A Model for Empowering Rural Solutions for Cervical Cancer Prevention (He Tapu Te Whare Tangata): Protocol for a Cluster Randomized Crossover Trial.

BACKGROUND: Maori are the Indigenous people of Aotearoa (New Zealand). Despite global acceptance that cervical cancer is almost entirely preventable through vaccination and screening, wahine Maori (Maori women) are more likely to have cervical cancer and 2.5 times more likely to die from it than non-Maori women. Rural Maori residents diagnosed with cervical cancer have worse outcomes than urban residents. Living in rural Aotearoa means experiencing barriers to appropriate and timely health care, resulting from distance, the lack of community resourcing, and low prioritization of rural needs by the health system and government. These barriers are compounded by the current screening processes and referral pathways that create delays at each step. Screening for high-risk human papillomavirus (hrHPV) and point-of-care (POC) testing are scientific advances used globally to prevent cervical cancer. OBJECTIVE: This study aims to compare acceptability, feasibility, timeliness, referral to, and attendance for colposcopy following hrHPV detection between a community-controlled pathway and standard care. METHODS: This is a cluster randomized crossover trial, with 2 primary care practices (study sites) as clusters. Each site was randomized to implement either pathway 1 or 2, with crossover occurring at 15 months. Pathway 1 (community-controlled pathway) comprises HPV self-testing, 1-hour POC results, face-to-face information, support, and immediate referral to colposcopy for women with a positive test result. Pathway 2 (standard care) comprises HPV self-testing, laboratory analysis, usual results giving, information, support, and standard referral pathways for women with a positive test result. The primary outcome is the proportion of women with hrHPV-positive results having a colposcopy within 20 working days of the HPV test (national performance indicator). Qualitative research will analyze successes and challenges of both pathways from the perspectives of governance groups, clinical staff, women, and their family. This information will directly inform the new National Cervical Screening Program. RESULTS: In the first 15-month period, 743 eligible HPV self-tests were performed: 370 in pathway 1 with POC testing and 373 in pathway 2 with laboratory testing. The positivity rate for hrHPV was 7.3% (54/743). Data collection for the second period, qualitative interviews, and analyses are ongoing. CONCLUSIONS: This Maori-centered study combines quantitative and qualitative research to compare 2 clinical pathways from detection of hrHPV to colposcopy. This protocol draws on rural community practices strengths, successfully engaging Maori from a whanau ora (family wellness) approach including kanohi ki te kanohi (face-to-face), kaiawhina (nonclinical community health workers), and multiple venues for interventions. It will inform the theory and practice of rural models of the use of innovative technology, addressing Maori cervical cancer inequities and facilitating Maori wellness. The findings are anticipated to be applicable to other Indigenous and rural people in high-income countries. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12621000553875; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12621000553875. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51643.

Culturally Safe Neonatal Care: Talking With Health Practitioners Identified as Champions by Indigenous Families.

The burden of health inequities borne by Indigenous peoples can be overwhelming, especially when mothers and newborns' lives are at stake and health services seem slow to invest in responsiveness. In Aotearoa (New Zealand), urgent action is required to eliminate persistent systemic inequities for Maori (Indigenous) whanau (family collectives that extend beyond the household). This Kaupapa Maori (by Maori, for Maori) qualitative study aimed to explore the views of health practitioners identified as champions by whanau of preterm Maori infants. Ten health practitioners were interviewed and asked about their involvement with the whanau, their role in explanations and communication, and their thoughts on whanau coping. Interview data were analysed using interpretative phenomenological analysis. Three superordinate themes were identified: working together in partnership, a problem shared is a problem halved, and sacred space. Collaboration between health practitioners and with whanau was important to the champions and central to their goal of enabling whanau autonomy. This was built on a foundation of connectivity, relationships, and a full appreciation that childbirth is a sacred time that is potentially disrupted when an infant is born prematurely. The values- and relationship-based practices of these champions protected and uplifted whanau. They showed that health practitioners have important roles in both the elimination of inequities and the sustaining of Maori self-determination. This championship is an exemplar of what culturally safe care looks like in day-to-day practice with Maori and is a standard that other health practitioners should be held to.

Infant Sleep Hazards and the Risk of Sudden Unexpected Death in Infancy.

OBJECTIVE: To examine the effects of infant sofa-sleeping, recent use by caregivers of alcohol, cannabis, and/or other drugs, and bed type and pillows, on the risk of sudden unexpected death in infancy (SUDI) in New Zealand. STUDY DESIGN: A nationwide prospective case-control study was implemented between March 2012 and February 2015. Data were collected during interviews with parents/caregivers. "Hazards" were defined as infant exposure to 1 or more of sofa-sleeping and recent use by caregivers of alcohol, cannabis, and other drugs. The interaction of hazards with tobacco smoking in pregnancy and bed sharing, including for very young infants, and the difference in risk for Maori and non-Maori infants, also were assessed. RESULTS: The study enrolled 132 cases and 258 controls. SUDI risk increased with infant sofa-sleeping (imputed aOR [IaOR] 24.22, 95% CI 1.65-356.40) and with hazards (IaOR 3.35, 95% CI 1.40-8.01). The SUDI risk from the combination of tobacco smoking in pregnancy and bed sharing (IaOR 29.0, 95% CI 10.10-83.33) increased with the addition of 1 or more hazards (IaOR 148.24, 95% CI 15.72-1398), and infants younger than 3 months appeared to be at greater risk (IaOR 450.61, 95% CI 26.84-7593.14). CONCLUSIONS: Tobacco smoking in pregnancy and bed sharing remain the greatest SUDI risks for infants and risk increases further in the presence of sofa-sleeping or recent caregiver use of alcohol and/or cannabis and other drugs. Continued implementation of effective, appropriate programs for smoking cessation, safe sleep, and supplying safe sleep beds is required to reduce New Zealand SUDI rates and SUDI disparity among Maori.

Examining the potential preventability of adverse fetal/neonatal outcomes associated with severe maternal morbidity.

BACKGROUND: Severe maternal morbidity (SMM) occurs in 1-2% of pregnancies. Despite the knowledge that a SMM event can contribute to poor fetal/neonatal outcomes, little is known about the preventability of these adverse outcomes. AIMS: To examine adverse fetal/neonatal outcomes associated with SMM to determine if these outcomes were potentially preventable. MATERIALS AND METHODS: A New Zealand national retrospective cohort study examining cases of SMM with an adverse fetal/neonatal outcome. Maternity and initial neonatal care were explored by multidisciplinary panels utilising a preventability tool to assess whether the fetal/neonatal harm was potentially preventable. Adverse fetal/neonatal outcomes were defined as fetal or early neonatal death, Apgar score <7 at five minutes, admission to neonatal intensive care unit or special care baby unit and neonatal encephalopathy. RESULTS: Of 85 cases reviewed, adverse fetal/neonatal outcome was deemed potentially preventable in 55.3% of cases (n = 47/85). Preventability was related to maternal antenatal/peripartum care (in utero) in 39% (n = 33/85), to initial neonatal care (ex utero) in 36% (n = 29/80), and to both maternal and neonatal care in 20% (16/80) of cases. Main contributors to potential preventability were factors related to healthcare providers, particularly lack of recognition of high risk, delayed or failure to diagnose, and delayed or inappropriate treatment. CONCLUSIONS: Multidisciplinary panels found that over half of adverse fetal/neonatal harm associated with SMM was potentially preventable. The novel approach of examining both maternal and neonatal care identifies opportunities to improve fetal/neonatal outcomes associated with SMM at multiple points on the perinatal continuum of care.

Predicting regression of cervical intraepithelial neoplasia grade 2 in women under 25 years.

