Rapid HIV testing of women in labour in rural India feasible

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A study of a round-the-clock implementation of HIV rapid testing in a busy rural antenatal clinic in India has shown that such a programme can be feasibly implemented, and results in high levels of HIV case identification and prevention of mother-to-child transmission, in settings where many HIV-positive women may go undiagnosed throughout pregnancy. The study was reported, with an accompanying editorial, in the May issue of PLoS Medicine.

Women make up an estimated 38% of India's HIV cases, and some 60% of India's people with HIV are found in rural areas. A great many pregnant rural women (possibly half, by anecdotal reports) receive no antenatal care at all before actually presenting for delivery.

Furthermore, despite efforts by India's National AIDS Control Organization (NACO) to expand voluntary counseling and testing (VCT) services, extremely few women may be receiving VCT during pregnancy. One recent study (Sinha 2008) found that only 3.3% of a sample of recently pregnant women in rural Maharashtra State received VCT. (Of these, the vast majority received it through the private sector rather than the official NACO programme.)

Glossary

VCT

Short for voluntary counselling and testing.

antenatal

The period of time from conception up to birth.

mother-to-child transmission (MTCT)

Transmission of HIV from a mother to her unborn child in the womb or during birth, or to infants via breast milk. Also known as vertical transmission.

enzyme-linked immunosorbent assay (ELISA)

A diagnostic test in which a signal produced by an enzymatic reaction is used to detect and quantify the amount of a specific substance in a solution. Can be used to detect antibodies to HIV, p24 antigen or other substances.

deoxyribonucleic acid (DNA)

The material in the nucleus of a cell where genetic information is stored.

In this study, a team of Canadian, Indian and US researchers evaluated the uptake of 24-hour rapid HIV testing in an antenatal clinic in rural India. The objectives were to determine if such testing was feasible in the clinic setting, would lead to increased uptake, and could identify women in labour who could be offered prevention of mother-to-child transmission (PMTCT) treatment.

During January and September 2006, 1,252 women between 18 and 45 years of age were approached for consent as they presented at the labour and delivery centre at the Mahatma Gandhi Institute of Medical Sciences in Sevagram, Maharashtra State. All women admitted to the labour ward during this period were approached by the managing obstetrician or by attendants, on a round-the-clock daily basis; no eligible cases were missed (except exclusions due to obstetric emergencies and those with mental health problems).

Acceptance was almost universal: 1,222 (98%) of the women accepted the offer of VCT. The 30 (2%) who refused either knew the results of a prior test, or did not perceive themselves to be at any risk.

The mean age of the 1,222 women tested was 24 years, nearly all (99%) were married and monogamous, and 84% had had no symptoms of sexually transmitted diseases. About 80% had at least high school education, but most were poor: nearly 90% had total monthly household incomes below 5,000 rupees (approx. 125 USD).

The HIV testing algorithm itself was as follows: two rapid OraQuick tests, one on saliva and one on fingerstick blood. Rapid OraQuick results were available and presumptively acted upon within twenty minutes; results were confirmed by follow-up with standard reference tests on blood plasma (ELISA for negative rapid-test results; ELISA plus Western blot for rapid-test positives).

Of the 1,222 women tested, 563 (46%) had had some history of HIV testing during pregnancy, but most (58%) of these were unaware of the results, and a great many (219 of the 563) had such poorly documented results (often provided by unlicensed personnel at private clinics) that the results were suspect. The remaining 659 (54%) had never been tested.

A total of fifteen women in the study were identified as HIV-positive. This gave a prevalence rate of 1.23% (95% confidence interval [CI], 0.61–1.8%) – in accordance with the 1% anticipated from recent antenatal sentinel surveillance. Of these 15, four had presented with a previously reported HIV status, and 11 were newly detected cases.

All but one of the 15 HIV-positive women received PMTCT interventions. Two of the fifteen babies (both of whom were HIV DNA positive by PCR) born to these women died within a month; the remaining 13 were repeatedly HIV DNA negative up to four months after birth.

The investigators conclude that they "demonstrated the feasibility and impact of … round-the-clock rapid HIV testing and two-stage counseling", resulting in "successful documentation of HIV serostatus in a large proportion of women who were unaware of their HIV status when admitted," as well as providing nearly universal PMTCT interventions to the HIV-positive women.

As PLoS editor David Celentano points out in the accompanying editorial, the process by which this intervention was carried out was as important as the findings themselves. The time frames of the study activities were very short: five to ten minutes between determination of study eligibility and consent, fifteen minutes for pre-test counselling (with a second, more extended session provided postpartum), twenty minutes for the rapid testing algorithm (run concurrently with other study activities), and ten to fifteen minutes between HIV diagnosis and provision of PMTCT treatment.

Celentano comments: "It is clear that the labor and delivery setting offers the final opportunity to detect and prevent [mother-to-child transmission] of HIV. The program outlined by Pai and colleagues is efficient, acceptable, and leads to reduced morbidity. Scaling up this program is clearly the next challenge… Without such effective programs, women are unlikely to be tested – an unacceptable situation that is relatively easy to address at this time."

References:

Pai NP et al. Impact of round-the-clock, rapid oral fluid HIV testing of women in labor in rural India. PLoS Medicine 2008;5(5):e92.

Celentano DD. Is HIV screening in the labor and delivery unit feasible and acceptable in low-income settings? PLoS Medicine 2006;5(5):e107.