Risk - Emory Center for AIDS Research

Intervention Manual for Project nGage; akin to a broad SOP/protocol with surveys for study staff. Includes overview, baseline visit details, Session I: identifying network support and engaging support confidant, Module A: support matters! Providing support for young people living with HIV, PIE worksheet, Module B: motivating social support, Module C: information is power, essential information about HIV and AIDS, what happens at the clinic, HIV medications and adherence, common barriers to taking medications and attending appointments, Session II Module D: personalized care and support plan with worksheet, barriers and solutions worksheets, telephone follow-up sessions for index-support confidant dyads with scripts, references.

Project WERK: Fidelity Data Dictionary Spreadsheet (1198)

Project WERK Research Staff Instructions Project WERK Prevention Appointment Checklist Data Information PrEP Retention Staff Health Behavioral Behavior Adherence Black MSM Risk Linkage YBMSM Social Support Intervention Barriers Spreadsheet Insurance Fidelity Pilot Efficacy Minority Reduction Motivation IMB Model Network SMM YBSMM Negative Receipt Organic Maintenance Confidant Cultural Visualization Assessment Booster Dictionary Domestic 2024 Behavioral Prevention Community Health Health Equity Developmental Clinical Standard RCT Clinical Qual + Quant

Fidelity data dictionary spreadsheet, based off of the fidelity checklist for Project WERK study.

Project WERK: Fidelity Checklist (1197)

Project WERK Research Staff Instructions Project WERK Prevention Appointment Checklist Information PrEP Retention Staff Health Behavioral Behavior Adherence Black MSM Risk Linkage YBMSM Social Support Intervention Barriers Insurance Fidelity Pilot Efficacy Minority Reduction Motivation IMB Model Network SMM YBSMM Negative Receipt Organic Maintenance Confidant Cultural Visualization Assessment Booster Domestic 2024 Behavioral Prevention Community Health Health Equity Developmental Clinical Standard RCT Clinical Qual + Quant

Study staff fidelity checklist for Project WERK study.

Project WERK: Intervention Manual (1196)

Project WERK Research Staff Instructions Project WERK Prevention Screening Worksheet Appointment Baseline Follow-up Information Interview Overview PrEP Procedure Retention Staff Scripts SOP Survey Text Health Abuse Behavioral Behavior Adherence Black MSM Phone References Plan Risk Linkage Care Training YBMSM Social Status Support Intervention Barriers Clinic Insurance Primary Pilot Efficacy Minority Relationship Reduction Motivation IMB Model Network SMM YBSMM Negative Receipt Organic Maintenance Confidant Cultural Visualization Assessment Booster Sociogram Module Algorithm Brief Instrument Strain Disengagement Refusal Change Psychoeducation PIE Fact Personalized Monthly Sessions Domestic 2024 PW-Document Methods Clinical Qualitative Quantitative Behavioral Prevention Community Health Health Equity Developmental Clinical Standard RCT Clinical Qual + Quant

Intervention Manual for Project WERK; akin to a broad SOP/protocol with surveys and interview guides for study staff.

PrEP 2-1-1: Full Survey (1189)

PrEP 2-1-1 Surveys PrEP 2-1-1 Prevention Data Feedback Interview PrEP Survey Testing Behavior Sexual Adherence Mobile MSM Phone Risk Introduction Reporting Status Depression App Application Drug Usability Alcohol Perceived Intervention Demographics Partners PLWH Feasibility Acceptability Self-test Efficacy Technology Regimen Pill Infection Future On-demand 2-1-1 Accounting Development Harm Reduction Urine Effect Side Web Functionality Satisfaction Internet Motivation IMB Model Practices Unknown Component Rating Domestic 2024 P211-Document Methods Quantitative Prevention Community Health Behavioral Developmental mHealth Clinical Standard RCT Clinical Qual + Quant

Full survey for the PrEP 2-1-1 study, includes introduction and demographics, perceived risk of HIV infection, sexual practices, partners living with HIV, partners with HIV status unknown, partners believed to be HIV negative, alcohol and drug use, technology use, app use, PrEP use, usability and acceptability follow-up only, app component rating, general app feedback, on-demand PrEP and daily PrEP regimens, general PrEP use rating, depression, study feedback, future app use.

DOT Diary: Survey (1182)

DOT Diary Surveys DOT Diary Prevention Screening Baseline Data Oral PrEP Visit Substance Diary Behavior Sexual Adherence Mobile MSM Risk Incentive Longitudinal Social Application Questions Self-efficacy Usability Perceived Monitor Demographics Feasibility Pilot Tech Efficacy Picture SmartPhone Technology Observational Artificial Intelligence Reliability Automated Accessibility Develop Report Optimize Plausibility Individual Dose Regimen Young Infection Practice Impact HIV-ASES Future Domestic 2019 DD-Document Methods Quantitative Prevention Community Health Behavioral Developmental mHealth Clinical Standard RCT Clinical Qual + Quant

Full survey for DOT Diary study, includes baseline visit screening, demographics, perceived risk of HIV infection, sexual practices, substance use, tech, PrEP, DOT Diary usability/acceptability questions, incentive question, PrEP use self-efficacy (HIV-ASES), social impacts, future use of DOT Diary outside of a clinical trial, future use of PrEP.

