Geographic and therapeutic coverage and compliance to annual ivermectin treatment in areas of potential ivermectin resistance

IGeographic and Therapeutic Coverage and Compliance to Annual Ivermectin Treatment in Areas of Potential Ivermectin Resistance RESEARCH PROTOCOL Developed during a Workshop held from 13-16 October 2007 Ouagadougou WHO/APOC {Ghana Geographic and T herapeutic' ttncl Oonpliance Studl' l'rotocol LIST OF ACRONYMS ll APOC African Programme for Onchocerciasis Control CDD Community Directed Distributor CDTI Community Directed Treatment with Ivermectin LBV Lower Black Volta Onchocerciasis Control Programme Pru River Basin Special Intervention Zone World Health Organization OCP PRB SIZ wHo Ghana Geographic and T.herapeutic and Oonpliance Stud1, Protocol TABLE OF CONTENTS lll LIST OF ACRONYMS lt TABLE OF CONTENTS ...... iii l.INTRODUCTION 1.2 Research Questions and Study Objectives 1.3 Definition of Key Concepts 2. STUDY DESIGN AND METHODOLOGY............ 2.1 The Study Areas........ 2.2 Study Design 2.3 Population and Sample ....... 3. METHODOLOGY 3.1 Epidemiological and Social Science Methods for the Study 3.2 Data Collection ...... 3.2.1 Phase I : Coverage Data ..... 3.2.2Phase 2: Compliance study 4. DATA PROCESSING AND ANALYSIS I 2 J 5 5 7 7 9 9 9 9 9 13 5. TIMEFRAME ........... 5.1 Timeline for Phase l: Coverage Study 5.2 Timeline for Phase 2: Compliance Study...... t4 l5 t6 BUDGET FOR PHASE 1: COVERAGE STUDY. .................. 17 REFERENCES t8 INSTRUMENTS 19 Ghana Coverage Study Instruments Compliance Study Instruments, Procedures and Instructions...... .... l9 ,,,.22 Ghana Geographic and'l herapetilic and Oomltliance Study l'rolocol 1. INTRODUCTION 1.1 Background In order to effectively control onchocerciasis with ivermectin alone, there is the need to maintain a minimum annual population treatment coverage level of 650/o for at least l5 years (Plaisier et ol., 1997). A higher than this coverage level has been found to be achieved through a community directed treatment approach (CDTI) of the drug. This finding informed the decision of the African Program for Onchocerciasis Control (APOC) to adopt the CDTI as its main control strategy. Though this approach has been shown to be effective in reaching hundreds of previously neglected communities or those with limited access to health services, the rate of compliance of individuals who have been on ivermectin treatment since the inception of the APOC could be critical in achieving the objectives of the programme. Persistent non-compliant and or a higher percentage of low-compliant individuals could harbour parasites that could form the basis for re-emergence of the disease within the community. In 1987, the OCP introduced large-scale distribution of ivermectin, beginning in the Pru and Lower Black Volta (LBV) river basins in Ghana. ln 1997, field surveys in the LBV basin and in the Pru River basin, revealed individuals with persistent significant microfilaridermia (PSM). Other individuals from the same communities, with similar microfilarial loads in 1987 and exposed to the same environmental factors who received identical number of treatments to those found with PSM, were skin-snip-negative. Studies in these areas indicate that PSM is mainly attributable to the non-response of the adult female worms to ivermectin and "not to inadequate drug exposure or other factors" (Awadzi et a|2004) and that there is the possibility of resistance emerging in these adult female worrns (Osei-Atweneboana et al2007; Awadzi et aI2004). Various authors have indicated that the study of Osei-Atweneboana et al (2007), while bringing to the fore the issue of monitoring for any possible genetic changes that may indicate resistance, also leaves some unanswered questions (Hotez 2007; Ptemme et al 2007). For example, the issues of geographical treatment coverage, community coverage and compliance have been raised as possible reasons to explain the PSM observed. It is therefore necessary to carry out studies to clarify the situation and to enable the African Programme for Onchocerciasis control (APOC) to take evidence based decision. Recently, tools were developed for assessment of individual and community compliance to ivermectin treatment (Brieger et a\.2007). These tools will be used to determine the compliance with ivermectin in the CDTI communities in Ghana, including where the PSM has been observed. The main objective of this study is to determine the geographical and treatment coverage, as well as compliance with the ivermectin treatment over a period of eight consecutive I Ghana Geographic and'l herapeulic and Compliance Stud), I)rotocol years in CDTI communities situated in Northern, Brong Ahafo, Ashanti and Volta regions of Ghana. The study will be carried out in two phases. During the first phase, coverage data will be collected at the regional, district and community levels. Individual and community compliance to annual treatment with ivermectin in onchocerciasis endemic communities will be determined in the second phase. 1.2 Research Questions and Study Objectives The research question for Phase I study will be: l. What is the geographical and therapeutic coverage of ivermectin treatment? 2. What are the available sources of information and how reliable are these? Specific Objectives for phase I will be L To determine the availability of treatment records at the district and community levels. 2. To review available records at district and community levels and ascertain the quality of information on treatment with ivermectin. 3. To determine annual geographic and therapeutic coverage in CDTI communities over a period ofeight consecutive years. The following research questions will be addressed in phase II: l. What proportion of men, women, youth and children above 5 years old have complied with ivermectin treatment annually since the inception of community directed treatment with ivermectin? 2. What proportion of minority groups complied with ivermectin treatment every year since the inception of community directed treatment with ivermectin? a. Are there minority groups? b. Have they been treated annually? If not, why not treated? What factors influence individual compliance to treatment including perceptions of social and health benefits? 