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Impact of one and two human papillomavirus (HPV) vaccine doses on community-level HPV prevalence in South African adolescent girls: study protocol and rationale for a pragmatic before-after design

Por: Machalek · D. · Rees · H. · Chikandiwa · A. · Munthali · R. · Travill · D. · Mbulawa · Z. · Petoumenos · K. · Delany-Moretlwe · S. · Kaldor · J. · On behalf of the HOPE Study team
Introduction

Vaccines against human papillomavirus (HPV) are the key to controlling cervical cancer in low/middle-income countries (LMICs) where incidence is highest, but there have been limited data from these settings on programme impact on HPV prevalence, and none in a population with endemic HIV infection. Furthermore, for many LMICs, the currently recommended two-dose schedule is difficult to deliver at scale, so there is mounting interest in a single-dose schedule.

Methods and analysis

The Human Papillomavirus One and Two-Dose Population Effectiveness Study is a hybrid impact evaluation of the national South African HPV vaccination programme, which has targeted grade 4 girls aged at least 9 years in public schools with two doses of vaccine since 2014, and a single-dose vaccine ‘catch-up’ programme delivered in one district in 2019. Impacts of both schedules on the prevalence of type-specific HPV infection will be measured using repeat cross-sectional surveys in adolescent girls and young women aged 17–18 years recruited at primary healthcare clinics in the four provinces. A baseline survey in 2019 measured HPV prevalence in the cohort who were ineligible for vaccination because they were already above the target age or grade under either the national programme or the single-dose programme in the selected district. HPV prevalence surveys are repeated in 2021 in the selected district, and in 2023 in all four provinces. We will calculate prevalence ratios to compare the prevalence of HPV types 16 and 18 in the single-dose (2021) and two-dose (2023) cohorts, with the vaccine-ineligible (2019) cohort.

Ethics and dissemination

The project was approved by the University of the Witwatersrand Human Research Ethics Committee (HREC #181005), and the University of New South Wales HREC (#181-005). Findings will be disseminated through peer-reviewed journals, scientific meetings, reports and community forums.

Model of delivery of cancer care in South Africas Eastern Cape and Mpumalanga provinces: a situational analysis protocol

Por: Chitha · W. · Swartbooi · B. · Jafta · Z. · Funani · I. · Maake · K. · Hongoro · D. · Godlimpi · L. · Mnyaka · O. R. · Williams · N. · Buthi · L. · Kuseni · S. · Zungu · C. · Sibulawa · S. · Mavimbela · A. · Giwu · O. · Mabunda · S. A. · Essel · V.
Introduction

Cancer contributes to a significant proportion of morbidity and mortality globally. Low-income and middle-income countries such as South Africa tend to be characterised by poor and inequitable access to cancer services. Cancer resources are more likely to be found in urban areas, tertiary centres and quaternary hospitals. However, little is known about the linkages to care, continuity of care and packages of cancer care in rural South African settings. This study describes cancer service delivery for South Africa’s Eastern Cape and Mpumalanga provinces.

Methods and analysis

A mixed-methods qualitative and quantitative research methods of three substudies which include semistructured interviews with patients, focus group discussions with health providers and a quantitative record review that will be carried out at both Rob Ferreira hospital, Witbank hospital and Nelson Mandela Academic hospital in Mpumalanga and Eastern Cape province, respectively. Instruments assess demographic characteristics, explore packages of cancer care, explore challenges experienced by health professionals, and maps out the referral pathway of patients with a cancer diagnosis in the study sites. Numerical, quantitative data will be explored for normality using the Shapiro-Wilk test and reported using either the mean, SD and range or the median and IQR depending on the normality of the distribution. Qualitative data will be analysed using the phenomenological approach.

Ethics and dissemination

Ethics approval was obtained from the Human Research Ethics Committee of Walter Sisulu University (040/2020) and the University of the Witwatersrand (M210211), South Africa. To the research team’s knowledge, this is the first study presenting the model of cancer delivery in South Africa’s Eastern Cape and Mpumalanga province. This will thus provide better understanding of cancer service delivery systems, packages of cancer care from primary care to quaternary care.

Practices and trends in clinical trial registration in the Pan African Clinical Trials Registry (PACTR): a descriptive analysis of registration data

Por: Ndwandwe · D. E. · Runeyi · S. · Pienaar · E. · Mathebula · L. · Hohlfeld · A. · Wiysonge · C. S.
Background

The Pan African Clinical Trials Registry (PACTR) is a WHO International Clinical Trials Registry Platform primary register, which caters for clinical trials conducted in Africa. PACTR is the first and, at present, the only member of the Network of WHO Primary Registers in Africa. The aim is to describe and report on the trends of trial records registered in PACTR.

Methods

PACTR was established in 2007 as the AIDS, Tuberculosis, and Malaria Clinical Trials Registry. The scope of the registry was then expanded in 2009 to include all diseases. This is a cross-sectional study of trials registered in PACTR from inception to 18 August 2021. A descriptive analysis of the use and trends of the following data fields: study intervention, disease condition, sex of the participants, sample size, ethics, funding and availability of results was conducted using Microsoft Excel.

Results

The number of trials registered has increased year on year, reaching 606 trials registered in 2020. The total number of trials registered at the time of the analysis was 2998. More than half of the trials in the registry (1655 of 2998, ie, 55%) were prospectively registered. Ethical approval was received by 90% (2691 of 2998) of the registered trials. Factorial assignment as an intervention model was in 20% (589 of 2998) of the trials registered. There were 36% (1083 of 2998) completed trials, of which 3% (94 of 1083) had results available in the registry. The most dominant funding source indicated was self-funding in 23% (693 of 2998) of the registered trials, and 55% (1639 of 2998) had no funding.

Conclusion

Registration on PACTR continues to grow; however, our analysis shows that researchers’ capacity-building is needed to understand the importance of the registry and how this information informs healthcare decisions. Promoting prospective trial registration remains critical to avoid selective reporting bias to inform research gaps.

Barriers to follow-up after an abnormal cervical cancer screening result and the role of male partners: a qualitative study

Por: Chapola · J. · Lee · F. · Bula · A. · Mapanje · C. · Phiri · B. R. · Kamtuwange · N. · Tsidya · M. · Tang · J. H. · Chinula · L.
Introduction

Cervical cancer is the leading cause of cancer deaths among women in Malawi, but preventable through screening. Malawi primarily uses visual inspection with acetic acid (VIA) for screening, however, a follow-up for positive screening results remains a major barrier, in rural areas. We interviewed women who underwent a community-based screen-and-treat campaign that offered same-day treatment with thermocoagulation, a heat-based ablative procedure for VIA-positive lesions, to understand the barriers in accessing post-treatment follow-up and the role of male partners in contributing to, or overcoming these barriers.

Methods

We conducted in-depths interviews with 17 women recruited in a pilot study that evaluated the safety and acceptability of community-based screen-and-treat programme using VIA and thermocoagulation for cervical cancer prevention in rural Lilongwe, Malawi. Ten of the women interviewed presented for post-treatment follow-up at the healthcare facility and seven did not. The interviews were analysed for thematic content surrounding barriers for attending for follow-up and role of male partners in screening.

Results

Transportation was identified as a major barrier to post-thermocoagulation follow-up appointment, given long distances to the healthcare facility. Male partners were perceived as both a barrier for some, that is, not supportive of 6-week post-thermocoagulation abstinence recommendation, and as an important source of support for others, that is, encouraging follow-up attendance, providing emotional support to maintaining post-treatment abstinence and as a resource in overcoming transportation barriers. Regardless, the majority of women desired more male partner involvement in cervical cancer screening.

Conclusion

Despite access to same-day treatment, long travel distances to health facilities for post-treatment follow-up visits remained a major barrier for women in rural Lilongwe. Male partners were identified both as a barrier to, and an important source of support for accessing and completing the screen-and-treat programme. To successfully eliminate cervical cancer in Malawi, it is imperative to understand the day-to-day barriers women face in accessing preventative care.

The Effect of Distraction Cards on Reducing Pain and Anxiety During Intramuscular Injection in Children

Abstract

Aim

The aim of the present study was to evaluate the effectiveness of distraction cards in reducing pain and anxiety during intramuscular (IM) injection in children aged between 6 and 11 years.

Methods

Sixty children were randomized into two groups, the distraction group and controls. The children in the distraction group viewed distraction cards during the procedure. The children in the control group were allowed to have their family nearby when the routine injection procedure was performed, but no distraction techniques were employed. Children's Fear Scale was used to assess children's anxiety levels. Pain levels were assessed using the Wong‐Baker FACES pain rating scale via self‐reports, which were completed by the children and also by the parents and observer.

Results

There were significant differences in the self‐, parent‐, and observer‐reported pain and parent‐ and observer‐reported anxiety levels between the distraction and control groups.

Linking Evidence to Action

Distraction methods, such as distraction cards, should be used as a nursing intervention to reduce pain and anxiety during IM injection in children. This study contributes to the literature on nonpharmacologic pain relief methods during IM injection in children.

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