Planning4PrEP: Interview Guide (1157)

Planning4PrEP Interview Guides Planning4PrEP HIV Prevention Guide Interview PrEP Provider Survey Methods Mixed Risk Female Partner Women AYAW Priority Influence Relationships Characteristics Prescription Domestic 2022 P4P-Document Methods Qualitative Prevention Behavioral Community Health Health Equity Clinical Qual + Quant Clinical Qualitative

Interview guide including HIV risk, PrEP priority, provider influence, relationships and partner characteristics, and PrEP prescription for the Planning4PrEP study.

PrEP@Home: Baseline Survey (1108)

PREP at Home Surveys PREP@Home Acute STI Baseline Laboratory PrEP Provider Survey System Testing Site Health Behavioral Substance History Sexual Monitoring Risk Care Persistence Remote Telemedicine Multi-Site Social Education Employment Marital Income Status Resiliency Literacy Stability Access Knowledge Mental Perceived Stigma Demographics Engagement Coverage Willingness Symptoms Healthcare PEP Ethnicity Gender Race Identity Attitude Intention Outness Pay Networking Geosocial Awareness Domestic 2023 PAH-Document Methods Quantitative Prevention Behavioral Health Equity mHealth Clinical Standard RCT Clinical Qual + Quant

Baseline survey including demographics, gender identity, race and ethnicity, education, employment, healthcare coverage, health access and engagement, health literacy, acute symptoms, marital status, HIV/STI testing history, sexual history, basic HIV knowledge, perceived HIV risk, PEP awareness, PrEP knowledge/attitudes, PrEP intentions, PrEP stigma, sexual stigma, outness to provider, mental health, resiliency, substance use, willingness to pay, income, housing stability, and use of social/geosocial networking sites for the PrEP@Home Study.

Project Adhere: Individual Interview Guide Working Draft (1049)

Project Adhere Interview Guides Project Adhere Guide Interview IRB PrEP Survey Adherence Black Mobile MSM Script Risk Discontinuation Longitudinal Psychosocial Persistence Qualitative YBMSM Researcher Domestic 2022 PA-Document Methods Qualitative Prevention Community Health Behavioral mHealth Health Equity Clinical Prospective Cohort Study Clinical Qual + Quant

PrEP information interview script guide for researcher in Project Adhere.

Project Adhere: Eligibility Screener (1048)

Project Adhere Recruitment Materials Project Adhere Eligibility Screening Interview IRB PrEP Survey Adherence Black Mobile MSM Script Risk Discontinuation Longitudinal Psychosocial Persistence Qualitative YBMSM Researcher Domestic 2022 PA-Document Methods Quantitative Prevention Community Health Behavioral mHealth Health Equity Clinical Prospective Cohort Study Clinical Qual + Quant

Eligibility screening guide script for researcher in Project Adhere.

Project Adhere: Standard Operating Procedures (1047)

Project Adhere SOP Project Adhere Eligibility Screening Interview PrEP Participant Recruitment SOP Survey Adherence Black Mobile MSM Risk Incentive Discontinuation Longitudinal Psychosocial Persistence Qualitative YBMSM Completion Initiation Notifications Timeline Tracking Domestic 2022 PA-Document Methods Quantitative Qualitative Clinical Prevention Community Health Behavioral mHealth Health Equity Clinical Prospective Cohort Study Clinical Qual + Quant

All SOPs for Project Adhere, including study timeline, recruitment and screening, participant initiation, periodic measure tracking and completion, dried blood spots, in-depth interviews, study incentives, study completion, and appendix of study notifications.

Project Adhere: Consent Form (1046)

Project Adhere Consent Forms Project Adhere Consent Form Interview IRB PrEP Survey Adherence Black Mobile MSM Risk Discontinuation Longitudinal Psychosocial Persistence Qualitative YBMSM Domestic 2022 Prevention Community Health Behavioral mHealth Health Equity Clinical Prospective Cohort Study Clinical Qual + Quant

Research participant consent form for Project Adhere.

C-PLEASURE: Data Safety Monitoring Plan (1016)

Protocols C-PLEASURE Clinical Condom Consent Fit Performance Pleasure Prevention Size Data Monitoring Safety Participants Plan Risk Domestic 2017 Prevention Behavioral Community Health Clinical Crossover RCT Qual + Quant Clinical

Plan to ensure the safety of the participants and their data for C-Pleasure Study.