HIV PreventionPROTECTNCT06845774
The PROTECT (PrEP Optimization Through Telehealth Care and Treatment) Trial
A study testing CDC PrEP with active referral and TelePrEP in people with HIV Prevention, run by Hilary L Surratt, PhD at 1 site in United States.
Trial summary
The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been minimal, most notably in rural areas. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- CDC PrEP with active referral and TelePrEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 13 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- report at least one occasion of injection drug use in the past month
- report an indication for PrEP in the past six months consistent with CDC guidelines for PrEP care
- be a documented client of the county health department-based SSP at the time of study entry
- express willingness to participate in a multi-session intervention and follow-up
Who cannot join
- HIV-positive status
- current PrEP care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Optimizing Low Threshold TelePrEP Care for People Who Inject Drugs in Appalachia
The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been minimal, most notably in rural areas. Structural barriers to healthcare access, lack of providers, and inadequate infrastructure to deliver PrEP are challenges in many rural areas. This study will integrate telehealth PrEP care within local health departments to reduce structural barriers to evidence-based HIV prevention through co-located comprehensive PrEP services, and test this against a standard of care approach in a pilot randomized clinical trial. The primary objective is to examine preliminary efficacy and effect sizes of novel integrated telehealth care versus standard education and active referral on the primary outcome of PrEP initiation in HIV-negative participants who inject drugs.
- Conditions
- HIV Prevention
- Being tested
- CDC PrEP with active referral, TelePrEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDC PrEP with active referralBehavioural
The single session SOC utilizes structured risk assessments and educational materials recommended by the CDC, based on the CDC PrEP 101 information, and delivered one-on-one by trained study staff in about 15 minutes. This will be followed by active referral to a local provider; local providers have been identified to receive study referrals in each community. This session will occur the same day or within one week of study enrollment.
TelePrEPBehavioural
The TelePrEP intervention includes an initial one-on-one in person intervention session with trained study staff that: 1) engages in provides basic education on PrEP care tailored for PWID; 2) encourages participation in a telehealth clinical evaluation for PrEP; and, 3) offers the opportunity to participate in point of care baseline testing for PrEP. At the conclusion of session 1, for those who express readiness to link with PrEP care, study staff will immediately facilitate access to the telehealth platform onsite. Four telehealth visits will be offered to access initial and follow-up clinical care for PrEP.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | One session standard of care (SOC) PrEP education (an in-use PrEP intervention based on CDC guidelines) with active referral to a local PrEP provider. Receives: Behavioral: CDC PrEP with active referral |
| Integrated Telehealth Care | Experimental | A multi-session PrEP education and intervention session that provides tailored PrEP education onsite combined with point-of-care PrEP testing and telehealth access to a PrEP provider. Receives: Behavioral: TelePrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Initiation
Number of participants initiating PrEP
Measured: 3 months post-baseline
PrEP Initiation
Number of participants initiating PrEP
Measured: 6 months post-baseline
Secondary outcomes (4)
PrEP Persistence
Number of participants with PrEP prescription refill
Measured: 3 months post-baseline
PrEP Persistence
Number of participants with PrEP prescription refill(s)
Measured: 6 months post-baseline
PrEP adherence
Number of participants with tenofovir (TFV) detected in dried blood spot testing
Measured: 3 months post-baseline
PrEP adherence
Number of participants with tenofovir (TFV) detected in dried blood spot testing
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start25 Sep 2025
- Primary completion13 Jan 2027 (estimated)
- Study completion13 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hilary L Surratt, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Hilary L Surratt, PhD, University of Kentucky
- Investigators
- Hilary L Surratt, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845774
- Sponsor's protocol ID
- 90392
- Other IDs
- R34DA060087-01
- Acronym
- PROTECT
- Status last verified
- May 2026
- First submitted
- 19 Feb 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: REDCap de-identified survey data and clinical data from report forms will be preserved and shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Low Threshold TelePrEP Care for People Who Inject Drugs in Appalachia
- ClinicalTrials.gov ID
- NCT06845774
- Acronym / sponsor ID
- PROTECT / 90392
- Conditions
- HIV Prevention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hilary L Surratt, PhDUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 13 Jan 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The expansion of HIV pre-exposure prophylaxis (PrEP) care has been endorsed as a key strategy for reducing new HIV infections, however, PrEP trials among people who inject drugs (PWID) are rare and uptake of PrEP has been minimal, most notably in rural areas. Structural barriers to healthcare access, lack of providers, and inadequate infrastructure to deliver PrEP are challenges in many rural areas. This study will integrate telehealth PrEP care within local health departments to reduce structural barriers to evidence-based HIV prevention through co-located comprehensive PrEP services, and test this against a standard of care approach in a pilot randomized clinical trial. The primary objective is to examine preliminary efficacy and effect sizes of novel integrated telehealth care versus standard education and active referral on the primary outcome of PrEP initiation in HIV-negative participants who inject drugs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: CDC PrEP with active referralOne session standard of care (SOC) PrEP education (an in-use PrEP intervention based on CDC guidelines) with active referral to a local PrEP provider. |
| Integrated Telehealth Care | Experimental | Behavioral: TelePrEPA multi-session PrEP education and intervention session that provides tailored PrEP education onsite combined with point-of-care PrEP testing and telehealth access to a PrEP provider. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- be at least 18 years of age
- report at least one occasion of injection drug use in the past month
- report an indication for PrEP in the past six months consistent with CDC guidelines for PrEP care
- be a documented client of the county health department-based SSP at the time of study entry
- express willingness to participate in a multi-session intervention and follow-up
Key exclusion criteria (2 listed)
- HIV-positive status
- current PrEP care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDC PrEP with active referralThe single session SOC utilizes structured risk assessments and educational materials recommended by the CDC, based on the CDC PrEP 101 information, and delivered one-on-one by trained study staff in about 15 minutes. This will be followed by active referral to a local provider; local providers have been identified to receive study referrals in each community. This session will occur the same day or within one week of study enrollment. | Behavioural | Standard of Care |
| TelePrEPThe TelePrEP intervention includes an initial one-on-one in person intervention session with trained study staff that: 1) engages in provides basic education on PrEP care tailored for PWID; 2) encourages participation in a telehealth clinical evaluation for PrEP; and, 3) offers the opportunity to participate in point of care baseline testing for PrEP. At the conclusion of session 1, for those who express readiness to link with PrEP care, study staff will immediately facilitate access to the telehealth platform onsite. Four telehealth visits will be offered to access initial and follow-up clinical care for PrEP. | Behavioural | Integrated Telehealth Care |
Primary outcome
PrEP Initiation
Time frame: 3 months post-baseline
Number of participants initiating PrEP
PrEP Initiation
Time frame: 6 months post-baseline
Number of participants initiating PrEP
4 secondary outcomes
PrEP Persistence
Time frame: 3 months post-baseline
PrEP Persistence
Time frame: 6 months post-baseline
PrEP adherence
Time frame: 3 months post-baseline
PrEP adherence
Time frame: 6 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Yes. REDCap de-identified survey data and clinical data from report forms will be preserved and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hilary L Surratt, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDC PrEP with active referral and TelePrEP in people with HIV Prevention, run by Hilary L Surratt, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Initiation (time frame: 3 months post-baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.