HIV/AIDSCQI-PMTCTNCT03048669
Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo
A study testing Continuous quality improvement in people with HIV/AIDS and Antiretroviral Therapy, run by Albert Einstein College of Medicine at 1 site in Democratic Republic of the Congo.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV/AIDS, Antiretroviral Therapy, Pregnancy Outcomes
- What is being tested?
- Continuous quality improvement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,053 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Nov 2016to 30 Jun 2022
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Kinshasa School of Public Health
Kinshasa
About this study
Official title: 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
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.
Read the detailed description
The US President's Emergency Plan for AIDS Relief (PEPFAR) goal of an AIDS-free generation, re-emphasized in PEPFAR 3.0, will not be achieved without substantial improvement in the adherence to the HIV care continuum among women in maternal and child health clinics (MCH) in resource-limited settings. In a recent meta-analysis of loss to follow-up (LTFU) across the prevention of mother-to-child transmission of HIV (PMTCT) cascade, about 50% of HIV+ pregnant women are already LTFU by delivery; within 3 months of delivery 33.9% of mother-infant pairs are also LTFU. Consequently, half of pediatric infections are currently estimated to occur in the postpartum period during breastfeeding and fewer than 40% of HEI are tested for HIV at 2-3 months. Determinants of this poor performance occur at multiple levels: healthcare delivery systems, providers, and beneficiaries (HIV-infected mothers). Current evidence suggest that beyond individual-level factors, healthcare delivery system level factors are paramount. Quality Improvement (QI) Collaborative is one of the most popular methods for organizing sustained improvement efforts at hospitals and ambulatory practices worldwide. In the Breakthrough Series approach also refer to as continuous quality improvement (CQI),10 QI teams from multiple sites across a region or country are brought together to focus on a common problem. Over one or two years, experts in clinical and performance improvement provide the group with periodic instructions and encourage the teams to share lessons learned and best practices. However, its popularity, CQI effectiveness has never been demonstrated in a randomized trial or a well-designed comparative study. The aims of the proposed study are: 1) to evaluate the effectiveness of CQI interventions in improving long-term retention in care and virological suppression in women who start lifelong ART in MCH clinics and 2) to identify modifiable health delivery system factors associated with retention in care and sustained virological suppression in women who start lifelong ART in MCH clinics. The study will be implemented in Kinshasa, Democratic Republic of Congo (DRC): an extremely resource-limited country that has struggled to emerge from decades of gross mismanagement, rampant corruption, and wars that have left its health infrastructures in shambles. We will conduct a cluster-randomized trial with health districts as the randomization unit. MCH clinics in the intervention group, will undergo CQI initiatives using participatory data-driven approaches and on-site monitoring and supervisory support. We will use surveys of health facilities, including selected staff, and service beneficiaries (HIV infected mothers) to collect data on key characteristics of the service delivery's organization and providers' and patients' perspective of the HIV care delivery performance. The main outcomes will be LTFU/retention in care, virological suppression and MTCT rates evaluated at 24 months postpartum.
- Being tested
- Continuous quality improvement
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous quality improvementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Continuous quality improvement (CQI) | Experimental | Quality improvement initiatives implemented at facility level using participatory data-driven approaches and on-site monitoring and supervisory support Receives: Other: Continuous quality improvement |
| Standard of care | No intervention | In 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss-to-follow-up
the proportion of participants for whom the whereabouts is unknown at the evaluation time
Measured: delivery, six weeks, 12 and 24 weeks postpartum
Virological suppression
Proportion of participants with undetectable viral load
Measured: delivery, 12 and 24 months postpartum
Secondary outcomes (4)
Timely Infant HIV diagnosis
Proportion of HIV-exposed infant with an appropriate HIV test result
Measured: delivery, six weeks, 12 and 24 weeks postpartum
Timely ART initiation
Proportion of HIV-infected participants (mother or infant) initiated on ART within two weeks of diagnosis
Measured: two weeks from HIV diagnosis
MTCT rates
Proportion of HIV-exposed infant who test positive for HIV
Measured: delivery, six weeks, 12 and 24 weeks postpartum
Survival
Proportion of participating mothers and infants know to be alive
Measured: delivery, six weeks, 12 and 24 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startNov 2016
- Primary completion30 Jun 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 5,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kinshasa School of Public Health
- Responsible party
- Principal investigator, Marcel Yotebieng, Albert Einstein College of Medicine
- Investigators
- Marcel Yotebieng, MD, PhD, Principal investigator, Albert Einstein College of MedicineEmile W Okitolonda, MD, PhD, Principal investigator, Kinshasa School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048669
- Sponsor's protocol ID
- 2020-12018
- Other IDs
- 1R01HD087993
- Acronym
- CQI-PMTCT
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2017
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31496051Yotebieng 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.
PubMed 28446232Mpody 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.
PubMed 31071145Thompson 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.
PubMed 35082320Zotova 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.
PubMed 35129301Yotebieng M, Rosa Ravelomanana NL, Kawende B, Tabala M, Malongo F, Lumande F, Zotova N, Babakazo P. Effect of health-system continuous quality improvement on long-term retention in HIV care among pregnant and breastfeeding women in the Democratic Republic of Congo: A cluster-randomized trial. medRxiv [Preprint]. 2026 Sep 25:2026.09.24.26363877. doi: 10.64898/2026.09.24.26363877.
