Given the large number of organizations involved in the survey, as well as the number of individuals and skills required to successfully implement all of the different stages of NFHS-3, several types of training workshops were held.
Health Coordinators’ Training:
Eight Health Coordinators, medical personnel, specially employed by IIPS for the NFHS-3 project for the supervision of data collection on biomarkers were trained for two weeks at IIPS in methods of blood collection, haemoglobin testing, and height/weight measurement. The training programme was conducted in June 2005. Dr. Jasbir Sangha, biomarker specialist at ORC Macro, was the resource person. The training involved classroom sessions, and practice sessions in the classroom, and at health centres and in the community.
Household Listing and Mapping Workshops:
Two household listing and mapping workshops of three days’ duration were organized at IIPS, Mumbai, one for each phase of fieldwork. The workshop for the states participating in the first phase of fieldwork was held during September 8-10, 2005, and for the second phase states was held during January 15-18, 2006. Two persons responsible for coordinating mapping and household listing from each Research Organization were trained in mapping and household listing operations. The training involved classroom sessions and field practice in rural and urban areas. IIPS coordinators and a consultant from ORC Macro imparted the training.
Training of Trainers (ToT) Workshops:
Two training workshops were held for training the trainers of field staff of the Research Organizations. The ToT for the first phase states was held during September 16-October 5, 2005 at Hotel Cidade de Goa, Goa, and for the second phase states the ToT was organized during January 30-February 15, 2006 at Hotel Holiday Inn, Ooty. At least two trainers for each state were trained in training interviewers, supervisors and editors. The training involved discussion on the questionnaires, lectures of guest speakers on special topics of HIV/AIDS, Domestic violence, Family Planning Methods, and classroom and field practice. IIPS members of PMU and Macro consultants imparted the training.
Health Investigators’ Training:
The centralized training of two weeks’ duration was organized at IIPS for all the health investigators, separately for phase 1 and phase 2 states. The training programme for first phase states was conducted during November 7-19, 2005, and for second phase states during March 13-25, 2006. The Health Coordinators and Macro consultants were the resource persons. The training comprised of classroom lectures, demonstrations, classroom practice, and practice in health centres and in the community.
Data Processing Training:
Two coordinators from each research organization were trained at IIPS in office editing of data and data entry software. For each phase of data collection, separate training of two weeks’ duration was arranged at IIPS. The training for first phase states was conducted during November 28-December 9, 2005, and for second phase states was conducted during April 3-14, 2006. Consultants from ORC Macro imparted the training.
NFHS-3 fieldwork was carried out in two phases. The first phase activities started in August 2005 and data collection was done from December 2005 to May 2006. The second phase started in January 2006 and data collection was carried out from April to August 2006. In the first phase, 12 states were covered and in the second phase the remaining 17 states were covered.
Data processing involved office editing, data entry using CSPro software, verification of data entry, secondary editing, and final cleaning of data at IIPS. For quality assurance, field check tables were generated on a regular basis, starting soon after a few questionnaires were entered.
NFHS-3 outputs planned are:
State and National Fact Sheets
National Report in two volumes
Specialized Subject Reports
Key Findings Report
To maintain uniform survey procedures across the states and minimize non-sampling errors, the following comprehensive manuals were prepared.
MANUAL FOR HOUSEHOLD LISTING AND MAPPING
The manual for household listing and mapping describes the procedures for drawing location and layout maps of sampled areas, household listing, and selecting households for the survey. This manual also describes the roles and responsibilities of mappers and listers.
Interviewer’s manual describes the interviewing techniques, procedure for filling the questionnaire and discussion on each question of all the questionnaires. The manual also provides the details of all fieldwork procedures.
SUPERVISOR’S AND EDITOR’S MANUAL
The supervisor and editor’s manual describes in detail the preparation, organization and monitoring of the fieldwork. The roles and responsibilities of supervisor and editor are discussed in this manual.
This manual was produced as an aid to all organizations involved in implementing NFHS-3 fieldwork, to design and implement field staff training. This document provides general guidelines for organizing and conducting the training of the field staff.
ANTHROPOMETRY, ANAEMIA AND HIV TESTING FIELD MANUAL
This manual describes all the field procedures to be followed in the process of measurement of biomarkers, with illustrative diagrams. The steps to be followed in the measurement of height and weight and haemoglobin content in the blood of children and adults are discussed in details. The procedures of blood collection for HIV testing, making Dried Blood Samples (DBS), and transporting DBS to collection centres of the central laboratory are described. The protocol for disposal of biohazard waste is also described.
TRAINING INTERVIEWERS TO IMPLEMENT THE HOUSEHOLD RELATIONS SECTION (SECTION 10) OF THE NFHS-3 WOMAN’S QUESTIONNAIRE
This is an addendum to the Interviewer’s manual. Since domestic violence is a very sensitive issue, and many women may be reluctant to disclose experiences of violence, these training guidelines give particular emphasis to developing the necessary awareness and skills for maximizing disclosure, without placing respondents or staff at risk.
PROJECT DIRECTOR’S MANUAL
This manual provides a short list of all the activities and protocols involved in NFHS-3, which are useful for the Project Director in the central office who is overall in-charge of NFHS-3 in the state and is expected to oversee all the project activities.
MANUAL FOR SECONDARY DATA EDITS
This manual describes methods for data entry and secondary editing.
Since most of the key indicators to be estimated from NFHS-3 refer to ever-married women in the reproductive ages of 15-49, the target sample size for NFHS-3 in each state is estimated in terms of the number of ever-married women in the reproductive ages to be interviewed.
In NFHS-3, the initial target sample size was 4,000 completed interviews with ever-married women in states with a 2001 population of more than 30 million, 3,000 completed interviews with ever-married women in states with a 2001 population between 5 and 30 million, and 1,500 completed interviews with ever-married women in states with a population of less than 5 million. In addition, because of the sample-size adjustments required to meet the need for HIV prevalence estimates for the high HIV prevalence states and for slum and non-slum estimates in selected cities, the sample size in some states was higher than that fixed by the above criteria.
The sample size of HIV tests is estimated on the basis of the assumed HIV prevalence rate, the design effect of the sample, and the acceptable level of precision. With an assumed level of HIV prevalence of 1.25% and 15% relative standard error, the estimated sample size is 6400 tests each for men and women in high HIV prevalence states. At the national level, the assumed level of HIV prevalence of less than one percent (or 0.92%) and less than 5% standard error gave an estimate of 125,000 HIV tests needed at the national level.
All ever-married and never-married women age 15-49 and all men age 15-54 in all of the sample households in Uttar Pradesh and the six high HIV prevalence states were interviewed and blood was collected for HIV testing in all of those states except Nagaland. In the remaining 22 states, all ever-married and never-married women age 15-49, but all men age 15-54 from only a subsample of sampled households, were interviewed. The HIV tests were carried out only in a subsample of households in which men were interviewed.
The urban and rural samples within each state were drawn separately and, to the extent possible, the sample within each state was allocated proportionally to the size of the state’s urban and rural populations. A uniform sample design was adopted in all the states. In each state, the rural sample was selected in two stages: the selection of Primary Sampling Units (PSUs), which are villages, with probability proportional to population size (PPS) at the first stage, followed by the random selection of households within each PSU in the second stage. In urban areas, a three-stage procedure was followed. In the first stage, wards were selected with PPS sampling. In the next stage, one census enumeration block (CEB) was randomly selected from each sample ward. In the final stage, households were randomly selected within each sample CEB.
In rural areas, the 2001 Census list of villages served as the sampling frame. The list was stratified by a number of variables. The first level of stratification was geographic, with districts being subdivided into contiguous regions. Within each of these regions, villages were further stratified using selected variables from the following list: village size, percentage of males working in the nonagricultural sector, percentage of the population belonging to scheduled castes or scheduled tribes, and female literacy. In addition to these variables, HIV prevalence status, i.e. “High”, “Medium” and “Low” as estimated for all the districts in high HIV prevalence states, was used for stratification in high HIV prevalence states. Female literacy was used for implicit stratification (i.e., the villages were ordered prior to selection according to the proportion of females who were literate) in most states although it may be an explicit stratification variable in a few states.
Mapping and Listing Operation
In every state, a mapping and household listing operation was carried out in each sample area. The listing provided the necessary frame for selecting households at the second stage. The household listing operation involved preparing up-to-date notional and layout sketch maps of each selected PSU, assigning numbers to structures, recording addresses of these structures, identifying residential structures, and listing the names of heads of all the households in residential structures in the selected PSUs.
HIV TESTING IN NFHS-3
In response to the urgent need to have nationally-representative data on HIV prevalence and comprehensive information on knowledge and attitudes about HIV/AIDS, high-risk sexual behaviour, and practices related to HIV testing in India, it was proposed to incorporate these issues in NFHS-3. It was planned to provide HIV seroprevalence levels for the population of women age 15-49 and men age 15-54 at the national level and for each of the six high HIV prevalence states as identified by National AIDS Control Organization (NACO), namely, Andhra Pradesh, Karnataka, Maharashtra, Manipur, Nagaland and Tamil Nadu. Considering the large sample size in Uttar Pradesh it was further decided to provide estimates of HIV prevalence for the state of Uttar Pradesh also. NFHS-3 is the first large scale nationwide survey in which a technique of testing Dried Blood Spots was used fot HIV testing.
In NFHS-3, HIV testing was limited to women age 15-49 and men age 15-54. The survey approach was different in the six high HIV prevalence states and in the rest of India.
In the six high HIV prevalence states and Uttar Pradesh, all eligible women and men were asked to complete a detailed interview that focused on HIV/AIDS and other health, population, and nutrition information. All of the interviewed respondents were asked to provide a blood sample for HIV testing. This design allowed individual information on HIV status to be linked to all of the other attitudinal and behavioural information collected in the interview for the entire sample.
In the remaining states, the number of HIV tests was less than the number of interviews with eligible women and men. The reason for this difference is that the required number of HIV tests is determined by the need to calculate HIV prevalence at the national level whereas the number of individual interviews is determined by the need to provide state level estimates for all attitudinal and behavioural indicators. For statistical reasons, it is not possible to estimate HIV prevalence in every state as the number of tests required to be done for estimating the prevalence in low HIV prevalence states would have been very large.
Anonymous, linked design for HIV testing
The HIV testing was anonymous. No names or other contact information were recorded on the dried blood spot (DBS) samples. Instead, a bar code label with randomly generated numbers was pasted on the filter paper sample and on the questionnaires. Respondents were not to receive the results of the testing since the protocol design made it impossible for the survey staff to know the HIV status of individual participants. All of the information obtained from the household and individual interviews, however, would be linked to the HIV test results through the bar codes. In order to preserve the anonymity of the results, the original cluster and household identifiers were replaced in the data set by randomly generated cluster and household numbers.
Since the survey team was expected to be in any given enumeration area for only 3-4 days, it was not be possible to provide a full range of HIV counseling and testing services as well as follow-up care. Consequently, the proposed design called for HIV testing in a central laboratory. Since the testing was anonymous, it was highly recommended that all individuals who were eligible for testing in the survey, whether they accepted the testing or not, received referrals for free HIV counseling and testing at a local health facility.
Dried blood spot (DBS) samples were collected on filter paper in the field and tested in one or more central laboratories. The specimens were obtained using the finger prick technique. The risk of the blood collection procedure is considered to be low. The area from which blood was drawn was thoroughly cleaned with an alcohol prep swab before a small puncture was made with a non-reusable lancet. The first drop of blood was wiped away with sterile gauze. Subsequent drops of blood were used to completely fill 3-5 preprinted circles on a filter paper bloodspot collection card.
Only medical personnel or other personnel with specific training on the procedure and on universal precautions regarding blood-borne pathogens were used for collecting the blood samples. Lancets and all blood-contaminated materials were disposed of in a biohazard bag according to an established protocol.
After collection, the blood spot samples were placed in a specially designed collection box where they were stored overnight to dry. The plastic collection box had a paper drying rack to hold the sample filter paper cards in a horizontal position. Pouches of non-regeneratable desiccants were placed in the collection boxes to assist the drying process, particularly in high humidity environments. A humidity indicator card was placed in the drying box to allow the humidity level to be monitored.
As already mentioned, the testing was anonymous, i.e., personal identifiers for individual respondents were not retained with the DBS samples so that the results of the testing could not be reported back to the respondents.
Proposed laboratory testing protocol
The current recommendations of WHO/UNAIDS for population-based seroprevalence estimation were followed. This algorithm involved the following steps:
Step 1: Select two antibody tests from different manufacturers (Assays A and B).
Step 2: Test the sample using Assay A:
• IF the result is negative, report the final result as negative.
Step 3: IF the result is positive, test the sample using Assay B.
• IF the result is again positive, report the final result as positive.
Step 4: IF the result is negative, retest the sample with BOTH Assays A and B:
• IF the 2nd pair of results are both negative, report the final result as negative.
• IF the 2nd pair of results are both positive, report the final result as positive.
• IF the 2nd pair of results are inconsistent (1 positive and 1 negative), report the final result as indeterminate.
Note: Steps 3 and 4 may also be followed for a subsample of 5-10% of the negative samples.
Figure 1 in Attachment D provides an example of a standard protocol of HIV testing using DBS.
This proposed protocol for HIV testing was approved by the IIPS ethical review board in India and the institutional review boards of the funding agencies and the technical assistance agency.
Maintaining anonymity of the testing in the laboratories
SRL Ranbaxy laboratory was selected for testing DBS for HIV, mainly due to its vast network of collection centers and capacity to store and test such large scale blood samples. All the samples tested positive and 5-10 percentage of samples tested negative by Ranbaxy were sent to National AIDS Research Institute (NARI), Pune for retesting, as part of external quality control. In case of any discordance in the test results by two laboratories, both laboratories together retested the samples and unanimously decided about the test results. Ranbaxy was responsible for creating a data file that contained the sample ID number (from the bar code) and test results for all HIV assays completed for each specimen. After verification the data forwarded to IIPS. All the samples would be destroyed after all parties are satisfied that any remaining samples are no longer needed for HIV antibody testing or retesting
Obtaining informed consent for testing
All individuals selected in the sample for HIV testing were asked to provide informed voluntary consent to the testing. As part of this process, a detailed statement summarizing the procedures to be used and the potential benefits and risks was read to each individual. In addition to the formal informed consent statement, respondents were given an opportunity to ask any questions about the survey that would help them decide whether or not they want to participate. In the case of respondents age 15-17, a parent, guardian or other responsible adult present in the household at the time of the survey was first asked to give their consent for the blood sample to be collected from the minor; then the minor was personally asked to consent to the testing. The test was carried out only if both the minor and the responsible adult agreed to the testing.
National AIDS Control Organization (NACO) provided guidance in all the procedure for blood collection, transporting DBS to collection centers, testing DBS in laboratory and external quality control. Representatives from NACO, ICMR and NARI.