Barriers and facilitators to the uptake of Test and Treat in Mozambique: A qualitative study on patient and provider perceptions.

BACKGROUND: In mid-2016, Mozambique began phased implementation of the 'Test-and-Treat' policy, which enrolls HIV positive clients into antiretroviral treatment (ART) immediately regardless of CD4 cell count or disease stage. Novel insights into barriers and facilitators to ART initiation among healthy clients are needed to improve implementation of Test and Treat. METHODS AND FINDINGS: A cross-sectional qualitative study was conducted across 10 health facilities in Mozambique. In-depth interviews (IDIs) were conducted with HIV-positive clients (60 who initiated/20 who did not initiate ART within Test and Treat) and 9 focus group discussion (FGDs) were conducted with health care workers (HCWs; n = 53). Data were analyzed using deductive and inductive analysis strategies. Barriers to ART initiation included: (1) feeling 'healthy'; (2) not prepared to start ART for life; (3) concerns about ART side effects; (4) fear of HIV disclosure and discrimination; (5) poor interactions with HCWs; (6) limited privacy at health facilities; and (7) perceptions of long wait times. Facilitators included the motivation to stay healthy and to take care of dependents, as well as new models of ART services such as adaptation of counseling to clients' specific needs, efficient patient flow, and integrated HIV/primary care services. CONCLUSIONS: ART initiation may be difficult for healthy clients in the context of Test-and-Treat. Specific strategies to engage this population are needed. Strategies could include targeted support for clients, community sensitization on the benefits of early ART initiation, client-centered approaches to patient care, and improved efficiency through multi-month scripting and increased workforce.

Validity of reported retention in antiretroviral therapy after roll-out to peripheral facilities in Mozambique: Results of a retrospective national cohort analysis.

BACKGROUND: Retention in anti-retroviral therapy (ART) presents a challenge in sub-Saharan Africa. In Mozambique, after roll-out to peripheral facilities, the 12-month retention rate was reported mostly from sites with an electronic patient tracking system (EPTS), representing only 65% of patients. We conducted a nationally representative study, compared 12-month retention at EPTS and non-EPTS sites, and its predictors. METHODS: Applying a proportionate to population size sampling strategy, we obtained a nationally representative sample of patients who initiated ART between January 2013 and June 2014. We calculated weighted proportions of the patients' status at 12 months after ART initiation, and 12-month incidence of lost to follow-up (LTFU) and death. We assessed determinants of LTFU and death by calculating adjusted hazard ratios (AHR) through multivariate cox-proportional hazard models. RESULTS: Among 19,297 patients sampled, 54.3% were still active, 33.1% LTFU, 2.0% dead, 2.6% transferred-out and 8.0% had unknown status, 12 months after ART initiation. Total attrition rate (LTFU or dead) was 45.5/100PY, higher at facilities without EPTS (51.8/100PY) than with EPTS (37.7/100PY). Clinical stage IV (AHR = 1.7), CD4 count ≤150 (AHR = 1.3) and being pregnant (AHR = 1.6) were significantly associated with LTFU. Clinical stage III or IV (AHR = 2.1 and 3.8), CD4 count ≤150 (AHR = 3.0), not being pregnant (AHR = 3.0), and ART regimens with stavudine (AHR = 4.28) were significantly associated with deaths. Patients enrolled in adherence support groups were 4.6 times less likely to be LTFU, but the number (n = 174) was too small to be significant (p = 0.273). CONCLUSION: Retention in ART was substantially lower at non-EPTS sites. EPTS should be expanded to all ART sites to facilitate comprehensive routine monitoring of retention in care. Retention in Mozambique is low and needs to be improved, especially among pregnant women and patients with advanced disease at ART initiation. The effect of ART adherence support groups needs to be further monitored.

