title: Feasibility of supervised self-testing using an oral fluid-based HIV rapid testing method: a cross-sectional, mixed method study among pregnant women in rural India.
abstract: HIV self-testing can increase coverage of essential HIV services. This study aimed to establish the acceptability, concordance and feasibility of supervised HIV self-testing among pregnant women in rural India.
  
  
  
  A cross-sectional, mixed methods study was conducted among 202 consenting pregnant women in a rural Indian hospital between August 2014 and January 2015. Participants were provided with instructions on how to self-test using OraQuick(®) HIV antibody test, and subsequently asked to self-test under supervision of a community health worker. Test results were confirmed at a government-run integrated counselling and testing centre. A questionnaire was used to obtain information on patient demographics and the ease, acceptability and difficulties of self-testing. In-depth interviews were conducted with a sub-sample of 35 participants to understand their experiences.
  
  
  
  In total, 202 participants performed the non-invasive, oral fluid-based, rapid test under supervision for HIV screening. Acceptance rate was 100%. Motivators for self-testing included: ease of testing (43.4%), quick results (27.3%) and non-invasive procedure (23.2%). Sensitivity and specificity were 100% for 201 tests, and one test was invalid. Concordance of test result interpretation between community health workers and participants was 98.5% with a Cohen's Kappa (k) value of k=0.566 with p<0.001 for inter-rater agreement. Although 92.6% participants reported that the instructions for the test were easy to understand, 18.7% required the assistance of a supervisor to self-test. Major themes that emerged from the qualitative interviews indicated the importance of the following factors in influencing acceptability of self-testing: clarity and accessibility of test instructions; time-efficiency and convenience of testing; non-invasiveness of the test; and fear of incorrect results. Overall, 96.5% of the participants recommended that the OraQuick(®) test kits should become publicly available.
  
  
  
  Self-testing for HIV status using an oral fluid-based rapid test under the supervision of a community health worker was acceptable and feasible among pregnant women in rural India. Participants were supportive of making self-testing publicly available. Policy guidelines and implementation research are required to advance HIV self-testing for larger populations at scale.
authors.affiliation: Research, Innovations, and Monitoring Unit, MAMTA Health Institute for Mother & Child, New Delhi, India; archanas@mamtahimc.orgarchana.sarkar5@gmail.com.
authors.forename: Archana
authors.initials: A
authors.lastname: Sarkar
authors.affiliation: Program Impact Unit, International HIV/AIDS Alliance, East Sussex, UK.|Division of Health Research, School of Health and Medicine, Lancaster University, Lancaster, UK.
authors.forename: Gitau
authors.initials: G
authors.lastname: Mburu
authors.affiliation: Department of Obstetrics & Gynaecology, Mahatma Gandhi Institute of Medical Sciences, Wardha, India.
authors.forename: Poonam Varma
authors.initials: PV
authors.lastname: Shivkumar
authors.affiliation: Research, Innovations, and Monitoring Unit, MAMTA Health Institute for Mother & Child, New Delhi, India.
authors.forename: Pankhuri
authors.initials: P
authors.lastname: Sharma
authors.affiliation: Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Fiona
authors.initials: F
authors.lastname: Campbell
authors.affiliation: Research, Innovations, and Monitoring Unit, MAMTA Health Institute for Mother & Child, New Delhi, India.
authors.forename: Jagannath
authors.initials: J
authors.lastname: Behera
authors.affiliation: Research, Innovations, and Monitoring Unit, MAMTA Health Institute for Mother & Child, New Delhi, India.
authors.forename: Ritu
authors.initials: R
authors.lastname: Dargan
authors.affiliation: Research, Innovations, and Monitoring Unit, MAMTA Health Institute for Mother & Child, New Delhi, India.
authors.forename: Surendra Kumar
authors.initials: SK
authors.lastname: Mishra
authors.affiliation: Research, Innovations, and Monitoring Unit, MAMTA Health Institute for Mother & Child, New Delhi, India.
authors.forename: Sunil
authors.initials: S
authors.lastname: Mehra
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis; D003376:Counseling; D003430:Cross-Sectional Studies; D005260:Female; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000276:immunology* / Q000302:isolation & purification; D006801:Humans; D007194:India; D008403:Mass Screening / Q000379:methods*; D009055:Mouth / Q000821:virology*; D011247:Pregnancy; D037841:Pregnant People; D012424:Rural Population; D012648:Self Care; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral
keywords: India; acceptability; feasibility; pregnant women; supervised HIV self-testing