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Conference Agenda

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Session Overview
5g. HIV/AIDS, TB: Patient-level Adherence Assessment and Support
Time: Thursday, 17/Nov/2011: 10:15am - 11:15am
Session Moderator: Jude Nwokike, Management Sciences for Health (MSH), United States of America
Session Moderator: Lilian Nyambura Gitau, Management Sciences for Health, Kenya
Session Rapporteur: Robert Stanley Summers, Medunsa National Pharmacovigilance Centre, South Africa
Location: Septeryan B1-B3


Strengthening Patient Adherence Monitoring through the Electronic Dispensing Tool (EDT)

Dawn Pereko1, Victor Sumbi2, David Mabirizi3

1Management Sciences for Health/ Strengthening Pharmaceutical Systems; 2Management Sciences for Health/ Strengthening Pharmaceutical Systems; 3Management Sciences for Health/ Strengthening Pharmaceutical Systems

Problem statement: Namibia reported an average of 99.9% availability of antiretrovirals (ARVs) in public hospitals in October 2007-September 2010. As obstacles to access are overcome, attention is being increasing focused on adherence to treatment.

Challenge: Self-report was the main standard measure of ART adherence at public health facilities in Namibia. Some ART sites in Namibia were using pill counts as a measure for monitoring adherence; however, pill count results were entered on patient-held records and thus there were no records of adherence kept at facilities. It was not possible for facilities to monitor patients’ adherence over time.

Intervention: The MoHSS with support from MSH/SPS program developed an adherence-monitoring module on the electronic dispensing tool (EDT) widely used in Namibia. The adherence module is able to provide patient data for a proxy adherence measure of on-time ARV pick up. This is easily monitored as the EDT automatically checks whether a patient on ART was on time (i.e., on or before their ARV refill appointment date) for each pharmacy visit.

Results: Analysis of ARV on-time pick up results from 33 selected health facilities for June 2011 shows that an average of 88% of patients collected their ARVs within 4 days of their appointment date. For these facilities, between 1% and 18.8% of patients were 4‐10 days late; between 0.6% and 18.8% were 11-19 days late while the percentage of those late by 20‐29 days was 0%‐12%. All hospitals can generate monthly reports of on‐time ARV pick up. At the facility level, an individual’s on‐time ARV pick-up history can be tracked and appropriate remedial measures taken where necessary. At managerial level, comparison of results for different facilities and for the same facility over time help district-, regional- and national-level managers identify facilities where the proportion of patients picking up their ARV refills on time is lower and thus initiate or support corrective measures.

Conclusion: Electronic data management tools like the EDT can serve as useful tools for effective monitoring of patients’ ARV refill data and thus identifying patients with adherence-related problems for appropriate follow-up.

Funding sources: United States Agency for International Development/Namibia


Improving Appointment Keeping and Adherence Monitoring In HIV Facilities in Kenya: Views of Providers and Patients

Susan Muthoni Njogo1, Dorine Kagai1, Lillian Gitau2, Peter Nguhiu2, Patrick Boruett2, Christine Awuor1, John Chalker1,5, Dennis Ross- Degnan4,5, Göran Tomson3, Rolf Wahlström3

1National AIDS/STI Control Program (NASCOP), KENYA; 2Management Sciences for Health/Strengthening Pharmaceutical Systems Program; 3Division of Global Health (IHCAR), Karolinska Institutet, Sweden; 4Harvard Medical School and Harvard Pilgrim Health Care, USA; 5International Network for the Rational Use of Drugs (INRUD) – IAA

Problem statement: Adherence monitoring and tracking appointment keeping for patients on antiretroviral therapy (ART) is challenging in Kenya because of lack of an efficient recording system. The focus of the national HIV/AIDS program is to increase the number of patients on treatment. However, there are limited systems to support monitoring of the quality of care.

Objective: To explore providers’ and patients’ views on introduction of an appointment keeping and adherence monitoring system

Design: Qualitative explorative part of a quasi-experimental study

Setting: 6 public hospitals at district level conveniently sampled

Study Population: 30 service providers and 12 patients were interviewed; focus group discussions (N = 6) conducted with patients

Intervention: A clinic patient appointment diary and revised patient clinic card were introduced at the HIV clinics. The diary was to track patients’ clinic visits longitudinally. The adherence indicator monitored monthly was the percentage of patients who attended the clinic within 3 days of their scheduled appointment. The revised patient card included a question that focused on patients recall on missed ARV doses in the past 3 days.

Outcomes: Description of facilitating and hindering factors for successful implementation of intervention components

Results: The appointment diary was perceived to be useful for monitoring of patients appointment keeping behavior. Standardization of question on patients self-report was reported to be more accurate. Facilities reported to have generated actual retention rates. Factors perceived to lead to missed appointments by patients included clinic operation days and hours, lack of transport, confidentiality, nonintegrated HIV services, nondisclosure and stigma. Staff reported a considerable increase in workload mainly due to staff shortage, however, they considered this extra workload manageable.