Validity of reported retention in antiretroviral therapy after roll-out to peripheral facilities in Mozambique: Results of a retrospective national cohort analysis

Retention in anti-retroviral therapy (ART) presents a challenge in sub-Saharan Africa. In Mozambique, after roll-out to peripheral facilities, the 12-month retention rate was reported mostly from sites with an electronic patient tracking system (EPTS), representing only 65% of patients. We conducted a nationally representative study, compared 12-month retention at EPTS and non-EPTS sites, and its predictors. Methods Applying a proportionate to population size sampling strategy, we obtained a nationally representative sample of patients who initiated ART between January 2013 and June 2014. We calculated weighted proportions of the patients' status at 12 months after ART initiation, and 12-month incidence of lost to follow-up (LTFU) and death. We assessed determinants of LTFU and death by calculating adjusted hazard ratios (AHR) through multivariate cox-proportional hazard models. Results Among 19,297 patients sampled, 54.3% were still active, 33.1% LTFU, 2.0% dead, 2.6% transferred-out and 8.0% had unknown status, 12 months after ART initiation. Total attrition rate (LTFU or dead) was 45.5/100PY, higher at facilities without EPTS (51.8/100PY) than with EPTS (37.7/100PY). Clinical stage IV (AHR = 1.7), CD4 count 150 (AHR = 1.3) and being pregnant (AHR = 1.6) were significantly associated with LTFU. Clinical stage III or IV (AHR = 2.1 and 3.8), CD4 count 150 (AHR = 3.0), not being pregnant (AHR = 3.0), and ART regimens with stavudine (AHR = 4.28) were significantly associated with deaths. Patients enrolled in adherence support groups were 4.6 times less likely to be LTFU, but the number (n = 174) was too small to be significant (p = 0.273)

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.

Wait and consult times for primary healthcare services in central Mozambique: a time-motion study.

BACKGROUND: We describe wait and consult times across public-sector clinics and identify health facility determinants of wait and consult times. DESIGN: We observed 8,102 patient arrivals and departures from clinical service areas across 12 public-sector clinics in Sofala and Manica Provinces between January and April 2011. Negative binomial generalized estimating equations were used to model associated health facility factors. RESULTS: Mean wait times (in minutes) were: 26.1 for reception; 43.5 for outpatient consults; 58.8 for antenatal visits; 16.2 for well-child visits; 8.0 for pharmacy; and 15.6 for laboratory. Mean consultation times (in minutes) were: 5.3 for outpatient consults; 9.4 for antenatal visits; and 2.3 for well-child visits. Over 70% (884/1,248) of patients arrived at the clinic to begin queuing for general reception prior to 10:30 am. Facilities with more institutional births had significantly longer wait times for general reception, antenatal visits, and well-child visits. Clinics in rural areas had especially shorter wait times for well-child visits. Outpatient consultations were significantly longer at the smallest health facilities, followed by rural hospitals, tertiary/quaternary facilities, compared with Type 1 rural health centers. DISCUSSION: The average outpatient consult in Central Mozambique lasts 5 min, following over 40 min of waiting, not including time to register at most clinics. Wait times for first antenatal visits are even longer at almost 1 h. Urgent investments in public-sector human resources for health alongside innovative operational research are needed to increase consult times, decrease wait times, and improve health system responsiveness.

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.

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.

Effects of a health information system data quality intervention on concordance in Mozambique: time-series analyses from 2009-2012.

BACKGROUND: We assessed the effects of a three-year national-level, ministry-led health information system (HIS) data quality intervention and identified associated health facility factors. METHODS: Monthly summary HIS data concordance between a gold standard data quality audit and routine HIS data was assessed in 26 health facilities in Sofala Province, Mozambique across four indicators (outpatient consults, institutional births, first antenatal care visits, and third dose of diphtheria, pertussis, and tetanus vaccination) and five levels of health system data aggregation (daily facility paper registers, monthly paper facility reports, monthly paper district reports, monthly electronic district reports, and monthly electronic provincial reports) through retrospective yearly audits conducted July-August 2010-2013. We used mixed-effects linear models to quantify changes in data quality over time and associated health system determinants. RESULTS: Median concordance increased from 56.3% during the baseline period (2009-2010) to 87.5% during 2012-2013. Concordance improved by 1.0% (confidence interval [CI]: 0.60, 1.5) per month during the intervention period of 2010-2011 and 1.6% (CI: 0.89, 2.2) per month from 2011-2012. No significant improvements were observed from 2009-2010 (during baseline period) or 2012-2013. Facilities with more technical staff (aß: 0.71; CI: 0.14, 1.3), more first antenatal care visits (aß: 3.3; CI: 0.43, 6.2), and fewer clinic beds (aß: -0.94; CI: -1.7, -0.20) showed more improvements. Compared to facilities with no stock-outs, facilities with five essential drugs stocked out had 51.7% (CI: -64.8 -38.6) lower data concordance. CONCLUSIONS: A data quality intervention was associated with significant improvements in health information system data concordance across public-sector health facilities in rural and urban Mozambique. Concordance was higher at those facilities with more human resources for health and was associated with fewer clinic-level stock-outs of essential medicines. Increased investments should be made in data audit and feedback activities alongside targeted efforts to improve HIS data in low- and middle-income countries.

