Recall and decay of consent information among parents of infants participating in a randomized controlled clinical trial using an audio-visual tool in The Gambia

Figures & data

Table 1. Socio-demographic characteristicsof mothers of infants enrolled to answer additional questions on consent during parent trial.

Variable	n (%)
Age groups of Respondent (years)
18–24	147 (39.0%)
25–29	104 (27.6%)
30+	126 (33.4%)
Occupation
Civil Servant	14 (3.7%)
Farming	1 (0.3%)
Others	29 (7.7%)
Trading	67 (17.8%)
Unemployed	266 (70.6%)
Years Of Education
0	65 (17.2%)
1–5	90 (23.9%)
6–10	140 (37.1%)
11–14	75 (19.9%)
15+	7 (1.9%)
Family Type
Monogamy	273 (72.4%)
Polygamy	100 (26.5%)
Single Parent	4 (1.1%)
Total	377

Table 2. Assessment of consent recall and decay in knowledge between visit 1 (D0) and visit 4 (D 90).

Question	Day 0 (pre-trial)	Day 90 (post trial)	p-value
Questions requiring correct answers before trial enrolment (ACQ)
N	377	377
This study will assess the pneumococcal vaccine already used in Gambia. (attempts)			1.00
1	376 (99.7%)	377 (100.0%)
2	1 (0.3%)	0 (0.0%)
Your child will receive trial vaccines on 2 occasions during the study. (attempts)			0.50
1	375 (99.5%)	377 (100.0%)
2	2 (0.5%)	0 (0.0%)
This study requires that you come to the clinic for a total of 4 visits. (attempts)			0.25
1	374 (99.2%)	377 (100.0%)
2	3 (0.8%)	0 (0.0%)
This new vaccine will protect your child against polio. (attempts)			0.50
1	375 (99.5%)	377 (100.0%)
2	2 (0.5%)	0 (0.0%)
A participant in this trial may receive the trial vaccine (attempts)			0.50
1	375 (99.5%)	377 (100.0%)
2	2 (0.5%)	0 (0.0%)
1 teaspoon of blood will be collected from your child at the 4^th visit. (attempts)			0.50
1	375 (99.5%)	377 (100.0%)
2	2 (0.5%)	0 (0.0%)
You are free to withdraw from this study at any time. (attempts)			0.50
1	375 (99.5%)	377 (100.0%)
2	2 (0.5%)	0 (0.0%)
Study nurses can tell anyone about your participation in the study (attempts)			0.50
1	375 (99.5%)	377 (100.0%)
2	2 (0.5%)	0 (0.0%)
You will be visited by a field worker for 5 d after each vaccination (attempts)			0.50
1	375 (99.5%)	377 (100.0%)
2	2 (0.5%)	0 (0.0%)
Your child's participation in the study will be for a period of 4 months (attempts)			0.50
1	375 (99.5%)	377 (100.0%)
2	2 (0.5%)	0 (0.0%)
Additional questions to assess consent recall and decay (AQ)
Vaccines will help to protect your child against getting diseases caused by germs.			0.75
False	4 (1.1%)	6 (1.6%)
True	373 (98.9%)	371 (98.4%)
How Many Babies need to be Recruited, n (%)			0.53
(10–400)	37 (9.8%)	43 (11.4%)
500	333 (88.3%)	330 (87.5%)
(600–2000)	7 (1.9%)	4 (1.1%)
When your child receives vaccines his/her body produces super heroes to fight infection			0.049
False	6 (1.6%)	16 (4.2%)
True	371 (98.4%)	361 (95.8%)
Your child will not receive other vaccines for his/her age while in the study			0.081
False	268 (71.1%)	290 (76.9%)
True	109 (28.9%)	87 (23.1%)
You can request a form to take home and discuss with your family			0.75
False	6 (1.6%)	4 (1.1%)
True	371 (98.4%)	373 (98.9%)
A malaria test will never be done if your child develops fever			<0.001
False	305 (80.9%)	357 (94.7%)
True	72 (19.1%)	20 (5.3%)
Which other person can sign the consent form?			0.77
Husband	348 (92.3%)	353 (93.6%)
Mother	9 (2.4%)	8 (2.1%)
Other	20 (5.3%)	16 (4.2%)
Babies may have pain but not swelling when a vaccine is given			0.24
False	70 (18.6%)	57 (15.1%)
True	307 (81.4%)	320 (84.9%)
The doctor will stop the study for your child if he/she thinks that your baby could be hurt			<0.001
False	50 (13.3%)	10 (2.7%)
True	327 (86.7%)	367 (97.3%)
If your baby is unwell 5 d after vaccination he must be admitted to hospital.			<0.001
True	47 (12.5%)	9 (2.4%)
False	330 (87.5%)	368 (97.6%)

Table 3. Assessment of consent recall and decay in knowledge based on socioeconomic parameters.

