Research on Oral Poliovirus Vaccines

The poliomyelitis eradication goal - set by the World Health Assembly in 1988 may be achieved within the next decade.  The program  is based on massive global vaccination campaigns usingoral polio vaccine (OPV). Cases of poliomyelitis have decreased dramatically from an estimated 350,000 cases in 1988 to less than 649 cases in 2011. However, OPV itself can cause disease. OPV can mutate into vaccine-derived poliovirus (VDPV) with prolonged replication, which have caused 18 separated outbreaks and are just as virulent as wild poliovirus. OPV can also quickly acquire well-known point mutations that are associated with the development of vaccine-associated paralytic poliomyelitis (VAPP), usually in infants after their first dose of OPV.  Thus continued OPV use may jeopardize poliomyelitis eradication.

We are interested in the following areas:

1. OPV and HIV:

Studies had shown that individuals with humoral immunodeficiencies may shed OPV for years.  Infants with perinatal human immunodeficiency virus (HIV) infection may have humoral as well as cellular immunodeficiencies, which might result in prolonged OPV replication. Zimbabwe, where OPV is given routinely to all infants and antenatal HIV prevalence is 16%, provides a natural setting to study the effect of perinatal HIV infection on OPV shedding, mutation, and transmission. Our cross-sectional study found that pediatric HIV infection is associated with a poor serologic response to OPV. The ongoing study funded by NIH was conducted in and around Chitungwiza, Zimbabwe. The stool, blood and health information were serially collected from 421 HIV positive and HIV negative infants during and after OPV administration through 24 months of age. We are investigating the determinants of OPV shedding in infants perinatally infected with HIV and their household contacts.

1. OPV and IPV:

Inactivated polio vaccine (IPV) does not have the potential to cause poliomyelitis because it is a killed virus vaccine. It is not entirely clear how IPV administration impacts OPV circulation in both the environment and vaccinated population. Children previously vaccinated with IPV are known to shed OPV for a longer period of time after an OPV challenge than children previously vaccinated with OPV.  Mexico switched to a primary IPV regimen in 2007, but still gives OPV during semiannual national immunization days (NIDs). With its unique vaccination practices, Mexico is an ideal setting to study the duration of OPV circulation in a population now vaccinated with IPV. Our cross-sectional study found that OPV circulation continues for at least 13 weeks after a NID. The ongoing study funded by WHO was conducted in municipalities near Orizaba, Mexico from August 2010 to July 2011. Monthly stool was collected from 72 children and 144 household contacts. Monthly sewage was also collected from 4 arroyos draining the municipalities. We are investigating OPV circulation and mutation after NID in sewage and stool, as well as OPV transmission in household contacts of vaccinees after NID.

Selected publications:

