HIV status disclosure, facility-based delivery and postpartum retention of mothers in a prevention clinical trial in rural Nigeria

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Study Justification:
The study aimed to evaluate the impact of HIV status disclosure on selected prevention of mother-to-child HIV transmission (PMTCT) continuum of care measures in rural Nigeria. The study was conducted within the context of a cluster randomized PMTCT trial and sought to determine the effect of disclosure on facility-based delivery and postpartum retention of mothers in HIV care.
Highlights:
– The study included 372 HIV-infected pregnant women, with 327 women having unknown HIV status or being treatment naïve at presentation to antenatal care.
– 86.5% of women disclosed their HIV status to their partner, with higher disclosure rates in the trial intervention arm.
– Women who disclosed were more likely to deliver at a health facility.
– Participants who disclosed had a trend towards being retained in care at 6 and 12 weeks postpartum.
– Facilitating HIV status disclosure to partners can increase utilization of facility obstetric services.
Recommendations:
– Encourage and support HIV-infected pregnant women to disclose their HIV status to their partners.
– Provide comprehensive PMTCT services that include transition of decentralized tasks to trained midwives, point-of-care testing, integrated mother-infant care services, involvement of influential family members, and community engagement.
– Emphasize the importance of facility-based delivery for HIV-infected pregnant women.
– Implement strategies to improve postpartum retention in HIV care.
Key Role Players:
– HIV-infected pregnant women
– Partners of HIV-infected pregnant women
– Trained midwives
– Healthcare providers
– Community leaders
– Peer mentors
Cost Items for Planning Recommendations:
– Training and capacity building for healthcare providers and midwives
– Point-of-care testing equipment and supplies
– Integrated mother-infant care services
– Community engagement activities
– Peer mentorship program
– Communication and awareness campaigns
– Monitoring and evaluation activities

The strength of evidence for this abstract is 7 out of 10.
The evidence in the abstract is fairly strong, but there are some areas for improvement. The study design is a cluster randomized trial, which is generally considered to be a strong design. The sample size is also relatively large, with 327 women included in the analysis. The study uses mixed effects logistic regression to estimate the impact of disclosure on facility delivery and postpartum retention, which is a statistically rigorous approach. However, there are a few limitations to consider. First, the study relies on self-reported HIV status disclosure, which may be subject to social desirability bias. Second, the study only assesses disclosure at 6 weeks postpartum, which may not capture the full impact of disclosure on postpartum retention. Finally, the study does not provide information on the generalizability of the findings or potential confounding factors that were not accounted for in the analysis. To improve the evidence, future studies could consider using objective measures of disclosure, such as partner testing or medical records. Additionally, assessing disclosure at multiple time points throughout the postpartum period would provide a more comprehensive understanding of its impact on retention. Finally, conducting sensitivity analyses to explore potential confounding factors would strengthen the evidence.

Background: Within the context of a cluster randomized prevention of mother-to-child HIV transmission (PMTCT) trial, we evaluated the impact of disclosure on selected PMTCT continuum of care measures. Methods: In 12 rural matched-pair clinics randomly assigned to an intervention package versus standard-ofcare, we enrolled 372 HIV-infected pregnant women from April 2013 to March 2014. This secondary analysis included 327 (87.9%) women with unknown HIV status or who were treatment naïve at presentation to antenatal care. We employed mixed effects logistic regression to estimate impact of disclosure on facility delivery and postpartum retention in HIV care at 6 and 12 weeks. Results: Fully 86.5% (283/327) of women disclosed their HIV status to their partner, more in the trial intervention arm (OR 3.17, 95% CI 1.39-7.23). Adjusting for intervention arm, maternal age, education and employment, women who disclosed were more likely to deliver at a health facility (OR 2.73, 95%CI 1.11-6.72). Participants who disclosed also had a trend towards being retained in care at 6 and 12 weeks’ postpartum (OR 2.72, 95% CI 0.79-9.41 and 2.46, 95% CI 0.70-8.63, respectively). Conclusions: HIV status disclosure at 6 weeks’ postpartum was positively associated with facility-based delivery, but not with early postpartum retention. Facilitating HIV status disclosure to partners can increase utilization of facility obstetric services.

