Nancy Czaicki

Rationale and design of a randomized study of short-term food and cash assistance to improve adherence to antiretroviral therapy among food insecure HIV-infected adults in Tanzania

BackgroundFood insecurity is an important barrier to retention in care and adherence to antiretroviral therapy (ART) among people living with HIV infection (PLHIV). However, there is a lack of rigorous evidence about how to improve food security and HIV-related clinical outcomes. To address this gap, this randomized trial will evaluate three delivery models for short-term food and nutrition support for food insecure PLHIV in Shinyanga, Tanzania: nutrition assessment and counseling (NAC) alone, NAC plus food assistance, and NAC plus cash transfers.Methods/DesignAt three HIV care and treatment sites, 788 participants will be randomized into one of three study arms in a 3:3:1 ratio, stratified by site: NAC plus food assistance, NAC plus cash transfer, and NAC only. Eligible participants are: 1) at least 18 years of age; 2) living with HIV infection; 3) initiated ART in the past 90 days; and 4) food insecure, as measured with the Household Hunger Scale. PLHIV who are severely malnourished (body mass index (BMI) < 16 kg/m2) will be excluded. Participants randomized to receive food or cash transfers are eligible to receive assistance for up to six months, conditional on attending regularly scheduled visits with their HIV care provider. Participants will be followed for 12 months: the initial 6-month intervention period and then for another 6 months post-intervention. The primary outcome is ART adherence measured with the medication possession ratio. Secondary outcomes include 1) retention in care; 2) nutritional indicators including changes in food security, BMI, and weight gain; 3) viral suppression and self-reported ART adherence; and 4) participation in the labor force.DiscussionThis rigorously designed trial will inform policy decisions regarding supportive strategies for food insecure PLHIV in the early stages of treatment. The study will measure outcomes immediately after the period of support ends as well as 6 months later, providing information on the duration of the interventions’ effect. The comparison of food to cash transfers will better inform policies favoring cash assistance or will provide rationale for the continued investment in food and nutrition interventions for PLHIV.Trial registrationClinicalTrials.gov: NCT01957917.

Understanding Sustained Retention in HIV/AIDS Care and Treatment: a Synthetic Review

Sustained retention represents an enduring and evolving challenge to HIV treatment programs in Africa. We present a theoretical framework for sustained retention borrowing from ecologic principles of sustainability and dynamic adaptation. We posit that sustained retention from the patient perspective is dependent on three foundational principles: (1) patient activation: the acceptance, prioritization, literacy, and skills to manage a chronic disease condition, (2) social normalization: the engagement of a social network and harnessing social capital to support care and treatment, and (3) livelihood routinization: the integration of care and treatment activities into livelihood priorities that may change over time. Using this framework, we highlight barriers specific to sustained retention and review interventions addressing long-term, sustained retention in HIV care with a focus on Sub-Saharan Africa.

Trypanosoma cruzi Survival following Cold Storage: Possible Implications for Tissue Banking

While Trypanosoma cruzi, the etiologic agent of Chagas disease, is typically vector-borne, infection can also occur through solid organ transplantation or transfusion of contaminated blood products. The ability of infected human cells, tissues, and cellular and tissue-based products (HCT/Ps) to transmit T. cruzi is dependent upon T. cruzi surviving the processing and storage conditions to which HCT/Ps are subjected. In the studies reported here, T. cruzi trypomastigotes remained infective 24 hours after being spiked into blood and stored at room temperature (N = 20); in 2 of 13 parasite-infected cultures stored 28 days at 4°C; and in samples stored 365 days at −80°C without cryoprotectant (N = 28), despite decreased viability compared to cryopreserved parasites. Detection of viable parasites after multiple freeze/thaws depended upon the duration of frozen storage. The ability of T. cruzi to survive long periods of storage at +4 and −80°C suggests that T. cruzi-infected tissues stored under these conditions are potentially infectious.

Estimated mortality on HIV treatment among active patients and patients lost to follow-up in 4 provinces of Zambia: Findings from a multistage sampling-based survey.

