Cervical Cancer Awareness Education to Aid Confidence and Screening upTake (ACT): A Pilot Randomised Control Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-64
SponsorTeesside University

About this trial

Cervical cancer remains a major threat to women's health and wellbeing, with the burden disproportionately concentrated in low- and middle-income countries such as Nigeria, where inadequate awareness, limited access to screening, screening-related anxiety, and other structural and sociocultural barriers contribute to low screening uptake, late presentation, and preventable mortality. Despite the urgent need to improve early detection, there remains a critical gap in culturally appropriate, co-produced interventions to address the barriers that shape cervical cancer screening behaviours. The proposed study will address this gap by piloting the feasibility and acceptability of "cervical cancer Awareness education to aid Confidence and screening upTake (ACT)" a novel, low-intensity, co-produced workshop intervention for women who are not up to date or only partially up to date with recommended cervical cancer screening. Delivered over approximately two hours, ACT is designed to increase awareness of cervical cancer and its symptoms, strengthen understanding of the consequences of delayed screening and the benefits of early detection, improve knowledge of available screening pathways, address misconceptions and screening-related anxiety, and build women's confidence and motivation to engage with screening services. In addition to assessing recruitment, retention, intervention engagement, acceptability and implementation feasibility, the study will pilot the proposed outcome measures and data collection procedures to inform a future definitive evaluation. It will also generate preliminary evidence on potential intervention mechanisms, screening-related outcomes, and approaches to assessing cost-effectiveness. Collectively, the study will establish whether ACT is feasible, acceptable and sufficiently promising to progress to a larger-scale trial evaluating its effectiveness and cost-effectiveness in improving cervical cancer screening uptake among women in Nigeria.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women aged between age 18 years and 64 who are not or partially up to date with cervical cancer

Able to provide full consent for their participation.

Able to speak the English Language.

Able to take part in the intervention and are available for the intervention assessment at baseline and end of intervention.

Disqualifiers

Less than 18 years

Unable to consent.

Currently undergoing severe mental health treatment. Unable to speak the English language not meeting the inclusion criteria.

Trial design

Design model

Parallel

Treatments tested in this trial

  • cervical cancer Awareness education to aid Confidence and screening upTake (ACT)

    Behavioral

    The ACT intervention is designed to raise awareness of cervical cancer, its symptoms, implications for late screening, the benefits of early screening, avenues for screening uptake, and also addressing anxiety related to screening uptake. It will also address screening related fear. The ACT intervention is low-intensity and lasts approximately two hours. Other Name:

  • Control group

    Other intervention

    Existing information provided by health care provider, including media around prostate cancer.

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: cervical cancer Awareness education to aid Confidence and screening upTake (ACT)Experimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Service Satisfaction Scale

A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention. Higher score denote positive outcomes and acceptability. Lower score denotes poor satisfaction and acceptability.

Time frame
[At the end of intervention (day 2)]

Secondary outcomes

1

Generalised Anxiety Disorder (GAD-7)

The GAD-7 is a seven item scale for screening, measuring and assessing the severity of generalised anxiety disorder. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.

Time frame
Baseline (day 1) and at the end of intervention (day 2)
2

Oslo Social Support Scale (OSSS-3)

The scale is a 3-item self-reported measure designed for assessing and measuring the level of social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support as indicated as follows: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support.

Time frame
Baseline (day 1) and at the end of intervention (day 2)
3

European Quality of Life Scale EQ-5D-5L

The EQ-5D-5L is a 5 item scale designed to aid assessment of the generic quality of life. In the EQ-5D-5L, each dimension has five response levels: no problems (Level 1); slight (Level 2); moderate (Level 3); severe (Level 4); and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).

Time frame
Baseline (day 1) and at the end of intervention (day 2)
4

Beliefs around cervical cancer and screening intention scale

A 8-item scale that measure beliefs around cervical cancer, knowledge and intention to engage in screening. Score range from 0-40 with higher score denoting knowledge and strong willingness to engage in early screening uptake.

Time frame
Baseline (day 1) and at the end of intervention (day 2)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Teesside University

Lead sponsor

University of Manchester

Collaborator

Jos University Teaching Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: