Clinical trial NCT03048669: Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Antiretroviral Therapy
Pregnancy Outcomes
HIV-exposed Infants
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Kinshasa School of Public Health
First posted: 2017-02-09
Enrollment: 5053
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Loss-to-follow-up
timeFrame: delivery, six weeks, 12 and 24 weeks postpartum
measure: Virological suppression
timeFrame: delivery, 12 and 24 months postpartum
Secondary outcomes:
measure: Timely Infant HIV diagnosis
timeFrame: delivery, six weeks, 12 and 24 weeks postpartum
measure: Timely ART initiation
timeFrame: two weeks from HIV diagnosis
measure: MTCT rates
timeFrame: delivery, six weeks, 12 and 24 weeks postpartum
measure: Survival
timeFrame: delivery, six weeks, 12 and 24 weeks postpartum
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
Study officials:
affiliation: Albert Einstein College of Medicine
name: Marcel Yotebieng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kinshasa School of Public Health
name: Emile W Okitolonda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Yotebieng 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.
citation: Mpody 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.
citation: Thompson 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.
citation: Zotova 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.