Background Survival represents the single most important indicator of successful HIV treatment. Routine monitoring fails to capture most deaths. As a result, both regional assessments of the impact of HIV services and identification of hotspots for improvement efforts are limited. We sought to assess true mortality on treatment, characterize the extent under-reporting of mortality in routine health information systems in Zambia, and identify drivers of mortality across sites and over time using a multistage, regionally representative sampling approach. Methods and findings We enumerated all HIV infected adults on antiretroviral therapy (ART) who visited any one of 64 facilities across 4 provinces in Zambia during the 24-month period from 1 August 2013 to 31 July 2015. We identified a probability sample of patients who were lost to follow-up through selecting facilities probability proportional to size and then a simple random sample of lost patients. Outcomes among patients lost to follow-up were incorporated into survival analysis and multivariate regression through probability weights. Of 165,464 individuals (64% female, median age 39 years (IQR 33–46), median CD4 201 cells/mm3 (IQR 111–312), the 2-year cumulative incidence of mortality increased from 1.9% (95% CI 1.7%–2.0%) to a corrected rate of 7.0% (95% CI 5.7%–8.4%) (all ART users) and from 2.1% (95% CI 1.8%–2.4%) to 8.3% (95% CI 6.1%–10.7%) (new ART users). Revised provincial mortality rates ranged from 3–9 times higher than naïve rates for new ART users and were lowest in Lusaka Province (4.6 per 100 person-years) and highest in Western Province (8.7 per 100 person-years) after correction. Corrected mortality rates varied markedly by clinic, with an IQR of 3.5 to 7.5 deaths per 100 person-years and a high of 13.4 deaths per 100 person-years among new ART users, even after adjustment for clinical (e.g., pretherapy CD4) and contextual (e.g., province and clinic size) factors. Mortality rates (all ART users) were highest year 1 after treatment at 4.6/100 person-years (95% CI 3.9–5.5), 2.9/100 person-years (95% CI 2.1–3.9) in year 2, and approximately 1.6% per year through 8 years on treatment. In multivariate analysis, patient-level factors including male sex and pretherapy CD4 levels and WHO stage were associated with higher mortality among new ART users, while male sex and HIV disclosure were associated with mortality among all ART users. In both cases, being late (>14 days late for appointment) or lost (>90 days late for an appointment) was associated with deaths. We were unable to ascertain the vital status of about one-quarter of those lost and selected for tracing and did not adjudicate causes of death. Conclusions HIV treatment in Zambia is not optimally effective. The high and sustained mortality rates and marked under-reporting of mortality at the provincial-level and unexplained heterogeneity between regions and sites suggest opportunities for the use of corrected mortality rates for quality improvement. A regionally representative sampling-based approach can bring gaps and opportunities for programs into clear epidemiological focus for local and global decision makers.

It helps me live, sends my children to school, and feeds me: a qualitative study of how food and cash incentives may improve adherence to treatment and care among adults living with HIV in Tanzania

ABSTRACT Financial and in-kind incentives have been shown to improve outcomes along the HIV care cascade, however the potential mechanismsthrough which they work remain unclear. To identify the pathways through which incentives improve retention in care and adherence to antiretroviral therapy (ART), we conducted a qualitative study with participants in a trial evaluating conditional food and cash incentives for HIV-positive food insecure adults in Shinyanga, Tanzania. We found that the incentives acted through three pathways to potentially increase retention in care and adherence to ART: (1) addressing competing needs and offsetting opportunity costs associated with clinic attendance, (2) alleviating stress associated with attending clinic and meeting basic needs, and (3) by potentially increasing motivation. Participants did not report any harmful events associated with the incentives, but reported myriad beneficial effects on household welfare. Understanding how incentives are used and how they impact outcomes can improve the design of future interventions.