BACKGROUND: A number of retrospective and prospective studies have documented substantial rates of regression in cervical intraepithelial neoplasia grade 2 lesions in young women. Initial observational management of cervical intraepithelial neoplasia grade 2 is increasingly accepted as appropriate for women under 25 years of age with screen-detected abnormalities and is included in a number of clinical guidelines. However, there has been a paucity of large prospective studies on observational management with strict inclusion criteria. A number of important questions remain, specifically regarding the clinical variables that are associated with the risk of progression or persistence of disease. To investigate these factors and to ensure that young women with cervical intraepithelial neoplasia grade 2 undergoing observational management were being managed in a well-monitored and an appropriately informed fashion, we conducted a large, multicenter prospective study on observational management of cervical intraepithelial neoplasia grade 2 in women under 25 years. OBJECTIVE: This study aimed to determine the regression rates and clinical, cytologic, and pathologic predictors of regression of cervical intraepithelial neoplasia grade 2 in women under 25 years undergoing observational management over 24 months. STUDY DESIGN: This study was a multicenter prospective study on observational management of cervical intraepithelial neoplasia grade 2 (ie, repeat colposcopy, cytology, and cervical biopsy every 6 months) for up to 24 months. A total of 615 consenting women under 25 years with newly-diagnosed, biopsy-proven cervical intraepithelial neoplasia grade 2 were recruited (from 2010 to 2016) through 16 hospital-based colposcopy units in New Zealand and Australia. RESULTS: At completion, 326 women had confirmed regression, 156 had persistent high-grade cervical intraepithelial neoplasia grade 2 or 3 or adenocarcinoma in situ, and 24 had unconfirmed regression (ie, first regression at the 24-month follow-up). A total of 109 women did not complete the protocol (41 because of delayed follow-up, 41 lost to follow-up, 22 elected treatment, 4 refused a biopsy, and 1 died of an unrelated cause). Confirmed regression was observed in 53% (326 of 615) of all women enrolled in the study and, when missing data were imputed, it was estimated that 64% of women (95% confidence interval, 60%-68%) would have experienced regression. Similarly, lesions regressed in 64% (326 of 506) of women who completed the observational protocol. Based on a multivariable analysis, detection of human papillomavirus 16 in a liquid-based cytology sample at the time of initial colposcopy decreased the chance of regression by 31% (risk ratio, 0.69; 95% confidence interval, 0.56-0.86; P<.001). In addition, at initial colposcopy, low-grade or normal colposcopic impression, later year of diagnosis, low-grade or normal cytology, and being a nonsmoker were all independently associated with an increased chance of regression. CONCLUSION: More than half of women under 25 years with cervical intraepithelial neoplasia grade 2 will regress to cervical intraepithelial neoplasia grade 1 or normal within 24 months without destructive treatment. The absence of human papillomavirus 16 is the most important predictor of regression.

Pepe-infant sleep practices and sudden unexpected death in infancy in Aotearoa New Zealand.

OBJECTIVE: To explore pepe [infant] sleep practices and the key motivators among selected Maori and non-Maori mama [mothers] in Auckland, New Zealand, in relation to the risk of sudden unexpected death in infancy (SUDI). METHODS: Qualitative research underpinned by a kaupapa Maori cultural framework was undertaken. In-depth face-to-face interviews occurred in the homes of mama with young pepe born in Counties Manukau, Auckland. Interview transcripts were analyzed using general purpose thematic analysis. RESULTS: Thirty mama participated, including 17 Maori. Two-thirds of mama reported previous or current bed sharing. The fundamental human need for adequate sleep motivated half the mama in the present study, and especially Maori mama, to bed share. The second most common reason given was closeness and convenience. This was followed by breastfeeding, which was cited as a reason by Maori mama only. These findings were interpreted in terms of intrinsic fear, culture, and mama deployment of knowledge. CONCLUSION: Service providers are encouraged to respond to the lived experiences and cultural realities, values, and beliefs of mama when designing and delivering effective SUDI prevention interventions. Innovative approaches for providing structured and opportunistic, culturally appropriate education and support around safe sleep are likely to be well-received by mama and their whanau [family/ies].

He Tamariki Kokoti Tau: Families of Indigenous Infants Talk about Their Experiences of Preterm Birth and Neonatal Intensive Care.

Maori (Indigenous peoples of Aotearoa New Zealand) bear an unequal burden of poor perinatal health outcomes, including preterm birth. An infant arriving preterm disrupts the birth imaginary of whanau (family collectives) and situates them in a foreign health environment that may not be culturally safe and nurturing. A cross-sectional interpretative phenomenological analysis of first interviews with 19 whanau participating in a Kaupapa Maori (by, with, for Maori) qualitative longitudinal study of preterm birth identified themes from their experiences and the meanings they attributed to them. Preterm birth was an emotional roller coaster, with the birth imaginary and anticipated roles disrupted as health practitioners took over the care of their infants. Whanau expressed the desire to be close to their infants, holding them, loving them, nurturing them, and emplacing them within whakapapa (genealogy, continual layering of foundations) networks. When health practitioners or hospital policies inhibited this intimacy by isolating, excluding, or discriminating, whanau were frustrated. Being familiar with hospital routines, staff, peers, infant cares, and being wrapped in wider whanau support were key for whanau coping. Whakawhanaungatanga (processes of establishing relationships) create safe spaces for whanau to be themselves. This quietens the 'storm' and returns whanau to a sense of calm, through the reclamation of their environment.

He Tamariki Kokoti Tau: Tackling preterm incidence and outcomes of preterm births by ethnicity in Aotearoa New Zealand 2010-2014.

