HIV-exposed infant follow-up in Mozambique: formative research findings for the design of a cluster randomized controlled trial to improve testing and ART initiation.

BACKGROUND: Early infant diagnosis (EID) of HIV-exposed and initiation of HIV-positive infants on anti-retroviral therapy (ART) requires a well-coordinated cascade of care. Loss-to-follow-up (LTFU) can occur at multiple steps and effective EID is impeded by human resource constraints, difficulty with patient tracking, and long waiting periods. The objective of this research was to conduct formative research to guide the development of an intervention to improve the pediatric HIV care cascade in central Mozambique. The study was conducted in Manica and Sofala Provinces where the adult HIV burden is higher than the national average. The research focused on 3 large clinics in each province, along the highly populated Beira corridor. METHODS: The research was conducted in 2014 over 3 months at six facilities and consisted of 1) patient flow mapping and collection of health systems data from postpartum, child-at-risk, and ART service registries, 2) measurement of clinic waiting times, and 3) patient and health worker focus groups. RESULTS: HIV testing and ART initiation coverage for mothers tends to be high, but EID and pediatric ART initiation are hampered by lack of patient tracking, long waiting times, and inadequate counseling to navigate the care cascade. About 76% of HIV-positive infants were LTFU and did not initiate ART. CONCLUSIONS: Effective interventions to reduce LTFU in EID and improve pediatric ART initiation should focus on patient tracking, active follow-up of defaulting patients, reduction in EID turn-around times for PCR results, and initiation of ART by nurses in child-at-risk services. TRIAL REGISTRATION: Retrospectively registered, ISRCTN67747315, July 24, 2019.

HIV-exposed infant follow-up in Mozambique: formative research findings for the design of a cluster randomized controlled trial to improve testing and ART initiation

Background: Early infant diagnosis (EID) of HIV-exposed and initiation of HIV-positive infants on anti-retroviral therapy (ART) requires a well-coordinated cascade of care. Loss-to-follow-up (LTFU) can occur at multiple steps and effective EID is impeded by human resource constraints, difficulty with patient tracking, and long waiting periods. The objective of this research was to conduct formative research to guide the development of an intervention to improve the pediatric HIV care cascade in central Mozambique. The study was conducted in Manica and Sofala Provinces where the adult HIV burden is higher than the national average. The research focused on 3 large clinics in each province, along the highly populated Beira corridor. Methods: The research was conducted in 2014 over 3months at six facilities and consisted of 1) patient flow mapping and collection of health systems data from postpartum, child-at-risk, and ART service registries, 2) measurement of clinic waiting times, and 3) patient and health worker focus groups. Results: HIV testing and ART initiation coverage for mothers tends to be high, but EID and pediatric ART initiation are hampered by lack of patient tracking, long waiting times, and inadequate counseling to navigate the care cascade. About 76% of HIV-positive infants were LTFU and did not initiate ART. Conclusions: Effective interventions to reduce LTFU in EID and improve pediatric ART initiation should focus on patient tracking, active follow-up of defaulting patients, reduction in EID turn-around times for PCR results, and initiation of ART by nurses in child-at-risk services. Trial registration: Retrospectively registered, ISRCTN67747315, July 24, 2019.

Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique.

BACKGROUND: This randomized trial studied performance of Option B+ in Mozambique and evaluated an enhanced retention package in public clinics. SETTING: The study was conducted at 6 clinics in Manica and Sofala Provinces in central Mozambique. METHODS: Seven hundred sixty-one pregnant women tested HIV+, immediately initiated antiretroviral (ARV) therapy, and were followed to track retention at 6 clinics from May 2014 to May 2015. Clinics were randomly allocated within a stepped-wedge fashion to intervention and control periods. The intervention included (1) workflow modifications and (2) active patient tracking. Retention was defined as percentage of patients returning for 30-, 60-, and 90-day medication refills within 25-35 days of previous refills. RESULTS: During control periods, 52.3% of women returned for 30-day refills vs. 70.8% in intervention periods [odds ratio (OR): 1.80; 95% confidence interval (CI): 1.05 to 3.08]. At 60 days, 46.1% control vs. 57.9% intervention were retained (OR: 1.82; CI: 1.06 to 3.11), and at 90 days, 38.3% control vs. 41.0% intervention (OR: 1.04; CI: 0.60 to 1.82). In prespecified subanalyses, birth before pickups was strongly associated with failure-women giving birth before ARV pickup were 33.3 times (CI: 4.4 to 250.3), 7.5 times (CI: 3.6 to 15.9), and 3.7 times (CI: 2.2 to 6.0) as likely to not return for ARV pickups at 30, 60, and 90 days, respectively. CONCLUSIONS: The intervention was effective at 30 and 60 days, but not at 90 days. Combined 90-day retention (40%) and adherence (22.5%) were low. Efforts to improve retention are particularly important for women giving birth before ARV refills.