4. For how long are people willing to take ivermectin and for what reasons are they willing to continue to take ivermectin for a long time? 5. What are community suggestions on improving compliance of individuals to annual and long-term ivermectin treatment? 2 J Ghana Geographic and'l herapetilic ancl ('on4tliance Stud), l'rolocol During phase II the study main objective will be l. To determine the rate of individual and community compliance to annual treatment with ivermectin 2. To assess perceived benefits in onchocerciasis endemic communities The specific objectives will be l. To determine the rate of annual compliance to ivermectin treatment among men, women, youths and children above 5 years of age, and how many years; 2. To determine the rate of annualcompliance to ivermectin treatment among minority groups. 3. To document community perceptions about CDTI including social and health benefits of taking ivermectin annually 4. To determine what factors influence individual compliance to treatment and how these influence compliance 5. To determine for how long individuals are willing to continue to take ivermectin and factors that affect willingness to continue treatment 6. Document ways to improve compliance of community members to annual and long-term ivermectin treatment. 1.3 Definition of Key Concepts Coveraqe o Geographical coverage is defined as the proportion of endemic communities, in a specified area, that received treatment in a given year o Therapeutic coverage refers to the proportion of the totalpopulation treated in a given year Compliance is normally defined as consistent following of medical recommendations including taking medications as prescribed and maintaining a dietary and activity regimen as recommended by a qualified health worker. In the case of annual ivermectin distribution, the process of compliance is simply defined as taking ivermectin at each annual distribution since the inception of CDTI in the village/settlement, unless the person does not meet eligibility requirements in a given year. Based on the coverage study and the intended start date of the full study, we will be looking at villages where a minimum 8 consecutive annual distributions have occurred since project inception. For the purpose of calculation, it will be necessary to work from a base of persons who were eligible by age and height to take ivermectin on the date of the first distribution. J Individual Compliance: o a o r] Ghana Geographic and'l.herapeutic and Compliance Study l)rotocol Non-compliance involves missing an annual distribution for reasons of refusal or absence, but not because of ineligibility (e.g. being pregnant or very sick at that distribution). If people in a village did not take ivermectin in a particular year because the medicine was not made available in the village, such a village would be excluded from the study as its residents were denied the chance to try to comply. Taking all six consecutive doses on an annual basis would be considered as full compliance and used as the basis for calculating a compliance rate. Minority Group Status o Minority group was categorized into Minority Groups within community and among communities. o A minority within a community is any group of people resident within a village or community who is disenfranchised or marginalized because of ethnicity, migration, displacement or other special characteristic. Such people are often not in the mainstream (not integrated into the) social, cultural and economic activities of the community. A minority community is a village or settlement within a district that is disenfranchised or marginalized because its residents belong to a culture, class, or ethnic group that is different from the main population of the district 4 a a a Ghana Geographic and 'l'herapeutic and Compliance Stud), ['rotocol 2. STUDY DESIGN AND METHODOLOGY 5 2.1 The Study Areas The study will be located in the Brong Ahafo and Northern as well as Ashanti and Volta regions of Ghana where Ivermectin distribution using the CDTI strategy has been implemented since 1998. Ghana lies on the West Coast of Africa between Latitudes 5o and I lo North of the Equator and between longitudes lo East and 3o West of the zero meridian. It is bordered by the Gulf of Guinea in the South, Togo in the East, Cote d'Ivoire in the West and Burkina Faso in the North. The country covers a total area of 238,537 sq km. The combination of low altitude and proximity to the equator gives Ghana a typical tropical climate. The rainfall figures are highest in the forested southwest and lowest in the north. The Harmattan winds blow from the northeast during the dry season bringing dust from the Sahara. Ghana's population is estimated to be about 22,769,412 in 2007 extrapolated from the population census in 2000. About 70o/o of the population live in rural areas and are mainly engaged in agriculture and fishing. There are many ethnic groups with diverse cultures and perceptions and also groups with religious beliefs and practices that may influence their attitudes and practices towards Onchocerciasis. Ghana is divided into l0 administrative regions and 138 administrative districts. All districts have been subdivided into an average of 7 sub-districts with each sub-district covering a defined geographic area of 20,000-30,000 people. Onchocerciasis is endemic in 9 out of l0 regions in Ghana. The total at risk population is 3,060,479. Brong Ahafo region has an at risk population of about 351,771 found in 8 out l9 districts. The total number of endemic communities in Brong Ahafo region is 430 with 215 in the special intervention area. Northern region has a total Onchocerciasis at risk population of ll0,l32 from 172 communities in 7 districts. Western region has an Onchocerciasis at risk population of 481,693 in 767 communities from l2 districts. All three regions commenced CDTI in 1998. Onchocerciasis control activities started in Ghana in 1974 and focused on aerial larviciding but lvermectin distribution in Ghana started with the use of mobile teams in 1987 and CDTI was introduced in 1998. The Special Intervention Zone was created in 2002 to serve as the focus of CDTI implementation after the devolution. However CDTI also continued in non-SIZ areas. The SIZ is an area (Brong Ahafo) of hyper endemic Oncho communities while all the other endemic areas (Northern and Western) outside the SIZ are meso-endemic areas. In 1998 257,243 people were treated by the programme in Ghana and