Nonadherence to antiretroviral therapy among HIVinfected patients in Zambia is concentrated among a minority of patients and is highly variable across clinics

Objectives: The distribution of adherence to antiretroviral therapy (ART) can indicates whether barriers are concentrated or more distributed. We quantified the medication possession ratio (MPR) and characterized the distribution of medication nonpossession in a network of clinics in Zambia to identify ‘hotspots’ and predictors of poorer adherence. Methods: We analyzed a population of adults on ART for more than 3 months who made at least one clinic visit between 1 January 2013 and 28 February 2015. Pharmacy refill and clinical information were obtained through the electronic medical record system used in routine care. We constructed a Lorenz curve to visualize the distribution of poor adherence and used a multilevel logistic regression model to examine factors associated with MPR. Results: Among 131 767 patients in 56 clinics [64% women, median age 34 years (interquartile range (IQR) 29–41), median CD4+ cell count at ART initiation 351 cells/&mgr;l (IQR 220–517)], the median MPR was 85.8% (IQR 70.8–96.8). During months 7–12 on ART, 45.6% of patients had 100% MPR and 10.5% accounted for 50% of medication nonpossession. Across clinics, median MPR ranged from 49.1 to 98.5, and clinic accounted for 12% of the variability in adherence after adjusting for individual and clinic-level characteristics. Conclusion: A small fraction of patients account for the majority of days of medication nonpossession. Further characterization of these subpopulations is needed to target interventions. Clinic also accounted for much variability in MPR. Health systems interventions targeting clinic ‘hot spots’ may represent an efficient use of resources to improve ART adherence.

Understanding preferences for HIV care and treatment in Zambia: Evidence from a discrete choice experiment among patients who have been lost to follow-up

Background In public health HIV treatment programs in Africa, long-term retention remains a challenge. A number of improvement strategies exist (e.g., bring services closer to home, reduce visit frequency, expand hours of clinic operation, improve provider attitude), but implementers lack data about which to prioritize when resource constraints preclude implementing all. We used a discrete choice experiment (DCE) to quantify preferences for a number of potential clinic improvements to enhance retention. Methods and findings We sought a random sample of HIV patients who were lost to follow-up (defined as >90 days late for their last scheduled appointment) from treatment facilities in Lusaka Province, Zambia. Among those contacted, we asked patients to choose between 2 hypothetical clinics in which the following 5 attributes of those facilities were varied: waiting time at the clinic (1, 3, or 5 hours), distance from residence to clinic (5, 10, or 20 km), ART supply given at each refill (1, 3, or 5 months), hours of operation (morning only, morning and afternoon, or morning and Saturday), and staff attitude (“rude” or “nice”). We used mixed-effects logistic regression to estimate relative utility (i.e., preference) for each attribute level. We calculated how much additional waiting time or travel distance patients were willing to accept in order to obtain other desired features of care. Between December 9, 2015 and May 31, 2016, we offered the survey to 385 patients, and 280 participated (average age 35; 60% female). Patients exhibited a strong preference for nice as opposed to rude providers (relative utility of 2.66; 95% CI 1.9–3.42; p < 0.001). In a standard willingness to wait or willingness to travel analysis, patients were willing to wait 19 hours more or travel 45 km farther to see nice rather than rude providers. An alternative analysis, in which trade-offs were constrained to values actually posed to patients in the experiment, suggested that patients were willing to accept a facility located 10 km from home (as opposed to 5) that required 5 hours of waiting per visit (as opposed to 1 hour) and that dispensed 3 months of medications (instead of 5) in order to access nice (as opposed to rude) providers. This study was limited by the fact that attributes included in the experiment may not have captured additional important determinants of preference. Conclusions In this study, patients were willing to expend considerable time and effort as well as accept substantial inconvenience in order to access providers with a nice attitude. In addition to service delivery redesign (e.g., differentiated service delivery models), current improvement strategies should also prioritize improving provider attitude and promoting patient centeredness—an area of limited policy attention to date.

Transitioning couple's voluntary HIV counseling and testing (CVCT) from stand-alone weekend services into routine antenatal and VCT services in government clinics in Zambia's two largest cities.

