ART Adherence Among Malawian Youth Enrolled in Teen Clubs: A Retrospective Chart Review.

To improve outcomes among HIV-positive adolescents, the Malawi Ministry of Health is supporting scale-up of "Teen Clubs," a facility-based antiretroviral treatment (ART) delivery model. Teen Clubs are monthly ART clinics for adolescents (10-19 years old) that provide clinical services and peer psychosocial support. This paper assesses ART adherence among Teen Club attendees in Malawi. We performed a retrospective analysis of medical records and Teen Club attendance data on 589 HIV-positive adolescents at 16 Partners in Hope (PIH)-Extending Quality Improvement for HIV/AIDS in Malawi (EQUIP) supported facilities across Malawi, from January to June of 2017, who attended at least two Teen Club sessions. Multi-level logistic regression models were used to examine the role of gender and age on optimal ART adherence (≥ 95% based on pill count) among HIV-positive adolescents enrolled in Teen Clubs. The median age of adolescents in this sample was 14 years, and 47% were male. Older adolescent males (15-19 years) were 64% more likely to achieve ≥ 95% ART adherence (aOR 1.64, 95% CI 1.16-2.31, p < 0.01) compared to younger (10-14 years) males. The effect of age on adherence was smaller and not significant among females (aOR 1.36, 95% CI 0.96-1.94, p = 0.08). In the full model including males and females, older adolescence was associated with higher odds of optimal adherence (aOR 1.48, 95% CI 1.16-1.90, p < 0.01). These results reinforce the need for age-specialized programming for adolescents, and future research should evaluate this in achieving optimal ART adherence.

Integrated care experiences and out-of-pocket expenditures: a cross-sectional survey of adults receiving treatment for HIV and hypertension in Malawi.

OBJECTIVES: As HIV-positive individuals' life expectancy extends, there is an urgent need to manage other chronic conditions during HIV care. We assessed the care-seeking experiences and costs of adults receiving treatment for both HIV and hypertension in Malawi. DESIGN, SETTING AND PARTICIPANTS: A cross-sectional survey was conducted with HIV-positive adults with hypertension at a health facility in Lilongwe that offers free HIV care and free hypertension screening, with antihypertensives available for purchase (n=199). Questions included locations and costs of all medication refills and preferences for these refill locations. Respondents were classified as using 'integrated care' if they refilled HIV and antihypertensive medications simultaneously. Data were collected between June and December 2017. RESULTS: Only half of respondents reported using the integrated care offered at the study site. Among individuals using different locations for antihypertensive medication refills, the most frequent locations were drug stores and public sector health facilities which were commonly selected due to greater convenience and lower medication costs. Although the number of antihypertensive medications was equivalent between the integrated and non-integrated care groups, the annual total cost of care differed substantially (approximately US$21 in integrated care vs US$90 for non-integrated care)-mainly attributable to differences in other visit costs for non-integrated care (transportation, lost wages, childcare). One-third of those in the non-integrated care group reported no expenditure for antihypertensive medication, and six people in each group reported no annual hypertension care-seeking costs at all. CONCLUSIONS: Individuals using integrated care saw efficiencies because, although they were more likely to pay for antihypertensive medications, they did not incur additional costs. These results suggest that preferences and experiences must be better understood to design effective policies and programmes for integrated care among adults on antiretroviral therapy.

Diagnostic Utility and Impact on Clinical Decision Making of Focused Assessment With Sonography for HIV-Associated Tuberculosis in Malawi: A Prospective Cohort Study.