• Altamirano J, Leary S, van Hoorebeke C, Sarnquist C, Behl R, García-García L, Ferreyra-Reyes L, Huang C, Sommer M, Maldonado Y. Validation of a High-throughput, Multiplex, Real-time Qualitative Polymerase Chain Reaction Assay for the Detection of Sabin Oral Polio Vaccine in Environmental Samples. Clinical Infectious Diseases. 2018 Oct 30;67(suppl_1):S98-102.
• Ferreyra-Reyes L, Cruz-Hervert LP, Troy SB, Huang C, Sarnquist C, Delgado-Sánchez G, Canizales-Quintero S, Holubar M, Ferreira-Guerrero E, Montero-Campos R, Rodríguez-Álvarez M. Assessing the individual risk of fecal poliovirus shedding among vaccinated and non-vaccinated subjects following national health weeks in Mexico. PloS one. 2017;12(10).
• Fu R, Altamirano J, Sarnquist CC, Maldonado YA, Andrews JR. Assessing the risk of vaccine-derived outbreaks after reintroduction of oral poliovirus vaccine in postcessation settings. Clinical Infectious Diseases. 2018 Oct 30;67(suppl_1):S26-34.
• Jarvis C, Altamirano J, Sarnquist C, Garcia-Garcia L, Reyes LF, Montero-Campos R, Cruz-Hervert LP, Holubar M, Talib A, Purington N, Halpern M. Silent Polio Transmission: A Spatial Analysis. InOpen forum infectious diseases 2017 (Vol. 4, No. suppl_1, pp. S65-S65). US: Oxford University Press.
• Altamirano J, Sarnquist C, Garcia-Garcia L, Reyes LF, Montero-Campos R, Cruz-Hervert LP, Holubar M, Talib A, Purington N, Halpern M, Behl R. Preventing Polio Post-eradication: Revertant Proportion Patterns of OPV Serotypes. InOpen forum infectious diseases 2017 (Vol. 4, No. suppl_1, pp. S123-S124). US: Oxford University Press.
• Sarnquist CC, Garcia-Gacia L, Reyes LF, Montero-Campos R, Cruz-Hervert LP, Altamirano J, Holubar M, Talib A, Purington N, Halpern M, Ferreira E. Preventing Polio Post-Eradication: Elucidating Polio Virus Shedding and Transmission Patterns in the Presence of Inactivated Polio Vaccine and Oral Polio Vaccine. InOpen Forum Infectious Diseases 2016 Dec 1 (Vol. 3, No. suppl_1). Oxford University Press.
• Immunologic response to oral polio vaccine in human immunodeficiency virus-infected and uninfected Zimbabwean children.
• Gnanashanmugam D, Troy SB, Musingwini G, Huang C, Halpern MS, Stranix-Chibanda L, Shetty AK, Kouiavskaia D, Nathoo K, Chumakov K, Maldonado YA.
  Pediatr Infect Dis J. 2012 Feb; 31(2):176-80.
• Intradermal fractional dose inactivated polio vaccine: a review of the literature.Nelson KS, Janssen JM, Troy SB, Maldonado Y.
  Vaccine. 2012 Jan 5; 30(2):121-5. Epub 2011 Nov 17. Review.
• Hematologic and immunologic parameters in zimbabwean infants: a case for using local reference intervals to monitor toxicities in clinical trials.
• Troy SB, Rowhani-Rahbar A, Dyner L, Musingwini G, Shetty AK, Woelk G, Stranix-Chibanda L, Nathoo K, Maldonado YA.
  J Trop Pediatr. 2012 Feb; 58(1):59-62. Epub 2011 Apr 18.
• Use of a novel real-time PCR assay to detect oral polio vaccine shedding and reversion in stool and sewage samples after a mexican national immunization day.
• Troy SB, Ferreyra-Reyes L, Huang C, Mahmud N, Lee YJ, Canizales-Quintero S, Flaster H, Báez-Saldaña R, García-García L, Maldonado Y.
  J Clin Microbiol. 2011 May; 49(5):1777-83. Epub 2011 Mar 16.
• Impact of fetal and neonatal viral (and parasitic) infections on later development and disease outcome.
• Maldonado YA.
  Nestle Nutr Workshop Ser Pediatr Program. 2008; 61:225-42.  Review.
• Shedding and reversion of oral polio vaccine type 3 in Mexican vaccinees: comparison of mutant analysis by PCR and enzyme cleavage to a real-time PCR assay.
• Gnanashanmugam D, Falkovitz-Halpern MS, Dodge A, Fang M, Wong LJ, Esparza M, Hammon R, Rivas-Merelles EE, Santos JI, Maldonado Y.
  J Clin Microbiol. 2007 Aug; 45(8):2419-25. Epub 2007 Jun 20.

MORE INFORMATION

For more information about this Poliovirus Research, please contact Dr. Yvonne (Bonnie) Maldonado at (650)723-5682.

Sexual assault is a major cause of injury, unplanned pregnancy, HIV infection, and mental health issues worldwide. In parts of sub-Saharan Africa, sexual assault has reached epidemic proportions. Our team is involved in studies evaluating interventions to reduce GBV in Kenya. These include: (1) researching the efficacy of an empowerment and self-defense intervention for adolescent girls in to decrease the incidence of sexual assault and harassment in Nairobi’s large informal settlements and (2) evaluating a micro-finance intervention aimed at improving economic conditions and decreasing GBV among survivors of intimate partner violence.

The group received a grant from the Medical Research Council of South Africa to conduct a cluster-randomized trial of this intervention among young adolescent girls.

Selected Publications

Sarnquist C, Sinclair J, Omondi Mboya B, Langat N, Paiva L, Halpern-Felsher B, Golden NH, Maldonado YA, Baiocchi MT. Evidence that classroom-based behavioral interventions reduce pregnancy-related school dropout among Nairobi adolescents. Health Education & Behavior. 2017 Apr;44(2):297-303.

