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Cycle 1
Reducing Loss-to-Follow-Up Among HIV-exposed Infants in Central Mozambique
Principal Investigator: Lucia da Costa Vieira, Beira Operations Research Center (CIOB) 
NIH-Supported Collaborator: James Pfeiffer, University of Washington
Title of NIH Award: Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique
Project Dates: October 2013 - September 2020
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. 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.
PH 1-64 2016Q1 photo 1PH 1-64 2016Q1 photo 2

Summary of Overall Activities:

This study helped the project team and institution in many aspects. Starting during the protocol review process to ensure the overall scientific quality, feasibility, and ethical integrity of the project, the team quickly developed its capacity. The main team members of the study were a principal investigator, one research coordinator, two research assistants, two data enters, one psychologist and two administrative assistants. The team also organized meetings for data analysis with all researchers and EUA collaborators at the University of Washington, including James Pfeiffer, Rachel Chapman and Reed Soren who analyzed and reviewed the qualitative and quantitative data of formative and intervention research.

To strengthen the quality of ARV programs in Manica and Sofala provinces, the study team promoted several meeting with the key DPS (Health Provincial Directorate) and other leaders of mother and child and HIV programs about the intervention and the lessons learned throughout the implementation of the research. The health centers in these provinces were receptive to the project results and have implemented the intervention for reducing loss-to follow-up among HIV exposed infants as standard practice.

The team took many opportunities to disseminate the results. Through a 2018 PEER Evidence to Action supplement, the team organized the first CIOB Conference on Maternal and child health. The conference was held in the Manica province and all institutions and NGOs operating in the area of maternal and child health were invited to submit their work.

Every three years the Mozambique MoH (Ministry of Health) organizes a national health conference. The team presented the formative results in 2015 and intervention results in 2018. All the presentations were well received and the team was able to answer many questions and generate interest in the study. The team also disseminated the preliminary results of the study in all our collaborator institutions, namely the health facilities of the study, Manica and Sofala Provincial Health Directorates, MOH, and USAID Mozambique.

In Maputo the dissemination was done at the MoH National Directorate of Public Health board meeting. In the meeting all heads of the public health departments were present. The meeting was very productive, because the team was able to transmit the results of the outcome to those who matter most, given the fact that they are the key policy makers and have the power to change health policy. The team was pleased to receive the news that the Health Ministry is starting HAART in CCR, which was one of the main recommendations to the Ministry of Health.

The team wrote and submitted one paper to the 7th HIV Pediatric International Conference in Vancouver, Canada and it was approved to be presented as poster by the PI. Additionally, the team is currently writing three articles of the study for publication in international journals. The articles are:
  1. “HIV-exposed infant follow-up in Mozambique: Formative research findings for the design of a cluster randomized controlled trial to improve testing and ART initiation” that was published in BMC Health Services,
  2. “Stepped-Wedge cluster randomized controlled trial to promote HIV-exposed infant follow-up in central Mozambique”
  3. “Reengagement after mobile phone messages, calls and active search in improve retention on exposed/infected HIV care children’s in Mozambique