Testing an Electronic Pre-exposure Prophylaxis (PrEP) Initiation and Maintenance Home Care System to Promote PrEP Among Adolescent Men Who Have Sex With Men (MSM) in Rural and Small Town Areas
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pre-exposure Prophylaxis
- Sponsor
- Emory University
- Enrollment
- 217
- Locations
- 4
- Primary Endpoint
- Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The premise for the study is that a tailored approach for rural young men who have sex with men (YMSM), addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of Pre-exposure Prophylaxis (PrEP) initiation and persistence in care.
Detailed Description
The premise for the study is that a tailored approach for YMSM from rural and small town areas, addressing known barriers of transportation, access to providers, and privacy, is most likely to yield high levels of PrEP initiation and persistence in care. The study sites are Alabama, Georgia, North Carolina, and Mississippi. Using a smartphone application (app), participants assigned to the intervention will receive and maintain a PrEP prescription without needing to leave their home (excepting pharmacy pick-up in some cases) - achieved through app-based surveys/screenings, telemedicine consultations, and home specimen self-collection.
Investigators
Aaron Siegler
Associate Professor
Emory University
Eligibility Criteria
Inclusion Criteria
- •Assigned male at birth
- •Age 18-29 (inclusive)
- •Live in a study state (Georgia, Mississippi, North Carolina, Alabama)
- •Able to provide informed consent and complete survey instruments in English
- •Willing to provide complete contact information (including 2 alternate contacts)
- •Able and willing to provide identification verification for viewing confirmation only
- •Laboratory confirmed HIV negative
- •Owns a smartphone capable of running the study app
- •Male sex partners in past 6 months or clinician discretion of epidemiologic context of HIV risk
- •Behavioral/epidemiological indication for PrEP :
Exclusion Criteria
- •HIV positive (self-report or laboratory confirmed)
- •Chronic Hepatitis B or no verification of hepatitis B vaccination
- •Currently enrolled in any HIV prevention trial (biomedical)
- •Currently taking oral PrEP based on self-report
- •Creatinine clearance \<60 ml/min based on the Cockcroft-Gault equation
- •Symptoms of acute HIV infection within the prior 30 days
- •Contraindications to oral PrEP
- •Personal diagnosis or family history of hemophilia
- •Health insurance with Kaiser Permanente (unable to prescribe PrEP through the study)
- •Investigator discretion to exclude anyone whose best interest is not to participate
Outcomes
Primary Outcomes
Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up
Time Frame: 6-month follow up
Measurements TFV-DP levels will be conducted for participants in both arms using liquid chromatography/tandem mass spectrometry methods on self-collected DBS samples. TFV-DP level can be translated to an interpretation that indicates the mean number of days per week PrEP is ingested over approximately 1 month preceding specimen collection. The cutpoint used for the primary outcome measure will be medication levels indicating \>4 doses/wk. For participants taking emtricitabine/tenofovir disoproxil fumarate, this will be TFV-DP levels: \>1000 femtomole per blood spot (fmol/punch). For participants taking emtricitabine/tenofovir alafenamide this will be TFV-DP levels: \>140 femtomole per blood spot (fmol/punch).
Secondary Outcomes
- Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up(12-month follow up)