Community-Based Communication Approaches for Blood Donation in Ghana

Study Overview
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Brief Summary
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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. SAMPLE SIZE The total sample size for all 3 components of the pilot study is n = 182. The planning of the docu-drama will involve participants who will take part in a drama design workshop discussion (n=20). In addition, we will recruit n=10 first- time donors to test-run and provide feedback on the docu-drama. Key informant interviews (n=24) will guide intervention development. The pilot RCT will enroll n=128 first-time blood donors. POPULATION The study population for the development of the docu-drama will include blood donors, non-blood donors (persons 18 years and above who have never donated blood before), drama professionals such as actors, and communication professionals. Key informant interviews for the WhatsApp intervention are drawn from community leaders, blood donation staff, blood donors and non-blood donors. The study population for the pilot RCT and acceptability assessment will be only first-time voluntary non-remunerated blood donors (VNRBD) and family/replacement blood donors (FRD) from the SZBC catchment area. REGIMEN Docu-drama pilot test run: Participants assigned to this group will meet once during the intervention. Participants will be asked to watch, in the group setting, a two-episode drama, each lasting 15 minutes. The docu-drama on blood donation will address their concerns for donating blood again and address common donor fears. Participants will also receive standard NBSG communications for first-time donors. 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.

Detailed Description
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Two components qualify as a clinical trial. For the purposes of registration for clinicaltrials.gov only the pilot RCT and the docu-drama test run will be entered.

Official Title
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Community-Based Communication Approaches for Blood Donation in Ghana

Conditions
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Blood Donors

Intervention / Treatment
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* Behavioral: WhatsApp
* Behavioral: Control
* Behavioral: Docu-drama


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: PRECEDE-PROCEED implementation science framework with a pilot randomized control trials of two behavioral interventions.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WhatsApp<br> | Behavioral: WhatsApp<br>* 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.<br>Behavioral: Docu-drama<br>* Participants will be exposed to a document-drama related to blood donation.<br>|
| Active Comparator: Control<br> | Behavioral: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of study design | Incidence of blood donation attempts within 6 months among first-time donors | 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood donation