HIV testing of pregnant women during labor and delivery is one of the last opportunities to prevent mother-to-child HIV transmission, especially in women who do not have access to antenatal care and HIV testing services early in pregnancy. In India, a sizeable proportion of rural women present to hospitals for delivery without any prior antenatal care [10
]. Even those women who do receive some antenatal care do not always get tested for HIV for various reasons.
In this study, we assessed the impact of introducing round-the-clock, rapid, point-of-care HIV counseling and testing in a labor ward in rural India. Our results show that it is feasible to introduce a program of round-the-clock oral rapid HIV testing, including abbreviated prepartum and extended postpartum counseling sessions, even in a very busy labor room setting in an Indian village. In our study, all women who consented were successfully counseled and tested. Counseling in the labor room setting was highly feasible, even in a busy rural hospital setting. Our data suggest that the availability of round-the-clock rapid HIV testing resulted in successful documentation of HIV serostatus in a large proportion of women who were unaware of their HIV status when admitted to the labor ward. In addition, 11 of a total of 15 HIV-positive women received PMTCT interventions because they underwent rapid testing in the labor ward. Lastly, with regard to rapid test accuracy, both oral and finger-stick OraQuick tests had excellent specificity (100%), with one false negative result.
An important finding of our study was that of the 564 women who claimed to have been tested for HIV some time during pregnancy, only 219 were confident in reporting test results. A majority of the women had failed to pick up their test results from private providers or had not been adequately informed about test results. Of the 15 HIV-positive women, only four reported having been tested in pregnancy. In our study, a majority of women sought HIV testing from private practitioners (including unlicensed providers) and were unaware of the test results. These data suggest that there are several missed opportunities for HIV testing during pregnancy.
In India, HIV testing is not routinely offered by health care providers, especially in the private health care sector [18
]. Further, several factors acting at individual, community, regional, and national levels prevent women from seeking voluntary HIV testing in pregnancy. Individual-level factors include poverty and difficulty in accessing health care, reluctance of rural women to seek hospital care as opposed to midwife-based home care, stigma, fear of obtaining a positive test result coupled with the fear of intimate partner violence and ostracism by the partner's family, and lack of awareness about the effectiveness of PMTCT interventions [18
]. Community-level factors include stigma, discrimination by community and health care professionals, and lack of social support [18
]. Regional- and national-level factors are: (1) lack of infrastructure (including availability of round-the-clock laboratory technicians); (2) irregular and insufficient supply of HIV rapid test kits; (3) cumbersome and time-consuming blood-based rapid tests; (4) lack of 24-h round-the-clock counseling services; and (5) women presenting late in labor (often within obstetric complications), which makes it difficult for obstetricians to arrange for urgent PMTCT interventions [4
]. In our study, by offering round-the-clock rapid testing and two-stage counseling, we were able to deliver PMTCT interventions to women who presented late in labor with no prior history of HIV testing and/or antenatal care.
Acceptability of rapid testing in our study was 98%, as compared to 83%–85% reported elsewhere [20
]. Preference for oral fluid–based tests over blood-based tests was 70%. This preference could be because oral fluid testing was convenient and did not elicit patients' fear of blood draw, or pain of needle stick and venipuncture. Our previous study in sexually transmitted disease clinic attendees in India documented a similarly high preference for the oral fluid–based rapid tests [4
Effective counseling sessions can play a major role in the institution of PMTCT interventions worldwide. However, counseling women in labor is a challenging endeavor [11
]. Besides, issues such as patient confidentiality, privacy of disclosure, and social support for the care of infant and mother all affect the emotional health of both mother and baby and need to be addressed [12
]. In our study, an abbreviated counseling session during labor and an extended postpartum counseling session led to a better uptake of advice from counselors in comparison to a one stage counseling session in labor used previously in routine practice settings [6
To our knowledge, our study is the first and largest study in a rural setting in the world, introducing round-the-clock rapid HIV testing and counseling in pregnant women in labor. The novel features of our study are: (1) use of an oral fluid–based OraQuick Rapid HIV-1/HIV-2 test; (2) use of a parallel testing strategy with finger-stick OraQuick Rapid HIV-1/HIV-2 test; (3) round-the-clock availability of trained counselors, and use of a two-stage (i.e., abbreviated prepartum and extended postpartum) counseling sessions; (4) evaluation of this strategy in a rural population in a resource constrained setting.
