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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 4
- 主要终点
- Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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 :
- •History of inconsistent or no condom use with more than one partner
- •History of inconsistent or no condom use with one partner who is not mutually monogamous
- •HIV-positive sexual partner
- •Any sexually transmitted infection (STI) diagnosed in past 6 months
- •Commercial sex work
- •African American MSM reporting anal sex in the past 6 months
- •Clinician discretion based on epidemiologic context of HIV risk
- •Willing to take FDA-approved daily oral PrEP
- •Willing to use study-provided PrEP navigation services
- •Willing to self-collect specimens
排除标准
- •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
- •Evidence of fraudulent participation, such as duplicate Internet Protocol (IP) address, multiple screening attempts, duplicate emails, etc
研究组 & 干预措施
ePrEP
Participants will receive the ePrEP home care system for telemedicine PrEP, permitting initiation and persistence in PrEP care. The ePrEP home care system consists of: a smartphone application (app) for video-based telemedicine PrEP consultations with a clinician; secure messaging; a system to track shipments to & from participants; and behavioral risk surveys that are complemented by home specimen kits. Self-collected specimens will be mailed to laboratories for routine, guideline-based testing for PrEP care. Home specimen collection will be used to determine the primary study outcome of tenofovir-diphosphate levels.
干预措施: ePrEP (Other)
Standard of care
Participants will be referred to a publicly available website that geolocates the nearest PrEP provider. They will receive standard of care, defined as what a member of the general public would be able to access for PrEP services. Home specimen self-collection will be used to determine the primary study outcome of tenofovir-diphosphate levels. Additional research assessments will include quarterly surveys.
结局指标
主要结局
Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 6 Months Follow-up
时间窗: 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).
次要结局
- Difference in Tenofovir-diphosphate (TFV-DP) Levels Between Intervention and Control Arms at 12 Months Follow-up(12-month follow up)
研究者
Aaron Siegler
Associate Professor
Emory University