Blood Donors
Conditions
Keywords
Blood donation
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.
Interventions
BEHAVIORALWhatsApp
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.
BEHAVIORALControl
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.
BEHAVIORALDocudrama
Participants will be exposed to a document-drama related to blood donation.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Blood Service Ghana
University of Ghana
Syracuse University
Liverpool School of Tropical Medicine
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A pilot stratified randomized control trials of WhatsApp compared to control and docudrama (before/after) among first time donors.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donation Attempt | 6 Months and 34 days | 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. |
Countries
Ghana
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FRD: Control FRD: Control participants received 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. | 34 |
| VNRBD: Control VNRBD: Control participants received 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. | 33 |
| FRD: WhatsApp FRD: WhatsApp participants received 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. | 30 |
| VNRBD: WhatsApp VNRBD: WhatsApp participants received 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. | 33 |
| Docudrama Participants will be exposed to a docudrama related to blood donation. | 14 |
| Total | 144 |
Baseline characteristics
| Characteristic | FRD: Control | VNRBD: Control | FRD: WhatsApp | VNRBD: WhatsApp | Docudrama | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 27.62 years STANDARD_DEVIATION 6.21 | 23.33 years STANDARD_DEVIATION 6.21 | 25.73 years STANDARD_DEVIATION 6.7 | 24.33 years STANDARD_DEVIATION 5.64 | 24.00 years STANDARD_DEVIATION 4.21 | 25.26 years STANDARD_DEVIATION 6.33 |
| Belongs to a Religious Faith Christian | 31 Participants | 32 Participants | 26 Participants | 32 Participants | 13 Participants | 134 Participants |
| Belongs to a Religious Faith Muslim | 3 Participants | 1 Participants | 4 Participants | 1 Participants | 1 Participants | 10 Participants |
| Children No; children | 23 Participants | 30 Participants | 20 Participants | 29 Participants | 13 Participants | 115 Participants |
| Children Yes; children | 11 Participants | 3 Participants | 10 Participants | 4 Participants | 1 Participants | 29 Participants |
| Employment Formal employment | 6 Participants | 8 Participants | 8 Participants | 13 Participants | 2 Participants | 37 Participants |
| Employment Homemaker/housewife | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Employment Informal/part-time employment | 7 Participants | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 14 Participants |
| Employment Out of school and/or unemployed | 6 Participants | 3 Participants | 6 Participants | 1 Participants | 0 Participants | 16 Participants |
| Employment Self-employed | 9 Participants | 1 Participants | 8 Participants | 3 Participants | 3 Participants | 24 Participants |
| Employment Student | 5 Participants | 18 Participants | 5 Participants | 15 Participants | 9 Participants | 52 Participants |
| Highest Level of Education Completed Degree | 10 Participants | 12 Participants | 9 Participants | 12 Participants | 7 Participants | 50 Participants |
| Highest Level of Education Completed Diploma | 6 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 14 Participants |
| Highest Level of Education Completed Junior high school | 1 Participants | 5 Participants | 6 Participants | 2 Participants | 1 Participants | 15 Participants |
| Highest Level of Education Completed Postgraduate level | 2 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 7 Participants |
| Highest Level of Education Completed Primary school | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Highest Level of Education Completed Senior high school | 14 Participants | 13 Participants | 12 Participants | 13 Participants | 4 Participants | 56 Participants |
| Home Situation I am a single parent without child/children | 0 Participants | 2 Participants | 1 Participants | 3 Participants | 0 Participants | 6 Participants |
| Home Situation I live alone | 13 Participants | 7 Participants | 7 Participants | 9 Participants | 4 Participants | 40 Participants |
| Home Situation I live with my husband/wife/partner and children | 8 Participants | 2 Participants | 6 Participants | 2 Participants | 0 Participants | 18 Participants |
| Home Situation I live with my parents/relatives/friends | 9 Participants | 21 Participants | 15 Participants | 19 Participants | 10 Participants | 74 Participants |
| Home Situation I live with only my husband/wife/partner | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants |
| Home Situation Other | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Income GH 1001.00-2000.00 | 3 Participants | 4 Participants | 4 Participants | 1 Participants | 0 Participants | 12 Participants |