BACKGROUND: The focused assessment with sonography for HIV-associated tuberculosis (TB) (FASH) ultrasound protocol has been increasingly used to help clinicians diagnose TB. We sought to quantify the diagnostic utility of FASH for TB among individuals with HIV in Malawi. METHODS: Between March 2016 and August 2017, 210 adults with HIV who had 2 or more signs and symptoms that were concerning for TB (fever, cough, night sweats, weight loss) were enrolled from a public HIV clinic in Lilongwe, Malawi. The treating clinicians conducted a history, physical exam, FASH protocol, and additional TB evaluation (laboratory diagnostics and chest radiography) on all participants. The clinician made a final treatment decision based on all available information. At the 6-month follow-up visit, we categorized participants based on clinical outcomes and diagnostic tests as having probable/confirmed TB or unlikely TB; association of FASH with probable/confirmed TB was calculated using Fisher's exact tests. The impact of FASH on empiric TB treatment was determined by asking the clinicians prospectively about whether they would start treatment at 2 time points in the baseline visit: (1) after the initial history and physical exam; and (2) after history, physical exam, and FASH protocol. RESULTS: A total of 181 participants underwent final analysis, of whom 56 were categorized as probable/confirmed TB and 125 were categorized as unlikely TB. The FASH protocol was positive in 71% (40/56) of participants with probable/confirmed TB compared to 24% (30/125) of participants with unlikely TB (odds ratio=7.9, 95% confidence interval=3.9,16.1; P<.001). Among those classified as confirmed/probable TB, FASH increased the likelihood of empiric TB treatment before obtaining any other diagnostic studies from 9% (5/56) to 46% (26/56) at the point-of-care. For those classified as unlikely TB, FASH increased the likelihood of empiric treatment from 2% to 4%. CONCLUSION: In the setting of HIV coinfection in Malawi, FASH can be a helpful tool that augments the clinician's ability to make a timely diagnosis of TB.

The HIV diagnostic assistant: early findings from a novel HIV testing cadre in Malawi.

OBJECTIVES: In 2015, Malawi piloted the HIV diagnostic assistant (HDA), a cadre of lay health workers focused primarily on HIV testing services. Our objective is to measure the effect of HDA deployment on country-level HIV testing measures. DESIGN: Interrupted time series analysis of routinely collected data to assess immediate change in absolute numbers and longitudinal changes in trends. METHODS: Data from all HDA sites were divided into two periods: predeployment (October 2013 to June 2015) and postdeployment (July 2015 to December 2017). Monthly rates of several key HIV testing measures were evaluated: HIV testing, including all tests done, new positives, and confirmatory testing. Syphilis testing at antenatal clinic (ANC) and early infant diagnosis were also assessed. FINDINGS: The number of patients tested for HIV per month increased after HDA deployment across all sex, age, and testing subgroups. The number of tests immediately increased by 35 588 (P = 0.031), and the postintervention trend was significantly greater than the preintervention slope (+3442 per month, P = 0.001). Of 7.4 million patients tested for HIV in the postdeployment period, 2.6 million (34%) were attributable to the intervention. The proportion of new positives receiving confirmatory tests increased from 28% preintervention to 98% postintervention (P < 0.0001). Syphilis testing rates at ANC improved, with 98% of all tests attributable to HDA deployment. The number and proportion of infants receiving DNA-PCR testing at 2 months experienced significant trend increases (P < 0.0001). INTERPRETATION: HDA deployment is associated with significant increases in total HIV testing, identification of new positives, confirmatory testing, syphilis testing at ANC, and early infant diagnosis testing.

Racing for results: lessons learnt in improving the efficiency of HIV viral load and early infant diagnosis result delivery from laboratory to clinic.

INTRODUCTION: In pursuit of the 90-90-90 goals, emphasis has been placed on accelerating centralized-laboratory HIV viral load testing of a population that is largely rural and decentralized. Successful outcome requires effective specimen transport, laboratory testing, and results delivery. This paper focuses on the methods currently employed for results delivery. New innovations in this area are yielding mixed results; we analyze different approaches and estimate the impact of each on achieving the third '90.' Areas covered: Strategies employing electronic or mobile health platforms, such as online portals, SMS, and SMS printers are showing potential to deliver results in significantly improved turnaround times but are not without challenges. Also, merely delivering a result to the clinic is not sufficient; results need to be actioned to ensure improved patient linkage and retention. Innovative solutions that not only support real-time reporting but monitor receipt of results and address infrastructure constraints faced by limited-resource settings are discussed. Expert commentary: There is tremendous opportunity to inform better patient care and directly contribute to '90-90-90' progress by developing digital systems for result delivery. Besides infrastructure and technical challenges, systems should address the entire cascade of care from initial diagnosis to monitoring treatment response.

