Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach.
BACKGROUND
Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended "Option B+" strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy.


METHODS
This study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care.


CONCLUSIONS
This pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care cascade in central Mozambique and to decrease the MTCT of HIV. This trial is designed to identify critical low-cost improvement strategies that can be bundled into a defined intervention. If this intervention has a measurable impact, it can be rapidly scaled up to other ANC in Mozambique and sub-Saharan Africa.


BACKGROUND
ClinicalTrials.gov: NCT02371265.
Department of Global Health, University of Washington Schools of Medicine and Public Health, 1705 NE Pacific St.,, Seattle, WA, 98195, USA. jcowan22@uw.edu.|Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. jcowan22@uw.edu.
James F
JF
Cowan
Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. mmicek@uw.edu.
Mark
M
Micek
Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. jfgreen@uw.edu.|Department of Family Medicine, University of Washington, Box 356390, Seattle, WA, 98195, USA. jfgreen@uw.edu.
Jessica F Greenberg
JF
Cowan
Beira Operations Research Center, Ministry of Health, Ponta Gea, Beira, Mozambique. manuel.napua@ins.gov.mz.
Manuel
M
Napúa
Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. roxanne.hoek@healthallianceinternational.org.
Roxanne
R
Hoek
Department of Global Health, University of Washington Schools of Medicine and Public Health, 1705 NE Pacific St.,, Seattle, WA, 98195, USA. sgimbel@uw.edu.|Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. sgimbel@uw.edu.|Department of Family and Child Nursing, University of Washington, Box 355809, Seattle, WA, 98195, USA. sgimbel@uw.edu.
Sarah
S
Gimbel
Department of Global Health, University of Washington Schools of Medicine and Public Health, 1705 NE Pacific St.,, Seattle, WA, 98195, USA. gloyd@uw.edu.|Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. gloyd@uw.edu.
Stephen
S
Gloyd
Department of Global Health, University of Washington Schools of Medicine and Public Health, 1705 NE Pacific St.,, Seattle, WA, 98195, USA. ksherr@uw.edu.|Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. ksherr@uw.edu.
Kenneth
K
Sherr
Department of Global Health, University of Washington Schools of Medicine and Public Health, 1705 NE Pacific St.,, Seattle, WA, 98195, USA. jamespf@u.washington.edu.|Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. jamespf@u.washington.edu.|Department of Anthropology, University of Washington, Box 353100, Seattle, WA, 98195, USA. jamespf@u.washington.edu.
James T
JT
Pfeiffer
Department of Global Health, University of Washington Schools of Medicine and Public Health, 1705 NE Pacific St.,, Seattle, WA, 98195, USA. rrc4@u.washington.edu.|Health Alliance International (HAI), 1107 NE 45th St., Suite 350, Seattle, WA, 98105, USA. rrc4@u.washington.edu.|Department of Anthropology, University of Washington, Box 353100, Seattle, WA, 98195, USA. rrc4@u.washington.edu.
Rachel R
RR
Chapman
D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000635:transmission*; D006801:Humans; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008875:Middle Aged; D009073:Mozambique; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy*; D058996:Quality Improvement / Q000458:organization & administration; D012107:Research Design; D014944:World Health Organization; D055815:Young Adult
D019380:Anti-HIV Agents