Slow Acceptance of Universal Antiretroviral Therapy (ART) Among Mothers Enrolled in IMPAACT PROMISE Studies Across the Globe

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Study Justification:
The study aimed to investigate the slow acceptance of universal antiretroviral therapy (ART) among mothers enrolled in IMPAACT PROMISE studies across the globe. The PROMISE trial enrolled asymptomatic HIV-infected pregnant and postpartum women and assessed the efficacy of different antiretroviral strategies for perinatal prevention, maternal/infant safety, and maternal health. The subsequent START study demonstrated the clear benefit of initiating ART regardless of CD4 count. However, one-third of participants did not initiate ART after being informed of the results, indicating a need to understand the reasons behind this slow uptake.
Highlights:
– The PROMISE study enrolled 5400 asymptomatic HIV-infected pregnant women in 15 countries across sub-Saharan Africa, Asia, and the Americas.
– Different antiretroviral strategies were assigned to assess HIV disease progression, vertical transmission, and safety.
– The slow uptake of universal ART highlights the need to educate individuals and sensitize communities about the personal and population benefits of the “Treat All” strategy.
Recommendations:
– Prepare individuals and sensitize communities about the benefits of universal ART.
– Provide clear and comprehensive information about the START study results and the importance of initiating ART.
– Develop standardized counseling procedures to ensure consistent and effective communication with participants.
– Monitor the rate of return of participants to clinics to ensure timely response and information delivery.
– Strengthen the linkage between study clinics and appropriate treatment services for those initiating ART.
Key Role Players:
– Researchers and study team members
– Community representatives
– Counselors and healthcare providers
– Site coordinators and administrators
– Policy makers and government officials
Cost Items for Planning Recommendations:
– Training and capacity building for counselors and healthcare providers
– Communication materials and resources for educating individuals and communities
– Monitoring and evaluation systems to track the rate of return and information delivery
– Collaboration and coordination efforts between study clinics and treatment services
– Administrative and logistical support for implementing the recommendations

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is moderately strong. The study was conducted at multiple research sites in 15 countries, which increases the generalizability of the findings. The study followed a large population of HIV-infected pregnant women and collected data on their decision to accept or reject universal antiretroviral therapy (ART). The study also provided detailed information on the study design, interventions, and data analysis methods. However, the abstract does not provide specific details on the statistical analyses performed or the results of those analyses. To improve the strength of the evidence, the abstract could include more information on the statistical significance of the findings and provide a summary of the key results.

The PROMISE trial enrolled asymptomatic HIV-infected pregnant and postpartum women not eligible for antiretroviral treatment (ART) per local guidelines and randomly assigned proven antiretroviral strategies to assess relative efficacy for perinatal prevention plus maternal/infant safety and maternal health. The START study subsequently demonstrated clear benefit in initiating ART regardless of CD4 count. Active PROMISE participants were informed of results and women not receiving ART were strongly recommended to immediately initiate treatment to optimize their own health. We recorded their decision and the primary reason given for accepting or rejecting the universal ART offer after receiving the START information. One-third of participants did not initiate ART after the initial session, wanting more time to consider. Six sessions were required to attain 95% uptake. The slow uptake of universal ART highlights the need to prepare individuals and sensitize communities regarding the personal and population benefits of the “Treat All” strategy.