this has progressed to 1,581,970 for the Onchocerciasis only areas by 2006. Despite this impressive Ghana Geographic and'l herapeutic and Compliance Study l)rotocol performance, Ivermectin resistance study conducted in Brong Ahafo and Northern Regions suggest the emergence of Ivermectin resistance. Brong Ahafo Region The Brong Ahafo region has a population of 1,815,408. [t is located in the middle belt of the country and is bounded by the Northern region to the north, Ashanti region to the south, Volta region to the east and Cote D'lvoire to the west. The Brong Ahafo Region covers an area of 39,557 square kilometers. It has 19 administrative districts, with Sunyani as the regional capital. The region lies in the forest zone and is a major cocoa and timber producing area. The northern part of the region lies in the savannah zone and is a major grain- and tuber-producing region. In the Brong Ahafo Region, eight out of thirteen districts area endemic for Onchocerciasis.. Available records show that 31,447 people were treated in 1998 and this has also increasedto 126,145 in2006. Northern Region The Northern Region, which occupies an area of about 70,383 square kilometers, is the largest region in Ghana in terms of land area. It shares boundaries with the Upper East and the Upper West Regions to the north, the Brong Ahafo and the Volta Regions to the south, and two neighbouring countries, the Republic of Togo to the east, and La Cote d' Ivoire to the west. The land is mostly low lying except in the north-eastem corner with the Gambaga escarpment and along the western corridor. The region is drained by the Black and white Volta and their tributaries, Rivers Nasia, Daka, etc. The population of the region is 1,820,806, representing9.6 per cent of the country's population. Seven out of thirteen districts are endemic for Onchocerciasis. In the Northern Region, 80,562 people were treated in 1998 and this has increased to 353,165 in 2006. Ashanti Region The region is the most populous and one of the most rapidly growing regions in the country. The region's populationis3,612,950, representing 19.1 per cent of the country's population. The region's share of the national population increased steadily from 16.5 per cent in 1960 to 17.3 per cent in 1970 but remained almost the same (17.0%) in 1984 before increasing to its current level (19.1%). The high level of urbanization in the region is due mainly to the high concentration of the population in the Kumasi metropolis (which has almost about a third of the region's population). In Ashanti region the earliest treatment figures were recorded in 2000 was 14,626. ln 2006 183,607 people were treated. Volta Region The region's population in 2000 was 1,635,421. This implies, an increase of 35.0 per cent over the 1984 count 1,211,907, giving an annual growth rate of 1.9 per cent. The intercensal groMh rate shows little change from 2.0 per cent in 1970, 1.8 per cent in 1984 6 G hana Ge ographic' and'l'herapettl i c and Cotnpl i ance Stttdy I' rotocol and 1.9 per cent in 2000. The population density of the region increased from 59 persons per square kilometre in 1984 to 79.5 persons in 2000. For the region as a whole, the usual resident population of 1,668,568 is 2.0 per cent higher than the de facto count of 1,635,421. Except for the Ho, Hohoe and the Nkwanta, Districts, the number of people who usually reside in the districts, is more than those present on Census Night. The proportion of the population living in urban localities (population of 5,000 or more) in the region has increased from 20.5 per cent in 1984 to 27.0 per cent in 2000, with the highest proportion of the population living in urban areas the in Keta(53.0%o). In 1998 14,626 people were treated however, in 2006 7l,026were treated with ivermectin. 2.2 Study Design This is a two-phased study. In phase I the geographical and therapeutic coverage of ivermectin distribution in the CDTI communities will be undertaken. Phase 2 will focus on measuring individual and community compliance to ivermectin treatment in the CDTI communities. 2.3 Population and Sample Phase l: The study will be carried out in Brong Ahafo and Northern regions where the Ivermectin resistance study was carried out and adjacent regions, namely, Ashanti and Volta regions. These regions have had at least eight rounds of ivermectin distribution. Each of the communities where ivermectin resistance study was carried out will be selected as primary communities. All communities within 20 kilometers of these primary communities will be included in the coverage study as secondary study communities. Information will also be collected from the districts in which any of these communities fall. Phase 2: Based on the findings of the coverage study, ten communities with records for eight consecutive ivermectin treatments will be selected from each district for the compliance study. The chart below addresses sampling and instrumentation issues. 7 Ghana Geographic and 7'herctpettic and Compliance Study Protocol Step-Down Process of Site Selection 8 STEPS Instruments PHASE I l. Select communities where the ivermectin resistance study was carried out. Checklist of 9 districts where resistance study was carried 2. Select all the communities within 20km radius of the Checklist of districts stu 3. Visit the communities to ascertain the Calculate potential population number of communities in the project site in communities with accurate with accurate records for a minimum of records based on findings in eight years steps I and 2 5. Collect information from districts, where communities in steps I and2 above are situated Checklist of district treatment summary record. 6. Collect information from regions, where Checklistof regional communities in steps I and 2 above are treatment summary record situated PHASE 2 l. Depending on the results of the phase I study list all the communities with complete treatment records for a minimum of 8 years Checklist of study communities available 2. From list of communities with complete treatment records select l0 Checklist of per a district including the Ivermectin resistance study compliance study communities communities 4. For each of these communities determine Checklistofall treatment month of annual treatment for each year, records. number and years of annual treatments and annual therapeutic coverage. Ghana Geographic and'l herapeutic and CompIiance ,\tudt' l'rolocol 3. METHODOLOGY 3.1 Epidemiological and Social Science Methods for the Study A number of epidemiological and social science methods of data collection will be used to collect data on the study objectives and research questions. Each method will have implications for the measurable indicators, unit of analysis and specific information needs of the research questions. These are summarized in Table I below. 