Systems Analysis and Improvement to Optimize pMTCT

HIV Clinical Trial

Official title:

Systems Analysis and Improvement to Optimize pMTCT: A Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023658
• Other study ID #: 44167-EG
• Secondary ID: R01HD075057
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: January 24, 2017
• Start date: January 2014
• Est. completion date: March 2015

Study information

• Verified date: January 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite significant increases in global health investment and the availability of low-cost, efficacious interventions designed to reduce mother to child HIV transmission in low and middle income countries with high HIV burden, the translation of these scientific advances into effective delivery strategies has been slow, uneven and incomplete. As a result, pediatric HIV infection remains largely uncontrolled. Enhancing the implementation of pMTCT interventions through contextually appropriate systems analysis and improvement approaches can potentially reduce drop-offs along the pMTCT cascade, leading to dramatic improvements in infant and maternal outcomes. The goal of this proposal is to develop a model for systematic assessment and improvement of pMTCT services in sub-Saharan Africa. In specific aim 1, we will identify health system factors and service delivery approaches associated with high and low performing pMTCT services in Côte d'Ivoire, Kenya and Mozambique. In specific aim 2 we will adapt evaluate the feasibility and impact of a systems analysis tool and associated performance enhancement approach for pMTCT services in Côte d'Ivoire, Kenya and Mozambique. This systems analysis tool and associated performance enhancement approach is currently being developed and piloted for pMTCT services in Mozambique. The results of this implementation research are expected to generate knowledge of global health significance, and by disseminating the study results and intervention tools through the broad PEPFAR network, can rapidly impact pMTCT service delivery enhancements across the highest need countries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• health facility with pMTCT services in central Mozambique, northern Cote d'Ivoire or western Kenya

• health facility with at least 20 HIV-infected women identified in antenatal care per year

Exclusion Criteria:

• health facility over 20 kilometers from a main transport corridor

• health facility with an ongoing prospective study or systems analysis and improvement approach in place

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• pMTCT systems analysis and improvement
Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.

Locations

Country	Name	City	State
Côte D'Ivoire	Ministry of Health	Bouake
Kenya	Ministry of Health	Nairobi
Mozambique	Ministry of Health	Beira	Sofala

Sponsors (6)

Lead Sponsor	Collaborator
University of Washington	Centro de Investigacao Operacional da Beira, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Health Alliance International, Network of AIDS Researchers of Eastern and Southern Africa, Universidade Eduardo Mondlane

Countries where clinical trial is conducted

Côte D'Ivoire,  Kenya,  Mozambique, 

References & Publications (2)

Gimbel S, Rustagi AS, Robinson J, Kouyate S, Coutinho J, Nduati R, Pfeiffer J, Gloyd S, Sherr K, Granato SA, Kone A, Cruz E, Manuel JL, Zucule J, Napua M, Mbatia G, Wariua G, Maina M; with input from the SAIA study team.. Evaluation of a Systems Analysis — View Citation

Sherr K, Gimbel S, Rustagi A, Nduati R, Cuembelo F, Farquhar C, Wasserheit J, Gloyd S; With input from the SAIA Study Team.. Systems analysis and improvement to optimize pMTCT (SAIA): a cluster randomized trial. Implement Sci. 2014 May 8;9:55. doi: 10.1186/1748-5908-9-55. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of HIV counseling and testing at first antenatal care visit	# women counseled and tested for HIV in their first ANC visit/# first ANC visits	Patients will be assessed at first antenatal care visit (average of 25 weeks gestational age)
Primary	Uptake of CD4 testing at antenatal care	# CD4 counts of HIV-infected pregnant women/# HIV-infected women newly identified in ANC	Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
Primary	Use of appropriate ARVs in pregnancy for prophylaxis or initiation of ART during pregnancy	# HIV-infected pregnant women starting AZT prophylaxis or ART /# women testing HIV-positive in ANC 3 months previously	Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
Primary	Infant HIV determination	# infants <6 weeks of age receiving a PCR test/# women testing HIV-positive in ANC 5 months previously	6 weeks post-partum