Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo
CQI-PMTCT
Continuous Quality Improvement Interventions to Improve Long Term Outcomes of Antiretroviral Therapy in Women Initiated on Therapy During Pregnancy or Breastfeeding in the Democratic Republic of Congo
2 other identifiers
interventional
5,053
1 country
1
Brief Summary
Despite the rapid adoption of the World Health Organization's 2013 guidelines, many children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health clinics (MCH). To achieve the UNAIDS goal eliminating mother-to-child HIV transmission, multiple, adaptive interventions will need to be implemented to improve adherence to the HIV continuum. The aim of this open label, parallel groups, randomized controlled trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district level to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthen to enable collection of high quality individual patient-level data necessary for the timely production of indicators and monitoring of program outcomes to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identified key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in DRC and other resource-limited settings to accelerate progress towards the goal of an AIDS free generation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 7, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedMay 2, 2025
April 1, 2025
4.7 years
February 7, 2017
April 29, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Loss-to-follow-up
the proportion of participants for whom the whereabouts is unknown at the evaluation time
delivery, six weeks, 12 and 24 weeks postpartum
Virological suppression
Proportion of participants with undetectable viral load
delivery, 12 and 24 months postpartum
Secondary Outcomes (4)
Timely Infant HIV diagnosis
delivery, six weeks, 12 and 24 weeks postpartum
Timely ART initiation
two weeks from HIV diagnosis
MTCT rates
delivery, six weeks, 12 and 24 weeks postpartum
Survival
delivery, six weeks, 12 and 24 weeks postpartum
Study Arms (2)
Continuous quality improvement (CQI)
EXPERIMENTALQuality improvement initiatives implemented at facility level using participatory data-driven approaches and on-site monitoring and supervisory support
Standard of care
NO INTERVENTIONIn health districts randomized to standard of care, the same strengthening of the data collection system for the monitoring of indicators as in the intervention group will be implemented. At least once a month, a study staff will visit each clinics irrespective of their randomization to extract information for the mother-infant register into an electronic database. No report on indicators will be produced for those clinic for the duration of the study. Staff from clinics and health district bureau in the standard of care group will not be associated with the quarterly review of the indicators. The study will not influence with any other HIV service provision activity in the standard of care group.
Interventions
A quality improvement team at the health district and at the clinics levels. A clinic level QI team will include at least one staff each from antenatal care (ANC), delivery/maternity, and well-child services. The head of the each QI team plus a supervisor from the health district bureau and a study team member constitute the district QI team. Immediately following randomization, we will bring together QI teams to review program and quality indicators from their clinics and across districts to identify key bottlenecks in the care delivery system and agree on an action plan to modify them. QI teams will be responsible for the implementation of the action plan at the level of their respective clinics. Every three months, using data from the monitoring system, the process will be repeated for a duration 18 months. To limit possible contamination, all staff from a randomized district/clinic who may have a dual appointment in another facility will be excluded from QI teams.
Eligibility Criteria
You may qualify if:
- All women diagnosed with HIV during pregnancy or breastfeeding in the participating maternal and child health (MCH) clinics and initiated on antiretroviral therapy (ART) during the enrollment period
You may not qualify if:
- Refuse to participate
- Clinics will be excluded if less than 500 pregnant women (less than 5 HIV-infected pregnant women) registered for antenatal care (ANC) in the clinic in 2015
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kinshasa School of Public Health
Kinshasa, Democratic Republic of the Congo
Related Publications (7)
Yotebieng M, Mpody C, Ravelomanana NL, Tabala M, Malongo F, Kawende B, Ntangu P, Behets F, Okitolonda E; CQI-PMTCT study team. HIV viral suppression among pregnant and breastfeeding women in routine care in the Kinshasa province: a baseline evaluation of participants in CQI-PMTCT study. J Int AIDS Soc. 2019 Sep;22(9):e25376. doi: 10.1002/jia2.25376.
PMID: 31496051BACKGROUNDYotebieng M, Behets F, Kawende B, Ravelomanana NLR, Tabala M, Okitolonda EW. Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial. BMC Health Serv Res. 2017 Apr 26;17(1):306. doi: 10.1186/s12913-017-2253-9.
PMID: 28446232BACKGROUNDMpody C, Thompson P, Tabala M, Ravelomanana NLR, Malongo F, Kawende B, Behets F, Okitolonda E, Yotebieng M; CQI-PMTCT study team. Hepatitis B infection among pregnant and post-partum women living with HIV and on antiretroviral therapy in Kinshasa, DR Congo: A cross-sectional study. PLoS One. 2019 May 9;14(5):e0216293. doi: 10.1371/journal.pone.0216293. eCollection 2019.
PMID: 31071145BACKGROUNDThompson P, Mpody C, Sayre W, Rigney C, Tabala M, Ravelomanana NLR, Malongo F, Kawende B, Behets F, Okitolonda E, Yotebieng M; CQI-PMTCT study team. Hepatitis C prevalence and quality of health services among HIV-positive mothers in the Democratic Republic of the Congo. Sci Rep. 2022 Jan 26;12(1):1384. doi: 10.1038/s41598-022-05014-3.
PMID: 35082320BACKGROUNDZotova N, Familiar I, Kawende B, Kasindi FL, Ravelomanana N, Parcesepe AM, Adedimeji A, Lancaster KE, Kaba D, Babakazo P, Yotebieng M. HIV disclosure and depressive symptoms among pregnant women living with HIV: a cross-sectional study in the Democratic Republic of Congo. J Int AIDS Soc. 2022 Feb;25(2):e25865. doi: 10.1002/jia2.25865.
PMID: 35129301BACKGROUNDNdlovu KS, Pavan RR, Corry J, Gregory AC, Mahamed S, Zotova N, Tabala M, Babakazo P, Funderburg NT, Yotebieng M, Klatt NR, Kwiek JJ, Sullivan MB. The vaginal microbiome of pregnant people living with HIV on antiretroviral therapy in the Democratic Republic of Congo: a pilot study and global meta-analysis. mSphere. 2026 Jan 26:e0059725. doi: 10.1128/msphere.00597-25. Online ahead of print.
PMID: 41586522DERIVEDBoisson-Walsh A, Thompson P, Fried B, Shea CM, Ngimbi P, Lumande F, Tabala M, Kashamuka MM, Babakazo P, Domino ME, Yotebieng M. Childhood immunization uptake determinants in Kinshasa, Democratic Republic of the Congo: ordered regressions to assess timely infant vaccines administered at birth and 6-weeks. Glob Health Res Policy. 2023 Dec 6;8(1):50. doi: 10.1186/s41256-023-00338-7.
PMID: 38057919DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcel Yotebieng, MD, PhD
Albert Einstein College of Medicine
- PRINCIPAL INVESTIGATOR
Emile W Okitolonda, MD, PhD
Kinshasa School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The intervention will be implemented at the health facility level by the health facility staff under the supervision of health districts supervisors and investigators. As such, care providers nor investigations cannot be masked from the intervention. however, participant will not be told about the intervention or which study group they are in.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 7, 2017
First Posted
February 9, 2017
Study Start
November 1, 2016
Primary Completion
June 30, 2021
Study Completion
June 30, 2022
Last Updated
May 2, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
The final dataset will include self-reported demographic and behavioral data from interviews with the subjects, clinical and laboratory data from the mother-infant pair, and blood specimens provided. Although the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for the proposed research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed and results publish.