PROMISE was conducted at 70 research sites in 15 countries within sub-Saharan Africa, Asia and the Americas. A total of 5400 asymptomatic HIV-infected pregnant women with high CD4 counts (above 350 cells/mm3 or the treatment threshold at that time) were assigned to different ARV strategies and followed for HIV disease progression, vertical transmission and safety. In settings where maternal ART and replacement feeding was standard, eligible women were randomized within 6 weeks of delivery to continue or stop ART and remain in follow-up for intense monitoring of HIV disease progression and adverse events in a protocol named 1077HS (for HAART standard) [8]. In settings where maternal ART was not standard for the prevention of vertical transmission, separate protocols were conducted—1077FF and 1077BF—in formula feeding and breastfeeding settings, respectively. Within 1077FF/BF, pregnant women were randomized to triple ART or prophylaxis with zidovudine throughout pregnancy and delivery in the Antepartum Component plus single dose nevirapine at delivery followed by a 2 week “tail” of tenofovir/emtricitabine [9]. Women who did not access HIV services in pregnancy could join the study around the time of delivery. Eligible mothers were randomized after delivery in the Postpartum Component to receive or not receive maternal ART. Once the period of risk for vertical transmission was over—at delivery for 1077FF and after weaning or after 18 months of study intervention, whichever came first, for 1077BF—women receiving ART were randomized in the Maternal Health Component to continue or stop ART. Enrolled women who were not eligible for subsequent randomizations were followed in an observational cohort through study completion. Participants were followed at least quarterly to monitor clinical, immunological and virologic status. Women randomly assigned to not take ART started ART once country criteria for treatment initiation were met. Women remained in PROMISE follow-up regardless of ART status. Figure 1 illustrates the timeline of events surrounding the action taken in response to the release of the START study results. The PROMISE study team directed sites to actively contact participants to return to the clinic to receive important information that could influence their decision to remain in follow-up. The rate of return was tracked at each site to ensure a timely response. The study team provided a structured script of simple talking points developed with input from the community and sites, although not formally piloted. After covering the essential elements of the START study population and findings, the script included a recommendation that all women in PROMISE take ART, seeing the START study had showed that it is better to start ART before a decline in CD4 count. Timeline of events in the PROMISE study and concurrent ARV guidelines When the participants returned to the study clinic, trained staff revisited the content of the PROMISE informed consent discussion with the women, emphasizing the study rationale, randomizations and role of the CD4 count in determining eligibility for initiating ART for the purposes of maternal treatment. The START study talking points were then delivered in a language chosen by the participant. Women already receiving ART were told that they would remain on ART and in follow-up through scheduled study exit in September 2016. Women not on ART were strongly advised to accept the offer to immediately initiate ART as the best antiretroviral strategy to preserve their own health. Participants were informed that remaining in follow-up was not dependent on being on ART; their willingness to continue participation was their choice. A discussion followed to verify comprehension of the implications for the individual study participant and address any questions raised. The comprehension discussion lead into an individual counselling session which followed the site’s routine counselling procedures. The approach adopted by the numerous counsellors across the different sites was not standardized due to the rapid nature of the action taken, and sessions were not audio-recorded. Women were encouraged to give their personal interpretation of the START results and to explore their reaction to the strong recommendation for all women with HIV to take ART in a free-ranging discussion. They could take as much time as they needed in the session to work out their feelings about continued study participation and, if relevant, to decide whether they wanted to accept or decline the offer of universal ART. For participants advised to initiate universal ART because of the START results, counsellors probed each woman to give her reasons for accepting or rejecting the offer, then to select her primary reason for doing so. The study physician subsequently completed the routine study review and linkage with appropriate treatment services for those initiating ART. Participants who chose not to initiate universal ART at the initial session repeated the process at subsequent visits scheduled quarterly until ART initiation or through study exit. After the counselling sessions, counsellors completed a structured data form to capture the information delivery process and decisions made. They categorized the responses into pre-set closed options derived from study team discussions with the community representatives and sites. They recorded additional detail as open text comments. Sites submitted data forms to a centralized database for analysis. These data forms were also completed at subsequent sessions for those participants who initially declined universal ART. Open text comments were subsequently categorized by two researchers following a code book developed by consensus through discussion of themes emerging from the line list of comments. These data analyses were based on women in follow-up off ART at the time of this action and with at least one counselling session. Frequencies, means, and percentiles were used for descriptive purposes. T-tests compared the mean difference between groups. The cumulative probability of remaining off ART over time was estimated using the Kaplan–Meier method. Sensitivity analyses were performed by using the antiretroviral drug record in place of the counselling form, with the conclusion that the analysis is robust to missing counselling session forms (data not shown). Analyses were performed using SAS version 9.4. P-values less than 0.05 were considered to be statistically significant. Based on these data generated from a large, multi-site clinical trial population with prior access to intense HIV disease monitoring and extensive counselling services, we report the uptake of universal ART over time by women not receiving ART at the time the START study results were communicated. We describe the primary reasons women gave in support of the decisions they made.

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Based on the provided information, here are some potential innovations that could improve access to maternal health:

1. Community Sensitization Programs: Develop and implement community-based programs to raise awareness about the importance of maternal health and the benefits of universal antiretroviral therapy (ART). These programs could include educational campaigns, workshops, and outreach activities to engage and inform pregnant women and their communities.

2. Mobile Health (mHealth) Solutions: Utilize mobile technology to deliver information and support to pregnant women. This could include sending SMS reminders for prenatal appointments, providing access to educational resources through mobile apps, and enabling telemedicine consultations for remote areas.

3. Task Shifting: Train and empower healthcare workers at various levels to provide antenatal and postnatal care, including ART initiation and monitoring. This could involve delegating certain tasks traditionally performed by doctors to nurses, midwives, and community health workers, thereby increasing the availability of skilled healthcare providers.

4. Integrated Care Models: Implement integrated care models that combine maternal health services with HIV care and treatment. This would ensure that pregnant women living with HIV receive comprehensive care, including ART, prenatal care, and prevention of mother-to-child transmission interventions, all in one setting.

