Barriers to vaccination decision in north-eastern Nigeria.
| ISRCTN | ISRCTN95083356 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95083356 |
| Secondary identifying numbers | HUM00063832 |
- Submission date
- 18/02/2019
- Registration date
- 19/02/2019
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Despite the huge benefits of preventing diseases at low cost, the persistent low vaccine take-up remains hard to explain. The relevance of psychological factors as barriers to vaccination has been commonly documented in Africa, without rigorous evidence. This study conducts a field experiment explicitly designed to evaluate psychic and monetary costs as potential barriers to tetanus vaccine take-up among women of childbearing age in 80 villages in Adamawa state, in rural Nigeria.
Who can participate?
Women aged 15 to 35 and had not received a tetanus vaccine less than six months prior to the baseline survey.
What does the study involve?
We have three interventions; 1) condition under which a respondent can receive the cash incentives (clinic visit s. clinic visit + vaccination), 2) amount of cash incentives (low, middle, and high), and 3) priming intervention (control flipcharts vs. " scared-straight" intervention)
What are the possible benefits and risks of participating?
The possible benefits include the tetanus-toxoid vaccination and cash incentives. Through receiving the tetanus-toxoid vaccination, they can be protected against tetanus. If the respondents are pregnant, vaccination can also protect their new-born baby from neonatal tetanus.
There are side effects of the tetanus-toxoid vaccination such as swelling of the body part of the injection, fever, and headache. However, these side effects are expected to be at minimal.
Where is the study run from?
This is a single-site study. We cover 10 health clinics which covers 80 villages in Jada local government areas in Adamawa state, Nigeria. The lead center is Adamawa Primary Healthcare Development Agency based in Yola, the capital city of Adamawa state.
When is the study starting and how long is it expected to run for?
March 2013 to August 2013
Who is funding the study?
This project was supported with research grants from the Institute for Research on Women & Gender, the Rackham Graduate School, the Department of Afroamerican and African Studies, the Department of Economics, and the Center for the Education of Women at the University of Michigan; the Japan Society for the Promotion of Science; and Yamada Scholarship Foundation.
Who is the main contact?
Ryoko Sato, rsato@hsph.harvard.edu
This study evaluates the relative importance of psychic costs of vaccination compared to monetary costs through a field experiment that randomizes several factors affecting tetanus vaccine take-up among women in rural Nigeria. We conducted our study in 80 villages in Adamawa state, which is in the northeastern region of Nigeria.
To capture monetary costs as potential barriers to vaccination, we randomized the amount of cash incentives provided to women whose condition was simply to attend a clinic. To capture psychic costs of vaccination as potential barriers, we gave a group of women their cash incentives with the additional condition of receiving a vaccine at the clinic. Because the only difference between these two conditions is whether or not a woman was is required to receive a vaccine for cash rewards upon arrival at the clinic, the difference in clinic attendance between these two groups captures the psychic costs of vaccination. Furthermore, if those women whose condition for cash provision was clinic attendance refused to take the vaccine after showing up at the clinic, this is directly attributed to the psychic costs of vaccination.
Finally, to examine the effect of priming on vaccination, we randomized a disease message: either a “scared-straight” message, which emphasizes the severity of tetanus, or a control message, which provides the same information on tetanus without emphasis on the severity of the disease.
