Lisa Vallely

Intermittent preventive treatment for malaria in pregnancy in Africa: What's new, what's needed?

Falciparum malaria is an important cause of maternal, perinatal and neonatal morbidity in high transmission settings in Sub-Saharan Africa. Intermittent preventive treatment with sulphadoxine-pyrimethamine (SP-IPT) has proven efficacious in reducing the burden of pregnancy-associated malaria but increasing levels of parasite resistance mean that the benefits of national SP-IPT programmes may soon be seriously undermined in much of the region. Hence, there is an urgent need to develop alternative drug regimens for IPT in pregnancy. This paper reviews published safety and efficacy data on various antimalarials and proposes several candidate combination regimens for assessment in phase II/III clinical trials.

Postpartum maternal morbidity requiring hospital admission in Lusaka, Zambia – a descriptive study

BackgroundInformation on the extent of postpartum maternal morbidity in developing countries is extremely limited. In many settings, data from hospital-based studies is hard to interpret because of the small proportion of women that have access to medical care. However, in those areas with good uptake of health care, the measurement of the type and incidence of complications severe enough to require hospitalisation may provide useful baseline information on the acute and severe morbidity that women experience in the early weeks following childbirth. An analysis of health services data from Lusaka, Zambia, is presented.MethodsSix-month retrospective review of hospital registers and 4-week cross-sectional study with prospective identification of postpartum admissions.ResultsBoth parts of the study identified puerperal sepsis and malaria as, respectively, the leading direct and indirect causes of postpartum morbidity requiring hospital admission. Puerperal sepsis accounted for 34.8% of 365 postpartum admissions in the 6-month period. Malaria and pneumonia together accounted for one-fifth of all postpartum admissions (14.5% & 6% respectively). At least 1.7% of the postpartum population in Lusaka will require hospital-level care for a maternal morbidity.ConclusionsIn developing country urban settings with high public health care usage, meticulous review of hospital registers can provide baseline information on the burden of moderate-to-severe postpartum morbidity.

How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania

BackgroundHIV prevention trials conducted among disadvantaged vulnerable at-risk populations in developing countries present unique ethical dilemmas. A key concern in bioethics is the validity of informed consent for trial participation obtained from research subjects in such settings. The purpose of this study was to investigate the effectiveness of a continuous informed consent process adopted during the MDP301 phase III vaginal microbicide trial in Mwanza, Tanzania.MethodsA total of 1146 women at increased risk of HIV acquisition working as alcohol and food vendors or in bars, restaurants, hotels and guesthouses have been recruited into the MDP301 phase III efficacy and safety trial in Mwanza. During preparations for the trial, participatory community research methods were used to develop a locally-appropriate pictorial flipchart in order to convey key messages about the trial to potential participants. Pre-recorded audio tapes were also developed to facilitate understanding and compliance with gel-use instructions. A comprehension checklist is administered by clinical staff to all participants at screening, enrolment, 12, 24, 40 and 50 week follow-up visits during the trial. To investigate womens perceptions and experiences of the trial, including how well participants internalize and retain key messages provided through a continuous informed consent process, a random sub-sample of 102 women were invited to participate in in-depth interviews (IDIs) conducted immediately after their 4, 24 and 52 week follow-up visits.Results99 women completed interviews at 4-weeks, 83 at 24-weeks, and 74 at 52 weeks (a total of 256 interviews). In all interviews there was evidence of good comprehension and retention of key trial messages including that the gel is not currently know to be effective against HIV; that this is the key reason for conducting the trial; and that women should stop using gel in the event of pregnancy.ConclusionsProviding information to trial participants in a focussed, locally-appropriate manner, using methods developed in consultation with the community, and within a continuous informed-consent framework resulted in high levels of comprehension and message retention in this setting. This approach may represent a model for researchers conducting HIV prevention trials among other vulnerable populations in resource-poor settings.Trial registrationCurrent Controlled Trials ISRCTN64716212

A model for community representation and participation in HIV prevention trials among women who engage in transactional sex in Africa

Abstract Actively engaging communities in effective partnerships for the design and implementation of HIV prevention research is vital to the successful conduct of ethically robust, locally-appropriate clinical trials in developing countries. This is especially true in vulnerable at-risk sub-populations, where definitions of “community”, “participation” and “representation” can be difficult to apply. This study was conducted to investigate the feasibility of a participatory model of community liaison among an occupational cohort of women at high-risk of HIV and sexually-transmitted infections in Mwanza City, northwest Tanzania in preparation for a Phase III vaginal microbicide trial. This approach was rooted in participatory action-orientated research and used tools adapted from participatory learning and action techniques. During the feasibility study, a mobile community-based sexual and reproductive health service for women working as informal food vendors or in traditional and modern bars, restaurants, hotels and guesthouses was established in 10 city wards. Participatory mapping was carried out by project fieldworkers and wards divided into 78 geographical clusters of facilities in consultation with community members and study participants. Representatives at cluster and ward level were elected in a process facilitated by the site Community Liaison Officer and a site-level Community Advisory Committee established. A logical framework was used to guide the implementation, monitoring and evaluation of the community liaison system (CLS) within the broader feasibility study. The CLS was essential to the successful conduct of the feasibility study and has now been consolidated and expanded as part of the on-going MDP301 Phase III microbicide trial in Mwanza. The participatory model presented in this paper is likely to be generalisable to other vulnerable, stigmatised, at-risk study populations in resource-limited settings.

Sustainability of community-capacity to promote safer motherhood in northwestern Tanzania: what remains?

Objective. To examine the remains of the Community-Based Reproductive Health Project (CBRHP) implemented by CARE-Tanzania to address high maternal mortality in two rural districts. Methods. In early 2007, data were collected from 29 villages and used to assess sustainability of emergency transport systems, retention of village health workers (VHWs), and their potential impact on maternal health. Surveillance data from the Ministry of Health were reviewed to assess changes in prenatal and service use indicators. Results. From 2001 through 2006, the CBRHP-trained VHWs have continued to provide education and referrals to women in their communities including prenatal and emergency obstetric care; six villages with emergency transport systems have continued for more than 5 years providing free or low-cost transport to health facilities. Selected maternal and infant health indicators, such as early prenatal care, identification of pregnancy-related danger signs, and data on maternal and infant outcomes, improved in the two targeted districts over time. Conclusions. The two components of CBRHP, work of VHWs and community-financing for emergency transport systems in six villages, have continued. Both of these promote maternal health and linkages with the health delivery systems. Surveillance data show changes in maternal health indicators that were targeted by the district-wide CBRHP interventions. Programs such as CBRHP, with focus on capacity-building and empowerment, can assist in mobilizing the formal and informal systems in communities, components of which may be sustained over time. (Global Health Promotion, 2010; 17(1): pp. 39—49)

Field Evaluation of Xpert HPV Point-of-Care Test for Detection of Human Papillomavirus Infection by Use of Self-Collected Vaginal and Clinician-Collected Cervical Specimens

ABSTRACT The World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected samples. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both specimen types were tested at the point of care by using the Xpert HPV test. Women were given their cervical test result the same day. Those with a positive hrHPV test and positive examination upon visual inspection of the cervix with acetic acid were offered same-day cervical cryotherapy. A total of 1,005 women were enrolled, with 124 (12.3%; 95% confidence interval [CI], 10.3%, 14.4%) being positive for any hrHPV infection. There was a 99.4% overall percent agreement (OPA) between vaginal and cervical tests for HPV-16 (95% CI, 98.9%, 99.9%), a 98.5% OPA for HPV-18/45 (95% CI, 97.7%, 99.3%), a 94.4% OPA for other hrHPV infections (95% CI, 92.9%, 95.9%), and a 93.4% OPA for all hrHPV types combined (95% CI, 91.8%, 95.0%). Self-collected vaginal specimens had excellent agreement with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. This approach provides for the first time an opportunity to incorporate point-of-care hrHPV testing into clinical cervical screening algorithms in high-burden, low-income settings.

Exploring women's perspectives of access to care during pregnancy and childbirth: A qualitative study from rural Papua New Guinea

OBJECTIVES to explore womens perceptions and experiences of pregnancy and childbirth in a rural community in PNG. DESIGN a qualitative, descriptive study comprising focus group discussions (FGDs) and in depth interviews. SETTING this study took place in a rural community in Eastern Highlands Province, PNG. PARTICIPANTS 51 women participated in seven focus group discussions. In depth interviews were undertaken with 21 women, including women recruited at the antenatal clinic, women purposively selected in the community and three key informants in the community. FINDINGS the majority of women mentioned the benefits of receiving antenatal care at the health facility and the importance of a supervised, facility birth. Women faced numerous challenges with regards to accessing these services, including geographical, financial and language barriers. Cultural and customary beliefs surrounding childbirth and lack of decision making powers also impacted on whether women had a supervised birth. KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE distance, terrain and transport as well as decision making processes and customary beliefs influenced whether a woman did or did not reach a health facility to give birth. While the wider issue of availability and location of health services and health system strengthening is addressed shorter term, community based interventions could be of benefit. These interventions should include safe motherhood and birth preparedness messages disseminated to women, men and key family and community members.

Prevalence and risk factors of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and other sexually transmissible infections among women attending antenatal clinics in three provinces in Papua New Guinea: a cross-sectional survey

Background Papua New Guinea (PNG) is estimated to have among the highest prevalences of HIV and sexually transmissible infections (STIs) of any Asia-Pacific country, and one of the highest burdens of maternal syphilis globally. The prevalence of curable STIs, such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), among pregnant women in PNG is relatively unknown. METHODS A cross-sectional bio-behavioural survey to investigate the epidemiology of CT, NG, TV and other STIs among pregnant women in three provinces of PNG was undertaken. Women aged 18-35 years attending their first antenatal clinic visit were invited to participate. Participants completed a short interview and provided self-collected vaginal specimens for CT, NG and TV laboratory-based nucleic acid amplification tests and a venepuncture specimen for laboratory testing for syphilis and Herpes simplex virus type-2 (HSV-2) serology. Routine antenatal assessment was conducted according to national guidelines, including HIV counselling and testing and point-of-care syphilis screening. RESULTS A total of 765 women were enrolled. Overall, 43% (95% confidence interval (CI): 39.2-46.4) had one or more of CT, NG or TV infection. CT was the most prevalent STI (22.9%, 175/765; 95% CI: 19.9-25.9), followed by TV (22.4%, 171/765; 95% CI: 19.4-25.4), and NG (14.2%, 109/765; 95% CI: 11.7-16.7). The prevalence of active syphilis was 2.2% (17/765; 95% CI: 1.2-3.3), HSV-2 was 28.0% (214/765; 95% CI: 24.8-31.2) and HIV, 0.8% (6/765; 95% CI: 0.2-1.4). Prevalences were highest among primigravid women, women aged <25 years, and among those in Central Province. CONCLUSION High prevalences of curable genital STIs were observed among women attending routine antenatal clinic services in PNG. These infections have been associated with adverse pregnancy outcomes and could be important contributors to poor maternal and neonatal health in this setting.Background: Papua New Guinea (PNG) is estimated to have among the highest prevalences of HIV and sexually transmissible infections (STIs) of any Asia-Pacific country, and one of the highest burdens of maternal syphilis globally. The prevalence of curable STIs, such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), among pregnant women in PNG is relatively unknown. Methods: A cross-sectional bio-behavioural survey to investigate the epidemiology of CT, NG, TV and other STIs among pregnant women in three provinces of PNG was undertaken. Women aged 18-35 years attending their first antenatal clinic visit were invited to participate. Participants completed a short interview and provided self-collected vaginal specimens for CT, NG and TV laboratory-based nucleic acid amplification tests and a venepuncture specimen for laboratory testing for syphilis and Herpes simplex virus type-2 (HSV-2) serology. Routine antenatal assessment was conducted according to national guidelines, including HIV counselling and testing and point-of-care syphilis screening. Results: A total of 765 women were enrolled. Overall, 43% (95% confidence interval (CI): 39.2-46.4) had one or more of CT, NG or TV infection. CT was the most prevalent STI (22.9%, 175/765; 95% CI: 19.9-25.9), followed by TV (22.4%, 171/765; 95% CI: 19.4-25.4), and NG (14.2%, 109/765; 95% CI: 11.7-16.7). The prevalence of active syphilis was 2.2% (17/765; 95% CI: 1.2-3.3), HSV-2 was 28.0% (214/765; 95% CI: 24.8-31.2) and HIV, 0.8% (6/765; 95% CI: 0.2-1.4). Prevalences were highest among primigravid women, women aged <25 years, and among those in Central Province. Conclusion: High prevalences of curable genital STIs were observed among women attending routine antenatal clinic services in PNG. These infections have been associated with adverse pregnancy outcomes and could be important contributors to poor maternal and neonatal health in this setting.

