Trial Outcomes & Findings for Community-Based Communication Approaches for Blood Donation in Ghana (NCT NCT04783077)
NCT ID: NCT04783077
Last Updated: 2024-01-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
144 participants
Primary outcome timeframe
6 Months and 34 days
Results posted on
2024-01-10
Participant Flow
Participant milestones
| Measure |
FRD: Control
Family Replacement Donors (FRD) assigned to 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.
|
VNRBD: Control
Voluntary Non-Remunerated Blood Donors (VNRBD) assigned to 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.
|
FRD:WhatsApp
Family Replacement Donors (FRD) assigned to 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.
|
VNRBD: WhatsApp
Voluntary Non-Remunerated Blood Donors (VNRBD) assigned to 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.
|
Docudrama
Participants will be exposed to a docudrama about blood donation.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
30
|
33
|
14
|
|
Overall Study
COMPLETED
|
27
|
30
|
28
|
31
|
14
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
2
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Community-Based Communication Approaches for Blood Donation in Ghana
Baseline characteristics by cohort
| Measure |
FRD: Control
n=34 Participants
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.
|
VNRBD: Control
n=33 Participants
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.
|
FRD: WhatsApp
n=30 Participants
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.
|
VNRBD: WhatsApp
n=33 Participants
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.
|
Docudrama
n=14 Participants
Participants will be exposed to a docudrama related to blood donation.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.62 years
STANDARD_DEVIATION 6.21 • n=5 Participants
|
23.33 years
STANDARD_DEVIATION 6.21 • n=7 Participants
|
25.73 years
STANDARD_DEVIATION 6.70 • n=5 Participants
|
24.33 years
STANDARD_DEVIATION 5.64 • n=4 Participants
|
24.00 years
STANDARD_DEVIATION 4.21 • n=21 Participants
|
25.26 years
STANDARD_DEVIATION 6.33 • n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
47 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
97 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Akan
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ewe
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Dagbani
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Ga/Dangbe
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hausa
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Region of Enrollment
Ghana
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
30 participants
n=5 Participants
|
33 participants
n=4 Participants
|
14 participants
n=21 Participants
|
144 participants
n=8 Participants
|
|
Marital status
Single
|
22 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
124 Participants
n=8 Participants
|
|
Marital status
Married
|
12 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Children
No; children
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
115 Participants
n=8 Participants
|
|
Children
Yes; children
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Home Situation
I live alone
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
|
Home Situation
I am a single parent without child/children
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Home Situation
I live with only my husband/wife/partner
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Home Situation
I live with my husband/wife/partner and children
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Home Situation
I live with my parents/relatives/friends
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
74 Participants
n=8 Participants
|
|
Home Situation
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Main Method of Transportation
Private
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Main Method of Transportation
Public
|
30 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
103 Participants
n=8 Participants
|
|
Main Method of Transportation
Other
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Highest Level of Education Completed
Primary school
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Highest Level of Education Completed
Junior high school
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Highest Level of Education Completed
Senior high school
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
56 Participants
n=8 Participants
|
|
Highest Level of Education Completed
Diploma
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Highest Level of Education Completed
Degree
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
|
Highest Level of Education Completed
Postgraduate level
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Employment
Student
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
|
Employment
Out of school and/or unemployed
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Employment
Homemaker/housewife
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Employment
Informal/part-time employment
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
|
Employment
Self-employed
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Employment
Formal employment
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
|
Income
No income
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Income
Less than GH 500.00
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Income
GH 500.00-1000.00
|
14 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Income
GH 1001.00-2000.00
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
|
Income
GH 2001.00-3000.00
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Income
More than GH 3000.00
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Income
Not sure
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Income
Prefer not to say
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
|
Owns item
Car
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
1 participants
n=21 Participants
|
16 participants
n=8 Participants
|
|
Owns item
Motorbike
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
8 participants
n=8 Participants
|
|
Owns item
Bicycle
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
5 participants
n=4 Participants
|
2 participants
n=21 Participants
|
22 participants
n=8 Participants
|
|
Owns item
Television
|
27 participants
n=5 Participants
|
26 participants
n=7 Participants
|
24 participants
n=5 Participants
|
25 participants
n=4 Participants
|
11 participants
n=21 Participants
|
113 participants
n=8 Participants
|
|
Owns item
Refrigerator or deep freezer
|
25 participants
n=5 Participants
|
17 participants
n=7 Participants
|
27 participants
n=5 Participants
|
20 participants
n=4 Participants
|
7 participants
n=21 Participants
|
96 participants
n=8 Participants
|
|
Owns item
Radio
|
30 participants
n=5 Participants
|
21 participants
n=7 Participants
|
28 participants
n=5 Participants
|
22 participants
n=4 Participants
|
6 participants
n=21 Participants
|
107 participants
n=8 Participants
|
|
Owns item
Cooking stove
|
24 participants
n=5 Participants
|
17 participants
n=7 Participants
|
24 participants
n=5 Participants
|
20 participants
n=4 Participants
|
9 participants
n=21 Participants
|
94 participants
n=8 Participants
|
|
Belongs to a Religious Faith
Christian
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
134 Participants
n=8 Participants
|
|
Belongs to a Religious Faith
Muslim
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 6 Months and 34 daysPopulation: 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.
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.
Outcome measures
| Measure |
FRD: Control
n=27 Participants
Family Replacement Donors (FRD) assigned to 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.
|
VNRBD: Control
n=30 Participants
Voluntary Non-Remunerated Blood Donors (VNRBD) assigned to 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.
|
FRD:WhatsApp
n=28 Participants
Family Replacement Donors (FRD) assigned to 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.
|
VNRBD: WhatsApp
n=31 Participants
Voluntary Non-Remunerated Blood Donors (VNRBD) assigned to 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.
|
Docudrama
Participants were exposed to a docudrama related to blood donation.
|
|---|---|---|---|---|---|
|
Donation Attempt
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
Adverse Events
FRD Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VNRBD Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FRD WhatsApp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
VNRBD WhatsApp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Docudrama
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The C-CAD pilot study was part of the BLOODSAFE initiative. The Publications and Presentations (P\&P) Committee reviews and approves all abstracts, presentations, and manuscripts that utilize data generated from BLOODSAFE. The BLOODSAFE P\&P Committee has voting members from the sponsor (NHLBI), the data coordinating center and each of the country-specific research teams (Ghana, Kenya, Malawi).
- Publication restrictions are in place
Restriction type: OTHER