| Income GH 2001.00-3000.00 | 0 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 9 Participants |
| Income GH 500.00-1000.00 | 14 Participants | 3 Participants | 5 Participants | 8 Participants | 1 Participants | 31 Participants |
| Income Less than GH 500.00 | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 7 Participants |
| Income More than GH 3000.00 | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Income No income | 10 Participants | 18 Participants | 9 Participants | 14 Participants | 9 Participants | 60 Participants |
| Income Not sure | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 0 Participants | 6 Participants |
| Income Prefer not to say | 4 Participants | 2 Participants | 6 Participants | 3 Participants | 1 Participants | 16 Participants |
| Main Method of Transportation Other | 3 Participants | 6 Participants | 2 Participants | 8 Participants | 4 Participants | 23 Participants |
| Main Method of Transportation Private | 1 Participants | 7 Participants | 1 Participants | 8 Participants | 1 Participants | 18 Participants |
| Main Method of Transportation Public | 30 Participants | 20 Participants | 27 Participants | 17 Participants | 9 Participants | 103 Participants |
| Marital status Married | 12 Participants | 1 Participants | 5 Participants | 2 Participants | 0 Participants | 20 Participants |
| Marital status Single | 22 Participants | 32 Participants | 25 Participants | 31 Participants | 14 Participants | 124 Participants |
| Owns item Bicycle | 6 participants | 5 participants | 4 participants | 5 participants | 2 participants | 22 participants |
| Owns item Car | 3 participants | 4 participants | 1 participants | 7 participants | 1 participants | 16 participants |
| Owns item Cooking stove | 24 participants | 17 participants | 24 participants | 20 participants | 9 participants | 94 participants |
| Owns item Motorbike | 3 participants | 1 participants | 1 participants | 1 participants | 2 participants | 8 participants |
| Owns item Radio | 30 participants | 21 participants | 28 participants | 22 participants | 6 participants | 107 participants |
| Owns item Refrigerator or deep freezer | 25 participants | 17 participants | 27 participants | 20 participants | 7 participants | 96 participants |
| Owns item Television | 27 participants | 26 participants | 24 participants | 25 participants | 11 participants | 113 participants |
| Race/Ethnicity, Customized Akan | 11 Participants | 19 Participants | 14 Participants | 20 Participants | 7 Participants | 71 Participants |
| Race/Ethnicity, Customized Dagbani | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Ewe | 6 Participants | 6 Participants | 2 Participants | 5 Participants | 1 Participants | 20 Participants |
| Race/Ethnicity, Customized Ga/Dangbe | 11 Participants | 4 Participants | 8 Participants | 4 Participants | 2 Participants | 29 Participants |
| Race/Ethnicity, Customized Hausa | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 14 Participants |
| Region of Enrollment Ghana | 34 participants | 33 participants | 30 participants | 33 participants | 14 participants | 144 participants |
| Sex: Female, Male Female | 4 Participants | 16 Participants | 8 Participants | 13 Participants | 6 Participants | 47 Participants |
| Sex: Female, Male Male | 30 Participants | 17 Participants | 22 Participants | 20 Participants | 8 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 30 | 0 / 28 | 0 / 31 | 0 / 14 |
| other Total, other adverse events | 0 / 27 | 0 / 30 | 0 / 28 | 0 / 31 | 0 / 14 |
| serious Total, serious adverse events | 0 / 27 | 0 / 30 | 0 / 28 | 0 / 31 | 0 / 14 |
Outcome results
Primary
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.
Time frame: 6 Months and 34 days
Population: The analyses followed a modified intention-to-treat (mITT) approach. Individuals who consented, were randomized and not withdrawn at screening were analyzed in the group to which they were originally assigned. Missing data from the mITT analysis was handled using multiple imputation via chained equations and included stratum, group assignment and baselines variable that met a minimum Kendall's tau of 0.2 with the primary outcome. No data was collected at 6 months 34 days for the Docudrama arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FRD: Control | Donation Attempt | 2 Participants |
| VNRBD: Control | Donation Attempt | 2 Participants |
| FRD:WhatsApp | Donation Attempt | 2 Participants |
| VNRBD: WhatsApp | Donation Attempt | 7 Participants |
| Docudrama | Donation Attempt | 0 Participants |
Comparison: The primary analysis applies only to the RCT participants (N=130). Docudrama participants were not assessed for return blood donation. Analysis used fitted logistic regression with outcome donation attempted (Y/N) on the modified intention-to-treat (mITT) population, adjusted for type of donor (FRD, VNRBD).p-value: 0.2395% CI: [0.61, 8.5]Regression, Logistic