An interventional study of Intervention Group in HIV/AIDS, sponsored by Michael Ohl. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by Michael Ohl · Not applicable, Interventional, and Prevention
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Among 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States — 111 open to participants now, 153 under way, 9 of them phase 3. Acquired Immunodeficiency Syndrome · United States.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, this one is the 300th largest by enrollment of the 1,290 interventional ones that give a count, is one of 68 that started in 2018, is one of 642 with no phase, and was the 1,220th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →111 of the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States are open now. Recruiting first, the newest first:
Nicky Mehtani, MD, MPH · Sites in United States
Ages 25–64
Columbia University · Sites in United States
Ages 18+ · Healthy volunteers
BioNTech SE · Sites in United States, South Africa
Ages 18–50 · Healthy volunteers
CAN Community Health · Sites in United States
Ages 18+
ViiV Healthcare · Sites in United States
Ages 18–55 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,670 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 384 · Phase 2 258 · Phase 3 156 · Phase 4 81
First in 1981; this study’s year is marked. 68 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 234 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 60 across the 1,290 interventional studies, 154 across the 195 observational. Of the 1,449 that completed or were terminated, 355 (24%) have results posted.
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510 of 1,670 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Michael Ohl as lead sponsor.
Michael Ohl has 1 study filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
56 of the studies in Acquired Immunodeficiency Syndrome with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04176172Phase 3Abramson Cancer Center at Penn MedicineOptimizing Tobacco Use Treatment for PLWHA | 2026-11-30 |
| NCT04958122Phase 3University of Southern CaliforniaCefixime Clinical Trial | 2027-01-01 |
| NCT07044297Phase 3Merck Sharp & Dohme LLCA Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) | 2027-07-22 |
| NCT04833829Emory UniversityCross-disciplinary HIV Integrated Mental Health Support Intervention | 2026-11 |
| NCT05159466Tulane UniversityTulane Abdominal Transplant Institute (TATI) of Solid Organ Transplantation of HIV-Positive Recipients From HIV-Positive Donors | 2026-11 |
Add all 56 to your calendar (.ics) → With an account.
Among the 1,670 studies in Acquired Immunodeficiency Syndrome with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this research study is to evaluate the preliminary impact of a public-health-partnered tele-pharmacist model for pre-exposure prophylaxis (PrEP) delivery in a rural state ("TelePrEP"). In brief, PrEP involves daily use of a medication (i.e. Truvada) to prevent HIV infection among people at risk for infection due to sexual exposure or needle sharing. In this study, PrEP eligible rural and small urban-dwelling public health clients wil be enrolled in a prospective study to follow their progression through PrEP care following public health referrals. The study will involve a baseline survey to gather data on participant beliefs and attitudes about PrEP and a follow up telephone survey 30-40 days later to ascertain whether participants have engaged in PrEP. Medical records will be requested as a second method to determine whether participants have started PrEP and whether they are still using PrEP after six months. The hypotheses that PrEP initiation and retention are higher in regions with TelePrEP programs will be tested against control regions.
The Iowa Department of Public Health (IDPH) and The University of Iowa (UI) have collaborated to develop a public-health-partnered tele-pharmacist model that meets these needs ("TelePrEP"). TelePrEP was developed and piloted as a quality improvement program and uses only standard of care interventions (e.g. PrEP) and routinely applied healthcare delivery strategies (e.g. telemedicine, pharmacist collaborative practice models). In overview, TelePrEP begins by systematically identifying clients with PrEP indications in county public health clinics and affiliated sexually-transmitted disease (STD) programs serving rural and small urban communities in Iowa. Public health personnel then refer clients with PrEP indications to a tele-pharmacist service at UIHC that uses mobile video visits, locally-obtained laboratory studies, and medication delivery by mail to provide PrEP, without requiring in-person provider visits. The overall goal is to improve PrEP access and engagement in rural and small urban areas by systematically identifying high risk-individuals in public health programs, and referring these individuals to a geographically-scalable tele-pharmacist PrEP clinic that overcomes barriers related to distance and stigma.
