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Telemedicine for PrEP Throughout Mississippi
NA trial testing Tele-PrEP Intervention in HIV/AIDS in 74 participants. Completed in 4 May 2022.
| Lead sponsor | Rhode Island Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 74 |
| Start date | 19 December 2019 |
| Primary completion | 4 May 2022 |
| Estimated completion | 4 May 2022 |
| Sites | 1 location across United States |
Rhode Island Hospital
18 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 3 months post-intervention.
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 8 |
Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 6 months post-intervention.
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 2 |
Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 3-month follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 22 |
Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 6-month follow-up.
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 17 |
Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30.
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 2.07 | ± 3.03 |
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 18.75 | ± 13.50 |
Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up).
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 43 | |
| Tele-PrEP Intervention | 11 | |
| Tele-PrEP Intervention | 9 |
Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up).
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 46 | |
| Tele-PrEP Intervention | 12 | |
| Tele-PrEP Intervention | 5 |
This 5-item measure was used to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP. Scores for the measure could range from 0 to 5 with higher scores indicating greater PrEP knowledge.
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 2.89 | ± 1.84 |
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 2.93 | ± 1.64 |
This measure was a subscale adapted from The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ), 2006. The motivational readiness to engage in PrEP care subscale consisted of eight items with 4-point Likert responses. The possible score range for this subscale is 8 to 32, with higher scores indicating higher motivation to engage in PrEP care.
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 25.95 | ± 4.69 |
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 26.50 | ± 4.11 |
Patients' perspective on the acceptability of using telemedicine for PrEP care was assessed with a modified version of the Client Satisfaction Questionnaire (CSQ-8). This measure was only given to participants who attended a PrEP-related telemedicine appointment. Scores for this measure could range from 2 to 8, with higher scores indicating greater satisfaction.
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 7.27 | ± 1.27 |
| Group | Value | 95% CI |
|---|---|---|
| Tele-PrEP Intervention | 7.50 | ± 1.00 |
This study will develop and test a program to deliver PrEP care in underserved communities in Mississippi (MS) through telemedicine, distance-based, clinical care delivered in local community based organizations (CBOs). The intervention will be developed in collaboration with medical specialists at the University of Mississippi Medical Center (UMMC) and local CBO stakeholders (providers, administrators and patients). Approximately 75 individuals will be recruited from CBOs in MS. Participants will be able to receive PrEP counseling in the CBO and PrEP care via telemedicine from a PrEP specialist at UMMC. Participants will complete three assessments in the six months after enrolling. Our study will provide a wealth of information about PrEP-related outcomes and HIV testing among MS residents living in underserved communities. If successful, this program will be able to be disseminated to other CBOs in the South.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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