Forcas Armadas de Defesa De Mocambique Treat all Study Support
Abstract
Since 2015, the World Health Organization (WHO) has recommended the “Treat All” approach for people living with HIV (PLHIV) irrespective of age, CD4 cell count or WHO clinical stage. Good adherence and retention to antiretroviral therapy (ART) results in sustained viral load (VL) suppression to undetectable levels and slows disease progression, leading to improved clinical outcomes as well as reductions in HIV transmission. The Government of Mozambique has been taking bold steps to adopt the latest WHO recommendations, and in late August 2016 began implementing the “Treat All” approach in 12 districts in Mozambique. Within this context, Jhpiego, an affiliate of the Johns Hopkins University (JHU), is pleased to offer the U.S. Department of Defense (DOD) a 36-month proposal for $2,000,000 to support the Military Specific HIV/AIDS Prevention, Care, and Treatment Program for the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)-Funded Countries. In close collaboration with the DOD, Jhpiego will work directly with the Forças Armadas de Defesa de Moçambique (FADM) to conduct a multi-year study to evaluate the impact of implementing the “Treat All” approach in a military setting and the impact of doing so on the health of military personnel and HIV incidence and transmission in surrounding communities. Building on its current DOD-supported work as the FADM prevention, care and treatment partner, Jhpiego is well positioned to lead study implementation. The study will involve three groups of study participants: men who are in the military and civilian men and women living in the catchment area of the military bases. For military study participants, Jhpiego, in coordination with FADM, will lead the recruitment, enrollment and follow-up of study participants, including all survey (demographics, behavioral) and biologic data collection, per the approved study protocol. Any consenting military personnel who test positive for HIV will immediately be linked to care and initiated on ART and provided adherence support through peer educators and community adherence support groups (CASGs), as well as continuous VL monitoring per study protocol and national guidelines. For community participants, Jhpiego will lead the implementation of three cross-sectional surveys which, similar to the military component, will include demographic, behavioral and biologic specimen data collection. For both components, Jhpiego will manage all biologic samples according to the study protocol. Jhpiego will train the study team on proper sample collection, storage and transport, including how to collect biologic samples for HIV-1 Limiting Antigen (LAg)-Avidity assays and phylogenetic testing. To provide oversight for the study and adherence to good clinical research practice, Jhpiego will establish a Research Steering Committee and Data Safety Monitoring Board (DSMB) to build ownership, ensure protection of human subjects, and follow study process data and outcomes including adverse events. The Research Steering Committee and DSMB will meet regularly and will be composed of representatives of the FADM, DOD, the National Health Institute (INS), Ministry of Health (MOH), community members and Jhpiego. A key focus of the study will be to build capacity of FADM in good clinical practice, including complete adherence to protocol, data quality assurance, record keeping, data analysis, ethics and protection of human subjects in research. To that end, Jhpiego will include FADM personnel in training activities alongside study staff to prepare for, implement and monitor study implementation, including assisting with regular supervision and other procedures of study sites for quality assurance. FADM staff will also participate in the review and discussion of preliminary study results, as well as development and dissemination of the study report.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Sep 28, 2017
- Source ID
- N002441710034
Entities
People
- Leonardo Chavane
Organizations
- United States Navy