Sarnquist C, Sinclair J, Omondi Mboya B, Langat N, Paiva L, Halpern-Felsher B, Golden NH, Maldonado YA, Baiocchi MT. Evidence that classroom-based behavioral interventions reduce pregnancy-related school dropout among Nairobi adolescents. Health Education & Behavior. 2017 Apr;44(2):297-303.

Sarnquist C, Kang JL, Amuyunzu-Nyamongo M, Oguda G, Otieno D, Mboya B, Omondi N, Kipkirui D, Baiocchi M. A protocol for a cluster-randomized controlled trial testing an empowerment intervention to prevent sexual assault in upper primary school adolescents in the informal settlements of Nairobi, Kenya. BMC public health. 2019 Dec 1;19(1):834.

Friedberg R, Sarnquist C, Nyairo G, Amuyunzu-Nyamongo M, Baiocchi M. Understanding the spatial burden of gender-based violence: Modelling patterns of violence in Nairobi, Kenya through geospatial information. arXiv preprint arXiv:2002.06710. 2020 Feb 16.

Sarnquist CC, Ouma L, Lang’at N, Lubanga C, Sinclair J, Baiocchi MT, Cornfield DN. The effect of combining business training, microfinance, and support group participation on economic status and intimate partner violence in an unplanned settlement of Nairobi, Kenya. Journal of interpersonal violence. 2018 Jun 1:0886260518779067.

Contact

Contact Clea Sarnquist.

Project Description

Stanford University managed the California* component of a 16-site nationwide perinatal surveillance program initiated by the Centers for Disease Control and Prevention (CDC). The EPS project collected confidential surveillance data on HIV-positive mothers and their HIV-exposed infants.

This program had many specific objectives:

1. To provide data to assist in the formulation of a perinatal prevention plan and to assist in the evaluation of prevention interventions for continued refinement of prevention activities.
2. To assess use of prenatal care by HIV-positive women and characterize the population of HIV-positive women for whom prenatal care is not timely and/or inadequate. (Hard to reach women, such as illicit drug users or incarcerated women, are target populations for prevention interventions.)
3. To determine the proportion of HIV-infected pregnant women giving birth each year that are known to be infected before delivery; to determine the proportion of pregnant HIV-infected women who were offered, accepted, and received HIV testing; to identify and characterize populations and health care settings where HIV testing is not timely; to identify populations of women who were not offered an HIV test or who refused an HIV test.
4. To determine the proportion of pregnant HIV-infected women who were offered, accepted, and received antiretroviral drugs during the prenatal and intrapartum periods, and whose children receive antiretroviral drugs postnatally; to identify and characterize populations and health care settings where maternal/neonatal antiretroviral drugs are less utilized; to identify populations of women who were not offered antiretroviral drugs, refused their use, and/or were noncompliant with their use.
5. To conduct follow-up of all HIV-exposed infants to determine their HIV infection status.
6. To estimate the effectiveness of ZDV and other antiretroviral drugs and evaluate changes in transmission rates due to receipt of these drugs.
7. To follow trends in rates of elective cesarean section and other interventions to reduce perinatal HIV transmission.
8. To determine the proportion of women who were tested at delivery, what kind of testing was conducted, if these test results are documented in the medical record; to characterize these women who receive HIV testing at delivery.
9. To characterize missed opportunities for prevention of perinatal HIV transmission.
10. To determine what proportion of HIV-infected women and HIV-exposed children are receiving follow-up care according to PHS guidelines (e.g., timeliness of initiation of HIV diagnostic testing, receipt of antiretroviral treatment, avoidance of breastfeeding, receipt of PCP prophylaxis).
11. If state laws permit, to assess any short-term (i.e. birth defects) or long-term (i.e. mutagenic, carcinogenic, or mitochondrial) adverse effects related to in-utero exposure to ZDV and other antiretroviral drugs, particularly in HIV-uninfected infants (seroreverters).

