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| ID | Type | Description | Link |
|---|---|---|---|
| UG3HL151599 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Blood Service Ghana | OTHER |
| University of Ghana | OTHER |
| Syracuse University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FRD Control | Active Comparator |
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| VNRBD Control | Active Comparator |
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| FRD WhatsApp | Experimental |
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| VNRBD WhatsApp | Experimental |
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| Docudrama | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Donation Attempt | Blood donation attempt at any time during follow-up. The planned follow-up (i.e., ļ¬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 ļ¬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 |
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Inclusion Criteria:
Exclusion Criteria:
ā¢ History of more than one lifetime whole blood donation (with any blood centre)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Blood Service Ghana | Accra | Ghana |
The BLOODSAFE project is committed to quickly sharing results and data. Papers will be submitted summarizing the primary results of the BLOODSAFE studies once the analysis is complete. These results will be published in major scientific journals and presented at scientific meetings.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | Docudrama | Participants will be exposed to a docudrama about blood donation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Randomization was into WhatsApp and Control was stratified by donation type (FRD/VNRBD). A separate group of participants will be invited to a single viewing of a filmed docudrama.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Donation Attempt | Blood donation attempt at any time during follow-up. The planned follow-up (i.e., ļ¬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 ļ¬nal follow-up window was extended by 34 days for all participants, so the participants in the WhatsApp arm would receive all planned messages. | The analyses followed a modiļ¬ed 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. | Posted | Count of Participants | Participants | 6 Months and 34 days |
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Participants were followed for serious adverse events (SAEs) from randomization until completion of follow-up, for a total of 6 months and 34 days. No SAEs were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FRD Control | FRD 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan Telke | University of Minnesota | 6125902697 | telke001@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 26, 2021 | Oct 11, 2023 | Prot_SAP_ICF_000.pdf |
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| OTHER |
| Liverpool School of Tropical Medicine | OTHER |
A pilot stratified randomized control trials of WhatsApp compared to control and docudrama (before/after) among first time donors.
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| Control | Behavioral | 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 | Behavioral | Participants will be exposed to a document-drama related to blood donation. |
|
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Docudrama | Participants will be exposed to a docudrama related to blood donation. |
| BG005 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Marital status | Count of Participants | Participants |
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| Children | Count of Participants | Participants |
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| Home Situation | Count of Participants | Participants |
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| Main Method of Transportation | Count of Participants | Participants |
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| Highest Level of Education Completed | Count of Participants | Participants |
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| Employment | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
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| Owns item | Number | participants |
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| Belongs to a Religious Faith | Count of Participants | Participants |
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| OG000 |
| 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | Docudrama | Participants were exposed to a docudrama related to blood donation. |
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|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | VNRBD Control | VNRBD 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. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | FRD WhatsApp | 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. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG003 | VNRBD WhatsApp | 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. | 0 | 31 | 0 | 31 | 0 | 31 |
| EG004 | Docudrama | Docudrama: Participants will be exposed to a document-drama related to blood donation. | 0 | 14 | 0 | 14 | 0 | 14 |
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).