The adolescent HIV executive function and drumming (AHEAD) study, a feasibility trial of a group drumming intervention amongst adolescents with HIV

Figures & data

Table 1. Primary outcome progression criteria for progression to a full-scale randomised controlled trial.

	Green (continue) criteria	Amber (amend) criteria	Red (stop) criteria
Enrolment (recruitment) rate of eligible adolescents	≥60%	40–59%	<40%
% of intervention arm participants attending 75% of sessions	≥60%	40–59%	<40%
% of intervention arm participants attending 50% of sessions	≥75%	60–74%	<60%
% of study participants completing baseline and endline assessments (retention)	≥70%	50–69%	<50%
Intervention perceived as acceptable by adolescents on acceptability questionnaire	≥70% positive ≥7.0 mean satisfaction	50–69% positive 5.0–6.9 mean satisfaction	<50% positive <5.0 mean satisfaction

Key:

• Green (continue): there are no concerns that might hinder the success of implementing a full-scale trial; progression is recommended.

• Amber (amend): there are potentially modifiable issues that if amended might allow a full-scale trial to proceed with caution.

• Red (stop): there are issues that cannot be modified; progression to a full-scale trial is not recommended.

Figure 1. AHEAD Study CONSORT flow diagram.

Table 2. Participant baseline sociodemographic characteristics.

Variable	Total (N = 68)	Intervention arm (n = 34)	Control arm (n = 34)
Age in years, mean (SD)	15.4 (2.4)	15.5 (2.3)	15.3 (2.4)
Female, n (%)	46 (67.7)	24 (70.6)	22 (64.7)
Married, n (%)	1 (1.5)	1 (2.9)	0 (0.0)
Country of birth:
South Africa, n (%)	67 (98.5)	33 (97.1)	34 (100.0)
Mozambique, n (%)	1 (1.5)	1 (2.9)	0 (0.0)
Low, n (%)	23 (34.9)	12 (36.4)	11 (33.3)
Middle, n (%)	32 (48.5)	16 (48.5)	16 (48.5)
High, n (%)	11 (16.7)	5 (15.2)	6 (18.2)
Education:
Attending school, n (%)	64 (94.1)	32 (94.1)	32 (94.1)
Repeated grade, n (%)	44 (64.7)	22 (64.7)	22 (64.7)
Completed primary, n (%)	39 (57.4)	20 (58.8)	19 (55.9)
Completed secondary, n (%)	4 (5.9)	2 (5.9)	2 (5.9)
Musical experience:
Played instrument, n (%)	11 (16.2)	5 (14.7)	6 (17.6)
Plays instrument, n (%)	8 (11.8)	4 (11.8)	4 (11.8)
Choral experience, n (%)	32 (47.1)	15 (44.1)	17 (50.0)
Dancing experience, n (%)	22 (32.4)	10 (29.4)	12 (35.3)

Key: SD = standard deviation; n = number; socio-economic status: low (lowest quartile), middle (middle two quartiles), high (highest quartile) based on an asset index.

Table 3. Participant clinical characteristics.

