NCT02023658

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable hiv

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

December 9, 2013

Last Update Submit

January 24, 2017

Conditions

HIV

Keywords

HIVpMTCT

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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

Study Arms (2)

Systems analysis and improvement

EXPERIMENTAL

pMTCT systems analysis and improvement

Other: pMTCT systems analysis and improvement

Control

NO INTERVENTION

No systems analysis and improvement intervention for prevention of mother to child HIV transmission services in place.

Interventions

pMTCT systems analysis and improvementOTHER

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

Systems analysis and improvement

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ministry of Health

Bouaké, Côte d’Ivoire

Location

Ministry of Health

Nairobi, Kenya

Location

Ministry of Health

Beira, Sofala, Mozambique

Location

Related Publications (4)

  • 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.

    PMID: 24885976BACKGROUND

  • 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.

    PMID: 27355497RESULT

  • 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.

    PMID: 27082507DERIVED

  • 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.

    PMID: 25335783DERIVED

Study Officials

  • Kenneth Sherr, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 30, 2013

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

CÔ(1)KE(1)MO(1)