3.2Data Collection 3.2.1 Phase 1: Coverage Data Three sets of instruments will be employed in collecting coverage data. The first set of instrument will obtain data from the regional level while the second set of instrument will ensure data from the district and village levels. The third instrument will be detailed field notes. 3.2.2 Phase 2: Compliance study Seven sets of instruments will be employed in the study each targeting different sources of information to investigate the research questions (see Table 2). These instruments included l. Household form for collecting data on treatment coverage of households selected in the study communities 2. Village distribution form 3. CDD register and summary form/village distribution form for collecting information on the compliance of members of the villages selected in the study 4. Health system form to collect information on the ability of the health system to support timely and adequate supply of ivermectin 5. Individual questionnaire to collect quantitative data on household compliance 6. Focus Group Discussion Guide for community members 7. 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"; 8.9 E ,gtibEPiio:E € 5:o- o.r -c E -= ^E:3(E 0)E E.q frotr33E .60F-oO CDc>'t '=o JO EEE. o!0 -^- o 9'o)(E.9 Ei; i;.8r o= = EE .fo@oo o o o a_ \' a q)(J \ U \) $ e, F\ U a_ I bo q) t\ t: Noz o Fqt IJJfo I otr IIJ(r, Lrlt >\(,)i=c E.9 @EEtro)69od \ \ \ >o .=oCEfoN EAttr 8E \ \ ."Eg€ \ \ o o.= -E H6f .g \ \ \ Ee oBP[3 \ \ \ (l, o__> -f:zo.., B E.ED'o \ \ \ bo 'E o. .ed Et,, \ \ \ oc -Yo E -.9E oo o o \ \ o E o ELo LL EEE oof o - - E o LL E .9 = -o.E .o o o o) o c.i eo E Ef U) od E oLr 0) .9 o)od ooo CO E o LL E o o U) E =oo - + o .= occ .9 ooJa ofE Ec rri op J o o(9 LL (o oo oz =.qlr Eo (u oo lt- 0 .nq) Itr clq) taq) L B o q) L t) a0 I 6l ta ?a q) 6lF o : q q) U U (.) $ q) N\ u $ 6ndq) t\ Ghana Geographic and'[heropeutic and Compliance Sludy 1>yrr1oro1 l3 4. DATA PROCESSING AND ANALYSIS Standard data entry programmes will be prepared with the EPI INFO programme for all quantitative data collection instruments. Quantitative data will be analysed using SPSS. All qualitative data will be entered in the computer using standard word processing software. A computer-assisted analysis of these data will be undertaken using computer programmes for qualitative data analysis, such as ATLAS.ti, to ensure a standardized and comparable analysis and interpretation of the qualitative data across study sites. (lhana Geographic and'l-herapeulic and Complianc'e Sludt, Prolocol t4 5. TIMEFRAME The study is planned to commence in October 22, 2007. All data entering should be completed in all sites and copies sent to Professor W.B Brieger by November 20, 2007. These files should also be copied to APOC Management. The detailed time frame of activities is presented below ola E E0)tr ,TE (t o- (llc0 ,74 (! (!(!FE ., o).= tr)aciOtAZ E(Bocu)l '= 0) b.x a-o c.l X e.l X o\ X X€ r- X \o X (n X + X c.) X o.l X X X o\ X oo X Xt'- X\o tr) X $ X co X Xo.l X a X X o q,) C, oo coEc Q.)o) 'E o.t mC o PC8.9.:c>oobqP v(Bo .;i o -c >rE(6CE 'E'a - S .= >.!.=EE A.Edk9' U) ^() -(t9> (H oa ooX '=o .r- (0 OF! o o o(s() l-1 () U :x0) o0 oo'6 t*i .c c.9 e *C'trtr8 +i c$ !2 XE(tr()Etr. ^-Li-IJoG)(,O q) 0)L q) q) q) a o C, q) q) o 6! ! o q) Lr 6l Lq) ct 0) ar) o) 6l 6l Etr ocllE l,f Ld ==oLOoJ o.5 EE 5.Uq)L Hc! ao) a.= oo)PE (.) otr u6t q o.: nr c! OO ortrtrE oU E Hc) EFIGld t-r tr) oU o a- \' 4 U a- U i) q) e. G \) u \ 00 r\ Ohana Geographic and'l'herapeutic and Oomplianc'e Stud1, Protocol 5.2 Timeline for Phase 2: Compliance Study Phase 2 study will be conducted between January and February 2008. Detailed timeline of activities will be provided at the end of phase l. l6 G ho na (ieographic and'l-herapeu t ic and C ontplianc'e Study I> vol rrrul BUDGET FOR PHASE 1: COVERAGE STUDY t7 Budget for lvermectin Coverage Survey in Ghana QT No. of Rate TotalY days (GH6) (GH/) Amount inusD ($)Particulars Activitv 1: Recruitment and One-day Orientation of Research Assistants 1 .1: Conference package (Hall rental and refreshment) 1.2: Stationery and Photocopy of materials sub-tota! Activitv 2: Procurement of Logistics 2.2. GPS equtpment sub-total Activitv 3: Hiring ol4x4 Vehicles 3.1: Renting of Vehicles for 12 days field work sub-total Activitv 4b: Field Work (Dafa Collection, Entry and Analysisl 4.5: Per diem for Local Research Managers 4.6: Per diem for Research Assistants 4.8: Per diem for Data Managers 4.9: Per diem for Drivers 4.10: Per diem for local guides 4.11: Fuel and Lubricants 4.12: Communication sub-total Total BUDGET SUMMARY Activity 1 Activity 2 15 1 30 450 8'190 8,190 489 543 1,033 8,902 8,902 652 1,304 1,826 3,443 217 14,748 24,683 5 1 100 500 950 5 12 136.5 3 14 60 2,520 2,739 7 12 50 4,200 4,565 1 5 168 512 5 12 12 1 12 1 600 1,200 1,680 3,168 200 13,568 22,708 50 20 10 4.4 40 GHi usD ($/950 1,033 Activity 3 Activity 4b Cost for external team not inclusive. 9,190 13,568 8,902 14,748 Total 708 683 Ghana Geographic and'fherapeutic and Compliance Sludy Prolocol l8 REFERENCES Awadzi K, Boakye DA, Edwards G, Opoku NO, Attah SK., Osei-Atweneboana MY, Lazdins- Helds JK, Ardrey AE, Addy ET, Quartey BT, Ahmed K, Boatin BA and Soumbey-Alley EW. An investigation of persistent microfilaridermia despite multiple treatments with ivermectin in two onchocerciasis endemic foci in Ghana. Annals of Tropical Medicine and P aras ito lo gt. 2004; 98(3) :23 | -249. Brieger WR, Okeibunor JC, Abiose A, Wanji S, Ndyomugyenyi R, Elhassan E, Amazigo UV. Feasibility of Measuring Compliance to Annual Ivermectin Treatment in the African Programme for Onchocerciasis Control. Tropical Medicine and International Health 2007; r2(2):260-268 Hotez PJ. Control of Onchocerciasis: The Next Generation. Lancet 2007;369: 1979-1980 Osei-Atweneboana MY, Eng JKL, Boakye DA, Gyapong JO, Prichard RK. Prevalence and intensity of Onchocerca volvulas infection and efficacy of ivermectin in endemic