OBJECTIVE: To explore preterm birth among Maori indigenous peoples through Kaupapa Maori research of preterm birth in Aotearoa New Zealand. METHODS: Linked maternity, mortality, and hospital data were analyzed for women and their infants born between January 1, 2010 and December 31, 2014. Relative risks (RR) were calculated for each ethnic group for preterm birth, small for gestational age (SGA), and mortality. RESULTS: Adjusted rates showed that compared with Maori women, European women were at significantly less risk of having extremely and very preterm infants (RR 0.86, 95% confidence interval [CI] 0.76-0.95). Preterm infants of European women had a significantly lower adjusted RR of early neonatal death (RR 0.65, 95% CI 0.45-0.93) or post-neonatal death (RR 0.41, 95% CI 0.26-0.64). In addition to ethnicity, preterm rates were influenced by maternal age, body mass index, smoking status, and SGA status. CONCLUSION: This study demonstrates that the Aotearoa New Zealand maternity system privileges whiteness, suggesting that clinical pathways for evidence-based medical care are not delivered systemically and equitably for all. Health pathways that focus on equity as a fundamental right will enhance health outcomes for Maori women and their infants.

He Tapu Te Whare Tangata (sacred house of humanity): Under-screened Maori women talk about HPV self-testing cervical screening clinical pathways.

OBJECTIVE: To develop an in-depth understanding of HPV self-testing cervical screening clinical pathways for never-/under-screened Maori women. METHODS: Based on a community-based cluster randomized controlled trial in Aotearoa (New Zealand), a Kaupapa Maori (by Maori, for Maori) qualitative study enrolled Maori women who met the eligibility criteria of the HPV trial intervention (aged 25-69 years, no screen in >4 years). In total, 28 were recruited (22 had a negative test, six had a positive test and colposcopy). They were asked about their clinical pathway. RESULTS: The HPV self-test was seen as empowering and promoting bodily autonomy, although some women expressed fears or misconceptions about this new technology. While those with a negative test were relieved, for the six women who had a positive test, there were many fears, compounded by seeking out information on the Internet. When attending colposcopy, the importance of support and responsive care was emphasized. CONCLUSION: HPV self-testing has the potential to improve access to cervical screening and reduce inequities for Maori. Care must be taken in the delivery of screening and colposcopy results. Primary care and colposcopy services need to take special care with never-/under-screened Maori women to provide sensitive, responsive care, and mitigate trauma.

A call for action that cannot go to voicemail: Research activism to urgently improve Indigenous perinatal health and wellbeing.

In this call to action, a coalition of Indigenous and non-Indigenous researchers from Australia, Aotearoa New Zealand, United States and Canada argue for the urgent need for adequately funded Indigenous-led solutions to perinatal health inequities for Indigenous families in well-resourced settler-colonial countries. Authors describe examples of successful community-driven programs making a difference and call on all peoples to support and resource Indigenous-led perinatal health services by providing practical actions for individuals and different groups.

Achieving cervical cancer elimination among Indigenous women.

Achieving the World Health Organisation (WHO) cervical cancer elimination target of fewer than four new cases per 100,000 woman-years requires scaling up HPV vaccination of girls, cervical screening, and pre-cancer and cancer treatment. We reviewed data from four high-income colonised countries (Australia, Canada, Aotearoa New Zealand (NZ), and the United States (US)) to identify how each is currently performing compared to the cervical cancer incidence elimination and triple-intervention targets, nationally and in Indigenous women. We also summarise barriers and enablers to meeting targets for Indigenous women. To achieve elimination, cervical cancer incidence must be reduced by 74% in Indigenous women in Australia, and 63% in Maori women in NZ; data were not published in sufficient detail to compare incidence in Indigenous women in Canada or the US to the WHO target. Only Australia meets the vaccination coverage target, but uptake appears comparatively equitable within Australia, NZ and the US, whereas there appears to be a substantial gap in Canada. Screening coverage is lower for Indigenous women in all four countries though the differential varies by country. Currently, only Australia universally offers HPV-based screening. Data on pre-cancer and cancer treatment were limited in all countries. Large inequities in cervical cancer currently exist for Indigenous peoples in Australia, Canada, New Zealand and the US, and elimination is not on track for all women in these countries. Current data gaps hinder improvements. These countries must urgently address their systemic failure to care and provide health care for Indigenous women.

He Korowai Manaaki (Pregnancy Wraparound Care): Protocol for a Cluster Randomized Clinical Trial.