The TelePrEP program was piloted locally in Johnson County, and in 2018 the IDPH and UI will collaborate to scale it up across Iowa. In parallel with scale up of the TelePrEP program, a research study will be conducted to determine the impact of TelePrEP on PrEP use among rural and small urban -dwelling public health clients. In a quasi-experimental study, the local public health departments in Iowa and their affiliated HIV/STD programs will be divided into TelePrEP intervention and control groups, based on geographic region. This is appropriate because it will not be feasible to implement the TelePrEP program in all Public health sites simultaneously, so some sites will start the program later than others by necessity. Public health personnel in control regions will refer PrEP-eligible clients to available community-based PrEP providers, the current "standard of care." Public health personnel in TelePrEP intervention regions will refer clients to their choice of in-person visits with available community PrEP providers or TelePrEP.
Primary Objective: Estimate the impact of TelePrEP on the overall rate of PrEP engagement among rural and small urban public health clients.
Secondary Objective: Quantify retention of public health clients in TelePrEP.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-negative by recent (\< or = 14 days) testing AND one of following
men sexually active with male partner(s) in the past six months, not in a monogamous partnership with a recently-tested HIV negative man, and reporting either anal sex without condoms in the past six months, any STI in past six months, or relationship with an HIV-positive partner,
OR
sexually-active heterosexual men and women not in a monogamous relationship with an HIV-negative partner and reporting either condom-less sex with partners of unknown HIV status at high risk for HIV infection, or an ongoing sexual relationship with an HIV-positive partner,
OR
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Public health personnel identify PrEP-eligible clients. 2. PrEP-eligible clients are given a list of PrEP providers in Iowa and a brochure with info on getting PrEP. Clients are referred to a PrEP navigator, who facilitates linkage to clients' choice of TelePrEP or to community PreP providers. 3. Public health clients choosing TelePrEP complete a video visit with the tele-pharmacist and obtain PrEP relevant lab tests. 4. PrEP medication is mailed to the client and follow up video visits and lab testing are performed. 5. Within 7 days of enrollment, the subject will complete a survey regarding PrEP beliefs (20 minutes). 6. 30 to 40 days after enrollment, the subject will complete a second survey with 4 questions about initiation of PrEP since study enrollment (10 minutes). 7. 6 months following enrollment, a study team member will obtain medical records for the subject from PrEP providers in Iowa to determine if the subject has initiated and been retained in PrEP.
Behavioral: Intervention Group
1. Public health personnel identify PrEP-eligible. 2. Public health personnel give PrEP-eligible clients a list of PrEP providers in Iowa, and a brochure with information on getting PrEP. 3. The client initiates contact with a PrEP provider in Iowa and schedules an appointment. 4. PrEP medication is mailed to the client and follow up video visits and lab testing are performed. 5. Within 7 days of enrollment, the subject will complete a survey regarding PrEP beliefs (20 minutes). 6. 30 to 40 days after enrollment, the subject will complete a second survey with 4 questions about initiation of PrEP since study enrollment (10 minutes). 7. 6 months following enrollment, a study team member will obtain medical records for the subject from PrEP providers in Iowa to determine if the subject has initiated and been retained in PrEP.
The goal of this research study is to evaluate the preliminary impact of a public-health-partnered tele-pharmacist model for pre-exposure prophylaxis (PrEP) delivery in a rural state ("TelePrEP"). In brief, PrEP involves daily use of a medication (i.e. Truvada) to prevent HIV infection among people at risk for infection due to sexual exposure or needle sharing.
Impact of TelePrEP on overall rate of PrEP engagement
Rates of PrEP engagement among PrEP-eligible clients in intervention and control regions
Time frame: 30 days
Retention of clients in TelePrEP
Proportion of clients who are retained in PrEP six months following engagement
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Feb 2019, 12 months.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 12 months is below that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →