To be successful in resource poor settings research methods and technologies must meet the needs of study subjects and health workers as well as researchers. If not, studies are subject to multiple problems including poor recruitment, poor acceptance by study staff, poor quality of data, poor quality of clinical services, and delays in accessibility of data for analysis. We propose to bring together Behavioral Scientists, Engineers, Medical Scientists, Epidemiologists and Health Economists to create a new Audio Computer Assisted Self Interview (ACASI), interactive counseling and self-testing computer tool (CARE-India) to support HIV prevention research. The new technology will allow minimally educated research staff to provide more acceptable methods for HIV counseling and testing, while ensuring that high quality data is collected, high quality counseling and referrals are provided, accurate rapid HIV test results are recorded, and that study data for multi-level analysis is reported in a timely manner. The initial technology will be developed for use among health workers in Southern India, the country with the highest number of HIV cases in the world, and will be validated in both government clinic and community internet centers. This technology will build on the federally funded CARE platform, an ACASI and interactive computer counseling tool that has been used successfully to expand access to HIV counseling and testing in resource poor settings in the United States, and that has shown high acceptability in a Gates foundation funded qualitative study in Southern India. During the first 2 years of this project we will develop and pilot the CARE-India tool. During the second 2 years we will test the tool's functionality in community and clinic research settings in Southern India.
Our Aims are to: 1) Culturally adapt the CARE tool for Southern India and to add functionality for fingerprint recognition and confidential linking of longitudinal risk data, and automated computer interpretation of rapid HIV test results;and 2) Field test the CARE-India tool among 300 participants to determine the accuracy of fingerprint identification and the accuracy of computer assisted self-testing for HIV, and when offered on random days (n=20 per site) to measure the acceptability of staff assessment and testing vs. the acceptability of optional ACASI assessment and computer assisted self-testing when delivered in a general health assessment and offered with Diabetes testing. CARE-India may allow the option of HIV self-testing methodology, with improved accuracy of interpretation and documentation, and may enhance participation in HIV related research studies. This will be the first tool to integrate staff- measured process outcomes with ACASI individual level risk, socioeconomic and biologic data, while guiding minimally trained staff through all research and clinical procedures, and allowing accurate linking of behavioral and biological data longitudinally through finger-print recognition. It will also be the first study to evaluate the accuracy of self-testing as a research methodology. If successful, this new technology and methodology will enhance interdisciplinary HIV prevention and vaccine research globally. 7. Project Narrative The goal of this application is to develop a new technology and methodology that will facilitate interdisciplinary research for HIV prevention and vaccine trials. This will be the first technology to integrate staff- measured process outcomes with ACASI individual level risk, socioeconomic and biologic data, while guiding minimally trained staff through all research and clinical procedures, and allowing accurate linking of behavioral and biological data longitudinally through finger-print recognition. It will also be the first study to evaluate the accuracy of self-testing as a new research methodology. If successful, this new technology and methodology will enhance interdisciplinary HIV prevention and vaccine research impacting public health globally.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Exploratory/Developmental Grants (R21)
Project #
3R21HD058468-02S1
Application #
8010072
Study Section
Special Emphasis Panel (ZDA1-GXM-A (27))
Program Officer
Newcomer, Susan
Project Start
2008-06-16
Project End
2012-03-31
Budget Start
2009-04-01
Budget End
2010-03-31
Support Year
2
Fiscal Year
2010
Total Cost
$100,129
Indirect Cost
Name
Research Triangle Institute
Department
Type
DUNS #
004868105
City
Research Triangle
State
NC
Country
United States
Zip Code
27709