participant surveys and interviews, PHSKC staff interviews). Hypothesis: HB-PrEP will increase PrEP retention rates by >10% at 18 months and 60% of those offered HB-PrEP will use it for over half of visits. - AIM 2: Perform a cost analysis of HB-PrEP service implementation at the PHSKC SHC compared to SOC. Investigators will track resource use and prospectively collect unit costs for laboratory fees, healthcare worker time and other clinic resources to estimate the total monthly cost of providing HB-PrEP services overall and the monthly cost per person retained in PrEP care in the HB-PrEP and SOC arms. Hypothesis: HB-PrEP cost will fall within the HIV prevention budget and be affordable with comparable costs to SOC. - AIM 3: Conduct a HB-PrEP scale-up assessment with healthcare organizations (HCO) and other key stakeholders to determine the scalability of HB-PrEP within Washington State. To evaluate institution-level factors that may impede or facilitate statewide HB-PrEP scale-up, investigators will conduct semi-structured interviews with key stakeholders from a countywide EHE HCO collaborative. The Aim 1 study is a pragmatic, non-blinded, hybrid type 1 (clinical-implementation) RCT and includes mixed-methods assessments to evaluate both qualitative and quantitative data for the primary and secondary outcomes. Aim 3 is a qualitative study using in-depth interviews. ;
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 |