	Day 0 (pre trial)		Day 90 (post trial)		Difference (Visit1-Visit4)
Variables	Mean(95%CI)	P value	Mean(95%CI)	P value	Mean(95%CI)
Age of Respondent (years)		0.570		0.768
18–24	87.8(86.7; 88.9)		89.3(88.6; 90.0)		−1.5(−2.7; −0.2)
25–29	88.7(87.4; 90.0)		89.0(88.2; 89.8)		−0.3(−1.8; 1.2)
30+	89.8(88.6; 91.1)		89.0(88.3; 89.7)		0.8(−0.5; 2.2)
Occupation		0.144		0.821
Civil Servant	89.6(86; 93.3)		88.9(86.7; 91.1)		0.7(−3.4; 4.8)
Farming	75.0(61.4; 88.6)		90.0 (81.8; 98.2)		−15.0(−30.2; 0.2)
Other	86.7(84.2; 89.2)		88.6(87.1; 90.1)		− 1.9(−4.7; 0.9)
Trading	89.1(87.4; 90.8)		89.6(88.6; 90.6)		− 0.5 (−2.4; 1.3)
Unemployed	88.9(88.0; 89.7)		89.1(88.6; 89.6)		− 0.2 (−1.1; 0.7)
Education Level		0.786		0.14
Arabic Only	89.3(88; 90.7)		88.5(87.7; 89.3)		0.8(−0.7; 2.3)
None	88.5(86.8; 90.2)		89.1(88.1; 90.1)		−0.6(−2.5; 1.3)
Part Primary	87.9(85.3; 90.4)		88.8(87.2; 90.3)		−0.9(−3.8; 2)
Part Secondary	88.8(87.4; 90.1)		89.8(89.0; 90.5)		−1.0(−2.5; 0.4)
Part Tertiary	86.9(82.0; 91.7)		86.9(84.0; 89.7)		0.0(−5.4; 5.4)
Primary	85.9(81.8; 90)		90.9(88.5; 93.4)		−5.0(−9.6; −0.4)
Secondary	89.4(87.2; 91.6)		88.7(87.4; 90)		0.6(−1.8; 3.1)
Tertiary	89.0(85.5; 92.5)		90.3(88.2; 92.4)		−1.3(−5.3; 2.6)
Years Of Education (caretaker)		0.86		0.496
0	88.5(86.8; 90.2)		89.1(88.1; 90.1)		−0.6(−2.5; 1.3)
1–5	89.2(87.7; 90.6)		88.7(87.9; 89.6)		0.4(−1.2; 2.1)
6–10	88.3(87.2; 89.5)		89.5(88.8; 90.2)		−1.1(−2.4; 0.1)
11–14	89.2(87.6; 90.8)		89.2(88.3; 90.1)		0.0(−1.8; 1.8)
15+	89.3(84.1; 94.5)		87.1(84.1; 90.2)		2.1(−3.6; 7.9)
Religion		0.252		0.524
Christianity	86.1(81.6; 90.7)		90.0(87.3; 92.7)		−3.9(−9.0; 1.2)
Islam	88.8(88.1; 89.5)		89.1(88.7; 89.5)		−0.3(−1.1; 0.5)
Family Type		0.808		0.257
Monogamy	88.6(87.8; 89.4)		89.1(88.6; 89.6)		−0.5(−1.4; 0.4)
Polygamy	89.1(87.7; 90.4)		89.0(88.2; 89.8)		0.1(−1.5; 1.6)
Single Parent	90.0(83.2; 96.8)		92.5(88.4; 96.6)		−2.5(−10.1; 5.1)

Figure 1. Excerpt from speaking book: Front cover and select pages. © Pfizer. Reproduced by permission of Pfizer. Permission to reuse must be obtained from the rightsholder.