Effects of a health information system data quality intervention on concordance in Mozambique: time-series analyses from 2009­2012

We assessed the effects of a three-year national-level, ministry-led health information system (HIS) data quality intervention and identified associated health facility factors. Monthly summary HIS data concordance between a gold standard data quality audit and routine HIS data was assessed in 26 health facilities in Sofala Province, Mozambique across four indicators (outpatient consults, institutional births, first antenatal care visits, and third dose of diphtheria, pertussis, and tetanus vaccination) and five levels of health system data aggregation (daily facility paper registers, monthly paper facility reports, monthly paper district reports, monthly electronic district reports, and monthly electronic provincial reports) through retrospective yearly audits conducted July-August 2010­2013. We used mixed-effects linear models to quantify changes in data quality over time and associated health system determinants. Median concordance increased from 56.3% during the baseline period (2009­2010) to 87.5% during 2012­2013. Concordance improved by 1.0% (confidence interval [CI]: 0.60, 1.5) per month during the intervention period of 2010­2011 and 1.6% (CI: 0.89, 2.2) per month from 2011­2012. No significant improvements were observed from 2009­2010 (during baseline period) or 2012­2013. Facilities with more technical staff (aß: 0.71; CI: 0.14, 1.3), more firstantenatal care visits (aß: 3.3; CI: 0.43, 6.2), and fewer clinic beds (aß: -0.94; CI: −1.7, −0.20) showed more improvements. Compared to facilities with no stock-outs, facilities with five essential drugs stocked out had 51.7% (CI: −64.8 -38.6) lower data concordance. A data quality intervention was associated with significant improvements in health information system data concordance across public-sector health facilities in rural and urban Mozambique. Concordance was higher at those facilities with more human resources for health and was associated with fewer clinic-level stock-outs of essential medicines. Increased investments should be made in data audit and feedback activities alongside targeted efforts to improve HIS data in low- and middle-income countries.

Stock-outs of essential health products in Mozambique - longitudinal analyses from 2011 to 2013.

OBJECTIVES: To assess the relationship between health system factors and facility-level EHP stock-outs in Mozambique. METHODS: Service provisions were assessed in 26 health facilities and 13 district warehouses in Sofala Province, Mozambique, from July to August in 2011-2013. Generalised estimating equations were used to model factors associated with facility-level availability of essential drugs, supplies and equipment. RESULTS: Stock-out rates for drugs ranged from 1.3% for oral rehydration solution to 20.5% for Depo-Provera and condoms, with a mean stock-out rate of 9.1%; mean stock-out rates were 15.4% for supplies and 4.1% for equipment. Stock-outs at the district level accounted for 27.1% (29/107) of facility-level drug stock-outs and 44.0% (37/84) of supply stock-outs. Each 10-km increase in the distance from district distribution warehouses was associated with a 31% (CI: 22-42%), 28% (CI: 17-40%) or 27% (CI: 7-50%) increase in rates of drug, supply or equipment stock-outs, respectively. The number of heath facility staff was consistently negatively associated with the occurrence of stock-outs. CONCLUSIONS: Facility-level stock-outs of EHPs in Mozambique are common and appear to disproportionately affect those living far from district capitals and near facilities with few health staff. The majority of facility-level EHP stock-outs in Mozambique occur when stock exists at the district distribution centre. Innovative methods are urgently needed to improve EHP supply chains, requesting and ordering of drugs, facility and district communication, and forecasting of future EHP needs in Mozambique. Increased investments in public-sector human resources for health could potentially decrease the occurrence of EHP stock-outs.