A randomized trial of two postexposure prophylaxis regimens to reduce mother-to-child HIV-1 transmission in infants of untreated mothers

  • AIDS, Volume 19, No. 12, Year 2005

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Study Justification:
The study aimed to compare the effectiveness of two postexposure prophylaxis regimens in reducing mother-to-child transmission (MTCT) of HIV-1. The use of single-dose nevirapine (NVP) prophylaxis is common in resource-constrained settings, but in cases where women do not have access to antenatal care or HIV testing, alternative strategies are needed. This study sought to determine if a single-dose of NVP given to infants could provide protection against HIV-1 infection in infants of untreated mothers.
Highlights:
– The study compared single-dose NVP with 6 weeks of zidovudine (ZDV) as postexposure prophylaxis in infants.
– The study was conducted in South Africa from October 2000 to September 2002.
– HIV-1 infection rates were assessed at birth, 6 weeks, and 12 weeks of age.
– The overall MTCT probability at 6 weeks was 12.8%, and at 12 weeks it was 16.3%.
– Among infants not infected at birth, the NVP arm had a lower infection rate (7.9%) compared to the ZDV arm (13.1%) at 12 weeks.
– Factors associated with infection following birth included ZDV use, maternal CD4 cell count < 500 × 106 cells/l, maternal viral load > 50,000 copies/ml, and breastfeeding.
– The study concluded that a single-dose of NVP given to infants can offer protection against HIV-1 infection and should be considered as a strategy for infants of mothers with untreated HIV infection.
Recommendations:
Based on the study findings, the following recommendations can be made:
1. Implement the use of single-dose NVP as postexposure prophylaxis in infants of mothers with untreated HIV infection.
2. Ensure access to antenatal care and HIV testing to reduce the need for alternative prophylaxis strategies.
3. Monitor maternal CD4 cell count and viral load to identify high-risk cases and provide appropriate interventions.
4. Promote safe infant feeding practices to further reduce the risk of MTCT.
Key Role Players:
1. Healthcare providers: Responsible for implementing the recommended prophylaxis strategies and monitoring maternal health.
2. Policy makers: Responsible for developing and implementing policies to support the use of single-dose NVP and improve access to antenatal care and HIV testing.
3. Community organizations: Involved in raising awareness about the importance of HIV testing and promoting safe infant feeding practices.
Cost Items for Planning Recommendations:
1. Training and capacity building for healthcare providers on the use of single-dose NVP and monitoring maternal health.
2. Development and dissemination of educational materials for healthcare providers and the community.
3. Strengthening antenatal care services to ensure access to HIV testing and early interventions.
4. Support for community-based organizations to conduct awareness campaigns and provide counseling on safe infant feeding practices.
5. Monitoring and evaluation activities to assess the impact of the recommendations and make necessary adjustments.

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong. The study is a randomized, open-label clinical trial with a large sample size (1051 infants) and a multicentre design. The study compares two postexposure prophylaxis regimens (single-dose nevirapine and 6 weeks of zidovudine) to reduce mother-to-child HIV-1 transmission. The study reports HIV-1 infection rates at birth, 6 weeks, and 12 weeks of age. However, the study does not provide information on the randomization process, blinding, or potential biases. To improve the evidence, future studies could include a double-blind design, provide more details on the randomization process, and address potential biases.

Background: Single-dose nevirapine (NVP) prophylaxis to mother and infant is widely used in resource-constrained settings for preventing mother-to-child transmission (MTCT) of HIV-1. Where women do not access antenatal care or HIV testing, post-exposure prophylaxis to the infant may be an important preventative strategy. Methods: This multicentre, randomized, open-label clinical trial (October 2000 to September 2002) in South Africa compared single-dose NVP with 6 weeks of zidovudine (ZDV), commenced within 24 h of delivery among 1051 infants whose mothers had no prior antiretroviral therapy. HIV-1 infection rates were ascertained at birth, and at 6 and 12 weeks of age. Kaplan-Meier survival methods were used to estimate HIV-1 infection rates in an intention-to-treat analysis. Results: Overall, 6 week and 12 week MTCT probability was 12.8% [95% confidence interval (Cl), 10.5-15.0] and 16.3% (95% Cl, 13.4-19.2), respectively. At 12 weeks, among infants who were not infected at birth, 24 (7.9%) infections occurred in the NVP arm and 41 (13.1%) in the ZDV arm (log rank P = 0.06). Using multivariate analysis, factors associated with infection following birth were ZDV use [odds ratio (OR), 1.8; 95% Cl, 1.1-3.2; P = 0.032), maternal CD4 cell count 50 000 copies/ml (OR, 3.6; 95% Cl, 2.0-6.2; P < 0.0001) and breastfeeding (OR, 2.2; 95% Cl, 1.3-3.8; P = 0.006). Conclusion: A single-dose of NVP given to infants offers protection against HIV-1 infection and should be a strategy used in infants of mothers with untreated HIV infection. © 2005 Lippincott Williams & Wilkins.