Research capacity building integrated into PHIT projects: leveraging research and research funding to build national capacity.

BACKGROUND: Inadequate research capacity impedes the development of evidence-based health programming in sub-Saharan Africa. However, funding for research capacity building (RCB) is often insufficient and restricted, limiting institutions' ability to address current RCB needs. The Doris Duke Charitable Foundation's African Health Initiative (AHI) funded Population Health Implementation and Training (PHIT) partnership projects in five African countries (Ghana, Mozambique, Rwanda, Tanzania and Zambia) to implement health systems strengthening initiatives inclusive of RCB. METHODS: Using Cooke's framework for RCB, RCB activity leaders from each country reported on RCB priorities, activities, program metrics, ongoing challenges and solutions. These were synthesized by the authorship team, identifying common challenges and lessons learned. RESULTS: For most countries, each of the RCB domains from Cooke's framework was a high priority. In about half of the countries, domain specific activities happened prior to PHIT. During PHIT, specific RCB activities varied across countries. However, all five countries used AHI funding to improve research administrative support and infrastructure, implement research trainings and support mentorship activities and research dissemination. While outcomes data were not systematically collected, countries reported holding 54 research trainings, forming 56 mentor-mentee relationships, training 201 individuals and awarding 22 PhD and Masters-level scholarships. Over the 5 years, 116 manuscripts were developed. Of the 59 manuscripts published in peer-reviewed journals, 29 had national first authors and 18 had national senior authors. Trainees participated in 99 conferences and projects held 37 forums with policy makers to facilitate research translation into policy. CONCLUSION: All five PHIT projects strongly reported an increase in RCB activities and commended the Doris Duke Charitable Foundation for prioritizing RCB, funding RCB at adequate levels and time frames and for allowing flexibility in funding so that each project could implement activities according to their trainees' needs. As a result, many common challenges for RCB, such as adequate resources and local and international institutional support, were not identified as major challenges for these projects. Overall recommendations are for funders to provide adequate and flexible funding for RCB activities and for institutions to offer a spectrum of RCB activities to enable continued growth, provide adequate mentorship for trainees and systematically monitor RCB activities.

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.

BACKGROUND: Despite large investments to prevent mother-to-child-transmission (PMTCT), pediatric HIV elimination goals are not on track in many countries. The Systems Analysis and Improvement Approach (SAIA) study was a cluster randomized trial to test whether a package of systems engineering tools could strengthen PMTCT programs. We sought to (1) define core and adaptable components of the SAIA intervention, and (2) explain the heterogeneity in SAIA's success between facilities. METHODS: The Consolidated Framework for Implementation Research (CFIR) guided all data collection efforts. CFIR constructs were assessed in focus group discussions and interviews with study and facility staff in 6 health facilities (1 high-performing and 1 low-performing site per country, identified by study staff) in December 2014 at the end of the intervention period. SAIA staff identified the intervention's core and adaptable components at an end-of-study meeting in August 2015. Two independent analysts used CFIR constructs to code transcripts before reaching consensus. RESULTS: Flow mapping and continuous quality improvement were the core to the SAIA in all settings, whereas the PMTCT cascade analysis tool was the core in high HIV prevalence settings. Five CFIR constructs distinguished strongly between high and low performers: 2 in inner setting (networks and communication, available resources) and 3 in process (external change agents, executing, reflecting and evaluating). DISCUSSION: The CFIR is a valuable tool to categorize elements of an intervention as core versus adaptable, and to understand heterogeneity in study implementation. Future intervention studies should apply evidence-based implementation science frameworks, like the CFIR, to provide salient data to expand implementation to other settings.