communities in Ghana: a two phase epidemiological study. Lancet 2007;3692 2021-29. Plaisier AP, Alley ES, van Oortmarssen GJ, Boatin BA, Habbema JDF. Required duration of combined annual ivermectin treatment and vector control in the Onchocerciasis Control programme in West Africa. Bulletin of the World Health Organization 1997;75(3):237- 245 Remme JHF, Amazigo U, Engels D, Barryson A, Yameogo L. Efficacy of Ivermectin against Onchocerca Volvulus in Ghana. Lancet 2007 ; 370:1123-24. Ghanu Gectgraphic and'l-herapettlic and ('omplianc'e Sndy Protocol INSTRUMENTS Ghana Coverage Study Instruments SUBDIVISION DISTRIBUTION CHECKLIST (Step 2): Obtained from Project Headquarters Project Name/Site ist'resistance districts first and circl as Needed COMMUNIry DISTRIBUTION CHECKLIST (Step 3) Project Name/Site: District Name: Page _ of _ (List 'resistance study' villages first and circle) - Obtained from District Headquarters and Village Visit t9 District Name 1 997 1 998 1 999 2000 2001 2002 2003 2004 2005 2006 2007 TotalTimes Dist Y/N % Mon. Ohana Geographic and'l-herapeutic and ('ompliance Sntdy Prolctcol Use Second Sheet as Needed 20 Community Name Current Population 1 997 1998 1 999 2000 2001 2002 2003 2004 2005 2006 2007 Total Time Distri GIS Y/N Yo Mon Ghana Geographic and T herapetilic and Compliance Stud), l)rolocol Study Districts 2l Resistance Study Areas Neighboring Region District Region District Northern West Gonja Northern East Gonja Volta Krachi W Brong Ahafo Atebubu Northern Salaga Kintampo Northern Bole Nkoranza Ashanti Eiura TOTAL 4 5 Ghana Geographic and T.herapeulic and Con4tliance Study I'rotocol COMPLIANCE STUDY INSTRUMENTS, PROCEDURES AND INSTRUCTIONS COMPLIANCE TO ANNUAL IVERMECTIN TREATMENT Please read the study procedures on the following pages carefully before using the instruments listed below. Give a copy of these procedures to ALL study personnel including interviewers, moderators, recorders and data entry staff. Review these procedures carefully during a training that includes all staff. Data entry staff should be involved in all training to help them spot data problems later. A. Annual Village Distribution Summary Plan and Ivermectin Availability B. Household Annual Treatment Form C. Focus Group Discussion Guide D. Individual Questionnaire E. Detailed Field Notes 22 Ghana Geographic and'l herapetilic and Compliance Study I'rotocol 23 Study Procedures and Instructions 1. General - Prior to actual interviewins a. Print instrument from the protocol appendices b. Select sample villages/communities including minority communities c. Identify specific minority settlements (e.g. Fulani gao, pygmy villages, refugee camps) for separate sampling d. Determine sampling number - households and individuals - for each community e. Determine most recent treatment month for each chosen community f. Visit community leaders in each community and seek approval g. Visit CDDs past and present and encourage them to get their records in order identify households to survey and calculate annual coverage h. Learn name of key event in district/area that occurred in 1998. Try to find an even when something positive happened. i. Fill in general information on forms (e.g. country, district) in advance to save time j Find out local names for onchocerciasis and ivermectin and use in interviews 2. On day qf interriew Greet village leaders and introduce interview team Select the sample of 15 households based on people present that day using systematic sampling technique with sampling interval based on the CDD register Identify specific minority groups in the community for separate sampling Review CDD register i. Fill out the summary form ii. Systematically select a sample of l5 households iii. Fill in household members and total treatments - columns I and l2 on the Household form for iv. Enter household identifier information - e.g. number on house of head of household name v. Give household a code: 0l ,02,03 (base on register if possible) Go to each selected household i. Gather all available members together ii. Explain nature and purpose of interviews - household form and individual questionnaires a. b. c. d. e Ghana Geographic and'l'herapeulic and Compliance Slttdy Prolocol 24 iii. Seek permission to continue with interviews iv. Ensure privacy from neighbors f. Explain that after the household form is filled out, two house hold members will be asked to provide further information on the individual questionnaire. g. Divide up the interviewers and field assistants according to the chart found at the end of this section. 3. Household Form a. In column I i. Verify names of all members as obtained from register ii. Add others as needed and note that they were not in register iii. For household members who are absent, find out if they really are normally resident in the village, e.g. they did not move to the city some years ago and only visit the community for a holiday. If they are not normally resident, comment next to their names b. In columns 7 and 9, be sure to mention the key area event that is listed at the top of the form and is used to mark the inception year (1998) of the CDTI project. c. Based on minority groups in area, create codes for column I I d. Anytime 'other' is a response for a column, write in that exact response in the appropriate row. e. For columns 8 and 9, we are trying to ensure that we focus only on 'official' community distributions where the CDD measured people. It is know that people may have taken ivermectin on their own, and these times should not count. f. In column 9, note that responses should range between 0-7 (maybe 0-8 depending on when field work starts). Any response beyond 7 (or 8) should be queried. g. In column 10, include as many codes as the person mentions because they may have several different reasons in different years. h. On Back (section 82) record treatments recorded from CDD reister 4. Individual Interview Ouestionnaires qn Benefits, Costs, etc. a. 20 individuals to be interviewed will be selected on two criteria, gender and level of compliance. Compliance is termed 'high' if a person took ivermectin 5 or more times and 'low' if the person took it 2 or fewer times. Only high and low compliers will be studied. This yields four groups of 5 interviewees each. b. First select the sample of high complying females. Use the CDD register and randomly select a page (which