Male to male HIV transmission is responsible for 5-10% of infections worldwide. In Nigeria, the national prevalence is about 4%, while prevalence among men who have sex with men (MSM) in Abuja is 42%. There are several barriers that prevent access to treatment for this group, which include strong negative social attitudes and legal prohibitions. The purpose of the TRUST study is to evaluate the impact of providing comprehensive and integrated prevention, treatment and care at a community venue operated by local organization supportive of MSM.
To this end, 600 participants would be recruited at the International Center for Advocacy and Right Community Centre, Garki, Abuja and Garki Hospital, Garki. The study would later be expanded to Lagos where 600 participants would be recruited at the Harvey Road Community Health Center, Yaba and Lagos University Teaching Hospital, Ikeja. Recruitment would be done using Respondent Driven Sampling where researchers rely on their participants to recruit other participants.
Upon visiting the lab, the participant is required to read and sign the informed consent document to be enrolled in the study. Once a participant has been enrolled, an HIV test would be performed using the standard of care rapid assay algorithm by the study nurse. Participants would be referred to the study physician who performs routine examinations. Two anal swabs must be collected at every visit using the APTIMA swab kits. If ulcerative lesions are present, additional two dry swabs must be taken. If anal warts are present, participants are referred to the Military Center at Mogadishu Cantonment. The Physician must perform the standard of care for management of HIV infection. The patient is then escorted to the lab for additional sample collection. For HIV+ participants, the lab technician or assistant collects 30ml of blood using two 10ml purple top EDTA vacutainers and one 10ml red top serum vacutainer. For HIV- participants, the lab technician or assistant collects 4ml of blood using one 4ml purple top EDTA vacutainer. For all participants, 20ml of urine is collected into an appropriate collection device. HIV+ participants are escorted to the pharmacist, and subsequently to the counselor for adherence counseling. A sputum sample is also collected into a container.
The IHVN biorepository is responsible for processing, storage, and triaging samples for standard of care tests. Tests will be performed at the Asokoro Hospital Lab and the Asokoro Laboratory Training Center. STI assays would be performed at Defense Headquarter (DHQ) Medical Centre Reference Laboratory. For HIV+ participants, 1.5ml of whole blood from the 2x10mL EDTA purple top tube would be used for 5 dried blood spots, CD4 count, CBC, PCV and thick blood smear for malaria. The plasma would be aliquoted into six 1.5ml tubes. One tube would be used for HIV-1 RNA analysis while the others would be stored for future analysis. Five 1ml aliquots of serum would be created from the 10ml serum red top tube. 1 aliquot would be used for VDRL test for syphilis diagnosis, Hepatitis B testing, and VITROS chemistries and lipids analysis. The other aliquots would be stored for future analysis such as HSV-2 KALON ELISA, SediaBED and BioRad Avidity1/2.
These tests would be performed at the Asokoro Hospital Lab and the Asokoro Laboratory Training Center. At the Defense Headquarters (DHQ) Medical Centre Reference Laboratory, the urine collected using Gen-Probe collection devices would be tested for NG, CT, TV and MG. One Gen-probe swab would be used to test for NG, CT and TV, while the second one would be used to test for MG and storage. For HIV- participants, 1ml whole blood from the 4ml EDTA tube would be used to perform thick blood smear for malaria, VDRL test for syphilis diagnosis and Hepatitis B testing. One 1.5ml aliquot of plasma would be stored. At the Defense Headquarters (DHQ) Medical Centre Reference Laboratory, the same tests carried out for HIV+ participants would be performed on the urine and swab samples. The sputum sample collected from ALL participants is transferred to the Garki Hospital for TB smear microscopy.
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