In previous studies, blood-based rapid HIV tests have been used in pregnant women in both antenatal clinics and labor rooms [6
]. The US Centers for Disease Control and Prevention (CDC)–funded Mother Infant Rapid Intervention at Delivery (MIRIAD) study evaluated the feasibility and performance of the blood-based rapid OraQuick Rapid HIV test in 4,849 pregnant women in labor across 16 hospitals in the US [21
]. Of 7,381 potential participants, 4,849 women consented (84%) for testing [21
]. In comparison, our consent rate was 98%.
Three studies have been conducted in pregnant women in antenatal clinics and delivery rooms in urban India [10
]. In the first study, 1,258 consenting women were tested with blood-based rapid HIV and salivary brush OraQuick HIV tests. A lower sensitivity of 75% for OraQuick saliva test was detected due to inadequate salivary sample collection and use of inferior quality gold standard ELISA test [10
]. In our study, an advanced version of oral fluid–based OraQuick Rapid HIV-1/HIV-2 in a parallel strategy with a reference standard of dual ELISA and Western blot improved our estimates of diagnostic accuracy. In the second Indian study, about 522 of 1,322 women (44%) consented to test with four rapid HIV tests (i.e., three rapid finger-stick and one rapid saliva test). Approximately, 61% women presented with a prior history of HIV testing, and four new cases of HIV were identified [11
]. In our study, a majority (82%) of women presented with no history of HIV testing, and eleven new cases were identified. In the third study, 61% (417 of 613) women accepted testing and counseling, as compared to 98% in our study [20
]. The higher acceptance rate in our study could be attributed to the use of an oral fluid HIV test and a two-stage counseling session that were not employed in earlier studies [20
Our study has strengths and limitations. Strengths include a fairly large sample size, a high response rate, inclusion of several rural women with no prior antenatal care, and provision of round-the-clock two-stage counseling and point-of-care oral rapid HIV testing services even in a busy rural labor room setting.
With regard to limitations, our study was not designed to detect HIV seroprevalence in all pregnant women. Further, our sensitivity estimates of OraQuick tests were imprecise because of the relatively few HIV-positive women diagnosed during the study period. Our study was conducted in a rural, labor ward setting in India, and therefore our results may not be generalizable to all settings. Due to the fact that we utilized the existing hospital resources and rapid HIV test kits donated to us for the study, we were unable to precisely assess the total costs involved in setting and implementing our testing and counseling program. We are currently planning cost-effectiveness and cost-benefit analyses of introducing a round-the-clock rapid HIV testing program in the labor ward. Lastly, while we have demonstrated the feasibility and impact of introducing a round-the-clock rapid HIV testing program in the labor ward, the sustainability of such projects and their evaluation for implementation at the country level will require involvement of government and international agencies.
In a busy, rural labor ward setting in India, we demonstrated the feasibility and impact of introduction of a round-the-clock rapid HIV testing and two-stage counseling program. Our data suggest that this testing approach resulted in successful documentation of HIV serostatus in a large proportion of women who were unaware of their HIV status when admitted to the labor ward. Additionally, a high proportion of HIV-positive women received PMTCT interventions due to rapid testing in labor. These findings may inform existing PMTCT programs in similar settings worldwide to upgrade the current testing services in rural resource constrained settings. This includes incorporation of patient preferred oral rapid point-of-care HIV tests and patient-tailored two-stage counseling sessions that worked well in our setting. Such targeted initiatives may also help estimate burden of HIV infection in pregnant women with unknown serostatus in similar settings worldwide.