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Antiretroviral

PrEP for HIV Prevention

N/A

Waitlist Available

Led By Nickolas D Zaller, Ph.D

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having condomless vaginal or anal sex with more than one partner

Having a sex partner with one or more HIV risk (e.g. PWID, a sex worker)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months and 12 months

Awards & highlights

Study Summary

This trial will explore what makes it easy or hard for people to get and use PrEP, a medication that can prevent HIV. The study will focus on groups of people who are most at risk for HIV and who are hard to reach, including men who have sex with men and substance users. The results of the trial will be used to improve ways of preventing HIV.

Who is the study for?

This trial is for adults over 18 who've recently left the Pulaski County Regional Detention Facility, are HIV negative, and at high risk of HIV (e.g., unprotected sex with multiple partners or a partner with HIV). They must speak English, give consent, and provide contact information. Those with severe mental illness that prevents informed consent are excluded.Check my eligibility

What is being tested?

PrEP-LINK aims to connect high-risk individuals from jail to Pre-Exposure Prophylaxis (PrEP) to prevent HIV. It will compare PrEP-LINK intervention against an enhanced standard of care in preventing HIV among men who have sex with men and substance users.See study design

What are the potential side effects?

While specific side effects aren't listed here, PrEP medications can generally cause symptoms like nausea, headaches, fatigue, and stomach issues. Long-term use may affect bone density or kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had unprotected sex with multiple partners.

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My sexual partner is at high risk for HIV.

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I have been diagnosed with a sexually transmitted infection (STI).

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of PrEP Uptake Among Participants based on Medical Chart Review

Satisfaction of the utilization of the CHW to aid in accessing PrEP assessed by the Client Satisfaction Questionnaire-Revised

Secondary outcome measures

Rate of PrEP Adherence and Retention based on self-reported surveys (PrEP-Use, PrEP-Attitude, PrEP-Adherence)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Community Health Worker Involved Enhanced Standard of CareExperimental Treatment1 Intervention

PrEP education, referral to a community-based PrEP provider, and referral to a CHW who will facilitate access to community-based PrEP and other healthcare and social-support services.

Group II: Enhanced Standard of CareActive Control1 Intervention

PrEP education and referral to a community-based PrEP provider (enhanced standard of care)

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

150,253 Total Patients Enrolled

Nickolas D Zaller, Ph.DPrincipal InvestigatorUniversity of Arkansas

Media Library

PrEP-LINK (Antiretroviral) Clinical Trial Eligibility Overview. Trial Name: NCT04064567 — N/A

HIV/AIDS Research Study Groups: Community Health Worker Involved Enhanced Standard of Care, Enhanced Standard of Care

HIV/AIDS Clinical Trial 2023: PrEP-LINK Highlights & Side Effects. Trial Name: NCT04064567 — N/A

PrEP-LINK (Antiretroviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04064567 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation still recruiting participants?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical experiment, which was initially posted on September 30th 2019, is actively looking for participants. Around 120 people need to be recruited from 7 different sites."

Answered by AI

How many participants are in this clinical trial?

"That is correct. Per the information on clinicaltrials.gov, this trial is actively enrolling participants and has been doing so since September 30th 2019. It requires at least 120 individuals from 7 different sites to complete the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK

2019. "Linking High-Risk Jail Detainees to HIV Pre-Exposure Prophylaxis: PrEP-LINK". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04064567.

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