Variable	Total (N = 68)	Intervention arm (n = 34)	Control arm (n = 34)
HIV-positive, n (%)	68 (100.0)	34 (100.0)	34 (100.0)
Route of HIV transmission, n (%)
Perinatal	61 (89.7)	31 (91.1)	30 (88.2)
Behavioural	7 (10.3)	3 (8.8)	4 (11.8)
WHO disease stage at diagnosis, n (%)
1	34 (50.0)	14 (41.2)	20 (58.8)
2	15 (22.1)	10 (29.4)	5 (14.7)
3	11 (16.2)	6 (17.7)	5 (14.7)
4	2 (2.9)	2 (5.9)	0 (0.0)
Unknown	6 (8.8)	2 (5.9)	4 (11.8)
ART regimen, n (%)
NNRTI-based
Efavirenz	51 (75.0)	26 (76.5)	25 (73.5)
Nevirapine	1 (1.5)	1 (2.9)	0 (0.0)
PI-based (Lopinavir/ritonavir)	16 (23.5)	7 (20.6)	9 (26.5)
Past virological failure, n (%)
Yes	17 (25.0)	7 (20.6)	10 (29.4)
No	44 (64.7)	24 (70.1)	20 (58.8)
Unknown	7 (10.3)	3 (8.8)	4 (11.8)
Biological data
Nadir CD4 count (cells/mm^3), mdn (IQR)	276 (153–398)	294 (168–428)	251 (144–366)
Current CD4 count (cells/mm^3), mdn (IQR)	429 (271–630)	429 (290–740)	426 (238–577)
Peak viral load (copies/ml), mdn (IQR)	898 (119–49418)	1795 (95–25450)	444 (145–99000)
Current viral load (copies/ml), mdn (IQR)	199 (49–2430)	147 (49–2300)	274 (49–12700)
Viral load < 1000 copies/ml, n (%)	42 (61.8)	21 (61.8)	21 (61.8)
Viral load undetectable < 40 copies/ml, n (%)	13 (19.1)	6 (17.7)	7 (20.6)
ART duration (years), mdn (IQR)	4.0 (2.1–7.5)	3.9 (1.2–7.1)	4.3 (2.4–7.5)

Key: n = number; WHO = World Health Organisation; ART = antiretroviral therapy; NNRTI = non-nucleoside reverse transcriptase inhibitor; PI = protease inhibitor; CD4 = cluster of differentiation 4; mm³=  cubic millimetre; mdn = median; IQR = interquartile range; ml = millimetre.

Table 4. Participant perinatal and psychiatric history.

Variable	Total (N = 68)	Intervention arm (n = 34)	Control arm (n = 34)
Perinatal:
Antenatal drug or alcohol exposure, n (%)
Yes	2 (3.0)	1 (2.9)	1 (3.0)
Unknown	8 (11.9)	6 (17.7)	2 (6.1)
No	57 (85.1)	27 (79.4)	30 (90.9)
Preterm birth, n (%)
Yes	5 (7.5)	3 (8.8)	2 (6.1)
Unknown	2 (3.0)	2 (5.9)	0 (0.0)
No	60 (89.6)	29 (85.3)	31 (93.9)
Perinatal hospital admission, n (%)
Yes	6 (9.0)	4 (11.8)	2 (6.1)
Unknown	6 (9.0)	4 (11.8)	2 (6.1)
No	55 (82.1)	29 (85.3)	26 (78.8)
Psychiatric, n (%):
Psychiatric diagnosis	2 (2.9)	1 (2.9)	1 (2.9)
On psychotropics	2 (2.9)	1 (2.9)	1 (2.9)

Key: n = number.

Table 5. Caregiver baseline sociodemographic and clinical characteristics.

Variable	Total (N = 67)	Intervention arm (n = 34)	Control arm (n = 33)
Age in years, m (SD)	48.1 (13.7)	47.9 (11.0)	48.3 (16.0)
Female, n (%)	62 (91.2)	33 (97.1)	29 (85.3)
Relationship:
Mother, n (%)	27 (40.3)	15 (44.1)	12 (36.4)
Grandmother, n (%)	16 (23.9)	8 (23.5)	8 (24.2)
Other, n (%)	24 (35.8)	11 (32.4)	13 (39.4)
Country of birth:
South Africa, n (%)	59 (88.1)	29 (85.3)	30 (90.9)
Mozambique, n (%)	8 (11.9)	5 (14.7)	3 (9.1)
Married, n (%)	26 (38.8)	12 (35.3)	14 (42.4)
Currently employed, n (%)	6 (9.0)	3 (8.8)	3 (9.0)
Education:
Completed primary, n (%)	33 (49.3)	15 (44.1)	18 (54.6)
Completed secondary, n (%)	13 (19.4)	5 (14.7)	8 (24.2)
Psychiatric:
Psychiatric diagnosis, n (%)	5 (7.5)	3 (8.8)	2 (6.1)
SRQ-20 score, m (SD)	4.94 (4.83)	5.47 (5.14)	4.39 (4.51)

Key: m = mean; SD = standard deviation; n = number; SRQ-20 = Self-Reporting Questionnaire-20.

Table 6. Baseline summary statistics of cognitive and socio-emotional scale scores of participants in both trial arms with adequate conditions of test.

Score (m, SD)	Total (N = 68)	Intervention arm (n = 34)	Control arm (n = 34)
Digit span forwards	5.00 (1.09)	4.97 (1.19)	5.03 (0.98)
Digit span backwards	3.16 (1.19)	3.18 (1.11)	3.15 (1.28)
Trails baseline accuracy	0.75 (0.24)	0.74 (0.23)	0.77 (0.24)
Trails switch accuracy	0.36 (0.22)	0.40 (0.23)	0.33 (0.22)
Trails switch accuracy cost	0.50 (0.28)	0.53 (0.27)	0.46 (0.29)
Rule-finding task	0.37 (0.17)	0.40 (0.19)	0.35 (0.14)
Iowa Gambling Task net	0.07 (0.28)	0.09 (0.33)	0.05 (0.23)
Go/no-go d-prime	2.67 (1.10)	2.41 (1.06)	2.90 (1.10)
Dot recall	−134.86 (50.96)	−135.28 (52.13)	−134.47 (50.67)
Simon	−14.30 (58.74)	−11.26 (51.27)	−17.45 (66.28)
Adolescent-rated
SRQ-20 depressed mood item	0.10	0.15	0.06
SRQ-20	3.90 (3.04)	4.32 (3.13)	3.47 (2.93)
MSPSS	3.48 (0.52)	3.43 (0.63)	3.54 (0.39)
Caregiver-rated
SRQ-20	4.94 (4.83)	5.47 (5.14)	4.39 (4.51)

Key: m = mean; SD = standard deviation; SRQ-20 = Self-Reporting Questionnaire 20; MSPSS = Multidimensional Scale of Perceived Social Support.

Figure 2. Plot of drumming session attendance rate with 95% confidence intervals in Weeks 1–8.

Table 7. Comparison of baseline characteristics of intervention arm compliers (attended 75% or more) versus non-compliers (attended < 75%).

Variable, mean (SD) unless indicated	Total (N = 34)	Compliers (n = 22)	Non-compliers (n = 12)
Age	15.46	14.99 (2.22)	16.31(2.43)
Female (%)	70.59	72.73	66.67
Behavioural HIV (%)*	8.82	0.00	25.00
Primary (%)	58.82	50.00	75.00
School-enrolled (%)*	94.12	100.00	83.33
SES (asset index)	0.73 (0.11)	0.71 (0.11)	0.75 (0.09)
SRQ-20	4.32 (3.13)	4.05 (2.57)	4.83 (4.04)
Depressed (%)	14.71	13.64	16.67
MSPSS	3.43 (0.63)	3.41 (0.73)	3.46 (0.41)
Digits forwards	4.97 (1.19)	4.91 (1.38)	5.08 (0.79)
Digits backwards	3.18 (1.11)	3.18 (1.33)	3.17 (0.58)
Trails baseline	0.74 (0.23)	0.77 (0.23)	0.69 (0.23)
Trails switch	0.53 (0.27)	0.49 (0.28)	0.60 (0.26)
Rule-finding	0.40 (0.19)	0.40 (0.23)	0.40 (0.11)
Iowa Gambling	0.09 (0.33)	0.12 (0.37)	0.03 (0.25)
D-prime	2.41 (1.06)	2.17 (1.02)	2.77 (1.05)
Dot recall	135.28 (52.13)	−142.93 (52.20)	−123.81 (52.10)
Simon	−11.26 (51.27)	−8.90 (55.99)	−15.77 (42.96)

Key: SD = standard deviation; t = t-statistic from two-samples t-test; z = z-statistic from the Wilcoxon rank-sum test; behavioural HIV = behaviourally acquired HIV; SES = socio-economic index (asset index); SRQ = Self-Reporting Questionnaire; Depressed = adolescent SRQ-20 depressed mood item; MSPSS = Multidimensional Scale of Perceived Social Support; * P < 0.10

Figure 3. Intervention arm qualitative data coding tree.

Figure 4. Control arm qualitative data coding tree.

Table 8. Primary outcome results compared to progression criteria for progression to a full-scale randomised controlled trial.

	Green (continue) criteria	Amber (amend) criteria	Red (stop) criteria	Outcome
Enrolment (recruitment) rate of eligible adolescents	≥60%	40–59%	<40%	96% (95% CI 88–99)
% of intervention arm participants attending 75% of sessions	≥60%	40–59%	<40%	65% (95% CI 46–80)
% of intervention arm participants attending 50% of sessions	≥75%	60–74%	<60%	76% (95% CI 59–89)
% of study participants completing baseline and endline assessments (retention)	≥70%	50–69%	<50%	99% (95% CI 92–100)
Intervention perceived as acceptable by adolescents on acceptability questionnaire	≥70% positive ≥7.0 mean satisfaction	50–69% positive 5.0–6.9 mean satisfaction	<50% positive <5.0 mean satisfaction	94% positive (95% CI 80–99) 8.7 mean satisfaction (95% CI 8.4–9.1)

Key: 95% CI = 95% confidence interval.

Table 9. Comparison of cognitive and socio-emotional scale outcomes using multivariable regression models (controlling for baseline score, education level, socio-economic status) of intervention arm compliers (attended 75% or more of intervention) versus control arm.

Test	Control arm mean (95% CI)	Intervention arm mean (95% CI)	Difference (95% CI)	P value
DF	5.32 (4.86, 5.78)	5.41 (4.81, 6.01)	0.09 (−0.67, 0.85)	0.808
DB	3.67 (3.13, 4.21)	3.94 (3.24, 4.64)	0.28 (−0.61, 1.16)	0.532
TB	0.82 (0.75, 0.89)	0.86 (0.76, 0.95)	0.04 (−0.08, 0.16)	0.531
TS	0.47 (0.36, 0.58)	0.50 (0.36, 0.63)	0.03 (−0.15, 0.20)	0.768
Rule	0.41 (0.36, 0.46)	0.35 (0.29, 0.41)	−0.06 (−0.14, 0.02)	0.115
IGT	0.07 (−0.03, 0.18)	0.07 (−0.07, 0.20)	−0.01 (−0.18, 0.17)	0.950
d’	3.02 (2.73, 3.31)	2.93 (2.52, 3.34)	−0.09 (−0.60, 0.42)	0.721
Dot	−139.43 (−152.62, −126.24)	−132.65 (−150.03, −115.26)	6.78 (−15.22, 28.78)	0.537
Simon	−26.99 (−46.63, −7.36)	−50.13 (−73.39, −26.88)	−23.14 (−53.68, 7.40)	0.134
SRQ-C	6.39 (4.84, 7.95)	4.07 (2.14, 5.99)	−2.33 (−4.82, 0.17)	0.067*
SRQ-A	4.12 (3.19, 5.04)	3.68 (2.51, 4.84)	−0.44 (−1.94, 1.06)	0.556
Depr	0.13 (0.05, 0.22)	−0.02 (−0.13, 0.09)	−0.15 (−0.29, −0.02)	0.030*
PSS	3.65 (3.48, 3.81)	3.49 (3.29, 3.70)	−0.16 (−0.42, 0.11)	0.245

Key: A higher score is better in all measures except SRQ-C; SRQ-A; Depr. 95% CI = 95% confidence interval; P value = probability value; DF = digit span forwards; DB = digit span backwards; TB = trails baseline; TS = trails switch cost; Rule = rule-finding; IGT = Iowa Gambling Task; d’ = d-prime; Dot = dot recall; SRQ-A = Self-Reporting Questionnaire 20 (SRQ-20) adolescent total score; Depr = adolescent SRQ-20 depressed mood; SRQ-C = SRQ-20 caregiver total score; PSS = multidimensional scale of perceived social support total score.

*P < 0.10.

Table

Task	Measure	Construct measured	Modification
Trails	Switching accuracy cost	Planning/sequencing; set-shifting	180 s duration cut-off
Iowa Gambling Task	Net score = proportion of Advantageous choices minus proportion of disadvantageous choices in the last thirty trials	Affective inhibition / risk-Taking / decision-making In the context of uncertain reward	Starting score of 6000
Rule-finding	Accuracy = proportion of correct moves	Visuospatial pattern recognition/problem-solving; set-shifting	None
Emotional go/no-go	d-Prime (d’ = z[accuracy on go trials] – z[commission error rate])	Affective inhibition	Male and female versions of task with African facial stimuli from the Chicago Facial Database (Ma et al., 2015);
Digit recall	Backwards span	Verbal working memory	None
Dot location recall	accuracy difference	Visuospatial working memory	None
Simon task	Reaction time difference	Non-affective inhibition	None

Figure A1. AHEAD Study RACER dot recall spatial working memory task: examples of stimulus configurations in low-load (left) and high-load (right) trials.

Figure A2. AHEAD Study RACER Simon inhibitory control task: examples of same-side trials with purple-pink dot stimuli and opposite-side trials with striped yellow-and-black dot stimuli.

Table

Cognitive task, n (%)	Total (N = 68)	Intervention arm (n = 34)	Control arm (n = 34)	χ2	P
Digit recall	1 (1.5)	0 (0.0)	1 (2.9) interruptions	2.06	0.357
Trails	3 (4.4)	1 (2.9) interruptions	2 (5.9) 1 x technical problem 1 x examiner error	3.02	0.389
Rule-finding	0 (0.0)	0 (0.0)	0 (0.0)	-	-
Iowa Gambling	0 (0.0)	0 (0.0)	0 (0.0)	-	-
Go/no-go	5 (7.4)	4 (11.8) interruptions	1 (2.9) interruptions	1.94	0.163
Dot recall	5 (7.4)	4 (11.8) 2 x interruptions 2 x other	1 (2.9) interruptions	2.47	0.290
Simon	5 (7.3)	2 (5.9) 1 x examiner error 1 x other	3 (8.8) 2 x interruptions 1 x other	3.02	0.389

Key: n = number.

Table

Cognitive task, n (%)	Total (N = 68)	Intervention arm (n = 34)	Control arm (n = 34)	χ2	p
Digit recall	7 (10.3)	5 (14.7) 1 x technical problem 4 x interruptions	2 (5.9) interruptions	1.81	0.404
Trails	1 (1.5)	1 (2.9) interruptions	0 (0.00)	1.01	0.314
Rule-finding	0 (0.0)	0 (0.0)	0 (0.0)	-	-
Iowa Gambling	0 (0.0)	0 (0.0)	0 (0.0)	-	-
Go/no-go	1 (1.5)	0 (0.0)	1 (2.9) interruptions	1.02	0.314
Dot recall	0 (0.0)	0 (0.0)	0 (0.0)	-	-
Simon	1 (1.5)	1 (2.9) interruptions	0 (0.0)	0.99	0.321

Key: n = number

Ma, D. S., Correll, J., & Wittenbrink, B. (2015, December). The Chicago face database: A free stimulus set of faces and norming data. Behav Res Methods, 47(4), 1122–1135. https://doi.org/10.3758/s13428-014-0532-5

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