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Cycle 1
Reducing Loss-to-Follow-Up Among HIV-exposed Infants in Central Mozambique
Principal Investigator: Manuel Napua, Beira Operations Research Center 
NIH-Supported Collaborator: James Pfeiffer, University of Washington
Title of NIH Award: Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique
Project Overview
Diagnosis and care for children exposed to HIV remains a major challenge throughout the developing world. Identifying HIV-exposed infants, diagnosing HIV infection and starting HIV-positive infants on treatment requires a well-coordinated care cascade. This care cascade has proven challenging in many developing countries, including Mozambique. Preliminary research suggests that the current system in Manica and Sofala Provinces in Mozambique retain less than 50% of HIV-exposed infants in appropriate care. Failure to properly identify and treat HIV-positive infants contributes to childhood morbidity and mortality. In addition, the problem of vertical HIV transmission is compounded by limited access to family planning services for HIV-positive women. In Manica and Sofala Province, only 13% of women use family planning methods. In 2012, the WHO adopted a “test-and-treat” approach, referred to as “Option B+”, that seeks to streamline the treatment cascade by starting ART in all HIV-positive women at the time of diagnosis in antenatal care services (ANC) regardless of CD4 count to avoid delays and multiple visits that contribute to LTFU.The new Option B+ approach has been adopted by the Ministry of Health (MoH) in Mozambique and is in the early phases of implementation. In Mozambique, antenatal care (ANC) and HIV testing coverage is high but there is substantial loss-to-follow-up (LTFU) at successive stages in the treatment cascade, limited counseling for women and many barriers to actively tracking those women lost to follow-up. Early Ministry of Health data suggests significant challenges remain for long-term adherence for women started on ART via the new Option B+ framework in Manica and Sofala provinces and throughout Mozambique. This project will build off an existing NIH grant– a clustered (facility) randomized controlled implementation science trial to improve the rollout of “Option B+”, in which HIV positive pregnant women initiate ART during pregnancy regardless of CD4 count and continue treatment for life.
The objectives of this study are to identify causes of loss-to-follow-up of HIV-exposed infants in care cascade and barriers to family planning access and then design and implement an intervention that will increase the proportion of infants tested for HIV and enrolled in pediatric HIV care as well as increase the proportion of HIV-positive women receiving family planning services.
This study will identify causes of loss-to-follow-up of HIV-exposed infants in the care cascade and barriers to family planning access through qualitative and quantitative formative research. In close collaboration with the Ministry of Health, the investigators will then design an intervention based on formative research findings which utilizes three core components: enhanced system tracking and linkages for HIV-exposed infants, improved counseling for infant caregivers regarding appropriate care for HIV-exposed and HIV-positive infants, and integration of family planning counseling in well child, postpartum and child at risk clinic visits. Once this intervention is developed, the study team will implement the intervention through a clustered (facility-level) randomized controlled trial using a stepped-wedge design to test the effectiveness of the intervention.
Public Health Impact:
This project has the potential to influence current USAID and Ministry of Health practices by testing an approach that could be scaled up at similar facilities throughout Mozambique that suffer similar challenges with loss-to-follow-up of HIV-exposed infants and poor contraception access.

NIH Collaborator:
Dr. Pfeiffer is currently collaborating with the Beira Operations Research Center on an NIH supported clustered (facility) randomized controlled implementation science trial to improve the rollout of “Option B+” in Mozambique, which focuses on the HIV positive pregnant women.

Health Cycle 1 Recipients