Contact information
Scientific
161 S. Huntington Ave
APT 218
Boston
02130
United States of America
 ORCID ID |
0000-0001-7040-317X |
|---|---|
| Phone | 2022905064 |
| rsato@hsph.harvard.edu |
Study information
| Study design | Interventional single-centre study randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | None available |
| Scientific title | Psychic vs. Economic Barriers to Vaccine Take-up: a Field Experiment in Nigeria in Northeastern Nigeria |
| Study objectives | It is expected that psychological factors are major barriers to vaccination, and that cash incentive and emphasizing the severity of the disease increase vaccine take-up |
| Ethics approval(s) | Approved 09/11/2012, University of Michigan Health Sciences and Behavioral Sciences Institutional Review Board (2800 Plymouth Road, Bldg. 520, Rm. 1169, Ann Arbor, MI 48109-2800; +1 (734) 936-0933; irbhsbs@umich.edu), ref: HUM00063832 |
| Health condition(s) or problem(s) studied | We studied the uptake of tetanus-toxoid vaccine. |
| Intervention | To capture monetary costs as potential barriers to vaccination, we randomly chose the amount of cash incentives provided to women whose condition was simply to attend a clinic. To capture psychic costs of vaccination as potential barriers, we gave another group of women their cash incentives with the additional requirement of receiving a vaccine at the clinic. As the only difference between these two conditions is whether or not a woman was is required to receive a vaccine for cash rewards upon arrival at the clinic, the difference in clinic attendance between these two groups captures the psychic costs of vaccination. Furthermore, if those women whose condition for cash provision was clinic attendance refused to take the vaccine after showing up at the clinic, this is directly attributed to the psychic costs of vaccination. Finally, to examine the effect of priming on vaccination, we randomized a disease message: either a “scared-straight” message, which emphasizes the severity of tetanus, or a control message, which provides the same information on tetanus without emphasis on the severity of the disease. There were 9 groups in the study: group 1) clinic visit condition + control flipcharts + 5 naira group 2) clinic visit condition + control flipcharts + 300 naira group 3) clinic visit condition + control flipcharts + 800 naira group 4) vaccination condition + control flipcharts + 5 naira group 5) vaccination condition + control flipcharts + 300 naira group 6) vaccination condition + control flipcharts + 800 naira group 7) vaccination condition + scared-straight flipcharts + 5 naira group 8) vaccination condition + scared-straight flipcharts + 300 naira group 9) vaccination condition + scared-straight flipcharts + 800 naira Participants were randomised into groups upon enrollment. Baseline survey forms contained randomisation information in the middle page: interviewers randomly picked one of the baseline survey forms (without looking at the middle page) and initiated the baseline interview. |
| Intervention type | Behavioural |
| Primary outcome measure | The primary outcome is the take-up of the tetanus-toxoid vaccination measured by observation at health clinics. |
| Secondary outcome measures | The risk perception is measured by interview at baseline and at follow-up survey (right after the intervention). |
| Overall study start date | 01/01/2012 |
| Completion date | 31/07/2013 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 2500 |
| Total final enrolment | 1660 |
| Key inclusion criteria | Female, between the ages of 15 and 35 |
| Key exclusion criteria | Received the tetanus-toxoid vaccine within 6 months prior to the study |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 31/03/2013 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Jimeta
NA
Nigeria
Sponsor information
University/education
540 East Liberty Street, Suite 202
Ann Arbor
48104
United States of America
| Phone | +1 734 9360933 |
|---|---|
| irbhsbs@umich.edu | |
"ROR" |
https://ror.org/00jmfr291 |
Funders
Funder type
Research organisation
Government organisation / National government
- Alternative name(s)
- KAKENHI, 日本学術振興会, Gakushin, JSPS KAKEN, JSPS Grants-in-Aid for Scientific Research, JSPS
- Location
- Japan
Government organisation / Universities (academic only)
- Alternative name(s)
- Department of Afroamerican and African Studies, UM Department of Afroamerican and African Studies, U-M Department of Afroamerican and African Studies, DAAS, DAAS, UM
- Location
- United States of America
Government organisation / Universities (academic only)
- Alternative name(s)
- Institute for Research on Women and Gender, Institute for Research on Women & Gender, University of Michigan, IRWG
- Location
- United States of America
Government organisation / Universities (academic only)
- Alternative name(s)
- Rackham Graduate School, Rackham U-M
- Location
- United States of America
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/04/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | We intend to publish the results of the trial in public health journals, upon completion of the data analysis. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the sensitive and identifiable nature of the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/12/2020 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