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One potential innovation to improve access to maternal health in this context could be the development and implementation of a mobile health (mHealth) application. This application could be designed to provide pregnant women and new mothers with important information and reminders about HIV prevention and treatment, including the use of post-exposure prophylaxis (PEP) for infants. The mHealth app could also offer resources for locating nearby healthcare facilities that offer HIV testing and antenatal care services. By leveraging the widespread use of mobile phones, this innovation could help reach women who may not have easy access to traditional healthcare services.
AI Innovations Description
The recommendation from the study is to use a single-dose of nevirapine (NVP) as post-exposure prophylaxis to infants of mothers with untreated HIV infection. This strategy aims to reduce mother-to-child transmission (MTCT) of HIV-1 in resource-constrained settings where women may not have access to antenatal care or HIV testing. The study compared the effectiveness of single-dose NVP with 6 weeks of zidovudine (ZDV) in preventing MTCT. The results showed that the NVP regimen had a lower rate of HIV-1 infection in infants compared to the ZDV regimen. Factors associated with increased risk of infection included ZDV use, maternal CD4 cell count < 500 × 106 cells/l, maternal viral load > 50,000 copies/ml, and breastfeeding. Overall, the study suggests that a single-dose of NVP given to infants can be an effective strategy to improve access to maternal health and reduce MTCT of HIV-1.
AI Innovations Methodology
Based on the provided information, here are two potential recommendations for improving access to maternal health:

1. Strengthening Antenatal Care and HIV Testing: Implementing strategies to increase access to antenatal care and HIV testing can help identify pregnant women with HIV infection and provide them with appropriate interventions, such as antiretroviral therapy (ART) to prevent mother-to-child transmission (MTCT) of HIV. This can involve community outreach programs, mobile clinics, and partnerships with local healthcare providers to ensure that pregnant women have access to these essential services.

2. Promoting Infant Post-Exposure Prophylaxis (PEP): Enhancing the provision of post-exposure prophylaxis to infants born to mothers with untreated HIV infection can be an effective strategy to reduce MTCT. This can involve training healthcare providers on the administration of PEP medications, ensuring the availability of these medications in healthcare facilities, and educating mothers about the importance of PEP for their infants.

To simulate the impact of these recommendations on improving access to maternal health, a methodology could involve the following steps:

1. Data Collection: Gather data on the current access to maternal health services, including antenatal care utilization rates, HIV testing rates, availability of antiretroviral therapy, and provision of post-exposure prophylaxis to infants.

2. Define Metrics: Identify key metrics to measure the impact of the recommendations, such as the percentage increase in antenatal care attendance, the percentage increase in HIV testing rates, and the reduction in MTCT rates.

3. Baseline Assessment: Determine the baseline values for the identified metrics based on the collected data.

4. Intervention Implementation: Implement the recommended interventions, such as strengthening antenatal care and HIV testing, and promoting infant post-exposure prophylaxis.

5. Monitoring and Evaluation: Continuously monitor the implementation of the interventions and collect data on the identified metrics at regular intervals.

6. Comparative Analysis: Compare the post-intervention data with the baseline data to assess the impact of the recommendations. This can involve statistical analysis to determine the significance of any changes observed.

7. Interpretation and Reporting: Analyze the results and provide a clear interpretation of the impact of the recommendations on improving access to maternal health. This can include quantifying the reduction in MTCT rates and improvements in antenatal care and HIV testing utilization.

By following this methodology, policymakers and healthcare providers can gain insights into the potential impact of these recommendations and make informed decisions to improve access to maternal health.


Statistics:
Citations: 79
Identifiers:
DOI: 10.1097/01.aids.0000180100.42770.a7
ISSN: 02699370
Research Areas:
Health System and Policy, Infectious Diseases, Maternal Access, Maternal and Child Health
Study Countries:
South Africa
Study Design:
Case-Control Study
Participants Gender:
Female
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