Nigerian National Agency for the Control of AIDS Demonstration Project
Evaluates the effectiveness of models for delivery of PrEP and TasP as combination prevention strategy for 600 heterosexual, serodiscordant couples.
IEC Materials
Study Standard Operating Procedures (SOP)
Admin SOP
- SOP 101: SOP Preparation, Maintenance, and Training
- SOP 102: Attendance Policy and Management
- SOP 103: Procurement and Shipping
- SOP 104: Roles, Responsibilities, and Delegation of Duties
- Appendix to SOP 104: Study Staff Responsibilities and Duties Log
- SOP 105: Training and Education
- Appendix to SOP 105: Educational Program Compliance Form
- SOP 106: Documentation and Records Retention
- Appendix to SOP 106: Harmonised Tripartite Guideline for Good Clinical Practice
- SOP 107: Protocol Implementation
- SOP 108: Protocol Deviation and Management
Clinical SOP
- SOP 201: Clinic Flow
- SOP 202: Participant Screening and Enrollment
- Appendix to SOP 202: Screening and Enrollment Sheet Template
- SOP 203: Verification of Eligibility
- SOP 204: Obtaining Informed Consent
- SOP 205: Couples Counselling
- SOP 206: Study Visits and Missed Visits
- SOP 207: Monitoring, Reporting, and Recording Adverse Events
- Appendix to SOP 207: Adverse Events Log
Lab SOP
- SOP 301: Blood Specimen Collection
- SOP 302: Specimen Receipt and Handling Procedures
- SOP 303: HIV Counselling and Testing
- SOP 304: Enumeration of CD4 T Lymphocyte
- SOP 305: HIV-1 Viral Load Assay
- SOP 306: Hepatitis B Surface Antigen (HBsAg) Test
- SOP 307: Creatine Testing and Determination of Creatine Clearance
Pharmacy SOP
- SOP 401: Investigational Drug Management
- SOP 402: Dispensing of Investigational Drug
- SOP 403: Investigational Drug Adherence Counselling
Data Management SOP
- SOP 501: CRF Completion and Correction
- SOP 502: CRF Data Entry
- SOP 503: Data Query Resolution
- SOP 504: CRF Filing
- SOP 505: CRF Quality Assurance
- SOP 506: Data Security
- SOP 507: Data Retention
Quality Assurance SOP
Study Case Record Forms (CRF)
Enrollment CRF
- Demographics
- Index Medical History
- WHO Adult HIV Staging System
- Sexual Behavior
- Safer Conception
- Alcohol and Depression Scales
- Index Social Support and Stigma
- Social Harm Report
- Index Prevention Preference Questionnaire
- Risk Taking Behaviors 1: HIV Positive
- Risk Taking Behaviors 2: HIV Positive
- Index Physical Examination
- Index Drug Dispensing Record
- Index Enrollment Checklist
Follow-up CRF
- Sociodemographic Update
- Knowledge Index
- Index Medical History
- CD4 and Viral Load
- WHO Adult HIV Staging System
- Sexual Behavior
- Safer Conception
- Alcohol and Depression Scales
- Index Social Support and Stigma
- Social Harm Report
- Index Prevention Preference Questionnaire
- Risk Taking Behaviors 1: HIV Positive
- Risk Taking Behaviors 2: HIV Positive
- Index Physical Examination
- Index Drug Dispensing Record
- Study Drug Adherence
- Index Visit Summary
Enrollment CRF
- Demographics
- Partner Medical History
- Sexual Behavior
- Safer Conception
- Alcohol and Depression Scales
- Partner Social Support and Stigma
- Social Harm Report
- Partner Prevention Preference Questionnaire
- Partner Discordance and Relationship Satisfaction Scale
- Risk Taking Behaviors 1: HIV Negative
- Risk Taking Behaviors 2: HIV Negative
- Partner Physical Examination
- Partner Drug Dispensing Record
- Partner Enrollment Checklist
Follow-up CRF
- Sociodemographic Update
- Knowledge Partner
- Partner Medical History
- Sexual Behavior
- Safer Conception
- Alcohol and Depression Scales
- Partner Social Support and Stigma
- Partner Prevention Preference Questionnaire
- Partner Discordance and Relationship Satisfaction Scale
- Risk Taking Behaviors 1: HIV Negative
- Risk Taking Behaviors 2: HIV Negative
- Partner Physical Examination
- Partner Drug Dispensing Record
- Study Drug Adherence
- Participant Initiated Periodic PrEP Use
- Partner Visit Summary
Non-Routine CRF