5. Peer Support Programs: Establish peer support programs where women who have successfully initiated ART during pregnancy can provide guidance and support to pregnant women who are hesitant or undecided about starting treatment. Peer support can help address concerns, provide personal experiences, and encourage adherence to treatment.

6. Strengthening Health Systems: Improve the capacity and infrastructure of healthcare facilities to provide quality maternal health services. This may involve training healthcare providers, ensuring the availability of essential medicines and supplies, and improving the overall quality of care.

7. Policy Advocacy: Advocate for policy changes that prioritize and support maternal health, including universal access to ART for pregnant women living with HIV. This could involve engaging with policymakers, raising awareness among key stakeholders, and advocating for increased funding and resources for maternal health programs.

These innovations aim to address the slow acceptance of universal ART among pregnant women and improve access to maternal health services, ultimately leading to better health outcomes for both mothers and infants.
AI Innovations Description
The recommendation to improve access to maternal health based on the described study is to focus on preparing individuals and sensitizing communities about the personal and population benefits of the “Treat All” strategy. This strategy involves initiating antiretroviral therapy (ART) for all HIV-infected pregnant and postpartum women, regardless of their CD4 count.

To implement this recommendation and develop it into an innovation, the following steps can be taken:

1. Community Engagement: Engage with local communities to raise awareness about the benefits of universal ART for maternal health. This can be done through community meetings, workshops, and educational campaigns.

2. Health Education: Provide comprehensive health education to pregnant women and their families about the importance of ART in preventing vertical transmission of HIV and improving maternal health outcomes. This can include information about the benefits of early initiation of ART and the impact on CD4 count.

3. Training and Capacity Building: Train healthcare providers on the latest guidelines and evidence-based practices for maternal health, including the “Treat All” strategy. This will ensure that healthcare providers are equipped with the knowledge and skills to provide appropriate counseling and support to pregnant women.

4. Access to ART: Ensure that ART is readily available and accessible to all pregnant women in need. This may involve strengthening healthcare systems, improving supply chains, and addressing any barriers to accessing ART, such as cost or stigma.

5. Continuous Monitoring and Evaluation: Establish a system for monitoring and evaluating the implementation of the “Treat All” strategy. This will help identify any challenges or gaps in the delivery of maternal health services and allow for timely adjustments and improvements.

By implementing these recommendations and developing them into an innovation, access to maternal health can be improved, leading to better outcomes for both mothers and infants.
AI Innovations Methodology
To improve access to maternal health, here are some potential recommendations:

1. Mobile health (mHealth) interventions: Develop mobile applications or text messaging services to provide pregnant women with information on prenatal care, nutrition, and reminders for appointments. These interventions can also facilitate communication between healthcare providers and pregnant women, allowing for remote monitoring and support.

2. Community health workers: Train and deploy community health workers to provide maternal health education, antenatal care, and postnatal care in underserved areas. These workers can bridge the gap between healthcare facilities and remote communities, ensuring that pregnant women receive the necessary care and support.

3. Telemedicine: Implement telemedicine services to enable remote consultations between pregnant women and healthcare providers. This can be particularly beneficial for women in rural or remote areas who may have limited access to healthcare facilities.

4. Maternal health clinics: Establish dedicated maternal health clinics that provide comprehensive care for pregnant women, including prenatal care, delivery services, and postnatal care. These clinics can be equipped with skilled healthcare professionals and necessary resources to ensure safe and quality care.

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 group of pregnant women who would benefit from the innovation, such as those in underserved areas or with limited access to healthcare facilities.

2. Collect baseline data: Gather information on the current state of maternal health access in the target population, including indicators such as the number of prenatal visits, rates of complications, and maternal mortality rates.

3. Introduce the innovation: Implement the recommended innovation, whether it’s mHealth interventions, community health workers, telemedicine, or maternal health clinics. Ensure that the innovation is accessible and tailored to the needs of the target population.

4. Monitor and evaluate: Track the implementation of the innovation and collect data on relevant indicators. This could include measuring the uptake of the innovation, changes in prenatal care utilization, improvements in maternal health outcomes, and user satisfaction.

5. Compare data: Compare the data collected after the implementation of the innovation with the baseline data to assess the impact. Analyze the changes in maternal health access indicators and determine if the innovation has led to improvements in access to maternal health services.

6. Adjust and refine: Based on the findings, make any necessary adjustments or refinements to the innovation to further enhance its impact on improving access to maternal health. This could involve scaling up successful interventions, addressing any barriers or challenges identified, and continuously monitoring and evaluating the impact.

By following this methodology, it is possible to simulate the impact of recommendations on improving access to maternal health and make informed decisions on implementing and scaling up effective innovations.

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