Virological profile of pregnant HIV positive women with high levels of CD4 count in low income settings: Can viral load help as eligibility criteria for maternal triple ARV prophylaxis (WHO 2010 option B)?

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Study Justification:
The objective of this study was to determine the HIV-1 RNA load profile during pregnancy and assess the eligibility for maternal triple antiretroviral prophylaxis. The study aimed to provide evidence on whether viral load can be used as an eligibility criterion for maternal triple antiretroviral prophylaxis in low-income settings.
Highlights:
– The study included a cohort of pregnant HIV positive women with CD4 cell count > 350/mm3.
– CD4 cell count and viral load measurements were taken to assess eligibility for maternal triple antiretroviral prophylaxis.
– 61% of the women had a viral load of 4.4 log10/ml and were eligible for maternal triple antiretroviral prophylaxis.
– The study suggests that more than 6 in 10 pregnant HIV positive women with CD4 cell count > 350/mm3 may require triple antiretroviral prophylaxis to prevent mother-to-child transmission of HIV.
Recommendations:
– The study recommends considering viral load as an eligibility criterion for maternal triple antiretroviral prophylaxis in low-income settings.
– The findings suggest that universal access to triple antiretroviral prophylaxis should be considered in HIV high burden countries to move towards the virtual elimination of HIV mother-to-child transmission.
Key Role Players:
– Referral center staff and healthcare providers in antenatal clinics for implementing the recommendations.
– Ministry of Public Health for supervision and coordination of the intervention.
– Center for HAART treatment and the local board in charge of fighting against HIV and AIDS for coordination and support.
Cost Items for Planning Recommendations:
– Costs for viral load testing: The study mentions a unit cost of $30 per sample for HIV-1 RNA load measurement.
– Costs for antiretroviral drugs: Budget items would include the cost of procuring and providing triple antiretroviral prophylaxis to eligible pregnant women.
Please note that the cost items mentioned are for planning purposes and not the actual costs.

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong. The study was an observational cohort of pregnant HIV positive women, which provides valuable information. The sample size was relatively small (n=266), which may limit the generalizability of the findings. Additionally, the study only included pregnant women in low-income settings, so the results may not be applicable to other populations. To improve the evidence, future studies could consider increasing the sample size and including a more diverse population.

Introduction: The objective of the study was to determine HIV-1 RNA load profile during pregnancy and assess the eligibility for the maternal triple antiretroviral prophylaxis. It was an observational cohort of pregnant HIV positive women ignorant of antiretroviral therapy with CD4 cell count of > 350/mm3 Methods: Routine CD4 cell count assessment in HIV positive pregnant women completed by non exclusive measurement of the viral load by PCR /ARN in those with CD4 cell count > 350/mm3. Exclusion criteria: highly active antiretroviral therapy prior to pregnancy. Results: Between January and December 2010, CD4 cell count was systematically performed in all pregnant women diagnosed as HIV-infected (n=266) in a referral center of 25 antenatal clinics. 63% (N=170) had CD4 cell count > 350/mm3, median: 528 (IQR: 421-625). 145 underwent measurement of viral load by PCR/RNA at a median gestational of 23 weeks of pregnancy (IQR: 19-28). Median viral load 4.4log10/ml, IQR (3.5-4.9).19/145(13%) had an undetectable viral load of=1.8log10/ml. 89/145(61%) had a viral load of 4.4 log10/ml and were eligible for maternal triple ARV prophylaxis. Conclusion: More than 6 in 10 pregnant HIV positive women with CD4 cell count of > 350/mm3 may require triple antiretroviral for prophylaxis of MTCT. Regardless of cost, such results are conclusive and may be considered in HIV high burden countries for universal access to triple antiretroviral prophylaxis in order to move towards virtual elimination of HIV MTCT. © Anne Esther Njom Nlend et al.

The study population was an observational cohort of pregnant HIV positive women. Pregnant women with350/mm3. Maternal baseline serum samples were quantified for HIV-1 RNA load using real Time reverse transcriptase PCR (Generic HIV viral load, Biocentrics). All the samples were analyzed with the Laboratoire Centre Pasteur in Yaoundé acting as service provider at a unit cost of 30US$. ZDV was started for all the others non eligible for triple antiretroviral treatment at 14 weeks of pregnancy, while waiting for the result of the viral load. The following qualitative variables were considered: maternal age, WHO clinical stages. Quantitative variables included: CD4 cell count and HIV Viral load. Viral load values were log10 transformed and stored in an Excel sheet form. A threshold of≤1.8 log10 was considered as undetectable viral load. For this descriptive analysis we considered (frequency, percentage, medians with their quartile). A confidence interval of 95% was considered as the margin for percentage accuracy. All interventions within this project were implemented under the supervision of the District Office of the Ministry of Public Health. Data collection and monitoring of the intervention was part of the routine activities of the Health District. Free measurement of HIV1 RNA viral load was offered to all the eligible mothers at the referral center where all activities were coordinated by the Center for HAART treatment and the local board in charge of fighting against HIV and AIDS.