usually represents a family or household). Go page-by-page untilthe first female high complier is identified. Do not select more than one person per household, so therefore continue searching the Ghana Geographic and T herapetttic and Compliance Stud1, Protocol 25 subsequent pages until four more high complying women are identified. Verify with the CDD that the people are actually present in the village. If one reaches the end of the register, simply go back to the front and continue. c. Repeat the process for male high compliers by balloting for a new starting page. Again, repeat this for female low compliers and male low compliers. d. Note that it may be possible that up to five persons in each category are not available for interview. Therefore, one can only interview the number who are available. e. Prior to beginning the individual interview, fill in the available socio- demographic and treatment history from the CDD register. Ask additional questions as needed to complete the table. f. Seek permission from the individual again to proceed with the questionnaire. 5. Focus Groups ARRANGEMENTS o Ideally one would conduct FGDs until no new data appear. We are suggesting that each team aim at one FGD per village altemating between males and females o Among your 20 study villages, ballot for five where you will conduct male FGDs and another five (different) villages where you will do female FGDs. Do additional FGDs in any minority settlement/village within your study area. o Please aim for six participants per group. No more than eight or less than four should be allowed. o Select normal village citizens, not leaders or prominent individuals, as such should be covered with the Village Leader in-depth interview. o Hold the FGD in a quiet place where participants will not be distracted or overheard by passers-by. o Again note, that minority group FGDs will be formed where an adequate number of such residents actually exist. This will involve purposive sampling. o Technically, a FGD should consist of people who are not well known to each other. This is often difficult in a small village. In this case effort should be made to recruit participants from different locations or sections of the community. o Each FGD will be moderated by one field assistant while the second will serve as a recorder. The recorder will ensure that all comments from the group are written. INTERVIEWING o The person recording will write out transcripts for all sessions. Also a tape recorder will be used. The written transcript/minutes of the session can later be refined into a full transcript by listening to the tape recorder. Do not rely solely on a tape recorder because of technical problems. o a Ghana Geographic and 'l herapeutic and Compliance Study l)rolocol 26 o The transcript should be written exactly in the words expressed by the participant. o The moderator needs to ask consent of all participants to take part in the discussion and whether they agree to the conversation being recorded. o The moderator should encourage many people to speak. THE FGD should run like a normal conversation among villagers. o Do not settle for one answer by one participant for any question, even if others just sit there and nod their heads. Tum to another participant and ask, "What are your views on the subject." In FGDs silence is not consent. o If a participant uses unfamiliar terms, ask him/her to explain. o If a respondent gives a vague answer, ask him or her to expound on the issue. For example, "The ivermectin helps those intemal diseases." The moderator should ask, "Give us examples of those 'internal' diseases." If a respondent says, "I did not like the way the CDD behaved," the moderator should ask, "Please tell us what the CDD did and why you did not like this." o In short, be alert to what people say and ask PROBES even if the word 'probe' is not written next to a question. DATA MANAGEMENT o At the end of the FGD, the recorder and the moderator will sit down and listen to the take recording together and compare this with the handwritten notes. The tape recording will be used to revise and flesh out these notes. o After the session notes are finalized, these will be typed in either MSWord or WordPerfect. The field assistants will review the typed transcript to ensure accuracy. o Do not summarize what participants said. Write out everything each person said exactly as he/she expressed it. A transcript consists ofthe real words of the people present. o If participants are properly encouraged to speak, if the moderator takes initiative to probe, if everything is written down exactly as participants say it, then an hour-long FGD transcript can easily reach ten typed pages. a 6. Detailed Field Notes The leader of the field team to a particular site should compile detailed field notes each day at the close of work while experiences are still fresh in mind. If two or more teams are operating simultaneously, each team should have a set of notes. The site PI will be responsible for compiling all field notes into one comprehensive document with an introduction and, most importantly, conclusions and lesson learned. Ghana Geographic and'l'herapetilic and Compliance Sludy l'rotocol 27 12. Daily Assienment Chart Note that there will be approximately l5 regular interviewers and 4 more senior field assistants per site. All work in chosen village for the day so finish that village and avoid bias of returning on a second day giving villagers opportunity to discuss the interviews. *Health Facility instruments may require separate visits to those locations by the field assistants and scientists unless the facility is located within walking distance of the day's chosen communities. Event/lnstrument Arrival Morning Afternoon Concurrent lntroductions Scientists/Team Leaders introduce all staff to localleaders, community members and CDDS Scientists/Team Leaders will review forms and data as collected, make corrections and adjustments in interviewer allocations to meet gaps Household Form lnterviewers complete all household forms lndividual Questionnaire lnterviewers follow up with selected individuals Village Distribution interview with CDDs and Leader field assistant FGDs field assistants do first group field assistants do second group Field Notes Each evening the leader of the field team willcompile notes on the day's experiences 6 fr 0) I -rE5>, 9.i =o -o'E*(nv TJ o.; 3q,50)q-r Potr rEo) .,stJd rE cnO do) .