Simple Screening Tool to Help Identify High-Risk Children for Targeted HIV Testing in Malawian Inpatient Wards.

BACKGROUND: To meet global AIDS goals, pediatric HIV diagnosis must be strengthened. Provider-initiated testing and counseling, which is recommended by the WHO, faces persistent implementation challenges in low-resource settings. Alternative approaches are needed. SETTING: Malawi has achieved high coverage of HIV diagnosis and treatment, but there are gaps among pediatric populations. This study assessed the sensitivity and specificity of a brief screening tool to identify at-risk pediatric patients for targeted HIV testing in Malawi. METHODS: A tool containing 6 yes/no items was used for children (aged 1-15 years) in the inpatient pediatric wards at 12 hospitals in Malawi (July 2016-July 2017). Questions were based on an established tool, translated to Chichewa, and implemented by HIV diagnostic assistants. All participating children were provided HIV testing and counseling per Ministry of Health guidelines. Analysis estimated the tool's characteristics including sensitivity, specificity, negative, and positive predictive values. RESULTS: HIV prevalence among the 8602 participants was 1.1% (n = 90). Children with a screening tool score of 1 had double the odds of being HIV positive than those with a score of 0. Frequent sickness was the most sensitive predictor of HIV status (55.1%), and having a deceased parent was the most specific (96.7%). False classification of HIV-negative status was rare (n = 14) but occurred more often among boys and younger children. CONCLUSIONS: A brief screening tool for pediatric inpatients helped target HIV testing in those most at risk in a low-pediatric-prevalence, resource-constrained setting. Future research should include a direct, rigorous comparison with PITC including comparative effectiveness, efficiency, and cost effectiveness.

Provider perspectives on barriers to reproductive health services for HIV-infected clients in Central Malawi.

Despite widespread availability of Depo-Provera in HIV clinics in Malawi, coverage of family planning (FP) remains low. We sought to understand provider perspectives about the challenges of providing reproductive health services to HIV-infected clients in antiretroviral therapy (ART) clinics in Central Malawi by conducting surveys and semi structured in-depth interviews with 31 ART providers across 16 clinical sites. Additionally, site surveys were performed to assess contraceptive resources. Major barriers to the provision of FP in ART clinics were inadequate staff in the facility, shortage of trained providers, limited time to counsel on FP, and lack of private space for the provision of FP services. These barriers limit the direct delivery of FP in ART clinics. Strategies to integrate FP with HIV/ART services and task shifting FP service provision to non-ART providers should be explored in Malawi as a means to improve coverage of services to HIV-infected clients.

M#1045: Training Course in Focused Assessment with Sonography for HIV/TB in HIV Prevalent Medical Centers in Malawi.

PURPOSE: Training medical providers of different backgrounds the "focused assessment with sonography for HIV-associated TB" (FASH) exam to expand the availability of ultrasound for TB diagnosis in resource poor settings in the central region of Malawi. METHODS AND MATERIALS: A survey was completed by the 19 eligible participants before and after a 4-day training course regarding the utility of the FASH exam. A six-question quiz was used to assess knowledge of the use of ultrasound in the FASH exam before and after the course. RESULTS: Participants' knowledge of the FASH technique significantly improved after the four-day course with a 32% increase in total quiz questions answered correctly (p<0.001).Ninety-five percent (n= 18) of participants answered that they would "likely" incorporate FASH in their clinical practice. Furthermore, 100% (n=19) of participants agreed that the FASH exam would improve their ability to diagnose TB and 95% (n=18) agreed that FASH would improve patient care in their clinic. CONCLUSIONS: After completing a 4-day training course, medical providers were more knowledgeable about the FASH exam and its findings, and felt more comfortable using ultrasound for the diagnosis of TB. Participants were also unanimous in opinion that the FASH ultrasound exam would improve their ability to diagnose TB.

Supporting Quality Data Systems: Lessons Learned from Early Implementation of Routine Viral Load Monitoring at a Large Clinic in Lilongwe, Malawi.