Infant feeding in the context of HIV: a qualitative study of health care workers’ knowledge of recommended infant feeding options in Papua New Guinea

BackgroundInterventions to prevent mother to child transmission of human immunodeficiency virus (HIV) during childbirth and breastfeeding can reduce HIV infections in infants to less than 5% in low and middle income countries. The World Health Organization (WHO) recommends all mothers, regardless of their HIV status, practice exclusive breastfeeding for the first six months of an infant’s life. In line with these recommendations and to protect, promote and support breastfeeding, in 2009 the PNG National Department of Health revised their National HIV infant feeding guidelines, reinforcing the WHO recommendation of exclusive breastfeeding for the first six months followed by the introduction of other food and fluids, while continuing breastfeeding.The overall aim of this paper is to explore health care workers’ knowledge regarding infant feeding options in PNG, specifically as they relate to HIV exposed infants.MethodsAs part of a study investigating women’s and men’s experiences of prevention of mother to child transmission (PMTCT) services in two sites in PNG, 28 key informant interviews were undertaken. This paper addresses one theme that emerged from thematic data analysis: Health care workers’ knowledge regarding infant feeding options, specifically how this knowledge reflects the Papua New Guinea National HIV Care and Treatment Guidelines on HIV and infant feeding (2009).ResultsMost informants mentioned exclusive breastfeeding, the majority of whom reflected the most up-to-date National Guidelines of exclusive breastfeeding for six months. The importance of breastfeeding continuing beyond this time, along with the introduction of food and fluids was less well understood. The most senior people involved in PMTCT were the informants who most accurately reflected the national guidelines of continuing breastfeeding after six months.ConclusionProviding advice on optimal infant feeding in resource poor settings is problematic, especially in relation to HIV transmission. Findings from our study reflect those found elsewhere in identifying that key health care workers are not aware of up-to-date information relating to infant feeding, especially within the context of HIV. Greater emphasis needs to be placed on ensuring the most recent feeding guidelines are disseminated and implemented in clinical practice in PNG.

Unsafe abortion requiring hospital admission in the Eastern Highlands of Papua New Guinea - a descriptive study of women’s and health care workers’ experiences

BackgroundIn Papua New Guinea induced abortion is restricted under the Criminal Code Law. Unsafe abortions are known to be widely practiced and sepsis due to unsafe abortion is a leading cause of maternal mortality.MethodsWe undertook a six month, prospective, mixed methods study at the Eastern Highlands Provincial Hospital. Semi structured and in depth interviews were undertaken with women presenting following induced abortion. This paper describes the reasons why women resorted to unsafe abortion, the techniques used, decision to seek post abortion care and women’s reflections post abortion.Results28 women were admitted to hospital following an induced abortion. Reasons for inducing an abortion included: wanting to continue with studies, relationship problems and socio-cultural factors. Misoprostol was the most frequently used method to end the pregnancy. Physical and mechanical means, traditional herbs and spiritual beliefs were also reported. Women sought care post abortion due to excessive vaginal bleeding, and severe abdominal pain with some afraid they would die if they did not seek help.ConclusionIn the absence of contraceptive information and services to avoid, postpone or space pregnancies, women in this setting are resorting to unsafe means to end an unwanted pregnancy, putting their lives at risk. Women need access to safe, effective means of abortion.