*(except Los Angeles County)

Results

• Clea C. Sarnquist, DrPH, MPH, Shayna D. Cunningham, PhD, MHS, Barbara Sullivan, RN, and Yvonne Maldonado, MD. “Evaluation of the relationship between state and national policy and implementation of perinatal HIV prevention interventions”. American Journal of Public Health, June 2007; 97: 1041-1046.
• Sturt AS, Halpern MS, Maldonado YA. Relationship of Pediatric HIV CDC Category B Diagnoses to Progression to Category C Disease and Death. Infectious Diseases Society of America National Meeting, 2010. Vancouver, Canada. Poster #572 (3241).
• Sturt AS et al. Temporal Trends in Mucocutaneous Findings Among Human Immunodeficiency Virus-1 Infected Children in a Population-based Cohort. Infectious Diseases Society of America National Meeting, 2011. Boston, Massachusetts. Poster Abstract Session. PDF (attached)
• Sturt AS, Halpern MS, Sullivan B, Maldonado YA. Timing of Antiretroviral Therapy Initiation and its Impact on Disease Progression in Perinatal Human Immunodeficiency Virus-1 Infection. Pediatr Infect Dis J. 2012 Jan;31(1):53-60.
• Currently under review: Sturt AS et al. Temporal Trends in Mucocutaneous Findings Among Human Immunodeficiency Virus-1 Infected Children in a Population-based Cohort.

Stanford University, in collaboration with the Office of AIDS and five California County Health Departments, was one of 16 grantees in a CDC nationwide perinatal prevention project. The purpose of this project was to prevent perinatal HIV transmission by providing non-threatening and accessible perinatal HIV preventions services and risk reduction information to pregnant women from all sociodemographic populations within California. The project was based in five California counties with technical assistance and evaluation provided by epidemiologists at Stanford University.

*Note: The CA Perinatal HIV Prevention Project has been replaced by the Rapid HIV Testing in Labor and Delivery (RTLD) project.

First Phase of the Intervention Implementation: January-June, 2002

• The five California counties were: Alameda, Los Angeles, Sacramento, San Diego, and San Joaquin
• Each county created an implementation plan based on the regional needs assessment

Steps taken

• Met with collaborating organizations, community advisory groups, etc., to review implementation plan and pool resources;
• Created or collected remaining necessary educational and training materials;
• Pilot tested interventions with target groups (clients or providers);
• Continued to create a data monitoring and evaluation plan as well as data collection forms in collaboration with Stanford;
• Closely monitored implementations and adapt data collection instruments or protocol as needed in conjunction with Stanford.

MORE INFORMATION

For more information about the CA Perinatal HIV Prevention Project, please contact Clea Sarnquist

In 2007, Stanford University conducted a survey focused on the experiences of HIV-positive women in rural parts of California, since medical outcomes and service needs for this group are poorly studied. These women were selected from a sample of rural health care facilities that provide HIV care to rural populations in California. The data collection had two components: one face-to-face interview and medical chart abstractions. Interview questions covered topics such as HIV testing and treatment, health services, quality of life, and access to social services. A total of 64 patient interviews and medical chart abstractions were completed.

Some Important Findings:

Access to Services

• This population of HIV-infected women living in rural areas of California has numerous unmet HIV care and social service needs.
• The greatest unmet needs were assistance finding a healthcare provider (62%), chore services (50%), volunteer support services (44%), and finding housing or shelter (44%).
• Barriers may be compounded by poor socioeconomic status:
  • 70% were unemployed,
  • 45% were living below the Federal Poverty Level, and
  • 33% are the sole provider for a child under 18.
• In interviews, specific chore and volunteer services needed were help with:
  • Grocery shopping,
  • House cleaning, and
  • Cooking.
• Three of the four major reasons that women couldn’t access services were related to either not knowing about the service or the service being difficult to access.
• Some of these services are likely not available within a reasonable distance of the areas in which these women live.
• Nonetheless, these women could benefit from having their existing HIV service providers link them with services that are available in the community.
• In particular, since the need for case management seems to be largely met, perhaps case managers could take an expanded role in linking individuals to existing services.

Barriers to Care

• The most reported barriers were physical health problems and lack of transportation.
• More women younger than 50 reported transportation as a barrier— this may be due to more aging support services available for older women.
• Low income & unemployed women especially lacked transportation which may be due to transportation costs.
• However, this did not affect physical health as a barrier--women with poor health have barriers despite being employed and/or having financial support.
• Unmarried women may lack the social support to access transportation and manage physical health problems.
• Women whose primary language is English reported problems navigating the healthcare system— a greater proportion of these women were African American.

Economic Status

• The majority of women were >40 (75%) and white (50%), followed by Latina (30%).
• Most were currently single (84%), and spoke primarily English (78%).
• 78% had an annual household income <$20,000 per year, with 33% reporting an income <$10,000 per year.
• However, 66% had at least a high school education, with 41% reporting at minimum some college.
• 53% reported that their job situation had changed since learning their HIV status, with 71% of that group needing to leave work or limit on hours due to health status and another 18% being laid-off due to HIV.

