Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique
Condition: HIV
MeSH terms: HIV Seropositivity
Study type: Interventional

Summary: 
      The overall objective of the study is to develop and test a pilot intervention in central
      Mozambique to implement the new WHO "Option B+" guidelines that seek to increase the
      proportion of HIV-positive pregnant women in six antenatal care clinics who start
      antiretroviral therapy (ART) prior to delivery, and are retained in care after 90- days.
    

Detailed description: 
      For over 10 years, services to prevent maternal to child HIV-1 transmission (PMTCT) have been
      scaled-up and integrated into antenatal care (ANC) in the national health system across
      Mozambique. In 2004, scale-up of anti-retroviral treatment (ART) also began in Mozambique and
      is now provided at hundreds of health units. In 2010, the World Health Organization developed
      new treatment guidelines, termed "Option B" that emphasized early initiation of ART in
      antenatal care for all HIV-positive pregnant women. In 2012, the WHO issued a programmatic
      update endorsing a third option termed "Option B+" in which HIV positive pregnant women
      initiate ART during pregnancy regardless of disease progression and continue treatment for
      life.

      The new "Option B+" approach has been adopted by the Ministry of Health (MoH) in Mozambique
      and is in the early phases of implementation. As in many African settings, numerous health
      system factors present major challenges to successful adoption of the guidelines. In
      Mozambique, 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.

      The successful implementation of new WHO guidelines therefore requires major streamlining of
      links among ANC, PMTCT, and ART services. The overall objective of this study is to develop
      and test a pilot intervention in central Mozambique to implement the new WHO guidelines, and
      increase the proportion of HIV-positive pregnant women in target ANC clinics who start ART
      prior to delivery, without reducing ART adherence in the first 3 months of therapy. The
      intervention will emphasize a WHO defined "Option B+" approach; HIV-positive mothers will be
      referred for ART at the time they receive a positive HIV test result in their first ANC
      visit. The project utilizes an innovative formative research process, which has already been
      completed, and a stepped wedge implementation science design to evaluate the intervention.
      The entire study is being conducted in close collaboration with the Center for Operations
      Research in Beira (known by its Portuguese acronym as CIOB) that is one of three research
      centers in Mozambique managed by the MOH National Institute of Health (the research arm of
      the MoH).
    

Intervention name(s): Adherence and retention package
Intervention type(s): Other
Intervention description(s): Based on formative research findings, the following core components of the B+ study intervention have been designed and will be stepped in at the study sites to improve early retention in care and adherence:
Workflow modification: 1) Redefinition of key roles of MCH nurses and task shifting to community health workers (CHW's), and 2) enhanced patient tracking via improved management of registries/charts;
Adherence and retention package: 1) Creation of "Adherence Committees" at each site to coordinate and systematize patient follow-up, 2) active patient follow-up and home visits by community health workers (CHWs or activistas), 3) use of text messaging to patients by MCH nurses, 4) improved and intensified counseling coordinated with active CHW and text follow-up, and 5) intensified and improved Option B+ training and supportive supervision.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: HIV; Mozambique; antenatal care; adherence; retention; pregnancy; HIV-positive mothers retained in ART after 90 days