HIV Prevention Clinical Trial
Official title:
A Pharmacist-run, Community-based PrEP Program for High-risk women-the OPTIMIZE Study
The primary objective of this study is to evaluate uptake and retention of long acting cabotegravir (LA-CAB) also known as Apretude versus daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) also known as Truvada for PrEP among high-risk women in metro-Orlando through week 48 (to also include reasons for lack of retention in PrEP care)
This is a 48-week, open-label, single center pharmacist-run study to assess PrEP uptake and persistence among women at high-risk of HIV-1 acquisition in metro-Orlando at a community-based organization called Let's Beehive. All participants in the study will chose whether they want to start IM LA-CAB (with or without the oral lead-in) vs. daily oral TDF/FTC for PrEP. The study will include a Screening Phase (up to 56 days), and an open-label phase (Day 1 up to Week 48). Approximately 50 women defined as "high-risk" for HIV-1 infection who have a confirmed negative HIV test will be enrolled. All insured participants will be responsible for using their insurance plan to obtain coverage for their chosen PrEP medication, in addition to any labs required by the study. This expectation is clearly outlined in the informed consent. The study team will work with participants to minimize their co-pays for study medications and labs through the use of manufacturer and other external assistance programs. For participants who are under-or-uninsured, the study sponsor will provide financial coverage for approximately 20 participants (10 on LA-CAB and 10 on TDF/FTC) to receive PrEP medication and undergo study-required laboratory testing at no cost. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03411577 -
Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program
|
N/A | |
| 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 | |
| Active, not recruiting |
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 | |
| Active, not recruiting |
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 |