Quality of Life

• The majority of women perceived their general health to be good. However, 61% reported experiencing limitations in carrying out activities, with 51% attributing their limitations to their HIV.
• 70% of the women interviewed for this study reported being unemployed, which has been a strong predictor of poor QOL in past research.
• In the 4 weeks prior to being interviewed, 75% of women felt down & over 90% reported being worn out.
• Women aged 40 and older were more likely to report accomplishing less due to physical health limits.
• Latinas reported less interference in their normal work and social activities due to stressors such as pain, low physical health, or emotional problems. This may be due to under-reporting, as some previous studies have shown that cultural factors play a role in Latinas limiting their disclosure of health issues.
• There was a strong association (p=0.003) of women with lower income accomplishing less as a result of any emotional problems. This may be due to the fact that low-income women tend to have more stress, less social support, and less access to mental and physical health services.

Presentations and Publications:

• Sarnquist, Clea C, Soni, Shila, Hwang, Helen, Topol, Barbara B., Mutima, Salima, and Maldonado, Yvonne A. (2011) “Rural HIV-infected women’s access to medical care: ongoing needs in California”, AIDS Care, First published on: 31 January 2011 (iFirst)
• 2011 American Public Health Association (APHA) Conference, Washington DC. “Satisfaction with medical care among HIV-infected women in rural California”
• 2011 National HIV Prevention Conference (NHPC), Atlanta. “Quality of life among HIV-infected women in rural California”
• 2010 International AIDS Conference, Vienna. “Rural HIV-infected women: Access to services in California”
• 2010 American Public Health Association (APHA) Conference, Denver. “Quality of medical care and treatment among HIV-infected women in rural California”
• 2008 International AIDS Conference, Mexico City. “Rural HIV-infected women’s access to care: Lessons from California”
• 2008 American Public Health Association (APHA) Conference, San Diego. “Economic status of HIV-infected women living in rural areas in California”

The CA MMP is a national supplemental HIV/AIDS surveillance project funded by the Centers for Disease Control and Prevention (CDC), and conducted by the California Department of Public Health, Office of AIDS (OA) in collaboration with Stanford University. This project was designed to capture the experiences and needs of people who are getting care for HIV. The state of California was one of 23 states and cities that are participating in this nationwide project.

The goals of this project were to:

1. provide local, state, and national estimates for the population in care for HIV
2. determine health-related behaviors and access to and use of prevention and support services
3. gain knowledge of the care and treatment provided
4. examine variations of factors by geographic area and patient characteristics.

This project produced generalizable data that have been analyzed and shared with HIV prevention community planning groups, providers of HIV care, Ryan White CARE Act planning councils, and other stakeholders. This information can be used to support requests for more funding to provide services to people with HIV/AIDS, to help make HIV/AIDS-related policy decisions, and to improve evaluation of HIV/AIDS prevention and treatment programs.

National Presentations

• CDC MMWR (Centers for Disease Control and Prevention, Morbidity and Mortality Weekly Report) Surveillance Summaries/Vol. 60/No.11 Sept 2, 2011, "Clinical and Behavioral Characteristics of Adults Receiving Medical Care for HIV Infection—Medical Monitoring Project, United States, 2007"
• Centers for Disease Control and Prevention. Clinical and Behavioral Characteristics of Adults Receiving Medical Care for HIV Infection: Medical Monitoring Project, 2005 Pilot Data Collection Cycle. HIV Special Surveillance Report 6. Published June 2010.
• MMP Quarterly Newsletter, Volume 2, Issue 1 (June 2008)
• MMP Quarterly Newsletter, Volume 1, Issue 2
• MMP Quarterly Newsletter, Volume 1, Issue 1 (March 2007)
• McNaghten AD, Wolfe MI, Onorato I, Nakashima AK, Valdiserri RO, et al (2007) Improving the Representativeness of Behavioral and Clinical Surveillance for Persons with HIV in the United States: The Rationale for Developing a Population-Based Approach. PLoS ONE 2(6): e550. doi:10.1371/journal.pone.0000550

State Presentations

• CA MMP Factsheet
• CA MMP Newsletter Volume 2, Issue 1, Summer 2010
• CA MMP Newsletter Volume 1, Issue 1, Summer 2009
• County of San Diego Monthly STD Report, Issue No. 33: Data through Sept 30, 2011