Successful viral load programs rely on the presence of data systems and high quality of patient data. Using a cohort of 49 patients at Partners in Hope, a large, urban HIV clinic in Malawi, we performed a quality improvement assessment of a new viral load program with a focus on accuracy of data collected from patients as well as adherence to Malawi HIV Guidelines in regard to response to elevated viral loads (≥1,000 copies/mL). Data were obtained from three parallel medical record systems to investigate the proportion of patients with a repeat viral load and whether the three data systems agreed in regard to sociodemographic and clinical data. Fewer than 30% of patients had a repeat viral load within six months, as recommended in the Malawi HIV Guidelines. There were significant problems with data agreement across the three parallel databases used for care. Date of birth was consistent for 55.1% (N=27) of patients, while a different date of birth was noted in all three sources for 10.2% of pateints (N=1). For 65.3% (N=32), the viral load from the laboratory did not match the recorded viral load in the electronic or paper record. Scale-up of viral load monitoring must be accompanied by the development of data systems that support workflow from sample collection to lab and back to provider. Education of providers and strategies for data collection with minimal errors can facilitate scale-up of high quality programs.

Factors associated with retention in Option B+ in Malawi: a case control study.

INTRODUCTION: There are limited data on factors associated with retention in Option B+. We sought to explore the characteristics of women retained in Option B+ in Malawi, with a focus on the role of HIV disclosure, awareness of partner HIV status, and knowledge around the importance of Option B+ for maternal-child health. Methods We performed a case-control study of HIV-infected women in Malawi initiated on antiretroviral therapy (ART) under Option B+. Cases were enrolled if they met criteria for default from Option B+ (out of ART for >60 days), and controls were enrolled in approximately 3:1 ratio if they were retained in care for at least 12 months. We surveyed socio-demographic characteristics, HIV disclosure and awareness of partner HIV status, self-report about receiving pre-ART education, and knowledge of Option B+. Univariate logistic regression was performed to determine factors associated with retention. Multivariate logistic regression model was used to evaluate the relationship between HIV disclosure, Option B+ knowledge, and retention after adjusting for age, schooling, and travel time to clinic. RESULTS: We enrolled 50 cases and 153 controls. Median age was 30 years (interquartile range (IQR) 25-34), and the majority (82%) initiated ART during pregnancy at a median gestational age of 24 weeks (IQR 16-28). Ninety-one per cent of the cases (39/43) who started ART during pregnancy defaulted by three months postpartum. HIV disclosure to the primary sex partner was more common among women retained in care (100% versus 78%, p < 0.001). Odds of retention were significantly higher among women with: age >25 years (odds ratio (OR) 2.44), completion of primary school (OR 3.06), awareness of partner HIV status (OR 5.20), pre-ART education (OR 6.17), higher number of correct answers to Option B+ knowledge questions (OR 1.82), and support while taking ART (OR 3.65). Pre-ART education and knowledge were significantly correlated (r = 0.43, p < 0.001). In multivariate analysis, awareness of partner HIV status (OR 4.07, 95% confidence interval (CI) 1.51-10.94, p = 0.02) and Option B+ knowledge (OR 1.60, 95% CI 1.15-2.23, p = 0.004) remained associated with retention. CONCLUSIONS: Interventions that address partner disclosure and strengthen pre-ART education around the benefits of ART for maternal and child health should be evaluated to improve retention in Malawi's Option B+ programme.

Successes and Challenges of HIV Mentoring in Malawi: The Mentee Perspective.

