A cluster-randomized trial of enhanced labor ward-based PMTCT services to increase nevirapine coverage in Lusaka, Zambia.

OBJECTIVE: Determine whether enhanced labor ward-based services for prevention of mother-to-child transmission of HIV (PMTCT) would improve nevirapine (NVP) coverage. DESIGN: Cluster-randomized trial at 12 public-sector delivery centers in Lusaka, Zambia. METHODS: Following a baseline surveillance period, 12 labor wards were randomized, six to offer opt-in HIV testing to women of unknown serostatus (with NVP administration as indicated) and to assess NVP adherence among known HIV-infected women. The six control labor wards provided the standard of care. The NVP coverage endpoint was defined as the proportion of HIV-infected/exposed women/infant pairs with confirmed NVP ingestion. We used generalized estimating equations (GEE) to determine the odds of coverage associated with the intervention and ultimately used the parameters for the estimated GEE model to estimate relative risk. RESULTS: Between October 2005 and January 2006, 7664 women gave birth at participating clinics. We collected anonymous-linked blood from 7592 (99%) umbilical cords; tested 7438 (97%) for HIV, 1618 (22%) were seropositive, and of these, 1279 (79%) were tested for NVP. At baseline (preintervention), the probability of HIV-infected/exposed women/infant pairs receiving NVP in treatment clinics (42%) was 0.89 times the probability of being covered in control clinics (53%) whereas during the intervention period the probability of treatment clinic coverage (52%) was 1.22 the probability control clinic coverage (43%), representing a multiplicative effect of 1.37 upon the RR at baseline (ratio of relative risks 1.37, bootstrapped 95% CI, 1.04-1.77). CONCLUSION: Labor ward-based PMTCT programs are feasible and can have a significant, positive impact on NVP coverage.

Predictors of rapid HIV testing acceptance and successful nevirapine administration in Zambian labor wards.

BACKGROUND: Provision of HIV testing in labor provides an opportunity to reach susceptible women and infants. METHODS: As part of a cluster randomized trial of labor ward-based prevention of mother-to-child transmission services in Lusaka, Zambia, we determined predictors of testing acceptance and nevirapine (NVP) administration in labor. HIV counseling and testing were offered to women unaware of their HIV status. NVP was administered to women who tested positive, and an inert (calcium) tablet was provided to women who tested negative, to avoid stigmatization. RESULTS: Among the 2435 women who presented in labor, 393 (16%) were unaware of their HIV status, of whom 278 (71%) met eligibility criteria. We offered counseling to 217 (78%) of eligible women: 146 (67%) agreed, 82 (56%) of those counseled were tested for HIV, and 23 (28%) were seropositive. Testing rates were higher among primigravida women [adjusted odds ratio (AOR) 1.5; 95% confidence interval (CI): 1.1 to 2.1] and among those not offered HIV testing during their pregnancy (AOR 3.7; 95% CI: 2.8 to 5.1). Cervical dilation 1 hour (AOR 11.5; 95% CI: 4.5 to 29.2) and >2 hours (AOR 11.4; 95% CI: 4.7 to 27.5) before delivery. CONCLUSION: Labor ward HIV testing is feasible in this resource-limited setting.