Background

The potential to limit new paediatric HIV infections by improving access to acceptable and effective methods of family planning is immense. There is significant evidence that women, both HIV-infected and not, in sub-Saharan Africa desire to limit total fertility and close birth-spacing. Family planning access is additionally associated with improving women's (and family's) health and economic opportunities. Finally, helping HIV-infected pregnant women plan and space pregnancies also improves health outcomes for both mothers and infants, as women with uncontrolled HIV disease, and their neonates, have higher mortality and morbidity than those with well-controlled disease. Thus, there is an international call to integrate family planning into Prevention of Mother-to-Child Transmission (PMTCT) services in order to help women plan and space their pregnancies. However, there are very limited studies of integration projects that have been implemented and evaluated in the field, and the varying needs of different groups of HIV-infected women (for example with varying socioeconomic status), are poorly understood. We hope to address these deficiencies in current knowledge.

Objectives

The primary objective of this study is to understand the feasibility of and barriers to implementing a novel intervention to improve family planning counselling and access in antenatal and post-partum care in order to support the goal of preventing mother-to-child transmission (PMTCT) of HIV.

This intervention will have two complimentary pieces: (1) group-based sessions aimed at increasing condom and other contraceptive use intentions and sexual negotiation power, and (2) promotion of long-term family planning options as highly-effective forms of contraception.

We hypothesize that integration of enhanced family planning sessions and a routine offer of long-term family planning into existing PMTCT will improve contraceptive use among HIV-infected women. Allowing pregnancy planning and spacing promotes maternal HIV status optimization by allowing immunologic recovery and virologic suppression prior to additional pregnancies. Since improved maternal HIV status improves infant outcomes, and contraception is another method of PMTCT, this project strongly supports the PMTCT goals. This feasibility study will provide data to support a larger grant to consider the longitudinal impact of family planning/PMTCT integration.

Location

Seke North, St. Mary's, Seke South and Zengeza Clinics in Chitungwiza

Duration

September 2011 – February 2012

Participants

100 HIV-positive pregnant women

Collaborating Agencies

• U.S. National Institutes of Health/PEPFAR
• University of Zimbabwe College of Health Sciences
• Zimbabwean Ministry of Health and Child Welfare
• Chitungwiza Health Department
• Stanford University
• Zimbabwe PEPFAR EGPAF FAI Site
• University of California at San Francisco (UCSF)

Publications and Presentations

Integrating family planning and prevention of mother to child HIV transmission in Zimbabwe, CONTRACEPTION, Sarnquist, C. C., Moyo, P., Stranix-Chibanda, L., Chipato, T., Kang, J. L., Maldonado, Y. A.2014; 89 (3): 209-214

Integrating family planning and prevention of mother to child HIV transmission in Zimbabwe, poster at International AIDS conference 2012. http://pag.aids2012.org/EPosterHandler.axd?aid=6599

Intimate partner violence and HIV-infection among women in Zimbabwe: A complex interplay, Moyo, P., Stranix-Chinbanda, L., Kang, J.L., Sarnquist, C.C., Tagwira, V., Chang, D. poster presented at American Public Health Association Conference, 2014. 

In the News

Stanford School of Medicine article, "Birth control counseling may reduce AIDS transmission in Africa, say researchers" (July 25, 2012)

MORE INFORMATION

For more information about the Zimbabwe HIV/Family Planning Study, please contact Clea Sarnquist.

In Collaboration with UCSF and the University of Zimbabwe

Overview of Nevirapine Research Projects

What is Nevirapine?

Nevirapine is an inexpensive, easy-to-use drug that can help reduce the chances that HIV is passed from mother-to-infant during labor and delivery and breastfeeding. Nevirapine research projects have been running in Chitungwiza for almost 2 years.

Overall Objective and Goal

The goal of these projects is to identify a safe and effective regimen of Nevirapine that can be given to HIV-exposed infants (those with HIV+ mothers) so that infants can simultaneously breastfeed and also be protected against HIV virus in the mother's breastmilk.