Conclusion: Monitoring of defaulters helps in establishing or reinforcing adherence support and defaulter tracing. This information informs policy on quality of care improvement, specifically adherence and appointment keeping, and considerations should be made for national roll out to all facilities providing ART.

Funding sources: This is part of the INRUD Initiative on Adherence to Antiretrovirals funded by the Swedish International Development Cooperation Agency (Sida) with additional funding from the USAID-funded Strengthening Pharmacy Systems Project through Management Sciences for Health.


Development and Implementation of a Multi-Method Medication Adherence Assessment Tool Suitable for Antiretroviral Therapy Facilities in Resource-Constrained Settings

Gavin Steel1, Jude Nwokike2, Mohan P. Joshi3, Mupela Ntengu4

1Management Sciences for Health’s Strengthening Pharmaceutical Systems; Rhodes University, South Africa; 2Management Sciences for Health’s Strengthening Pharmaceutical Systems; 3Management Sciences for Health’s Strengthening Pharmaceutical Systems; 4Management Sciences for Health’s Strengthening Pharmaceutical Systems

Problem Statement: Optimal outcomes for antiretroviral therapy (ART) require near perfect levels of adherence. Successful adherence support and improvement interventions require information regarding the patient’s adherence levels. Currently, no gold standard for measurement of adherence exists and there is a consensus that acalls for multi-method approach should be used. A few studies have reported the resulted on concurrent findings using different methods but none have consolidated the findings into a single assessment.

Objectives: To develop and implement an adherence assessment strategy for patient care in resource constrained settings.

Design: Observational study to validate a multi-method for adherence in adult patients on ART treatment against the objective measures of viral load, CD4 count, and Medication Event Monitoring System. In addition, data was collected regarding the clinical feasibility of the assessment tool.

Setting: South African public sector ART at the national level

Study Population: For the validation study, a convenient sample was used to enroll adult patients who had been stabilised on ART.

Intervention: A multi-method adherence assessment tool was developed based on previously validated elements including self-report, visual analogue scale, pill identification test, and pill count. To assess the tool’s feasibility, we analyzed the administration time, demographic data believed to impact administration, and the subjective evaluations of the administering pharmacists. The tool was validated against viral load and MEMS adherence measurements for lamivudine. Once the tool had been validated, training workshops were conducted in all the provinces and the findings presented to key stake holders at the national level.

Outcome Measure:

A validated multi-method tool for assessing adherence to ART in adult patients that was adopted into national treatment guidelines.

Results: Clinical utility was demonstrated in a sample of 440 participants irrespective of level of education, age, and literacy. The median time taken to administer the tool was 5 minutes with a 9% CI of 3-15 min. A total of 40 patients who had given informed consent were enrolled and their lamivudine dispensed in a MEMS device according to the randomization schedule. The MEMS data was used to model a composite adherence assessment tool and a scoring system modelled to identify patients as having high, moderate, or low level of adherence, or nonadherence. The multi-method approach provided the best estimate of adherence relative to MEMS with r = 0.73, 95% CI 0.5 – 0.85. The tool was included in the 2010 national ART guidelines as standard of care for assessing adherence in all the 9 provinces of South Africa. Training workshops including training of trainers were held and 635 health care workers were trained in the use of the tool.

Conclusions: A validated multi method tool was developed and found to be suitable for national implementation.

Funding Source: SPS and Rational Pharmaceutical Management Plus through USAID


The Namibia Treatment Literacy Approach: Empowering Patients with Knowledge on Antiretroviral Therapy through Audiovisual Materials

Francis Kalemeera1, Jennie Lates1, Johannes Gaeseb1, Evans Sagwa2, David Mabirizi2, Assegid Mengistu1, Elena Moreno1, Emmy-Else Hango3, Francina Tjituka1, Meghan Majorowski4, Rebecca Oser4

1Ministry of Health and Social Services; 2Management Sciences for Health; 3Catholic Health Services; 4Broad Reach Health Care

Problem Statement: Namibia’s rapid scale-up of antiretroviral therapy (ART) that began in 2004 led to a steep rise in the number of HIV infected patients being initiated on ART. By early 2008, there was no standardized approach for empowering patients on their lifelong ART. As an intervention, the Treatment Literacy Approach (TLA) was proposed, since ART-educated patients are more likely to adhere to long-term treatment.

Objectives: Evaluate the effectiveness of the TLA in empowering patients on ART knowledge and the efficiency of the TLA in terms of time spent on educating HIV infected patients on ongoing ART

Design: Post-test with control group

Setting: Public sector ART facilities (6 pilot and 5 control)

Study Population: Patients who started ART from October 2009 to May 2010 at the selected sites

Intervention: Health worker-facilitated counseling sessions using the TLA. The TLA consists of a pictorial story-telling flip chart, videos featuring selected ART-experienced patients, and posters. The flipchart covers key areas such as disclosure, starting ART, adherence, and alcohol use. The videos are recordings of patients’ testimonies on (1) preparing to start ART, (2) starting ART, (3) alcohol and ART, and (4) long-term adherence to ART. The posters are images used to emphasize the messages in the flip chart and videos. Patients responded to a structured questionnaire: 181 patients from pilot sites and 93 from control sites. The questionnaire was used to get information from leader(s) at the sites. Information on number of patients starting ART; time spent counseling patients per month, etc., was abstracted.

