Point-of-care viral load testing among adolescents and young adults living with HIV in Haiti: a randomized control trial

Figures & data

Figure 1. Flow diagram of participant screening, enrollment, and follow-up.

Table 1 . Clinical and socio-demographic characteristics at study enrollment and ART initiation of 150 participants ages 10–24 years enrolled in HIV care at GHESKIO in Port-au-Prince, Haiti.

	All participants N = 150	Point-of-care arm N = 75	Standard care arm N = 75	p-value
Characteristics at study enrollment
Age (N%)
Range (years)	12–24	14–24	12–24
Median (IQR)	20 (18-22)	20 (18-21)	19 (18-22)	0.75
Mean (years (SD))	19.37 (3.21)	19 (2.64)	19 (2.96)	0.73
10-14	10 (6.6)	4 (5.3)	6 (8.0)	0.77
15-19	63 (42.0)	31 (41.3)	32 (42.7)
20-24	77 (51.3)	40 (53.3)	37 (49.3)
Sex (male)	60 (40.0)	25 (33.3)	35 (46.7)	0.13
Weight, kg (mean (SD))	52.71 (10.68)	52.82 (9.47)	52.61 (11.83)	0.91
BMI, N(%)
Mean (SD)	20.71 (3.57)	20.81 (3.23)	20.61 (3.9)	0.73
Underweight	29 (19.3)	14 (18.7)	15 (20.0)	0.78
Normal	108 (72.0)	53 (70.1)	55 (73.3)
Overweight	9 (6.0)	6 (8.0)	3 (4.0)
Obese	4 (2.7)	2 (2.7)	2 (2.7)
Transmission Route, N(%)
Behavioral	44 (29.3)	20 (26.7)	24 (32.0)	0.59
Perinatal	106 (70.7)	55 (73.3)	51 (68.0)
ART regimen, N(%)
NRTI + NNRTI^a	77 (51. 3)	40 (53.3)	37 (49.3)	0.38
NRTI + PI w/booster^b	68 (45.3)	34 (45.3)	34 (45.3)
NRTI + INSTI^c	5 (3.3)	1 (1.3)	4 (5.3)
Time on ART, N(%)
Mean (years (SD))	6.08 (5.47)	6.95 (5.49)	5.51 (4.65)	0.09
6 months – 2 years	54 (36.0)	25 (33.3)	29 (38.7)	0.47
2 to < 5 years	30 (20.0)	15 (20.0)	15 (20.0)
5 to < 10 years	28 (18.7)	12 (16.0)	16 (21.3)
≥ 10 years	38 (25.3)	23 (30.7)	15 (20.0)
Viral load (copies/µL), N(%)
≤40	60 (40.0)	28 (37.3)	32 (42.7)	0.56
41-1000	26 (17.3)	14 (18.7)	12 (16.0)
1001-50,000	47 (31.3)	22 (29.3)	25 (33.3)
>50,000	17 (11.3)	11 (14.7)	6 (8.0)
CD4+ T-cell count within past 3 years (cells/mm^3), N(%)
Mean(SD)
<200	25 (16.7)	11 (14.7)	14 (18.7)	0.19
200–499	42 (28.0)	27 (36.0)	15 (20.0)
>500	74 (49.3)	33 (44.0)	41 (54.7)
Value not available	9 (6.0)	4 (5.3)	5 (6.6)
Characteristics at ART Initiation
Age
Median (IQR)	14 (7.25-18)	14 (7-18)	15 (9-18.5)	0.21
Mean (years (SD))	13.29 (6.08)	12.63 (6.30)	13.91 (5.79)	0.20
ART regimen, N(%)
NRTI + NNRTI	147 (98.0)	74 (98.7)	73 (97.3)	0.51
NRTI + PI booster^d	3 (2.0)	1 (1.3)	2 (2.7)
CD4+ T-cell count (cells/mm^3), N(%)
Mean (SD)	463.02 (342.30)	459.38 (387.77)	467.27 (284.24)	0.91
<200	22 (14.6)	13 (17.3)	9 (12.0)	0.39
200–499	46 (30.7)	26 (34.7)	20 (26.7)
>500	36 (24.0)	17 (22.7)	19 (25.3)
Value not available	46 (30.7)	19 (25.3)	27 (36.0)

^a Includes AZT/3TC/EFV, AZT/3TC/NVP, TDF/3TC/EFV.

^b Includes AZT/3TC//LPV/r, TDF/3TC/ATV/r, TDF/3TC/LPV/r, TDF/3TC/AZT/r.

^c Includes TDF/3TC/DTG; Includes 3TC/D4 T/EFV, 3TC/DDI/EFV, AZT/3TC/ABC, AZT/3TC/EFV, AZT/3TC/NVP, TDF/3TC/EFV, TDF/3TC/NVP, TDF/DDI/EFV.

^d Includes ABC/3TC/LPV/r, TDF/3TC/LPV/r.

Table 2 . Implementation outcomes for point-of-care VL testing vs. standard laboratory VL testing.