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The study mentioned in the description focuses on improving access to maternal health for pregnant HIV positive women. The following innovations were used in the study:

1. Opt-out counseling: Pregnant women were provided with counseling on HIV testing and given the option to opt-out if they did not wish to be tested.

2. Serial HIV-1/2 algorithm antibody tests: The study used two different rapid HIV tests to screen for HIV infection in pregnant women.

3. CD4 cell count measurement: CD4 cell counts were measured in HIV positive women to assess their immune status.

4. Viral load measurement: Viral load testing was conducted in pregnant women with CD4 cell counts above a certain threshold to determine their HIV-1 RNA load profile.

5. Real-time reverse transcriptase PCR: Maternal baseline serum samples were quantified for HIV-1 RNA load using this molecular technique.

6. Undetectable viral load threshold: A threshold of ≤1.8 log10 was considered as an undetectable viral load.

7. Provision of ZDV: Pregnant women who were not eligible for triple antiretroviral treatment were started on Zidovudine (ZDV) at 14 weeks of pregnancy while waiting for the viral load result.

8. Data collection and monitoring: All interventions and data collection were implemented under the supervision of the District Office of the Ministry of Public Health.

These innovations helped in assessing the eligibility for maternal triple antiretroviral prophylaxis and improving access to maternal health for pregnant HIV positive women.
AI Innovations Description
The recommendation from the study is to consider using viral load as an eligibility criterion for maternal triple antiretroviral prophylaxis in low-income settings. The study found that more than 60% of pregnant HIV positive women with a CD4 cell count of >350/mm3 had a viral load that made them eligible for triple antiretroviral prophylaxis. This recommendation suggests that using viral load in addition to CD4 cell count can help identify pregnant women who may benefit from this treatment to prevent mother-to-child transmission of HIV. The study also highlights the importance of universal access to triple antiretroviral prophylaxis in order to move towards the virtual elimination of HIV transmission from mother to child.
AI Innovations Methodology
Based on the provided information, here are some potential recommendations to improve access to maternal health:

1. Increase awareness and education: Implement comprehensive education programs to raise awareness about maternal health, including the importance of HIV testing and antiretroviral therapy during pregnancy.

2. Strengthen healthcare infrastructure: Improve the capacity and resources of healthcare facilities in low-income settings to provide comprehensive maternal health services, including HIV testing, CD4 cell count assessment, and viral load monitoring.

3. Mobile health interventions: Utilize mobile technology to provide remote access to maternal health services, such as telemedicine consultations, appointment reminders, and educational resources.

4. Community-based interventions: Establish community-based programs that provide maternal health services, including HIV testing and antiretroviral therapy, in easily accessible locations, such as community centers or mobile clinics.

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

1. Define the target population: Identify the specific population that will be impacted by the recommendations, such as pregnant women in low-income settings.

2. Collect baseline data: Gather data on the current access to maternal health services, including HIV testing, CD4 cell count assessment, and viral load monitoring, in the target population.

3. Implement the recommendations: Introduce the recommended interventions, such as awareness and education programs, strengthening healthcare infrastructure, mobile health interventions, and community-based interventions.

4. Monitor and evaluate: Continuously monitor the implementation of the recommendations and collect data on the impact of the interventions on access to maternal health services. This can include tracking the number of pregnant women receiving HIV testing, CD4 cell count assessment, and viral load monitoring, as well as assessing changes in knowledge and awareness among the target population.

5. Analyze the data: Analyze the collected data to assess the impact of the recommendations on improving access to maternal health services. This can include comparing the baseline data to the post-intervention data to identify any changes or improvements.

6. Adjust and refine: Based on the analysis of the data, make any necessary adjustments or refinements to the recommendations to further improve access to maternal health services.

By following this methodology, it will be possible to simulate the impact of the recommendations on improving access to maternal health and make informed decisions on how to best allocate resources and implement interventions.

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