Option B+ in Mozambique: Formative Research Findings for the Design of a Facility-Level Clustered Randomized Controlled Trial to Improve ART Retention in Antenatal Care.

INTRODUCTION: With the rollout of "Option B+" in Mozambique in 2013, initial data indicated major challenges to early retention in antiretroviral therapy (ART) among HIV-positive pregnant women. We sought to develop and test a pilot intervention in 6 large public clinics in central Mozambique to improve retention of mothers starting ART in antenatal care. The results from the formative research from this study described here were used to design the intervention. METHODS: The research was initiated in early 2013 and completed in early 2014 in each of the 6 study clinics and consisted of (1) patient flow mapping and measurement of retention through collection of health systems data from antenatal care registries, pharmacy registries, ART clinic databases, (2) workforce assessment and measurement of patient waiting times, and (3) patient and worker individual interviews and focus groups. RESULTS: Coverage of HIV testing and ART initiation were over 90% at all sites, but retention at 30-, 60-, and 90-day pharmacy refill visits was very low ranging from only 5% at 1 site to 30% returning at 90 days. These data revealed major systemic bottlenecks that contributed to poor adherence and retention in the first month after ART initiation. Long wait times, short consultations, and poor counseling were identified as barriers. CONCLUSIONS: Based on these findings, we designed an intervention with these components: (1) workflow modification to redefine nurse tasks, shift tasks to community health workers, and enhance patient tracking and (2) an adherence and retention package to systematize active patient follow-up, ensure home visits by community health workers, use text messaging, and intensify counseling by health staff. This intervention is currently under evaluation using a stepped wedge design.

Suicide Attempts and Deaths in Sofala, Mozambique, From 2011 to 2014.

BACKGROUND: Mozambique was recently estimated to have the highest suicide rate in Africa. AIMS: To fill a knowledge gap on suicide attempts and deaths in Mozambique. METHOD: We reviewed a census of 898 emergency psychiatric consultations from March 2013 to July 2014 and 1,173 violent death autopsy records from June 2011 to August 2014 at Beira Central Hospital in Sofala, Mozambique. RESULTS: In all, 18.0% of emergency psychiatric consultations were suicide attempts. Females were disproportionately represented (68.3%, p < .001), and the mean age was 26.8 years. Rat poison was used in 66% of attempts, followed by unspecified methods (19.8%), and unspecified poisoning (6.8%). Of the violent death autopsies, 10% were suicides. Suicide deaths were more likely to be male (67.3%, p < .001), and the mean age was 30.8 years. Common methods were hanging (43.2%), unspecified substance (28.0%), or rat poison (26.3%). Common places of death were the hospital or hospital transit (46.4%) and the household (35.7%). Female suicide deaths more often involved toxic substances and males more often employed hanging. CONCLUSION: Females more often present with suicide attempts, but deaths due to suicide are more frequent among males. Females more often use toxic substances, whereas males more often use lethal methods, such as hanging. Policies to reduce the availability or toxicity of rat poison should be considered.

Outpatient Mental Health Services in Mozambique: Use and Treatments.

To describe current outpatient mental health service use and treatments in Mozambique, the authors reviewed registry entries for 2,071 outpatient psychiatric visits at the Beira Central Hospital in Sofala Province from January 2012 to September 2014. Service use was most common for schizophrenia, followed by epilepsy, delirium, and organic behavioral disorders. Only 3% of consultations for schizophrenia were first-visit patients. Treatment seeking among women was more likely for mood and neurotic disorders and less likely for substance use disorders and epilepsy. First-generation antipsychotics, most often paired with promethazine, dominated treatment regimens. Evidence-based reforms are needed to improve identification of mood disorders and broaden care beyond severe mental disorders.

Health facility determinants and trends of ICD-10 outpatient psychiatric consultations across Sofala, Mozambique: time-series analyses from 2012 to 2014.