	Point-of-care arm N = 75 N(%)	Standard care arm N = 75 N(%)	p-value
Month 1
Primary Outcome: Proportion of VL test results returned <6 weeks	74/75 (98.7)	67/75 (89.3)	0.04
VL Testing Cascade Steps:
Proportion of participants who provided blood sample for VL test	75/75 (100.0)	75/75 (100.0)
Proportion of VL tests processed	74/75 (98.7)	75/75 (100.0)
Reasons for failure	n = 1	n = 0
Stock-out of Xpert HIV-1 cartridge	1/75 (1.3)
Proportion of VL test results returned the same day	63/74 (85.1)	n/a
Reasons for failure	n = 11
Participant declined to wait	3/11 (27.3)	–
Result not available before clinic closed	8/11 (72.7)	–
Participant arrived after 11am	5/8 (62.5)	–
Proportion of VL tests processed with result returned <6 weeks	74/74 (100.0)	67/75 (89.3)
Reasons for failure	n = 0	n = 8
Participant did not attend next monthly visit	–	6/8 (75.0)
Result not available in the EMR	–	2/8 (25.0)
Time to VL test result receipt, Days (median (IQR))	0 (0-0)	34 (31-35)
Time in the clinic for test + receive result + adherence counseling ^a	4.7 (4.1-5.5)	4.6 (3.6-5.2)
Month 4^b	N = 38	N = 31
Primary Outcome: Proportion of VL test results returned <6 weeks	34/38 (89.5)	25/31 (80.6)	0.30
VL Testing Cascade Steps:
Proportion of participants who provided a blood sample for VL test	35/38 (92.1)	27/31 (87.1)
Reasons for failure	n = 3	n = 4
Participant lost to follow-up/died/withdrew	3/38 (7.9)	4/31 (12.9)
Proportion of VL tests processed	35/35 (100.0)	27/27 (100.0)
Proportion of participants’ VL test result returned the same day	27/35 (77.1)	n/a
Reasons for failure	n = 8
Stock-out of Xpert HIV-1 cartridge	1/8 (12.5)	–
Participant declined to wait	3/8 (37.5)	–
Result not available before clinic closed	4/8 (50.0)	–
Participant arrived after 11am	2/4 (50.0)	–
Proportion of VL tests processed with result returned < 6 weeks	34/35 (97.1)	25/27 (92.6)
Reasons for failure	n = 1	n = 2
Same-day result not available and did not attend next monthly visit	1/1 (100.0)	–
Result not available in the EMR	–	2/2 (100.0)
Time to VL test result receipt, Days (median (IQR))	0 (0-0)	29 (29-31)
Time in the clinic for test + receive result + adherence counseling ^a	3.7 (3.2-4.6)	3.7 (2.9-4.2)
Month 6	N = 75	N = 75
Primary Outcome: Proportion of VL test results returned <6 weeks	70/75 (93.3)	53/75 (70.7)	<0.01
VL Testing Cascade Steps:
Proportion of participants who provided a blood sample for VL test	72/75 (96.0)	69/75 (92.0)
Reasons for failure	n = 3	n = 6
Participant lost to follow-up/died/withdrew	3/75 (4.0)	6/75 (8.0)
Proportion of VL tests processed	72/72 (100.0)	69/69 (100.0)
Proportion of participants VL test result returned the same day	58/72 (80.5)	n/a
Reasons for failure	n = 14
Stock-out of Xpert HIV-1 cartridge	3/14 (21.4)	–
Participant declined to wait	2/14 (14.3)	–
Result not available before clinic closed	9/14 (64.3)	–
Participant arrived after 11am	8/9 (88.9)	–
Proportion of VL tests processed with result returned < 6 weeks	70/72 (97.2)	53/69 (76.8)
Reasons for failure	n = 2	n = 16
Same-day result not available and did not attend next monthly visit	2/2 (100.0)	–
Participant did not attend next monthly visit	–	14/16 (87.5)
Result not available in the EMR	–	2/16 (12.5)
Time to VL test result receipt, days (median, IQR)	0 (0-0)	30 (28-36)
Time in the clinic for test + receive result + adherence counseling ^b	3.6 (3.4-4.5)	3.4 (2.8-4.2)
Totals
Total VL tests processed/VL tests indicated	181/188 (96.3)	171/181 (94.5)
Total VL tests results returned the same day/VL tests processed	148/181 (81.3)	n/a
Total VL test results returned <6 weeks from testing/VL tests processed	178/181 (98.3)	145/171 (84.8)
Total VL test results returned <6 weeks from testing/VL tests indicated	178/188 (94.7)	145/181 (80.1)	<0.01

^a In the POC arm, time includes 1 visit when VL testing, return of result and adherence counseling occurred. In the SOC arm, time is the combination of 2 visits over which VL testing, return of result, and adherence counseling occurred.

^b Participants with VL >1000 copies/µL at Month 1.

Figure 2. Association of sub-optimal self-reported ART adherence and VL >1000 copies/mL at month 6.

