C-CAD: Community-based Communication for Blood Donation in Ghana

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05973890

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH), National Blood Service Ghana (Other), University of Ghana, College of Health Sciences (Other), Syracuse University (Other), Liverpool School of Tropical Medicine (Other), University of Minnesota, Coordinating Centers for Biometric Research (Other)

882

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A randomized controlled trial to evaluate the effectiveness of the WhatsApp groups or docudrama compared to a control group (usual engagement with blood services) on repeat blood donation attempts among first-time blood donors in Ghana. Secondary outcomes will be blood donor retention, blood donation knowledge, attitudes, beliefs, motivations, intention to donate, and relatedness as potential mediators of blood donation behavior among first-time blood donors. The RCT will have three arms: 1. WhatsApp; 2. docudrama; 3. control. Each participant in the WhatsApp and docudrama arms will receive the intervention for 14 months. Participants in the control arm will receive standard national blood donation communications and be followed for 14 months. Actualized blood donation is possible every four months using NBSG guidelines; consequently, participants may make multiple blood donation attempts. Return blood donation attempts will be evaluated using the Southern Zonal Blood Center (SZBC) records (primary outcome) and participant self-report (secondary outcome) at 7 months and 14 months. Secondary measures will be evaluated at baseline, 7 and 14 months from enrollment. The duration of the RCT will be 26 months allowing for 12 months to achieve enrollment goals and 14 months of follow-up for the last individual enrolled.

Condition or Disease	Intervention/Treatment	Phase
Increase Repeat Blood Donation Attempts Among First-time Donors	Behavioral: WhatsApp Behavioral: docudrama	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

882 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

parallel 3 arm randomized controlled study with equal allocationparallel 3 arm randomized controlled study with equal allocation

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Community-based Communication Interventions for Increasing Repeat Donation Among First- Time Blood Donors in Ghana: A Pragmatic Type 1 Effectiveness- Implementation Hybrid Trial

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Dec 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WhatsApp Participants assigned to the WhatsApp arm will receive messages, audios, images and videos in a moderated, closed WhatsApp group over a 14-month duration. The messages aim to motivate blood donation, encourage participants to discuss their blood donation experiences, and allow them to share their motivations for donating blood.	Behavioral: WhatsApp Participants assigned to the WhatsApp arm will receive messages, audios, images and videos in a moderated, closed WhatsApp group over a 14-month duration. The messages aim to motivate blood donation, encourage participants to discuss their blood donation experiences, and allow them to share their motivations for donating blood.
Experimental: docudrama Participants randomized to this arm will meet three times (Month 2; Month 5 and Month 10), in a group setting, during the intervention. Each group will have a maximum of 20-40 participants. This is a stand-alone activity, which is not associated with a donation event. During each meeting, participants will be asked to watch, in the group setting, an episode of drama, lasting 15 minutes. The docudrama on blood donation will address participant's concerns regarding blood donation and address common donor fears.	Behavioral: docudrama Participants randomized to this arm will meet three times (Month 2; Month 5 and Month 10), in a group setting, during the intervention. Each group will have a maximum of 20-40 participants. This is a stand-alone activity, which is not associated with a donation event. During each meeting, participants will be asked to watch, in the group setting, an episode of drama, lasting 15 minutes. The docudrama on blood donation will address participant's concerns regarding blood donation and address common donor fears.
No Intervention: control standard of care for repeat blood donation

Arm

Intervention/Treatment

Experimental: WhatsApp

Participants assigned to the WhatsApp arm will receive messages, audios, images and videos in a moderated, closed WhatsApp group over a 14-month duration. The messages aim to motivate blood donation, encourage participants to discuss their blood donation experiences, and allow them to share their motivations for donating blood.

Behavioral: WhatsApp

Experimental: docudrama

Participants randomized to this arm will meet three times (Month 2; Month 5 and Month 10), in a group setting, during the intervention. Each group will have a maximum of 20-40 participants. This is a stand-alone activity, which is not associated with a donation event. During each meeting, participants will be asked to watch, in the group setting, an episode of drama, lasting 15 minutes. The docudrama on blood donation will address participant's concerns regarding blood donation and address common donor fears.

Behavioral: docudrama

No Intervention: control

standard of care for repeat blood donation

Outcome Measures

Primary Outcome Measures

Repeat donation attempt [14 months]
The primary outcome for the RCT will be the number of blood donation attempts

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

At least 18 years-old
First-time whole blood donor with the SZBC of the NBSG
Eligible to donate again at the time of eligibility confirmation
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
Be willing to watch a docudrama on blood donation in a group setting

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI)
National Blood Service Ghana
University of Ghana, College of Health Sciences
Syracuse University
Liverpool School of Tropical Medicine
University of Minnesota, Coordinating Centers for Biometric Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT05973890

Other Study ID Numbers:

First Posted:

Aug 3, 2023

Last Update Posted:

Aug 3, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 3, 2023