BACKGROUND: Maternal and infant health inequities between Maori (the Indigenous peoples of Aotearoa New Zealand) and New Zealand European women are well documented and cannot be explained solely by socioeconomic status. A research center-iwi (tribal group) partnership aims to address these disparities and improve maternal and infant health outcomes by implementing an augmented maternity care pathway (He Korowai Manaaki) to improve access to services and evidence-informed care. OBJECTIVE: The objective of this study is to test whether an augmented maternity care pathway improves Maori infant health outcomes. METHODS: This is a Kaupapa Maori (by, with, and for Maori) cluster randomized clinical trial involving 8 primary care practices allocated to either an intervention arm or control arm. The intervention arm comprises an augmented maternity care pathway (He Korowai Manaaki) offering clinical care through additional paid health care appointments and improved access to social support (eg, housing, transport). The control arm is usual care. The primary outcome is increased timely vaccination for Maori infants, defined as all age-appropriate vaccinations completed by 6 months of age. RESULTS: Recruitment commenced in November 2018 and was completed in June 2020, with 251 enrolled women recruited in intervention primary care practices before 20 weeks of pregnancy. Publication of results is anticipated in late 2023. CONCLUSIONS: The results will inform primary health care policy including whether the provision of augmented maternal care pathways reduces disparities in the structural determinants of health. If effective, He Korowai Manaaki will strengthen the health and well-being of pregnant Maori women and their babies and improve their health outcomes, laying a strong foundation for lifelong health and well-being. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001155189; https://tinyurl.com/yypbef8q. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18154.

An Affront to Her Mana: Young Maori Mothers' Experiences of Intimate Partner Violence.

Young Maori mothers in Aotearoa/New Zealand are disproportionately vulnerable to intimate partner violence (IPV) due to multiple intersecting factors, such as relationship dynamics during youth, pregnancy, and racialized Maori (Indigenous) identity. An enduring legacy of settler colonialism has resulted in Maori being overrepresented as victims and perpetrators of violence. IPV, in particular, leads to adverse social, mental, and health outcomes over time, including those specific to mothers (e.g., postpartum depression, miscarriage). This study analyzed six narrative interviews with young Maori mothers aged 14 to 19 from the E Hine longitudinal maternal health care study. Kaupapa Maori (by Maori, for Maori) was the primary research framework, which allowed for the use of Maori modes of engagement and the centering of Maori women's voices in the research process. Using a thematic and interpretive phenomenological analysis (IPA), we aimed to understand the lived realities of young Maori mothers who have experienced IPV and to examine the extent to which service responsiveness has been culturally safe. Our findings illustrated how IPV manifests in the relationships of these six women. Their stories showed the various ways in which young Maori women resist violence, reclaim their Maori identities, and experience personal transformation during their motherhood journeys despite abuse. We find that whanau (extended family) is both a violence-perpetuating and immensely protective factor. Moreover, there are structural and institutional barriers to culturally safe service responsiveness for young Maori women. These come in the form of racism at the frontlines of government agencies, pervasive victim-blaming, and a lack of earnest decolonial structural change at the institutional level. We conclude that social services must be multisectoral, culturally safe, and specialized for Maori youth and families to support Maori mothers experiencing IPV.

Te Ha o Whanau: A culturally responsive framework of maternity care.

AIM: A nuanced healthcare framework, Te Ha o Whanau, aims to make the maternal-infant healthcare system more accessible and culturally responsive for Maori following unexpected events that led to the harm or loss of their baby. METHOD: Te Ha o Whanau was developed from three components. Firstly, it was grounded and informed by Kaupapa Maori qualitative research involving whanau who had experienced the harm or loss of their baby. These learnings were then combined with matauranga Maori (Maori knowledge) and built on three articles of Te Tiriti o Waitangi: Kawanatanga, Rangatiratanga and Oritetanga. RESULTS: Te Ha o Whanau has been developed to specifically guide the maternal-infant healthcare system in providing culturally responsive practice points and guidelines. These practice points and guidelines align with three tikanga Maori (customs): Tikanga manaakitanga, Tikanga rangatiratanga and Tikanga whakawhanaunga. CONCLUSION: To address the stark health inequities present, we must forge innovative models and strategies, rather than reproducing (less successful) paths that have the less resistance. Te Ha o Whanau is provided with the aim of providing better outcomes for all, not just Maori.

Examining adverse fetal/neonatal outcomes associated with severe maternal morbidity.