HIV clinical mentoring has been utilized for capacity building in Africa, but few formal program evaluations have explored mentee perspectives on these programs. EQUIP is a PEPFAR-USAID funded program in Malawi that has been providing HIV mentoring on clinical and health systems since 2010. We sought to understand the successes and challenges of EQUIP's mentorship program. From June-September 2014 we performed semi-structured, in-depth interviews with EQUIP mentees who had received mentoring for ≥ 1 year. Interview questions focused on program successes and challenges and were performed in English, audio recorded, coded, and analyzed using inductive content analysis with ATLAS.ti v7. Fifty-two mentees from 32 health centers were interviewed. The majority of mentees were 18-40 years old (79%, N = 41), 69% (N = 36) were male, 50% (N = 26) were nurses, 29% (N = 15) medical assistants, and 21% (N = 11) clinical officers. All mentees felt that EQUIP mentorship was successful (100%, N = 52). The most common benefit reported was an increase in clinical knowledge allowing for initiation of antiretroviral therapy (33%, N = 17). One-third of mentees (N = 17) reported increased clinic efficiency and improved systems for patient care due to EQUIP's systems mentoring including documentation, supply chain and support for minor construction at clinics. The most common challenge (52%, N = 27) was understaffing at facilities, with mentees having multiple responsibilities during mentorship visits resulting in impaired ability to focus on learning. Mentees also reported that medication stock-outs (42%, N = 22) created challenges for the mentoring process. EQUIP's systems-based mentorship and infrastructure improvements allowed for an optimized environment for clinical training. Shortages of health workers at sites pose a challenge for mentoring programs because mentees are pulled from learning experiences to perform non-HIV-related clinic duties. Evaluations of existing mentoring models are needed to continue to improve mentoring strategies that result in sustainable benefits for mentees, facilities, and patients.

CD4 Variability in Malawi: Implications for Use of a CD4 Threshold of 500 Cells/mm3 Versus Universal Eligibility for Antiretroviral Therapy.

Background. Given the uncertainty about the ability of a single CD4 count to accurately classify a patient as antiretroviral therapy (ART) eligible, we sought to understand the extent to which CD4 variability results in misclassification at a CD4 threshold of 500 cells/mm3. Methods. We performed a prospective study of CD4 variability in Malawian human immunodeficiency virus-infected, ART-naive, World Health Organization (WHO) stage 1 or 2, nonpregnant adults. CD4 counts were performed daily for 8 days. We fit a Bayesian linear mixed-effects model of log-transformed CD4 cell counts to the data. We used Monte Carlo approximations to estimate misclassification rates for different observed values of CD4. The misclassification rate was calculated based on the conditional probability of true CD4 given the geometric mean of observed CD4 measurements. Results. Fifty patients were enrolled from 2 sites. The median age was 33.5 years (interquartile range, 27.5-40.0) and 34 (68%) were female. Misclassification rates were <1% when the observed CD4 counts were ≤250 or ≥750 cells/mm3. Rates of misclassification were high at observed CD4 counts between 350 and 650 cells/mm3, particularly when a single measurement was used (up to 46.7%). Conclusions. Our data show that ART eligibility based on a single CD4 count results in highest risk of misclassification when observed CD4 counts are in the range of 350-650 cells/mm3. Given the benefits of early ART, countries should weigh the costs and complexity of CD4 testing using a 500 cell/mm3 threshold against the cost savings and public health benefits of universal eligibility.

High-risk human papillomavirus in HIV-infected women undergoing cervical cancer screening in Lilongwe, Malawi: a pilot study.

Rates of abnormal visual inspection with acetic acid and prevalence of high-risk human papillomavirus (HPV) subtypes have not been well characterized in HIV-infected women in Malawi. We performed a prospective cohort study of visual inspection with acetic acid (N = 440) in HIV-infected women aged 25--59 years, with a nested study of HPV subtypes in first 300 women enrolled. Of 440 women screened, 9.5% (N = 42) had abnormal visual inspection with acetic acid with 69.0% (N = 29) having advanced disease not amenable to cryotherapy. Of 294 women with HPV results, 39% (N = 114) of women were positive for high-risk HPV infection. Only lower CD4 count (287 cells/mm(3) versus 339 cells/mm(3), p = 0.03) and high-risk HPV (66.7% versus 35.6%, p < 0.01) were associated with abnormal visual inspection with acetic acid. The most common high-risk HPV subtypes in women with abnormal visual inspection with acetic acid were 35 (33.3%), 16 (26.7%), and 58 (23.3%). Low CD4 cell count was associated with abnormal visual inspection with acetic acid and raises the importance of early antiretroviral therapy and expanded availability of visual inspection with acetic acid. HPV vaccines targeting additional non-16/18 high-risk HPV subtypes may have greater protective advantages in countries such as Malawi.