We assessed the determinants of HIV status disclosure at 6 weeks postpartum in a cluster-randomized PMTCT implementation science trial.19,20 The trial was conducted in 12 health facilities in rural Niger state in north-central Nigeria. The sites were supported by Friends in Global Health (FGH), Vanderbilt University’s implementation partner for the U.S. President’s Plan for AIDS Relief (PEPFAR). Twelve sites were matched based on antenatal care (ANC) volume, HIV patient volume, urbanization of the area, and site accessibility, then randomized within matched pairs to intervention (n=6) or control (n=6) (Fig. ​(Fig.11). Flow chart depicting trial activities, Niger state, Nigeria. Participants in the full trial included women with HIV presenting for ANC and/or delivery who met one of the following inclusion criteria: unknown HIV status at time of presentation; history of antiretroviral prophylaxis or treatment, but not on prophylaxis/treatment at the time of presentation; or known HIV status but had never received treatment (treatment naïve). Permission to participate was obtained by research staff in the form of informed consent. The intervention sites received an integrated package of PMTCT services that included: transition of decentralized PMTCT tasks to trained midwives (task shifting); point-of-care CD4+ cell count and CD4% testing; integrated mother-infant care services; active influential family member (male partner); and community involvement. For the control arm, we referred women testing HIV-positive to nearby FGH-supported comprehensive clinics for clinical and laboratory evaluation, and antiretroviral therapy (ART) initiation. HIV clinical management was performed in accordance with current Nigeria PMTCT guidelines, as described elsewhere.19 The PMTCT continuum of care refers to a cascade of essential steps that are required for both the mother and her child to achieve the desired outcome of a HIV-free infant as well as optimal maternal retention, adherence and viral load suppression.22 For the purpose of this study we focused on two continuum of care measures: HIV status disclosure to the spouse and facility delivery. HIV status disclosure by the women enrolled in the trial to their partners was ascertained once, after enrollment, either during the 6 week postpartum visit or at home by a study coordinator if that 6 week visit was missed. Thus, disclosure was assessed many weeks after the ANC intervention period. HIV disclosure in the intervention arm was also completely voluntary. An important first stage of the male partner engagement component of the trial was entirely dependent on the woman—we provided personalized invitation letters to the HIV-positive woman who presented to antenatal care to give to her partner, encouraging the partner to accompany the woman to the next antenatal visit.19 The option of giving the letter to the partner was entirely at the discretion of the woman. In addition, the community component involved training spouses of HIV-infected women enrolled in the study as peer mentors so that they could educate other men, share their own experience and solicit the support of community leaders through one-on-one interactions and community forums. Peer mentors did not have access to information on the HIV status of other women and their role did not include liaising with other women with HIV. Study data were collected and managed using Research Electronic Data Capture (REDCap), a secure, web-based application hosted at Vanderbilt University.23 Only HIV-infected women who had unknown HIV status or who were treatment naïve at presentation to ANC were eligible for the trial, and among these only married women were included in this study of disclosure. Participant characteristics (e.g., age, education) and outcomes were summarized using descriptive statistics, including frequency and percentage for categorical variables with median and IQR for continuous variables. The χ2 and Wilcoxon rank-sum tests were used to compare characteristics across disclosure status at 6 weeks postpartum, ignoring effects of clustering. To estimate factors independently associated with disclosure, we used mixed effects logistic regression with a random effect for matched pairs to account for clustering. Potential determinants of disclosure status were identified a priori and ordered by importance based on literature and input from trial leadership. We considered that up to four covariates would be included in the final, multivariable model to prevent model overfitting, given our sample size. The top four covariates were intervention, age, education and employment. No stepwise model selection was performed. We performed post hoc adjustment for ethnicity, as this factor was on the original covariate listing and was associated with disclosure. We also used mixed effects logistic regression to assess the association between disclosure and postpartum retention of mother-infant pairs at 6 and 12 weeks, and with in-facility delivery. We adjusted models for maternal age, education, employment status, and study arm. For each of the three models, we tested for an interaction effect between study arm and disclosure status at 6 weeks postpartum and for mediation of the intervention effect through disclosure.24 For the retention analyses, mother–infant pairs were excluded if the mother or infant died or was transferred or relocated within 14 weeks of delivery. For the delivery analyses, one mother was excluded who had miscarried. An intent-to-treat approach was used for all analyses. R-software version 3.3.1 (www.r-project.org) was used for data analyses.

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

1. Mobile health (mHealth) interventions: Develop mobile applications or text messaging services to provide pregnant women with information about maternal health, including the importance of facility-based delivery and postpartum care. These interventions can also be used to encourage HIV status disclosure to partners.

2. Community-based interventions: Implement community outreach programs to raise awareness about the benefits of facility-based delivery and postpartum retention in HIV care. These programs can involve peer mentors who can educate and support pregnant women and their partners in making informed decisions about maternal health.

3. Task shifting: Train midwives and other healthcare providers to perform decentralized PMTCT tasks, such as point-of-care CD4+ cell count testing and integrated mother-infant care services. This can help improve access to essential maternal health services in rural areas where healthcare resources may be limited.

