Clinical trial NCT02023658: Systems Analysis and Improvement to Optimize pMTCT
Official title: Systems Analysis and Improvement to Optimize pMTCT: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
pMTCT
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Network of AIDS Researchers of Eastern and Southern Africa
name: Centro de Investigacao Operacional da Beira
name: Health Alliance International
name: Eduardo Mondlane University
First posted: 2013-12-30
Enrollment: 36
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Uptake of HIV counseling and testing at first antenatal care visit
timeFrame: Patients will be assessed at first antenatal care visit (average of 25 weeks gestational age)
measure: Uptake of CD4 testing at antenatal care
timeFrame: Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
measure: Use of appropriate ARVs in pregnancy for prophylaxis or initiation of ART during pregnancy
timeFrame: Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
measure: Infant HIV determination
timeFrame: 6 weeks post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: Bouake
country: Côte D'Ivoire
facility: Ministry of Health
city: Nairobi
country: Kenya
facility: Ministry of Health
city: Beira
country: Mozambique
facility: Ministry of Health
state: Sofala
Study officials:
affiliation: University of Washington
name: Kenneth Sherr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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 and Improvement Approach to Optimize Prevention of Mother-To-Child Transmission of HIV Using the Consolidated Framework for Implementation Research. J Acquir Immune Defic Syndr. 2016 Aug 1;72 Suppl 2(Suppl 2):S108-16. doi: 10.1097/QAI.0000000000001055.
citation: Rustagi AS, Gimbel S, Nduati R, Cuembelo Mde F, Wasserheit JN, Farquhar C, Gloyd S, Sherr K; with input from the SAIA Study Team. Implementation and Operational Research: Impact of a Systems Engineering Intervention on PMTCT Service Delivery in Cote d'Ivoire, Kenya, Mozambique: A Cluster Randomized Trial. J Acquir Immune Defic Syndr. 2016 Jul 1;72(3):e68-76. doi: 10.1097/QAI.0000000000001023.
citation: Gimbel S, Voss J, Mercer MA, Zierler B, Gloyd S, Coutinho Mde J, Floriano F, Cuembelo Mde F, Einberg J, Sherr K. The prevention of mother-to-child transmission of HIV cascade analysis tool: supporting health managers to improve facility-level service delivery. BMC Res Notes. 2014 Oct 21;7:743. doi: 10.1186/1756-0500-7-743.