Protocol Conforms to the OSHA/HHS

I Certify that This Protocol Conforms to the OSHA/HHS Guidelines for HIV/HBV Occupational Safety. (Remember to Attach the Human Consent Forms.)
Target Population: Inclusion Criteria Exclusion Criteria Intervention
Adults with HIV-1 Adults only, diagnosed with HIV-1, Undetected viral load Children (individuals below 18 years), Individuals with HIV-2, individuals with underlying mental or psychosocial issues, individuals with detected CD4 Count The selected participants will receive doses of the New Cabenuva Prescription administered monthly. The dosage will be administered at a central location (chosen healthcare facility) for a five month duration (ending November 2021)

16. Description of the Research (Provide Sufficient Detail)
a. Statement of Problem
Patients suffering from HIV-1 must take the oral Current Antiretroviral Regimen (CAR) medication on a daily basis. There are more than 1.5 million people in the United States diagnosed with HIV-1. Globally, there are 25.4 million people who have seamless access to CAR medication, accounting for only 67% of the 38 million of total population (HIV, 2021). 12.6 million (33%) people do not have access to drugs or have challenges adhering to treatment regimen. Further, 59% of the total population suffering from this condition are virally suppressed (HIV, 2021). HIV-1 with undetected viral load is an issue of serious public health issue due to their likelihood of spreading the virus to other healthy individuals.
b. Data Collections Methods: How Do You Plan to Collect Your Data? (i.e. Self-Report, Survey Collection, etc.)
Data will be collected using a combination of surveys and clinical examinations of patient blood samples and health records.
c. Instruments to Be Used:
Consent forms (attached) will be used to obtain signed consent from the selected participants. Survey questions will be used to evaluate the knowledge and understanding of patients regarding the use of the Cabenuva Prescription.
d. Method of Recruitment of Participants:
Participants for this study will be recruited using judgmental/purposive sampling. This method of sampling allows the researcher to select participants with specific traits (adults with undetected HIV-1).
e. Incentives, Follow Ups, Compensation to Be Used:
There are no incentives offered for the selected participants. Follow-ups will be made to determine how each patient responds to the new Cabenuva prescription. Follow ups will be made four times every month (per week), and a detailed record of the previous month provided for each subsequent administration.

f. Detail Stress, Psychological, Social, Legal, or Physical Harm That Might Occur to Participants. How Are These Held to the Absolute Minimum? What Remediation Is Offered?
Patients who experience any complications will be referred to a designated medical team at the hospital where the study is conducted. Further, health teams will be dispatched to monitor the progress of each patient after the study. Medical clearance letters from healthcare providers of each participant will also be obtained.
g. Benefits of the Research: University Policy Requires that Any Risk Associated with Participation Be Outweighed by Potential Benefits to Participants and to Humankind in General
(a) Identify Any Benefits to Participants Resulting from This Research
Participants will gain information regarding their CD4 Count among other vital medical records for free. Individuals who participate in this study will receive medical advice and monitoring from time to time. The respondents will be allowed to consult 24/7 and seek medical help from any location during the study period.
(b) Identify Any Benefits to Humankind in General Resulting from This Research
This research will provide the general public with a better alternative to the traditional Current Antiretroviral (CAR) to improve viral suppression, aiding patients to cope with treatment of HIV-1.

h. Consent Form: How Will Legally Effective Informed Consent Be Obtained from All Participants (or Their Parent(s) or Guardian(s))? Include Form(S) to Be Used. If Deception Is Necessary, Please Justify, and Describe and Submit Debriefing Procedures
All participants will be drawn from English native language regions hence no need for a translator. The project does not involve any form of deception.
Minors and Others: If Minors or Other Vulnerable Participants Are Involved, Please Outline Procedures to Be Used in Obtaining Their Agreement (Assent) to Participate, in Addition to the Consent of the Parent(S) or Guardians). N/A