The Projects

• HIVNET 023: Phase I/II
• Location:
• Seke North Clinic, Chitungwiza
• Duration
• March 2000 - August 2001
• Administered by
• Zimbabwe AIDS Prevention Project (ZAPP)
• Participants
• 32 mother-infant pairs
• Description
• All mothers were given a single dose of Nevirapine at the onset of labor to reduce the chances of HIV transmission, and all infants were given a single dose of Nevirapine within 72 hours of birth. In addition, infants were randomized to receive one of three different Nevirapine dosing regimens (once a week, twice a week or a daily dose) for the first six months of life. Mothers were counseled and encouraged to maintain exclusive breastfeeding and wean at or before 6 months.
• Results
• Nevirapine was safe and well tolerated in the infants. Although the sample was too small to generalize broadly, only 9% of the infants were HIV-positive at 6 months, demonstrating a dramatic improvement in reduction of transmission.
• HPTN 046: Phase III
• 
  Location
• Seke North, St. Mary's, Seke South and Zengeza Clinics in Chitungwiza and Harare Hospital
• Duration
• Estimated Start Date of March 2002, for 3-5 years
• Administered by
• UZ-UCSF Collaborative Research Programme
• Participants
• 450-500 mother-infant pairs
• Description
• All mothers are given a single dose of Nevirapine at the onset of labor to reduce the chances of HIV transmission, and all infants are given a single dose of Nevirapine within 72 hours of birth. In addition, infants will be randomized to receive either a daily dose of Nevirapine or a daily dose of a Nevirapine placebo for the first six months of life.
• Results
• Coovadia HM, Brown ER, Fowler MG, et al. "Efficacy and safety of an extended nevirapine regimen in infant children of breastfeeding mothers with HIV-1 infection for prevention of postnatal HIV-1 transmission (HPTN 046): a randomized, double-blind, placebo-controlled trial." The Lancet, Volume 379, Issue 9812, 21-27 January 2012, pgs 221-228.
• Summary of HPTN 046 results, released on March 2, 2011 at the 18th Conference on Retroviruses and Opportunistic Infections (CROI) in Boston.
• For more information and the project's protocol, go here:http://www.hptn.org/research_studies/hptn046.asp
• The HPTN 046 Study is being administered by the UZ-UCSF Collaborative Programme in Women's Health, 15 Phillips Avenue, Belgravia, Harare, in collaboration with the University of Zimbabwe, Department of Community Medicine and Stanford University, Department of Pediatrics (USA).
•  

California Department of Public Health (CDPH)-Office of AIDS contracted with the Pacific AIDS Education and Training Center (PAETC) and Stanford University to provide training,technical assistance, and capacity building to hospitals in order to implement HIV rapid testing in L&D units ("RTLD"). PAETC clinician and program staff provided training and technical assistance, and Stanford provided program evaluation. The project ran from October 2006 through December 2011.

What was offered

Based in a systems change approach, technical assistance and training were tailored to each site, and frequently included:

• Sample policies, procedures, protocols, and forms used for conducting rapid testing in labor and delivery.
• Information on current available rapid testing technologies (i.e., cost, methods, sensitivity, etc.)
• Current recommendations for use of antiretroviral drugs in pregnant HIV-positive women.
• Resources and background materials that support the need for and efforts to identify HIV status in laboring women.
• Technical advice on applying to CDHS Lab Field Services for approval to offer HIV rapid testing.
• Information on the National Perinatal HIV Consultation and Referral Service (Perinatal Hotline, offering 24-hour expert advice) and additional resources.
• Training and consultation for staff on issues related to:
  • Implementation: e.g., initiating the HIV testing discussion with laboring women; gaining consent, laboratory procedures; how and when results are given; medication protocols for HIV medication to administer in L&D and postpartum.
  • Staff concerns related to systems changes, additional and new tasks, identifying and working with HIV-infected women.

Results

Baseline Survey

205/260 facilities (79%) responded to the survey. 36% of hospitals reported having rapid HIV testing available at L&D, but only 19% reported offering testing in 2005. Teaching hospitals and facilities with written protocols specific to rapid HIV testing on L&D were significantly more likely to have testing available. Facilities with less prenatal care record availability and facilities with more patients covered by Medi-Cal were more likely to report offering rapid HIV testing.

Process

Between January 2007 and December 2011 we interacted with 226 (80.4%) of the 281 hospitals operating labor and delivery units in California for at least some time during the project. Of the 226 participating facilities, 81 (35.8%) were already offering RTLD when we contacted them. Of the remaining 145 facilities, 87 (60%) began offering RTLD by the end of the project. On average, six email or telephone contacts (range 1-40) were made prior to a first face-to-face or telephone meeting. Despite regular small steps toward change, the entire process of RTLD implementation was frequently lengthy.

MORE INFORMATION

The Stanford University team provides evaluation and data support to this project. For more information, please contact Clea Sarnquist.

