HIVNCT02023658
Systems Analysis and Improvement to Optimize pMTCT
A study testing pMTCT systems analysis and improvement in people with HIV, run by University of Washington at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- pMTCT systems analysis and improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Systems Analysis and Improvement to Optimize pMTCT: A Cluster Randomized Trial
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.
- Conditions
- HIV
- Being tested
- pMTCT systems analysis and improvement
- Keywords
- HIV, pMTCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pMTCT systems analysis and improvementOther
Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.
| Study group | Role | What they receive |
|---|---|---|
| Systems analysis and improvement | Experimental | pMTCT systems analysis and improvement Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Network of AIDS Researchers of Eastern and Southern Africa, Centro de Investigacao Operacional da Beira, Health Alliance International, Eduardo Mondlane University
- Responsible party
- Principal investigator, Kenneth Sherr, University of Washington
- Investigators
- Kenneth Sherr, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023658
- Sponsor's protocol ID
- 44167-EG
- Other IDs
- R01HD075057
- Status last verified
- Jan 2017
- First submitted
- 9 Dec 2013
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24885976Gimbel 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.
PubMed 27355497Rustagi 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.
PubMed 27082507Gimbel 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.
PubMed 25335783
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Analysis and Improvement to Optimize pMTCT: A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT02023658
- Acronym / sponsor ID
- 44167-EG
- Conditions
- HIV
- Keywords
- HIV, pMTCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Network of AIDS Researchers of Eastern and Southern Africa, Centro de Investigacao Operacional da Beira, Health Alliance International, Eduardo Mondlane University
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systems analysis and improvement | Experimental | Other: pMTCT systems analysis and improvementpMTCT systems analysis and improvement |
| Control | No intervention | –No systems analysis and improvement intervention for prevention of mother to child HIV transmission services in place. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pMTCT systems analysis and improvementFive-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities. | Other | Systems analysis and improvement |
Primary outcome
Uptake of HIV counseling and testing at first antenatal care visit
Time frame: Patients will be assessed at first antenatal care visit (average of 25 weeks gestational age)
# women counseled and tested for HIV in their first ANC visit/# first ANC visits
Uptake of CD4 testing at antenatal care
Time frame: Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
# CD4 counts of HIV-infected pregnant women/# HIV-infected women newly identified in ANC
Use of appropriate ARVs in pregnancy for prophylaxis or initiation of ART during pregnancy
Time frame: Patients will be assessed during the antenatal care period (average of 25-40 weeks gestational age)
# HIV-infected pregnant women starting AZT prophylaxis or ART /# women testing HIV-positive in ANC 3 months previously
Infant HIV determination
Time frame: 6 weeks post-partum
# infants <6 weeks of age receiving a PCR test/# women testing HIV-positive in ANC 5 months previously
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Background: PubMed 24885976Sherr 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.
- Results publication: PubMed 27355497Gimbel 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.
- Derived from this study: PubMed 27082507Rustagi 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.
- Derived from this study: PubMed 25335783Gimbel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Sherr, PhD principal investigator
University of Washington
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pMTCT systems analysis and improvement in people with HIV, run by University of Washington at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Côte d’Ivoire, Kenya, Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of HIV counseling and testing at first antenatal care visit (time frame: Patients will be assessed at first antenatal care visit (average of 25 weeks gestational age)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02023658, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017.