BACKGROUND: Few peer-reviewed publications have taken a longitudinal or systems approach to mental healthcare (MH) utilization in low- and middle-income countries. We analyzed: (1) outpatient ICD-10 diagnoses over time and by gender; and (2) health facility determinants of MH service utilization. METHODS: We reviewed a census of 15,856 outpatient psychiatric consultations conducted at Ministry clinics in Sofala province, Mozambique from January 2012-June 2014. Generalized estimating equations were used to model facility determinants of ICD-10 diagnoses. RESULTS: Across the period, 48.9 % of consults were for epilepsy, 22.4 % for schizophrenia/delusional disorders, and 8.8 % for neurotic/stress-related disorders. The proportion of schizophrenia/delusional disorders has decreased over time (32 % in 2012; 13 % in 2014, p = 0.003), in favor of greater diversity of diagnoses. Epilepsy has increased significantly in absolute and proportional terms. Women are more likely to present for neurotic/stress-related conditions (12.8 % of consults for women, 5.7 % for men, p < 0.001), while men are more likely to present for substance use (1.9 % for women, 6.4 % for men, p < 0.001). Clinics with more psychiatric technicians have a 2.1-fold (CI: 1.2, 3.6) increased rate of schizophrenia/delusional disorder diagnoses. Rural clinics saw a higher proportion of epilepsy cases and a lower proportion of organic, substance use, schizophrenia, and mood disorder cases. DISCUSSION AND CONCLUSIONS: Outpatient MH service provision is increasing in Mozambique, although currently focuses on epilepsy and schizophrenia/delusional disorders. Mid-level psychiatric providers appear to be associated with a higher proportion of schizophrenia/delusional disorder diagnoses. Due to diagnostic or utilization differences, rural clinics may be missing important cases of organic, substance use, schizophrenia, and mood disorders. Models and decision-support tools for mental healthcare integration with primary care practice are needed in Mozambique to allow further scale-up of mental health services.

The availability of essential medicines for mental healthcare in Sofala, Mozambique.

OBJECTIVE: We assessed the availability of essential medicines for mental healthcare (MH) across levels of the public healthcare system to aid in future systems planning. DESIGN: Non-expired MH medications were assessed in 24 public health facilities and 13 district warehouses across Sofala Province, Mozambique, from July to August 2014. Medication categories included: antipsychotics, antidepressants, benzodiazepines, antiepileptics and mood stabilizers, and anticholinergics and antihistamines. RESULTS: Only 7 of 12 (58.3%) district warehouses, 11 of 24 (45.8%) of all health facilities, and 10 of 12 (83.3%) of facilities with trained MH staff had availability of at least one medication of each category. Thioridazine was the most commonly available antipsychotic across all facilities (9 of 24, 37.5%), while chlorpromazine and thioridazine were most common at facilities providing MH care (8 of 12, 66.7%). The atypical antipsychotic risperidone was not available at any facility or district warehouse. Amitriptyline was the most commonly available antidepressant (10 of 12 districts; 12 of 24 overall facilities; 9 or 12 MH facilities). Despite being on the national essential drug list, fluoxetine was only available at one quaternary-level facility and no district warehouses. CONCLUSIONS: Essential psychotropic medicines are routinely unavailable at public health facilities. Current essential drug lists include six typical but no atypical antipsychotics, which is concerning given the side-effect profiles of typical antipsychotics. Ensuring consistent availability of at least one selective serotonin reuptake inhibitor should also be a priority, as they are essential for the treatment of individuals with underlying cardiovascular disease and/or suicidal ideation. Similar to successful task-sharing approaches used for HIV/AIDS, mid-level providers could be retrained and certified to prescribe and monitor first-line psychotropic regimens.

Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach.

BACKGROUND: Despite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended "Option B+" strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy. METHODS: This study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care. DISCUSSION: This pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care cascade in central Mozambique and to decrease the MTCT of HIV. This trial is designed to identify critical low-cost improvement strategies that can be bundled into a defined intervention. If this intervention has a measurable impact, it can be rapidly scaled up to other ANC in Mozambique and sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02371265.