Partnerships in the Development of a Vaccine Safety and Safety Communication Curriculum for Medical Residents

Background/Introduction

In the U.S., subpopulations of children and adults continue to be under immunized, putting themselves and others at risk of vaccine-preventable diseases. Multiple barriers to full and timely immunizations exist, including lack of physician training and implementation of evidence-based strategies for communicating vaccine benefits and risks. Furthermore, some vaccines, including MMR and varicella, still carry stigmas that, while lacking an evidence-base, mean that parents and individuals may reject a potentially life-saving vaccine based on erroneous popularized conceptions of unfounded risks. As such, under immunization and missed opportunities for patients and among providers continue to present both a personal and public health risk that must be addressed.

Project Team

We brought together a group of project participants from professional medical societies, academia, public health, and a collaborative of community immunization coalitions to address the enhancement of resident education on immunization safety and safety communication. These include the American Academy of Pediatrics, California, the California Academy of Family Physicians, the California Immunization Coalition, California Department of Public Health, Immunization Branch, Children's Hospital, University of California San Diego, University of California Davis, and Stanford University School of Medicine.

Goals (all achieved as of 10/2011)

Goal 1: Identify major, common vaccine safety concerns

By December 15, 2009, complete a literature search to identify published common vaccine safety concerns, conduct at least 4 focus groups each of community members and physicians in order to further refine understanding of current major vaccine safety concerns, and design a survey for residents.

Goal 2: Develop an Immunization Safety Communication Curriculum for Medical Residents

Develop an Immunization Safety Communication Curriculum for Medical Residents: By June 15, 2010, prepare a variety of effective methods to teach vaccine safety communication to Medical Residents such that they can be delivered in different settings and with different levels of direct trainer involvement, including an online curriculum and training-of-trainers materials. We are planning two major methods for delivering the vaccine curriculum, an on-line interactive module and an in-person training using written materials.

Goal 3: Pilot Immunization Safety Communication Curriculum

Pilot Immunization Safety Communication Curriculum: By July 1, 2010 (the beginning of the year for residents), curriculum will be fully ready to use at 4 pilot sites (Stanford, UCSD, UCD, USC).

Goal 4: Disseminate an Immunization Safety Communication Curriculum to training programs in the United States

Disseminate an Immunization Safety Communication Curriculum to training programs in the United States: Contact 100% of residency training programs in the U.S. regarding their interest in supplementing their current primary care curriculum with the newly-developed curriculum. By January 1, 2011, identify at least 6 residency programs interested in using the on-line curriculum, and make this curriculum available to their residents. By January 1, 2011, identify at least 2 residency programs interested in train-the-trainer sessions, and complete these sessions in order to facilitate the incorporation of curricular materials into existing residency training programs. By March 1, 2011 re-contact 100% of residency training program that did not participate in the initial phases of the project regarding their interest in participating (should have data showing program effectiveness to share). By July 1, 2011 make this curriculum available to at least 10 additional residency programs.

Goal 5: Evaluate the effectiveness of the curriculum

Evaluate the effectiveness of the curriculum: Assess pediatric and family practice resident's acquisition and utilization of key elements of vaccine safety and vaccine risk communication and resulting increase in vaccination of children and adolescents.

Results

Needs Assessment Survey

The sample included residents in pediatrics (239, 80.2%), internal or family medicine (30, 10.1%), and dual medicine-pediatrics (29, 9.7%). 20.6% of the residents reported "not learning" about vaccine safety communication in their residency programs. Preferred learning methods, which were also the most commonly-utilized methods, included didactic lectures and role-modeling/cases. Electronic teaching method were less desired, but also very rarely utilized. Over 95% of residents reported thinking that vaccine safety communication would be very or somewhat important in their careers.

• See also: Sarnquist, C et al. "Communicating about vaccines and vaccine safety: What are medical residents learning and what do they want to learn?" Journal of Public Health Management and Practice. 2013.Jan-Feb;19(1):40-6. doi: 10.1097

Online cases and small group materials pilot

Responses to the online (87 participants) and small-group (64 participants) cases in the pilot phase of the project have been overwhelmingly positive. Over 97% of the residents participating in the pilot reported both that reviewing the cases was a good use of their time and that they anticipated utilizing the information they learned with their patients. Furthermore, over 90% reported both improved ability to communicate about vaccination as well as improved comfort level discussing vaccination with patients.