Table 3. Self-reported ART adherence by randomization arm at month 1 and month 6.

	Month 1			Month 6
	Point-of-care arm N = 75 N(%)	Standard care arm N = 75 N(%)	p	Point-of-care arm N = 72 N(%)	Standard care arm N = 69 N(%)	p
Question 1
Number of doses missed in the last 7 days
0-1	46 (61.3)	46 (61.3)	1.0	38 (52.8)	50 (72.5)	0.03
2+	29 (38.7)	29 (38.7)		34 (47.2)	19 (27.5)
Mean (SD)	1.5 (1.9)	1.4 (1.8)	0.86	2.0 (2.2)	1.0 (1.6)	<0.01
Mean (SD)^a	79.2 (26.4)	80.0 (26.1)	0.86	71.83 (31.07)	85.09 (22.6)	<0.01
Median (IQR)^a	85.7 (71.4-100)	85.7 (71.4-100)	0.86	85.7 (57.1-100)	100 (71.4-100)	<0.01
Question 2
In the last 7 days, how good of a job did you do at taking your ART in the way your MD told you?
Very good	31 (41.3)	19 (25.3)	0.06	31 (43.1)	40 (58.0)	0.15
Good/Fair/Poor/Very poor	44 (58.7)	56 (74.7)		41 (56.9)	29 (42.0)
Mean (SD)^a	81.9 (20.1)	77.6 (20.3)	0.20	76.1 (26.14)	87.8 (18.5)	<0.01
Median (IQR)^a	80.0 (80.0-100)	80.0 (80.0-90.0)	0.12	80.0 (60.0-100)	100 (80.0-100)	<0.01
Question 3
In the last 7 days how often did you take your ART medicine in the way your MD told you?
Always	29 (38.7)	31 (41.3)	0.87	33 (45.8)	41 (59.4)	0.15
Almost Always/Usually Sometimes/Rarely/Never	46 (61.3)	44 (58.7)		39 (54.2)	28 (40.6)
Mean (SD)^a	81.6 (20.8)	80.2 (22.4)	0.71	78.9 (26.8)	88.4 (18.4)	0.02
Median (IQR)^a	83.3 (66.7-100)	83.3 (66.7-100)	0.78	83.33 (66.7-100)	100 (83.3-100)	0.04
Composite 3-Question Score
Mean (SD)^a	80.9 (20.5)	79.3 (20.9)	0.63	75.6 (26.6)	87.1 (18.7)	<0.01
Median (IQR)^a	83.0 (71.7-93.3)	83.0 (76.9-100)	0.41	83.0 (59.7-100)	94.4 (82.2-100)	0.01

^a Question responses converted to a standardized score out of 100.

Table 4a. TDF-DP drug level outcomes by randomization arm and VL among first 62 participants enrolled at month 6.

	Point-of-care arm N = 31	Standard care arm N = 31	p-value
TDF-DP f/mol (mean(sd))	993.8 (942.4)	866.3 (781.7)	0.56
Dosing, N(%)
7 doses	6 (19.4)	6 (19.4)	0.98
4-6 doses	11 (35.5)	11 (35.5)
2-3 doses	4 (12.9)	3 (9.7)
<2 doses	10 (32.2)	11 (35.4)
	VL >1000 copies/µL N = 22	VL <1000 copies/µL N = 40
TDF-DP f/mol (mean(sd))	281.7 (373.2)	1286.7 (846.9)	<0.01
Dosing, N(%)
7 doses	0 (0.0)	12 (30.0)	<0.01
4-6 doses	2 (9.1)	20 (50.0)
2-3 doses	4 (18.2)	3 (7.5)
<2 doses	16 (72.7)	5 (12.5)

Table 4b . Viral load outcomes by randomization arm at month 6.

	Point-of-care arm N = 75; N (%)	Standard care arm N = 75; N (%)	p-value
Month 1
VL ≤40 copies/mL	28 (37.3)	32 (42.7)
VL 41–1000 copies/mL	14 (18.7)	12 (16.0)	0.79
VL >1000 copies/mL	33 (44.0)	31 (41.3)
Month 6
VL ≤40 copies/mL	32 (42.7)	35 (46.7)	0.57
VL 41–1000 copies/mL	12 (16.0)	8 (10.7)
VL >1000 copies/mL	28 (37.3)	26 (34.6)
VL not measured^a	3 (4.0)	6 (8.0)
Change in VL status between Month 1 and Month 6
Achieved VL <1000 copies/mL	11 (14.7)	10 (13.3)	0.87
Sustained VL <1000 copies/mL	33 (44.0)	33 (44.0)
Viral Rebound^b	9 (12.0)	8 (10.7)
Remained VL >1000 copies/mL	19 (25.3)	18 (24.0)
VL not measured at month 6^a	3 (4.0)	6 (8.0)

^a VL not measured for participants who were lost from follow-up, died, or withdrew from the study before completion.

^b VL <1000 copies/mL at Month 1 and >1000 copies/mL at Month 6.