PubMed 42818503Ndlovu 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 Feb 24;11(2):e0059725. doi: 10.1128/msphere.00597-25. Epub 2026 Jan 26.
PubMed 41586522Boisson-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.
PubMed 38057919
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03048669
- Acronym / sponsor ID
- CQI-PMTCT / 2020-12018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,053 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kinshasa School of Public Health
- Study start
- Nov 2016 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Feb 2017 (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 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.
Detailed description
The US President's Emergency Plan for AIDS Relief (PEPFAR) goal of an AIDS-free generation, re-emphasized in PEPFAR 3.0, will not be achieved without substantial improvement in the adherence to the HIV care continuum among women in maternal and child health clinics (MCH) in resource-limited settings. In a recent meta-analysis of loss to follow-up (LTFU) across the prevention of mother-to-child transmission of HIV (PMTCT) cascade, about 50% of HIV+ pregnant women are already LTFU by delivery; within 3 months of delivery 33.9% of mother-infant pairs are also LTFU. Consequently, half of pediatric infections are currently estimated to occur in the postpartum period during breastfeeding and fewer than 40% of HEI are tested for HIV at 2-3 months. Determinants of this poor performance occur at multiple levels: healthcare delivery systems, providers, and beneficiaries (HIV-infected mothers). Current evidence suggest that beyond individual-level factors, healthcare delivery system level factors are paramount. Quality Improvement (QI) Collaborative is one of the most popular methods for organizing sustained improvement efforts at hospitals and ambulatory practices worldwide. In the Breakthrough Series approach also refer to as continuous quality improvement (CQI),10 QI teams from multiple sites across a region or country are brought together to focus on a common problem. Over one or two years, experts in clinical and performance improvement provide the group with periodic instructions and encourage the teams to share lessons learned and best practices. However, its popularity, CQI effectiveness has never been demonstrated in a randomized trial or a well-designed comparative study. The aims of the proposed study are: 1) to evaluate the effectiveness of CQI interventions in improving long-term retention in care and virological suppression in women who start lifelong ART in MCH clinics and 2) to identify modifiable health delivery system factors associated with retention in care and sustained virological suppression in women who start lifelong ART in MCH clinics. The study will be implemented in Kinshasa, Democratic Republic of Congo (DRC): an extremely resource-limited country that has struggled to emerge from decades of gross mismanagement, rampant corruption, and wars that have left its health infrastructures in shambles. We will conduct a cluster-randomized trial with health districts as the randomization unit. MCH clinics in the intervention group, will undergo CQI initiatives using participatory data-driven approaches and on-site monitoring and supervisory support. We will use surveys of health facilities, including selected staff, and service beneficiaries (HIV infected mothers) to collect data on key characteristics of the service delivery's organization and providers' and patients' perspective of the HIV care delivery performance. The main outcomes will be LTFU/retention in care, virological suppression and MTCT rates evaluated at 24 months postpartum.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous quality improvement (CQI) | Experimental | Other: Continuous quality improvementQuality improvement initiatives implemented at facility level using participatory data-driven approaches and on-site monitoring and supervisory support |
| Standard of care | No intervention | –In 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Continuous quality improvementA 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. | Other | Continuous quality improvement (CQI) |
Primary outcome
Loss-to-follow-up
Time frame: delivery, six weeks, 12 and 24 weeks postpartum
the proportion of participants for whom the whereabouts is unknown at the evaluation time
Virological suppression
Time frame: delivery, 12 and 24 months postpartum
Proportion of participants with undetectable viral load
4 secondary outcomes
Timely Infant HIV diagnosis
Time frame: delivery, six weeks, 12 and 24 weeks postpartum
Timely ART initiation
Time frame: two weeks from HIV diagnosis
MTCT rates
Time frame: delivery, six weeks, 12 and 24 weeks postpartum
Survival
Time frame: delivery, six weeks, 12 and 24 weeks postpartum
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 2 May 2025.
- Background: PubMed 31496051Yotebieng 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.
- Background: PubMed 28446232Yotebieng 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.
- Background: PubMed 31071145Mpody 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.
- Background: PubMed 35082320Thompson 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.
- Background: PubMed 35129301Zotova 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.
- Derived from this study: PubMed 42818503Yotebieng M, Rosa Ravelomanana NL, Kawende B, Tabala M, Malongo F, Lumande F, Zotova N, Babakazo P. Effect of health-system continuous quality improvement on long-term retention in HIV care among pregnant and breastfeeding women in the Democratic Republic of Congo: A cluster-randomized trial. medRxiv [Preprint]. 2026 Sep 25:2026.09.24.26363877. doi: 10.64898/2026.09.24.26363877.
- Derived from this study: PubMed 41586522Ndlovu 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 Feb 24;11(2):e0059725. doi: 10.1128/msphere.00597-25. Epub 2026 Jan 26.
- Derived from this study: PubMed 38057919Boisson-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.
- 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 CongoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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.
Marcel Yotebieng, MD, PhD principal investigator
Albert Einstein College of Medicine
Emile W Okitolonda, MD, PhD principal investigator
Kinshasa School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous quality improvement in people with HIV/AIDS and Antiretroviral Therapy, run by Albert Einstein College of Medicine at 1 site in Democratic Republic of the Congo.
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 1 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 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. 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?
Loss-to-follow-up (time frame: delivery, six weeks, 12 and 24 weeks postpartum). The study lists 2 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 NCT03048669, which also lists 8 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 2 May 2025.