Outcome Measures: (1) Patient knowledge, (2) time spent per patient counseling new and ongoing ART patients, and (3) patient-reported adherence

Results: Pilot site patients scored higher than the control site patients in 27 out of 36 knowledge questions. The mean knowledge score was higher for patients at pilot sites than for patients at the control sites: 85% (30.4/36) vs. 79% (28.4/36), P value = 0.0002. Further, the pilot sites spent less time on pre-ART education than control sites per on-going ART patient (2.3 minutes vs. 9.7 minutes). A lower proportion of patients (11.7% vs. 20.7%, P value = 0.251) missed doses at pilot sites than at control sites. While the majority of patients at the pilot and control sites cited staff friendliness as reason for their happiness with the ART services; patients at the pilot sites also cited good education materials. The staff at the pilot sites said that the TLA had broader coverage of key themes than the tools they used prior to the TLA.

Conclusions: The TLA is effective in empowering patients with knowledge and it improves efficiency in time spent on educating patients. The TLA may be associated with a lower proportion of patients missing doses of ARVs. The TLA needs strengthening especially in the areas where the control sites outperformed the pilot sites.

Funding Source: Information not available


Adherence to and Outcome of Isoniazid Preventive Chemotherapy in Household Children Contact with Adults Having Pulmonary Tuberculosis: A Prospective Facility-Based Study in Alexandria, Egypt

Aida Mohey Mohamed

Alexandria Faculty of Medicine, Egypt

Problem statement: Current international guidelines recommend 6–9 months of isoniazid (INH) preventive chemotherapy to prevent the development of active tuberculosis in children exposed to a susceptible strain of M tuberculosis, but this treatment is dependent on good adherence, and retrospective studies have indicated that adherence to unsupervised INH preventive chemotherapy is poor.

Objectives: To describe the outcome of screening in children ages <5 years with household exposure to an adult pulmonary tuberculosis index case, to determine the prevalence and possible risk factors of infection among children contacts, and to determine the extent of adherence and outcome in children contacts to 6 months of unsupervised INH prophylaxis

Methods: A descriptive facility-based cross-sectional study was adopted from March 2009 to August 2010. Research settings were three of national TB control program chest dispensaries (primary care facilities) in Alexandria City, Egypt. During a 3-month period, facility-based tuberculosis treatment registers were used to prospectively identify all new adult (>15 years) pulmonary tuberculosis cases. All children <5 years old in household contact with index cases were identified and screened for tuberculosis. The child contacts were given unsupervised INH preventive chemotherapy once active tuberculosis was excluded. Adherence to and outcome of preventive chemotherapy were prospectively monitored. Preventive chemotherapy consisted of unsupervised INH monotherapy for 6 months with monthly collection of tablets from the clinic. Adherence was documented after completion of the 6-month preventive treatment period. Adherence will be considered reasonable if tablets were collected for more than 4 months, poor if collection occurred for 2–4 months, and very poor if monthly tablets are collected once or twice only (treatment period <2 months).

Outcome measure(s): (1) Prevalence of infection and disease and the possible risk factors, (2) the extent of adherence to and outcome in children contacts to 6 months of unsupervised INH prophylaxis, (3) factors behind poor adherence, and (4) new strategies that improve preventive prophylaxis adherence to be recommended

Results: In total, 197 adult tuberculosis index cases from 187 households were identified; 297 children <5 years old experienced household exposure, of whom 252 (84.9%) were fully evaluated. A tuberculin test was positive in 136 of 252 child contacts (54.0%), of which 130 were contacts of sputum-positive patients, while 6 were contacts of sputum-negative patients. The important risk factors for transmission of TB infection were younger age, boy gender, severe malnutrition, absence of BCG vaccination, contact with an adult who was sputum positive, mother as a source case, household overcrowding, and exposure to environmental tobacco smoke. Thirty-three children were diagnosed and treated for tuberculosis at the baseline screening, and 217 received preventive INH chemotherapy. Of the children who received preventive chemotherapy, only 16.6% completed ≥4 months of unsupervised INH monotherapy. During the subsequent follow-up period, 8 children developed tuberculosis (secondary attack rate for tuberculosis disease was 3.7%) of whom four received no preventive chemotherapy and four had very poor adherence.

Conclusions: The prevalence of tuberculosis infection and clinical disease among children in household contact with adult patients is high, and risk is significantly increased due to child contact, index patients, and environmental factors. Adherence to 6 months of unsupervised INH preventive chemotherapy was very poor. Strategies to improve adherence, such as using shorter duration multidrug regimens and/or supervision of preventive treatment require further evaluation, particularly in children who are at high risk to progress to disease following exposure.

Funding source(s): Self-funded