BACKGROUND: While there is a global focus on severe maternal morbidity (SMM), less is known about the impact of SMM on fetal and neonatal outcomes. AIMS: To examine fetal/neonatal outcomes associated with SMM. MATERIALS AND METHODS: A national New Zealand (NZ) retrospective cohort study describing fetal/neonatal outcomes of all women with SMM admitted to a NZ Intensive Care Unit (ICU) or High Dependency Unit (HDU) in 2014. Adverse fetal/neonatal outcomes were defined as one or more of the following: fetal or early neonatal death, hypoxic ischaemic encephalopathy, Apgar score less than seven at five minutes, admission to Neonatal Intensive Care Unit or Special Care Baby Unit. RESULTS: There were 400 women with SMM admitted to NZ ICU/HDU units in 2014, and 395 (98.8%) had complete birth/pregnancy outcome information. Of these, 49.4% (195/395) were associated with an adverse fetal/neonatal outcome. Indigenous Maori women had a 30% higher rate of adverse fetal/neonatal outcome compared to NZ European women (63.7% and 48.9% respectively; relative risk = 1.30, 95% CI 1.04-1.64). Pre-eclampsia was associated with an adverse fetal/neonatal outcome in 67% (81/120). Perinatal-related mortality rate was 53.1 per 1000 total births compared to NZ perinatal mortality of 11.2 per 1000 total births for 2014. CONCLUSION: SMM events are associated with high rates of adverse fetal/neonatal outcomes with a higher burden of adverse events for Maori. Further research is needed to explore opportunities in maternal and neonatal care pathways to improve fetal/neonatal outcomes and address inequities.

Evaluation of guidelines for observational management of cervical intraepithelial neoplasia 2 in young women.

BACKGROUND: A high rate of regression in young women with cervical intraepithelial neoplasia grade 2 has been recorded. However, there are few prospective data by which to evaluate management guidelines. OBJECTIVE: This study evaluates the American Society for Colposcopy and Cervical Pathology recommendations for follow-up of young women with cervical intraepithelial neoplasia 2 using data created by a large prospective multicenter study of observational management. MATERIALS AND METHODS: Participants were 616 women under 25 years with biopsy-diagnosed cervical intraepithelial neoplasia 2 following a referral to colposcopy for an abnormal smear with no previous high-grade abnormality. The protocol included colposcopy, cytology, and colposcopically directed biopsy at the initial visit and at 6- and 12-month follow-ups visits, and these data were analyzed. Histology from the corresponding cervical biopsy was treated as the reference diagnostic test. For young women with cervical intraepithelial neoplasia 2, we aimed to determine the following: (1) the ability of colposcopy to identify women with cervical intraepithelial neoplasia 3 or worse at 6 months; and (2) the ability of colposcopy, cytology, and a combination of cytology and colposcopy to identify residual high-grade abnormalities at 12 months. In addition, although not specified in the guidelines, we investigated the ability of high-risk human papillomavirus positivity alone or with cytology as a co-test to identify residual high-grade abnormalities at 12 months. RESULTS: At 6 months, cervical intraepithelial neoplasia 3+ colposcopic appearance identified only 28% (95% confidence interval, 18-40%) of women diagnosed with cervical intraepithelial neoplasia 3. At 12 months, a high-grade colposcopic appearance identified only 58% (95% confidence interval, 48-68%) of women with residual histological cervical intraepithelial neoplasia 2 or 3. At 12 months, high-grade cytology identified only 58% (95% confidence interval, 48-68%) of women with cervical intraepithelial neoplasia 2 or 3. However, the combination of either high-grade cytology or colposcopic appearance proved substantially more sensitive (81%; 95% confidence interval, 72-88%). High-risk human papillomavirus positivity at 12 months was a sensitive (96%; 95% confidence interval, 89-99%) indicator of persisting high-grade histology. However, this sensitivity came at the expense of specificity (52%; 95% confidence interval, 45-58%). A co-test of high-risk human papillomavirus positivity or high-grade cytology at 12 months provided a high sensitivity (97%; 95% confidence interval, 90-99%) but low specificity (51%; 95% confidence interval, 45%-58%). CONCLUSION: Colposcopy and cytology are limited in their ability to exclude persistent high-grade abnormality for young women undergoing observational management for cervical intraepithelial neoplasia 2. We recommend biopsy for all women at 12 months. High-risk human papillomavirus positivity is a sensitive indicator of persistent abnormality and should be considered in those not having a biopsy.