= bo oltotr) FT69>H 0) lrr ooC) .n li.F a, ,U)o=bov(co =E> '.5 =dso) dg0 -o= (€c >.r cB .-!iltr C.^r I ^-oge €a >tsdb ;o)trd !io EB. *(htrilG) a+ lt TJo ! 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Y V) q) \ oU U q)\ q) F\ U \ bc q) \J ii c) B o) t<(.) tr(* o (l) d olr Cd ho a (.) tr d z E oF r- N @ooN loooN $ooN (f)ooN NooN ooN oooN o, o) o) r @ o) o, t- o, o) c o o c) E(5 c I lz o i>\OE9dE> 9epI O0)gc;o 9r'-.-qrOo,o-o) -o - =o.SvO= PeE6 9-Zu-T. I I N (a s [o (o t- @ o) o N CO o oE oi([ Eot- I tjc c) E o EF ah o) o Ec o = o) o, -o LJo L .oo iDp oo o)of o - u oE cq)E c)a =o - ijoo 'o- (L c oo l-ro (/) oo 0)& (-) o dr tr o Cdo rE t<o <..i ca u a os{. \' h U a- \) U $\I t\ o $\ba o Ghana Geographic ancl Therapeulic' attd Compliunce Study Prolocol 31 C. FOCUS GROUP DISCUSSION GUIDE Eligible Adult Moles and Females Alternating Between Villages Introduction: Onchocerciasis and CDTI 1. Could you kindly tell me all about distribution of ivermectin in this community? (Probe) o When and how did it get started in this community? o What went well in organizing with ivermectin distribution in this community? o What have been some of the diffrculties experienced with ivermectin distribution in this community? o Why did these difficulties occur? o What was done to try to solve the problems? 2. Do you have people living here who are not originally from this community? Probe for o Where are they from? o Do they take the drug regularly? (Explain) 3. What/Who are the types of people who take the drug regularly each year? . Why do you think these people take is regularly? 4. What/Who are the types of people who usually miss taking the drug? . Why to you think these people tend to miss taking the drug? Perceived Social and Health Benefits 5. Are there benefits individuals get from taking this drug? 6. If yes, what would consider the benefits of taking this drug (ivermectin)? a. Probe: What are the health benefits? b. Probe: What other improvements besides health do people see in their lives? 7. Are there benefits to the whole community? If yes, what are these benefits? Willingness to continue treatment with ivermectin 8. For how long are you expected to take this drug? Why? 9. How long are you willing to take the drug? 'il/hy? 10. How long would you say members of your community will be willing to take this drug? whv? Factors associated with compliance 1 1. Why do you think people take ivermectin? 12. Why do you think people do not take the ivermectin? Suggestions for improving compliance 13. Could you please give your suggestions on how to encourage members of this community to take the drug annually and for many years? Ghana Geographic and Therapeulic and Compliance Stttdlt Pv61prr,1 THANK YOU VERY MUCH FOR YOUR TIME AND PATIENCE. )Z Ghana Geographic and l'herapeulic and Compliance Stutly Protocol JJ D. INDIVIDUAL QUESTIONNAIRE Select male ondfemale high and low compliersfrom the CDD registerfor interview. Project Site: District: Village: Where available in the CDD register Collect thefollowing information andfill in the table below, Ask additional questions as needed to complete the table. HH No. Ind. No. Sex Age Marital status Religion Educational status Ethnic group No. of Treatment Circle Years Treated 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Ask reason not taken 01=seriously sick at time o2=pregnant at time O3=under age 5 at time 04=too short at time (<height 1 tab) 05=absent, away from village 06=side effect of ivermectin 07=don't take orthodox drugs 08=not informed 09=refuse 10=drug had finished 1 1=no distribution 12=other (specify) Collect the following informotion from the selected Respondents 1. What is the income-earning activity that takes most of your time in a week? Farming/Flunting/Fishing/Wine Tapping Trader/Business Housewife Professional (Teacher, Nurse, etc) Artisan (Tailor, Hairdresser, Furnishing, etc) Retired Student Unemployed Labourer/Me ssengerAJnskilled Other (Please, specify t t t t t t t t t ) A. Perceived benefits, problems, effects 2. How likely do you think it would be that you might suffer from any of these Health problems Very Likely Likely Can't Say Not likely Skin rashes Blindness Swellings of the body Severe itchine 3. What are the different treatments you know for onchocerciasis (River blindness)? Ghana Geographic and Therapeutic and Compliance Study Protocol Herbs Banocide Ivermectin Others, please spec No idea at all tl If no idea at all, go to question 5. 4. Which of this do you think is the best? (pick only one) Herbs Banocide Ivermectin Others, please specify 5. Have you ever taken ivermectin since they started distributing it in this village? Yes No Can't Remember If no or can't remember, go to question 7. 6. What motivated you to take ivermectin the first time? (Tick as many as mentioned) We were told to take it I had problems with my skin I had problems of itching I had problem with my eye sight I saw others taking it I had problems of swelling To prevent oncho/filarial Others, please specify 7. Benefits a. Have you experienced any health benefits after taking Ivermectin annually for several years? Yes [ ]* No t I Don't know t l b. Have you personally noticed any improvements in your life generally since you started taking ivermectin?Yes [ ]* No t I Don't know t l *If yes, can you mention these benefits/improvements? (Encourage multiple responses and tick all those mentioned) 34 (note tick all mentioned) l l l t t t t t t t Social Benefits Health Benefits Improvement in school attendance De-worming Acceptance by peer Removal of lice Integration of minority group Cures scabies Can now work better Improvement of sight Self respect Improvement of skin Facilitates election to political office Increase sexuality Better interaction with others Improves fertility Can read more easily Reduced itching Can work longerlharder Increased strength Others: Reduce stomach problem t I t Ghatta Geographic and Therapeulic and Conpliunce Sludy Protocol Reduced swelling Eat well Others 8. Does taking ivermectin every year pose any difficulty or problems to you? Yes [ ]* No t I Can't Say t l *If yes, what are the difficulties or problems? (Tick as many as mentioned) 35 Swellings Inconvenient Others: Can't Say I] B. Factors that influence individual compliance to long-term annual ivermectin treatment 