Development, Implementation, and Evaluation of a National Cross-generational Strategy to Support Introduction of the Human Papillomavirus (HPV) Vaccine and Utilization of Cervical Cancer Screening in Nepal

Last registered on February 07, 2023

Pre-Trial

General Information

Title

RCT ID

AEARCTR-0010896

Initial registration date

January 31, 2023

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published

February 07, 2023, 11:22 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Name

Linda Kaljee

Affiliation

Henry Ford Health, Global Health Initiative

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Other Primary Investigator(s)

PI Name

Seema Joshi

PI Affiliation

Henry Ford Health, Division of Infectious Disease

Contact Investigator

PI Name

Bibek Kumar Lal

PI Affiliation

Nepal Ministry of Health and Population

Contact Investigator

PI Name

Deepak Bajracharya

PI Affiliation

Group for Technical Assistance

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Additional Trial Information

Status

In development

Start date

2023-02-08

End date

2024-12-31

Keywords

Behavior, Education, Health

Additional Keywords

sexual and reproductive health, outreach and communication

JEL code(s)

Secondary IDs

Prior work

This trial does not extend or rely on any prior RCTs.

Abstract

Since the approval and introduction of human papillomavirus (HPV) vaccines in 2006, the burden of new cervical cancer cases has steadily grown in low- and middle-income countries (LMIC). A 2016 study estimated that only 1% of women receiving the HPV vaccine worldwide were from LMICs and that as of 2020, the majority of the 604,000 new cervical cancer cases in the world occurred in LMICs. At this time, the Nepal Ministry of Health and Population (MOHP), Family Welfare Division is planning to apply to GAVI in September 2022 to initiate the introduction of HPV into the national immunization plan. It is anticipated that in mid-to-late 2023 HPV introduction will start in 8 to 12 districts and then move to national coverage.

In Nepal, cervical cancer is the most frequently diagnosed cancer among women and contributes to the highest number of cancer-related mortalities in the country. Limited data are available regarding women’s utilization of cervical cancer screening in Nepal, however one study suggests that only 15% of women surveyed had been screened. The Nepal government has prioritized cervical cancer screening as a free-of-cost priority program; however, multiple socio-cultural and economic factors affect screening including lack of knowledge about cervical cancer both within the healthcare professions and general population, social taboos regarding discussion of sexual and reproductive health, and limited laboratory facilities.

The proposed study is designed to adapt/develop a context-driven strategy to decrease risks of HPV infection and cervical cancer in Nepal through an integrated vaccination and cervical cancer screening campaign. The program will implement a cross-generational approach to encourage vaccination of young girls and screening of their mothers, aunts, grandmothers and other women in the communities. The key objectives are: 1) Assess policy and programmatic, health system, and community factors that affect intention to uptake HPV vaccines for girls ages 9 to 14 and use of cervical cancer screening services among women 30 to 60 years old. 2) Utilize data to adapt/develop: i) a healthcare provider training program in relation to HPV vaccine and cervical cancer screening; and, ii) a cross-generational comprehensive social mobilization and communication strategy to support HPV vaccine uptake and cervical cancer screening. 3) Implement and conduct a randomized control trial of the healthcare provider and community interventions during the initial roll out of HPV vaccines in selected districts. 4) Engage with policy makers, program managers, health care providers and community members (parents/adolescents) through scientific and community advisory boards (SAB/CABs) and a post-project dissemination workshop

External Link(s)

Registration Citation

Citation

Bajracharya, Deepak et al. 2023. "Development, Implementation, and Evaluation of a National Cross-generational Strategy to Support Introduction of the Human Papillomavirus (HPV) Vaccine and Utilization of Cervical Cancer Screening in Nepal ." AEA RCT Registry. February 07. https://doi.org/10.1257/rct.10896-1.0

Sponsors & Partners

Experimental Details

Interventions

Intervention(s)

Adaptation/development of interventions including training for healthcare providers and a cross-generational community social mobilization and communication strategy focused on HPV uptake and use of cervical cancer screening services.
The research team will review existing healthcare provider trainings focused on HPV vaccines and cervical cancer screening from the MOHP and other organizations (e.g., WHO) in Nepal, as well as other relevant materials/trainings available within the scientific literature that may be adaptable for use. In terms of the latter, we will focus on programs that have been evaluated and shown to be effective in terms of HPV vaccine awareness, uptake, and/or use of cervical cancer screening.
For the community programs, we will utilize a literature review of community interventions to increase uptake of HPV vaccine and/or cervical cancer screening. We will focus on evidence-based interventions and those implemented in LMIC and the South/Southeast Asian region. Our initial review of the literature suggests some of the following approaches and intervention characteristics that could be adapted for our cross-generational strategy.

1. Social mobilization models across generations.
2. Utilization of trusted community leaders and healthcare providers. As previously noted, healthcare providers were the most trusted sources of information about the COVID-19 vaccine in our hesitancy study in Nepal. Engagement of schools and educators has also been a successful approach in delivering information about HPV vaccines.
3. Focus on HPV vaccines as a means of cancer prevention.
4. Use of social media to provide information about the HPV vaccine. In our COVID-19 vaccine study, 96% and 85% of 18-to-30-year-olds and 31-to-59-year-olds respondents reported using Facebook.
5. Offering different options for cervical cancer screening – in particular, for self-sample collection.
6. Regular contact and reminders from clinic staff to women who have missed an appointment or are due for a screening.

