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Table 2 Summary of estimates for feasibility outcomes

From: Empirical progression criteria thresholds for feasibility outcomes in HIV clinical trials: a methodological study

Subgroup

Recruitment

Randomization

Intervention not received as planned

Lost to follow-up

Discontinued

Analyzed

 

n; % (95% CI)

n; % (95% CI)

n; % (95% CI)

n; % (95% CI)

n; % (95% CI)

n; % (95% CI)

Use of medication

Pharmacological

72; 69.5 (61.6, 76.9)

89; 98.3 (97.0, 99)

121; 2.7 (1.7, 4.0)

134; 3.7 (2.8, 4.6)

126; 7.9 (6.6, 9.3)

198; 94.9 (93.2, 96.4)

Non-pharmacological

84; 59.3 (50.9, 67.4)

99; 95.8 (93.0, 98.0)

95; 5.3 (3.6, 7.4)

117; 8.8 (7.1, 10.7)

89; 4.6 (3.2, 6.3)

172; 93.3 (91.5, 94.8)

Type of intervention

Educational

14; 55.4 (42.6, 67.8)

15; 94.4 (79.1, 100.0)

20; 6.0 (1.4, 13.4)

29; 15.0 (10.9, 19.6)

20; 7.4 (3.5, 12.5)

38; 92.5 (88.4, 95.8)

Mobile health

28; 63.9 (52.3, 74.6)

31; 93.2 (85.0, 98.4)

27; 3.7 (1.6, 6.7)

34; 8.7 (5.5, 12.5)

26; 7.4 (3.9, 11.9)

52; 93.4 (90.1, 96.2)

Counseling

41; 57.6 (48.1, 66.8)

51; 95.8 (91.4, 98.8)

47; 5.3 (2.3, 9.3)

58; 10.2 (7.6, 13.2)

43; 5.3 (3.1, 8.0)

92; 94.9 (92.7, 96.7)

Electronic

8; 72.8 (53.8, 88.2)

8; 97.3 (90.5, 100.0)

7; 7.9 (1.4, 18.4)

11; 11.0 (4.4, 20.1)

9; 6.4 (2.1, 12.6)

15; 89.0 (81.9, 94.6)

Change in healthcare delivery

81; 67.2 (60.2, 73.8)

94; 98.4 (97.3, 99.2)

105; 2.5 (1.5, 3.7)

119; 3.9 (3.0, 5.0)

115; 7.3 (6.0, 8.6)

174; 95.9 (94.3, 97.3)

Incentives

8; 47.1 (22.6, 72.5)

8; 86.8 (54.5, 100.0)

8; 1.4 (0.0, 5.5)

9; 8.2 (1.4, 19.5)

9; 6.1 (1.9, 12.3)

14; 99.4 (96.9, 100.0)

Peer support

6; 83.3 (70.5, 93.0)

7; 99.9 (99.4, 100.0)

6; 10.9 (0.5, 31.4)

9; 11.5 (6.1, 18.3)

3; 3.2 (0.7, 7.2)

13; 95.6 (91.0, 98.7)

Psychotherapy

23; 51.4 (39.9, 62.8)

30; 95.2 (87.5, 99.5)

16; 16.1 (5.9, 30.0)

18; 9.4 (6.1, 13.2)

18; 5.9 (3.1, 9.5)

37; 96.1 (93.5, 98.2)

Outreach

11; 72.0 (45.0, 92.4)

14; 98.7 (96.6, 99.9)

9; 11.4 (4.8, 20.3)

11; 9.0 (3.9, 15.9)

15; 8.5 (4.9, 13.0)

22; 94.8 (88.7, 98.7)

Type of study

Factorial

6; 74.9 (49.8, 93.3)

8; 98.3 (91.2, 100.0)

7; 0.5 (0.0, 1.6)

8; 3.6 (1.5, 6.0)

7; 8.4 (3.8, 14.4)

13; 95.7 (89.3, 99.4)

Multi-arm

41; 66.5 (52.3,79.4)

48; 98.1 (94.7, 99.9)

43; 4.1 (2.5, 6.0)

49; 7.5 (5.4, 9.9)

41; 5.9 (3.7, 8.6)

75; 95.0 (92.8, 96.9)

Crossover

10; 55.7 (38.6, 72.1)

15; 98.5 (95.7, 100.0)

15; 2.8 (0.3, 7.0)

15; 4.2 (1.7, 7.5)

14; 4.2 (1.2, 8.6)

22; 96.1 (92.5, 98.6)

Income level

High

54; 60.7 (52.9, 68.2)

20; 96.4 (92.7, 99.0)

89: 4.1 (2.5, 6.1)

102; 7.2 (5.5, 9.0)

91; 7.2 (5.7, 8.8)

153; 93.8 (92.0, 95.4)

Upper middle

25; 64.1 (51.4, 75.8)

29; 92.9 (85.9, 97.8)

35; 3.4 (1.4, 5.9)

39; 5.6 (2.8, 9.1)

36; 5.2 (2.7, 8.3)

59; 94.5 (91.3, 97.0)

Lower middle

33; 66.7 (50.0, 81.6)

37; 98.0 (95.3, 99.6)

35; 4.3 (1.9, 7.5)

42; 7.5 (5.3, 9.9)

30; 4.9 (3.1, 7.1)

63; 95.3 (93.0, 97.1)

Low

17; 52.7 (38.5, 66.7)

20; 96.8 (92.1, 99.6)

17; 5.1 (2.1, 9.3)

25; 6.1 (3.7, 9.2)

17; 2.6 (0.3, 6.8)

31; 92.8 (88.3, 96.2)

Mixed

27; 73.9 (55.4, 88.8)

33; 99.6 (99.2, 99.9)

40; 2.6 (1.0, 4.7)

43; 2.3 (1.3, 3.5)

41; 9.5 (7.2, 12.1)

64; 94.3 (90.6, 97.2)

WHO region

Africa

56; 62.4 (50.7, 73.4)

66; 98.2 (96.6, 99.3)

68; 4.3 (2.5, 6.4)

87; 5.9 (4.6, 7.4)

66; 4.7 (3.1, 6.5)

122; 94.5 (92.1, 96.4)

Americas

47; 54.3 (46.3, 62.2)

58; 94.7 (89.7, 98.2)

68; 5.1 (2.8, 8.0)

78; 8.7 (6.6, 11.1)

70; 6.7 (4.8, 8.8)

117; 93.0 (90.6, 95.1)

Eastern Mediterranean

2; 56.6 (50.3, 62.8)

2; 97.9 (94.5, 99.8)

4; 5.8 (2.8, 9.8)

4; 10.4 (0.6, 27.7)

3; 16.3 (1.1,42.0)

6; 89.1 (70.9, 99.3)

Europe

14; 78.1 (64.8, 88.9)

16; 96.5 (89.8, 99.9)

29; 2.7 (1.1, 4.8)

28; 3.8 (1.7, 6.4)

25; 8.1 (5.4, 11.2)

43; 95.3 (92.3, 97.5)

South East Asia

9; 70.6 (42.5, 92.1)

10; 93.3 (73.7, 100.0)

8; 1.6 (0.0, 5.9)

10; 3.7 (0.1, 10.9)

8; 0.6 (0.0, 2.5)

16; 98.2 (93.4, 100.0)

Western Pacific

8; 56.4 (35.5, 76.2)

8; 90.0 (70.7, 99.6)

8; 5.6 (1.0, 13.3)

7; 4.5 (0.8, 10.6)

8; 6.1 (1.6, 13.1)

12; 92.5 (84.7, 97.8)

Mixed

20; 80.2 (73.1, 86.4)

27; 99.9 (99.7, 100.0)

31; 1.6 (0.5, 3.1)

37; 2.9 (1.5, 4.7)

35; 10.0 (7.4, 13.0)

54; 94.4 (91.6, 96.6)

Participant type

Black

22; 64.7 (46.7, 80.8)

25; 99.8 (99.4, 100.0)

19; 3.1 (0.7, 7.1)

27; 5.4 (3.4, 7.8)

20; 10.2 (6.7, 14.4)

38; 94.3 (88.5, 98.2)

Men who have sex with men

12; 50.1 (36.0, 64.2)

15; 95.0 (79.9, 100.0)

11; 7.5 (2.3, 15.2)

14; 10.9 (5.7, 17.5)

6; 10.0 (4.5, 17.4)

19; 94.6 (88.9, 98.3)

Women

18; 54.3 (40.1, 68.2)

28; 97.2 (93.6, 99.4)

30; 5.5 (2.6, 9.3)

37; 6.8 (4.1, 9.9)

32; 4.9 (2.9, 7.2)

58; 93.1 (87.7, 97.0)

Youth

12; 48.3 (19.6, 77.6)

15; 98.2 (95.3, 99.8)

16; 4.5 (1.6, 8.6)

15; 7.5 (3.6, 12.5)

10; 10.0 (5.7, 15.3)

23; 92.8 (87.8, 96.6)

People who inject dugs

13; 43.9 (32.1, 56.0)

13; 91.8 (80.1, 98.7)

17; 2.4 (0.8, 4.8)

15; 14.9 (9.6, 21.1)

13; 6.8 (2.3, 13.3)

24; 97.4 (94.6, 99.2)

Prisoners

3; 59.7 (45.8, 72.9)

3; 95.3 (69.1, 100.0)

5; 13.9 (0.0, 56.1)

5; 14.5 (4.2, 29.6)

6; 8.0 (1.1, 19.7)

9; 97.5 (91.9, 100.0)

Transgender people

1; 11.8 (10.5, 13.3)

1; 84.4 (79.4, 88.3)

1; 2.3 (1.0, 5.3)

1; 29.8 (25.3, 34.7)

na

2; 99.6 (98.8, 100.0)

Children

9; 52.4 (18.0, 85.5)

11; 97.1 (92.0, 99.8)

7; 2.5 (0.3, 6.5)

11; 5.2 (2.3, 9.0)

14; 9.5 (5.9, 13.8)

16; 95.9 (91.1, 99.0)

Participant comorbidities

Tuberculosis

7; 64.4 (57.7, 70.03)

7; 98.3 (90.2, 100.0)

15; 2.7 (0.3, 7.0)

17; 7.3 (3.6, 12.0)

4; 8.9 (5.5, 26.8)

21; 94.7 (89.6, 98.2)

Mental health

8; 42.9 (22.9, 64.3)

10; 96.4 (86.7, 100.0)

2; 3.1 (1.7, 4.9)

7; 12.5 (5.0, 21.7)

4; 8.9 (0.3, 26.8)

12; 97.8 (94.2, 99.8)

Substance use

16; 49.3 (37.3, 61.4)

18; 93.2 (83.5, 99.0)

21; 2.9 (0.8, 5.9)

20; 12.8 (8.7, 17.5)

18; 5.9 (2.4, 10.5)

33; 97.0 (94.2, 99.0)

Cancer

6; 66.6 (305, 94.1)

6; 93.0 (69.3, 100.0)

3; 0.6 (0.0,2.3)

4; 11.3 (4.2, 21.0)

2; 16.1 (13.2, 19.2)

6; 95.2 (83.7, 100.0)

Source of funding

Industry alone

18; 76.7 (49.3, 95.5)

19; 94.2 (76.8, 100.0)

28; 1.2 (0.4, 2.5)

34; 1.8 (1.1, 2.7)

32; 7.2 (5.9, 8.7)

44; 95.9 (94.1, 97.5)

Non-industry

128; 62.7 (55.9, 69.3)

154; 97.2 (95.6, 98.4)

164; 4.2 (3.0, 5.6)

185; 6.7 (5.6, 7.9)

163; 6.6 (5.4, 8.0)

281; 94.0 (92.5, 95.4)

Both

4; 57.2 (26.6, 85.0)

5; 94.2 (76.8, 100.0)

9; 5.1 (1.5, 10.4)

12; 4.1 (1.8, 7.2)

9; 6.4 (1.6, 13.8)

20; 90.8 (80.2, 97.7)

Total

156; 64.1 (57.7, 70.3)

187; 97.1(95.8–98.3)

216; 3.8 (2.8–4.9)

251; 5.8 (4.9–6.8)

215; 6.5 (5.5–7.5)

367; 94.2 (92.9–95.3)