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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA060087-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDC PrEP with active referral | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Initiation | Number of participants initiating PrEP | 3 months post-baseline |
| PrEP Initiation | Number of participants initiating PrEP | 6 months post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Persistence | Number of participants with PrEP prescription refill | 3 months post-baseline |
| PrEP Persistence | Number of participants with PrEP prescription refill(s) |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Acceptability | Level of Intervention Acceptability for the experimental arm; measured by 10 item Intervention Acceptability Questionnaire (IAQ) completed by participants post-intervention; range is 10-50, lower scores are higher satisfaction | 2 weeks post-baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilary L Surratt, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
REDCap de-identified survey data and clinical data from report forms will be preserved and shared.
The study team will submit a de-identified and cleaned survey and clinical dataset to Dataverse at the completion of the project period, April 2027, or at publication of the primary outcomes paper, whichever is first.
Data will be made available on the Harvard Dataverse, for which the University of Kentucky has an institutional account. The Harvard Dataverse Repository is a free data repository open to all researchers from any discipline, both inside and outside of the Harvard community, where investigators can share, archive, cite, access, and explore research data.
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| TelePrEP | Behavioral | 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. |
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| 6 months post-baseline |
| PrEP adherence | Number of participants with tenofovir (TFV) detected in dried blood spot testing | 3 months post-baseline |
| PrEP adherence | Number of participants with tenofovir (TFV) detected in dried blood spot testing | 6 months post-baseline |