4. Male partner involvement: Develop strategies to actively engage male partners in the maternal health process, including encouraging their attendance at antenatal visits and promoting HIV status disclosure. This can help create a supportive environment for pregnant women and increase utilization of facility obstetric services.

5. Strengthening healthcare systems: Invest in improving the overall healthcare infrastructure, including increasing the availability of health facilities and skilled healthcare providers in rural areas. This can help ensure that pregnant women have access to quality maternal health services, including facility-based delivery and postpartum care.

It is important to note that the specific implementation of these innovations would require further research, planning, and collaboration with relevant stakeholders.
AI Innovations Description
Based on the information provided, the recommendation to improve access to maternal health is to facilitate HIV status disclosure to partners. This recommendation is based on the findings of a study conducted in rural Nigeria, which showed that women who disclosed their HIV status to their partners were more likely to deliver at a health facility. The study also found a trend towards increased postpartum retention in HIV care among women who disclosed their status.

To implement this recommendation, healthcare providers and organizations can take the following steps:

1. Provide education and counseling: Offer comprehensive education and counseling services to pregnant women regarding the importance of HIV status disclosure to their partners. This can include information on the benefits of facility-based delivery and postpartum retention in HIV care.

2. Supportive environment: Create a supportive and non-judgmental environment for women to disclose their HIV status. This can be achieved by training healthcare providers to offer empathetic and confidential care, and by implementing policies that protect the privacy and confidentiality of patients.

3. Partner involvement: Engage male partners in the antenatal care process and encourage their participation in decision-making regarding facility-based delivery and postpartum care. This can be done through personalized invitation letters, peer mentoring programs, and community forums that involve male partners.

4. Integration of services: Integrate HIV testing, counseling, and treatment services with antenatal care services to ensure seamless access to comprehensive care for pregnant women. This can include offering point-of-care CD4+ cell count and CD4% testing, as well as integrated mother-infant care services.

5. Monitoring and evaluation: Regularly monitor and evaluate the impact of HIV status disclosure on facility-based delivery and postpartum retention in HIV care. This can help identify any barriers or challenges and inform further improvements in the implementation of this recommendation.

By implementing these recommendations, healthcare providers and organizations can contribute to improving access to maternal health and reducing the risk of mother-to-child HIV transmission.
AI Innovations Methodology
Based on the provided information, one potential recommendation to improve access to maternal health is to implement a comprehensive HIV status disclosure program. This program would focus on encouraging and supporting HIV-infected pregnant women to disclose their HIV status to their partners. The goal of this recommendation is to increase utilization of facility-based delivery and improve postpartum retention in HIV care.

To simulate the impact of this recommendation on improving access to maternal health, a methodology could be developed as follows:

1. Study Design: Conduct a cluster-randomized controlled trial in rural areas of Nigeria, similar to the existing PMTCT trial mentioned in the description.

2. Selection of Intervention and Control Groups: Randomly assign matched-pair clinics to either the intervention group or the control group. The intervention group would receive a comprehensive HIV status disclosure program, including personalized invitation letters to partners, peer mentorship, and community engagement. The control group would follow standard-of-care practices.

3. Participant Enrollment: Enroll HIV-infected pregnant women who have unknown HIV status or are treatment-naive at presentation to antenatal care. Obtain informed consent from participants to participate in the trial.

4. Implementation of Intervention: Implement the comprehensive HIV status disclosure program in the intervention group. Provide necessary training and resources to healthcare providers and peer mentors involved in the program.

5. Data Collection: Collect data on various variables, including HIV status disclosure, facility-based delivery, and postpartum retention in HIV care at 6 and 12 weeks postpartum. Use a secure, web-based application like REDCap to collect and manage the data.

6. Statistical Analysis: Use mixed effects logistic regression to estimate the impact of HIV status disclosure on facility-based delivery and postpartum retention in HIV care. Adjust for potential confounding factors such as intervention arm, maternal age, education, and employment. Consider potential interaction effects between study arm and disclosure status, as well as mediation of the intervention effect through disclosure.

7. Interpretation of Results: Analyze the results to determine the association between HIV status disclosure and access to maternal health services. Assess the impact of the comprehensive HIV status disclosure program on improving access to maternal health, specifically facility-based delivery and postpartum retention in HIV care.

By following this methodology, researchers can simulate the impact of implementing a comprehensive HIV status disclosure program on improving access to maternal health. The results of the study can provide valuable insights and evidence for policymakers and healthcare providers to implement effective strategies for improving maternal health outcomes.

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