NCT04783077

Brief Summary

DESIGN This pilot study utilizes a mixed-methods approach to develop a novel docu- drama communication strategy, design WhatsApp intervention, evaluate the feasibility of a larger pragmatic randomized controlled trial (RCT) of the two communication strategies and assess acceptability of the communication strategies aimed to increase blood donation among first-time blood donors within the catchment areas of the Southern Zonal Blood Centre (SZBC) in Ghana. In sequence, this pilot study and larger RCT are grounded in the PRECEDE-PROCEED implementation science framework. The pilot study has four components: 1) a qualitative component will be used to design a docu-drama, 2) key informant interviews to guide intervention development, 3) a simultaneous randomized pilot trial will evaluate the feasibility of the larger trial design of communication interventions using WhatsApp compared to control, and 4) a final mixed- methods (quantitative survey and focus groups) assessment of participant views of acceptability, effectiveness, feasibility and cultural appropriateness of the two proposed communication interventions. OBJECTIVES The three objectives of this pilot study are the careful design of a novel docu- drama communication intervention and WhatsApp intervention, evaluation of the feasibility of a larger RCT of communication strategies, and assessment of participant views of the two proposed communication interventions and control among first time blood donors within the catchment areas of the SZBC. For the purposes of registration for clinicaltrials.gov only the randomized pilot trial communication interventions using WhatsApp compared to control is reported. The planned sample size for the pilot RCT is n=128 first-time blood donors. The study population for the pilot RCT is first-time voluntary non-remunerated blood donors (VNRBD) and family/replacement blood donors (FRD) from the SZBC catchment area. REGIMEN WhatsApp: Participants assigned to the WhatsApp group will receive weekly messages developed by communication specialists aimed to motivate blood donation, be encouraged to discuss their blood donation experiences, and share their own motivations for donating blood in a moderated, closed group over a six-month duration. The moderator will provide guidelines on acceptable use of WhatsApp in the group, including images they can or cannot share. Participants will also receive standard NBSG communications for first-time donors. Control: Participants in this group will receive the standard NBSG communications for first-time donors: 1) a thank you phone call and 2) and a reminder phone call two-weeks prior to the second blood donation eligibility. The second blood donation eligibility is four months after the first donation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

November 2, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
4 months until next milestone

Results Posted

Study results publicly available

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

February 26, 2021

Results QC Date

October 16, 2023

Last Update Submit

January 9, 2024

Conditions

Blood Donors

Keywords

Blood donation

Outcome Measures

Primary Outcomes (1)

  • Donation Attempt

    Blood donation attempt at any time during follow-up. The planned follow-up (i.e., final assessment) was at 6-months and 2 weeks from randomization. However, the local protocol IRB approval lapsed between 25 April 2022 and 23 May 2022 during which time participants were unable to receive WhatsApp messaging. In response, the final follow-up window was extended by 34 days for all participants, so the participants in the WhatsApp arm would receive all planned messages.

    6 Months and 34 days

Study Arms (5)

FRD Control

ACTIVE COMPARATOR
Behavioral: Control

VNRBD Control

ACTIVE COMPARATOR
Behavioral: Control

FRD WhatsApp

EXPERIMENTAL
Behavioral: WhatsApp

VNRBD WhatsApp

EXPERIMENTAL
Behavioral: WhatsApp

Docudrama

EXPERIMENTAL
Behavioral: Docudrama

Interventions

WhatsAppBEHAVIORAL

Participants assigned to the WhatsApp group will receive weekly messages developed by communication specialists aimed to motivate blood donation, be encouraged to discuss their blood donation experiences, and share their own motivations for donating blood in a moderated, closed group over a six-month duration. The moderator will provide guidelines on acceptable use of WhatsApp in the group, including images they can or cannot share. Participants will also receive standard NBSG communications for first-time donors.

FRD WhatsAppVNRBD WhatsApp
ControlBEHAVIORAL

Participants in this group will receive the standard NBSG communications for first-time donors: 1) a thank you phone call and 2) and a reminder phone call two-weeks prior to the second blood donation eligibility. The second blood donation eligibility is four months after the first donation.

FRD ControlVNRBD Control
DocudramaBEHAVIORAL

Participants will be exposed to a document-drama related to blood donation.

Docudrama

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years-old
  • First-time whole blood donor with the SZBC of the NBSG
  • Eligible to donate again
  • Consent to participate
  • Understands one of English, Twi, or Ga
  • Have a smart phone
  • Have, or be willing to sign up for an active WhatsApp account

You may not qualify if:

  • History of more than one lifetime whole blood donation (with any blood centre)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Blood Service Ghana

Accra, Ghana

Location

Results Point of Contact

Title
Susan Telke
Organization
University of Minnesota
telke001@umn.edu
6125902697

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A pilot stratified randomized control trials of WhatsApp compared to control and docudrama (before/after) among first time donors.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2021

First Posted

March 5, 2021

Study Start

November 2, 2021

Primary Completion

September 25, 2022

Study Completion

September 25, 2023

Last Updated

January 10, 2024

Results First Posted

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.

Locations

GH(1)