Assessing the effect of informative photo referral cards on eye care access in Kwale County, Kenya
| ISRCTN | ISRCTN16836952 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16836952 |
| Sponsor | London School of Hygiene & Tropical Medicine |
| Funders | Wellcome Trust, National Institute for Health and Care Research |
- Submission date
- 25/11/2025
- Registration date
- 19/12/2025
- Last edited
- 09/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
The Vision Impact Project (VIP) is a community eye health programme in Kenya. Previous research showed that many people referred for eye care do not attend the outreach clinics, especially younger men. This study aims to find out if giving people a referral card with their photo and clinic details can help more people attend. The card will include information about services, costs, opening hours, and contact details. If this works, it could improve access to eye care and guide future programmes.
Who can participate?
Adults in Kenya who have eye problems and are referred to local outreach clinics can take part.
What does the study involve?
Everyone in the study will receive counselling and text reminders after being referred. Some participants will also get a referral card with their photo and clinic information. Others will not receive the card. We will then check who attends the clinic.
What are the possible benefits and risks of participating?
The main benefit is that participants may find it easier to attend the clinic and get the eye care they need. There are no known risks from taking part.
Where is the study run from?
The study is run by the London School of Hygiene & Tropical Medicine in partnership with local teams in Kenya.
When is the study starting and how long is it expected to run for?
The study started in September 2025 and will run until March 2026.
Who is funding the study?
The study is funded by the Wellcome Trust and the National Institute for Health and Care Research (UK).
Who is the main contact?
Sarah Karanja, skaranja@kemri.go.ke
Prof Andrew Bastawrous, andrew.bastawrous@lshtm.ac.uk
Dr Malebogo Tlhajoanne, malebogo.tlhajoane@lshtm.ac.uk
Contact information
Scientific
KNH area, Hospital Road
Centre for Public Health Research
Nairobi
P.O. BOX 20752-00202
Kenya
 ORCID ID |
0000-0001-5275-5534 |
|---|---|
| Phone | + 254 (0) 754 232 232 |
| Skaranja@kemri.go.ke |
Principal investigator
International Centre for Eye Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| ORCID ID |
0000-0001-8179-556X |
|---|---|
| Phone | +44 (0) 20 7958 8315 |
| andrew.bastawrous@lshtm.ac.uk |
Public
International Centre for Eye Health
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0) 20 7958 8315 |
|---|---|
| malebogo.tlhajoane@lshtm.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | 48560_PIS_v3.0_05Aug2025.pdf |
| Scientific title | Assessing the effect of informative photo referral cards on access to eye care services within a community-based program in Kwale county: a randomized controlled trial |
| Study objectives | Primary objective: To assess whether informative photo referral cards improve attendance rates among left-behind groups (18-34 year-olds) compared with the standard of care in the Vision Impact Project screening programme in Kwale County Secondary objective: To assess whether informative photo referral cards improve attendance for individuals over 35 years old. compared with the standard of care in the Vision Impact Project screening programme in Kwale County. |
| Ethics approval(s) |
1. Approved 25/08/2025, KEMRI Scientific and Ethics Review Unit (SERU) (Off Raila Odinga road, Nairobi, 54840-00200, Kenya; +254 717 719 477; seru@kemri.go.ke), ref: SERU 5200 2. Approved 08/09/2025, London School of Hygiene and Tropical Medicine (LSHTM) ethics (Keppel Street, London, WC1E 7HT, United Kingdom; +44 (0)20 7927 2221; ethics@lshtm.ac.uk), ref: 29549 ‑ 5 |
| Health condition(s) or problem(s) studied | Eye problems identified by community-based screeners using the Peek Vision screening app. |
| Intervention | Randomisation process: We will use computer-generated random numbers to determine the allocation sequence, ensuring that all consented and referred participants are evenly distributed across the intervention groups. A simple algorithm integrated into the Peek app will perform this function when the screener indicates in the Peek Capture app that a patient requires a referral. When the random allocation algorithm within the Peek app assigns a patient to the intervention arm, the Peek app will display a notice to the screener that reads, ‘Photo’, indicating that the screener should take a photo of the participant, print it, and attach it to the referral card, then provide the informative photo referral card to the participant. The control arm will not receive the card. Both groups will receive the usual counselling at the point of referral, along with SMS reminders on the day of the referral, the day before the appointment, and on the day of the appointment. 1. Intervention arm: Participants will receive an informative photo referral card at the point of referral. The intervention was developed based on feedback from individuals who were referred to an outreach treatment clinic but were unable to attend. During interviews with 41 non-attenders from a left-behind group, 19 different suggestions for modifying services were identified. We then asked 399 additional non-attenders from the same group to rate these suggestions on a three-point Likert scale, indicating how likely each suggestion was to make a difference, ranging from "likely to make a large difference" to "likely to make a small/no difference." The top-ranked suggestions were discussed in a workshop that included representatives from the Kwale Eye Center, Christian Blind Mission, the county health management team, the community advisory board, and the Ministry of Health ophthalmic services unit. This group unanimously agreed to implement and test the informative photo referral card intervention. This card contains essential information, including the participant's details, appointment date, the importance of attending the clinic, available services, associated costs, and the clinic's opening hours. Additionally, it features a photo of the participant, which is taken using a project smartphone. The image is printed using a wireless mobile photo printer connected to the smartphone via Bluetooth and is attached to the referral card. Once printed, the photo is deleted from the device to ensure privacy. 2. Control arm: Participants will receive usual care, which involves counselling at the point of referral and SMS reminders. Total duration: Single exposure (informative photo referral card) at the point of referral. Follow-up duration: Depends on the appointment date (xx days post-referral for all arms, measuring clinic attendance) When a participant is referred, it is recorded within the Peek app and stored in the central database (which holds records of each participant’s eye care needs and sociodemographic characteristics) alongside their ophthalmic outreach clinic appointment date and the trial arm to which they have been allocated. When referred participants check in at ophthalmic outreach clinics, administrative staff record their attendance status in the Peek app, which automatically updates a central database. Once a participant's clinic appointment date has passed, their outcome status is set to indicate whether they attended. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/03/2026 |
Eligibility
| Participant type(s) | Patient, Service user |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 17280 |
| Key inclusion criteria | 1. 18 years or older 2. Willing to participate in the trial |
| Key exclusion criteria | 1. Lack of intention to stay in the study area for at least one month |
| Date of first enrolment | 16/09/2025 |
| Date of final enrolment | 31/12/2025 |
Locations
Countries of recruitment
- Kenya
Study participating centres
Nairobi
P.O. Box 54840 00200
Kenya
Kwale
P.O. BOX 901 - 80100
Kenya
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Stored in non-publicly available repository |
| IPD sharing plan | The data set generated in this study will be stored in non-publicly available repository. Summary data will be published in a journal article. Further anonymous data will be available upon request from Sarah Karanja at Skaranja@kemri.go.ke |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3.0 | 05/08/2025 | 09/12/2025 | No | Yes |
| Protocol file | version 3.0 | 05/08/2025 | 09/12/2025 | No | No |
Additional files
- 48560_PIS_v3.0_05Aug2025.pdf
- Participant information sheet
- 48560_Protocol_v3.0_05Aug2025.pdf
- Protocol file
Editorial Notes
09/12/2025: Study’s existence confirmed by the Scientific and Ethics Review Unit (SERU), Kenya Medical Research Institute (KEMRI), Office of the Director, Research & Development, Kenya.