Introduction Most HIV infections in Africa are acquired by married/cohabiting adults and WHO recommends couple’s voluntary HIV counseling and testing (CVCT) for prevention. The handover from NGO-sponsored weekend CVCT to government-sponsored services in routine weekday antenatal care (ANC) and individual voluntary testing and counseling (VCT) services in Zambia’s two largest cities from 2009–2015 is described. Methods Government clinic counselors were trained to provide CVCT, and along with community health workers they promoted CVCT services in their clinic and surrounding areas. When client volume exceeded the capacity of on-duty staff in ANC and VCT, non-governmental organization (NGO) subsidies were offered for overtime pay. Results Implementation of routine CVCT services varied greatly by clinic and city. The 12 highest volume clinics were examined further, while 13 clinics had CVCT numbers that were too low to warrant further investigation. In Lusaka, the proportion of pregnant women whose partners were tested rose from 2.6% in 2009 to a peak of 26.2% in 2012 and 24.8% in 2015. Corresponding reports in Ndola were 2.0% in 2009, 17.0% in 2012 and 14.5% in 2015. Obstacles to CVCT included: limited space and staffing, competing priorities, record keeping not adapted for couples, and few resources for promotion and increasing male involvement. Conflicting training models for ‘partner testing’ with men and women separately vs. CVCT with joint post-test counseling led to confusion in reporting to district health authorities. Discussion A focused and sustained effort will be required to reach a meaningful number of couples with CVCT to prevent heterosexual and perinatal HIV transmission. Establishing targets and timelines, funding for dedicated and appropriately trained staff, adoption of standardized data recording instruments with couple-level indicators, and expansion of community and clinic-based promotions using proven models are recommended.

Do incentives undermine intrinsic motivation? Increases in intrinsic motivation within an incentive-based intervention for people living with HIV in Tanzania

Background Cash and in-kind incentives can improve health outcomes in various settings; however, there is concern that incentives may ‘crowd out’ intrinsic motivation to engage in beneficial behaviors. We examined this hypothesis in a randomized trial of food and cash incentives for people living with HIV infection in Tanzania. Methods We analyzed data from 469 individuals randomized to one of three study arms: standard of care, short-term cash transfers, or short-term food assistance. Eligible participants were: 1) ≥18 years old; 2) HIV-infected; 3) food insecure; and 4) initiated antiretroviral therapy (ART) ≤90 days before the study. Food or cash transfers, valued at ~

Estimating the real-world effects of expanding antiretroviral treatment eligibility: Evidence from a regression discontinuity analysis in Zambia

11 per month and conditional on attending clinic visits, were provided for ≤6 months. Intrinsic motivation was measured at baseline, 6, and 12 months using the autonomous motivation section of the Treatment Self-Regulation Questionnaire (TSRQ). We compared the change in TSRQ score from baseline to 6 and 12 months and the change within study arms. Results The mean intrinsic motivation score was 2.79 at baseline (range: 1–3), 2.91 at 6 months (range: 1–3), and 2.95 at 12 months (range: 2–3), which was 6 months after the incentives had ended. Among all patients, the intrinsic motivation score increased by 0.13 points at 6 months (95% CI (0.09, 0.17), Cohen’s d = 0.29) and 0.19 points at 12 months (95% CI (0.14, 0.24), Cohen’s d = 0.49). Intrinsic motivation also increased within each study group at 6 months: 0.15 points in the food arm (95% CI (0.09, 0.21), Cohen’s d = 0.37), 0.11 points in the cash arm (95% CI (0.05, 0.18), Cohen’s d = 0.25), and 0.08 points in the comparison arm (95% CI (-0.03, 0.19), Cohen’s d = 0.21); findings were similar at 12 months. Increases in motivation were statistically similar between arms at 6 and 12 months. Conclusion Intrinsic motivation for ART adherence increased significantly both overall and within the food and cash incentive arms, even after the incentive period was over. Increases in motivation did not differ by study group. These results suggest that incentive interventions for treatment adherence should not be withheld due to concerns of crowding out intrinsic motivation.