Community-Based Communication Approaches for Blood Donation in Ghana

Blood Donors Clinical Trial

— C-CAD  

Official title:

Community-Based Communication Approaches for Blood Donation in Ghana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04783077
• Other study ID #: 326045
• Secondary ID: UG3HL151599
• Status: Completed
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: September 25, 2023

Study information

• Verified date: January 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 25, 2023
• Est. primary completion date: September 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Blood Donors

Intervention

Behavioral:
• 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.
• Docudrama
Participants will be exposed to a document-drama related to blood donation.

Locations

Country	Name	City	State
Ghana	National Blood Service Ghana	Accra

Sponsors (6)

Lead Sponsor	Collaborator
University of Minnesota	Liverpool School of Tropical Medicine, National Blood Service Ghana, National Heart, Lung, and Blood Institute (NHLBI), Syracuse University, University of Ghana, College of Health Sciences

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Donation Attempt	Blood donation attempt at any time during follow-up. The planned follow-up (i.e., ?nal 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 ?nal 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