9. Generally, are most people in your community taking ivermectin every year2 Yes [ ]* No [ ]** Don't know t l *If yes, what do you think makes people in your community take annual ivermectin treatment every year? They hear of /see the benef,rts Take to avoid itching Awareness has been created Can't Say Others: **If no, what do you think prevents people in your community from taking annual ivermectin treatment for several years? (Tick all responses mentioned.) Itching t lDizziness t lSleepiness t l Difficult to swallow the drug [ ] I I t l l 1 1 Take to avoid blindness Take to be healthy Gives them energy Late arrival of ivermectin Lack of information Non-availability of ivermectin Side effect Not feeling well Improved sight I t t l l l Others, please specify 10. Are there people around who encourage you to take or swallow ivermectin every year?Yes []* No tl *If yes, who are these people? (Tick all who are mentioned.) My mother My father My wifeihusband My children CDD Friends t t t t t t Health worker t lTeachers t lRelations t l Community leaders t l Others: Ghana Geographic and Therapeutic and Compliance Study Protocol 36 *Explain what they do to encourage you. (Encourage multiple answers; tick all mentioned.) House-to-house visit t ] Community mobilization t l Information when available t ] Tell us the benefits [ ] Can't say t ] Others: Ghana Geographic and T'herapeulic and Conpliance Stucb' Protocol 1 1. Are there people who try to discourage you from taking ivermectin every year? Yes []* No tl *If yes, who are these people? (Tick all who are mentioned.) My mother t l My father t l My wife/husband t l My children t l cDD tlFriends I l Health worker t lTeachers t lRelations t l Community leaders t ] Others 37 aGhana Geographic and T herapeulic and Compliance Study Protocol *Explain what they do to discourage you. (Encourage multiple answers; tick all mentioned.) 38 Express fear side effects Say it is expired Can't say Others: Say sick should not take Not meant for humans tltltl t t C. Willingness to swallow ivermectin for many years 12. Are you willing to take annual ivermectin every year for many more years? Yes [ ]* No [ ]** Not Certain [ ]** *If yes, what are the reasons for your willingness to continue taking the drugs? (Encourage multiple answers; tick all mentioned.) Improve eyesight For deworming Stomach problems Nice/Effective Others: Improve Skin Prevent oncho lmproved health Can't Say t t t t tltltltl **If no or uncertain, why? (Encourage multiple answers; tick all mentioned.) I am Sick I am Healthy Others: l l Don't need Can't Say t 13. Do you think most people in your community are willing to continue taking annual ivermectin many more years? Yes [ ]* No [ ]** Not Certain [ ]** a. For those who are willing to continue, what do you think are their reasons? (Encourage multiple answers; tick all mentioned.) Improve eyesight For deworming Stomach problems Nice/Effective Farming Community Others: Improve Skin Prevent oncho Improved health Can't Say t t t I I tltltltl Ghana Geographic and T herctpeutic and Conpliance Sltrd), Prolocol b. For those who are not willing to continue, what do you think are their reasons? (Encourage multiple answers; tick all mentioned.) 39 They are sick They are healthy Not aware Can't Say Others: l l l l They don't need Tired of it Side effects t t t D. Community suggestions for improving compliance 14. What are your suggestions on ensuring that many more people take the drugs for many more years? (Encourage people to give multiple ideas; tick as many as mentioned.) Health Education/en lightenment Compel Compliance House-to-House Distribution Show/Explain the benefi ts Treat before farming season Announce when drug arrives Others: Support CDD's Manage side effects Treat more often Drug available always Use town crier Can't Say tltltltlI]tl t t t t t t 15. Would you say that onchocerciasis is a serious disease or not so serious? Serious[ ] Notserious [ ]Uncertarn Please explain your answer. (Encourage multiple answers; tick all mentioned.) Causes blindness t l Causes poor vision t ] Causes severe itching t ] Reduces energy for work [ ] Any illness is bad t l Others: Blindness is a burden Is a stigma Causes inconveniences Affects the skin Can't say l l l l l 16. For each pair diseases/problems mentioned below, say which is the more serious of the two. (Read out each pair one at a time. Let person make a choice between the first or second disease mentioned. Then to the next Pair Number Disease I Tick here if Disease I more serious Disease 2 Tick here if Disease 2 more serious I Onchocerciasis Malaria 2 Schistosomiasis Onchocerciasis J Leprosy Onchocerciasis ,Ghana Geographic and 7'herapeutic and Compliance ,\tudy Protocol THANK YOU VERY MUCH FOR YOUR TIME AND PATIENCE. 40 4 Onchocerciasis Gonorrhoea 5 Onchocerciasis Diarrrhoea 6 Tuberculosis Onchocerciasis 7 Onchocerciasis AIDS 8. Headache Onchocerciasis Ghana Geographic and T.herapetilic ancl Compliance ^\tttd), l'rolocol 4t E. DETAILED FIELD NOTES 1. Within each research group there are likely to be two or more field teams visiting different districts and villages simultaneously. Each field team leader should be supplied with a notebook in which to record field experiences on a daily basis. 2. The front page should contain the team leader's name and ultimately a list of district health offices, health facilities and villages visited. The first entry in the book would correspond to the place visited. 3. the first page of information entry for a new place (office, facility, village) should be headed with a. the name of the place b. the key people met c. the date and time span of the visit 4. After this, the team leader should start jotting rough notes of observations and events 5. On returning to base in the evening, the team leader should write a full narrative of important conversations and events that may influence how the research was carries out that day and/or may influence the quality of ivermectin distribution in that area. 6. Other team members should be encouraged to read and amplify these notes. 7. The project site Principal Investigator will review field notes on a weekly basis and at the end of the research compile all notes from each team into a detailed site field report that includes each day's entry from each site as well as an introduction and a closing section on conclusions and lessons learned.