Intervention Start Date

2023-04-01

Intervention End Date

2023-07-01

Primary Outcomes

Primary Outcomes (end points)

The primary outcome variable will be likelihood to report discussions about HPV vaccines and cervical cancer screening with patients/parents of patients.
Additional variables will include: 1) knowledge and awareness of HPV, HPV vaccine, cervical cancer, and cervical cancer screening; 2) perceptions of disease severity and patients’ vulnerability to HPV/cervical cancer; and, 3) perceptions of support at the health facility and through the health system to facilitate HPV vaccine administration and cervical cancer services; and, 4) vaccine hesitancy constructs (confidence, convenience, complacency)

Parents:
The primary outcome variables will be intention to have their daughter receive the HPV vaccine once available within their district and use of available cervical cancer screening services/intention to use cervical cancer screening services.
Additional variables will include: 1) knowledge and awareness of HPV, HPV vaccine, cervical cancer and cervical cancer screening; 2) utilization of other vaccines (e.g., EPI); 3) utilization of reproductive sexual health services (e.g., pre-natal care, trained birth assistance); and 4) vaccine hesitancy constructs

The primary outcome variable will be willingness to receive the HPV vaccine once available within their district.
Additional variables will include: 1) knowledge and awareness of HPV, HPV vaccine and cervical cancer; 2) experience with receiving other vaccines and concerns about receiving vaccines (e.g., fear of needles); 3) perceptions of severity of HPV and cervical cancer; 4) perceptions of likelihood of being infected with HPV/being diagnosed with cervical cancer later in life

Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)

Secondary Outcomes (explanation)

Experimental Design

The study is a RCT including randomization of 4 study sites into intervention (2) and control (2). Evaluation of the intervention will include a baseline survey and a six-month post intervention survey. The study population includes healthcare workers, parents of girls 9 to 14 years, and their daughters (9 to 14 years).

Experimental Design Details

Not available

Randomization Method

Randomization will be conducted prior to collection of the baseline data (Phase 1, Assessment). From the 8 to 12 districts which will be part of the initial HPV vaccine roll out, we will stratify by characteristics (e.g., rural/urban, province, population characteristics). Once stratified, we will randomly select 2 urban and 2 rural districts. We will then randomly select 1 urban and 1 rural district as the intervention arm and 1 urban and 1 rural as control. Within these districts we will randomly select 4 study wards per district (total 16 wards). The parent/guardian-daughter dyads will be randomly selected from municipality/ward offices, primary care clinics, and school rosters. Lists of potential participants will be put into a SPSS file and the software randomization process will be used to select participants by ward. The sample size is 60 dyads/ward (see Section 2.7 Sample Size calculation). To address refusals and potential attrition between baseline and post-intervention, we will increase the initial sample by 20% (N=72).

Randomization Unit

There are two levels of randomization. Randomization of study 16 wards into control (8) / intervention (8). Within each study ward, parent-daughter dyads will be randomly selected to participate in the evaluation.

Was the treatment clustered?

Yes

Experiment Characteristics

Sample size: planned number of clusters

16 study wards in 4 districts

Sample size: planned number of observations

960 parent-daughter dyads

Sample size (or number of clusters) by treatment arms

8 wards per arm and 480 parent-daughter dyads per arm

Minimum detectable effect size for main outcomes (accounting for sample design and clustering)

We will utilize 4 districts randomly assigned to the intervention arm (1 rural/1 urban) and the control arm (1 rural/1 urban) In each of the districts, we will sample individuals in 4 wards for a total of 8 wards in each arm. A sample of 60 parent/guardian-daughter dyads will be selected at random from each ward. This will result in a total sample size of 480 individuals per arm. The initial analyses will examine the data for differences between groups at baseline and after the intervention using a Chi-squared test. This test will have 90% power to detect a small effect size with 480 per group and a two-sided 0.05 alpha value. This effect size is equivalent to detecting a difference in proportions from .3 to .4 or from .6 to .7. This is the same as detecting an odds ratio of 1.56. For example, with the parent survey, this would represent the difference in intention to vaccinate between the intervention and control arms. It will also be of interest to examine each group individually to assess the change in intention to vaccinate across time with a McNemar’s test. This test, with 480 subjects and a two-sided 0.05 alpha value, will have 90% power to detect a change in rates of 10 percentage points. This assumes that the percent of discordant pairs will be at most 45%. An estimate of change will be estimated for each of the 8 wards in each group. We anticipate a difference in the means of the two groups of 0.1 and a standard deviation of 0.05. The t-test will have greater than 90% power, with a two-sided 0.05 alpha value, to detect this difference.

Supporting Documents and Materials

IRB

Institutional Review Boards (IRBs)

IRB Name

IRB Approval Date

IRB Approval Number

Analysis Plan