Participation of women in HIV clinical trials: the IPEC-FIOCRUZ experience

Figures & data

Figure 1 IPEC-FIOCRUZ (Instituto de Pesquisa Clínica Evandro Chagas – Fundação Oswaldo Cruz) Women’s Cohort: screening and participation in clinical trials. Rio de Janeiro, Brazil, 1999–2008.

Table 1 Number of women enrolled in each clinical trial conducted at IPEC-FIOCRUZ (1999–2008)

	Clinical trial number	Year of enrollment	Number of women
ART-naïve	TMC 278	2005	5
	2NN	2001	4
	A5175	2005	35
	A5221	2007	2
	AI 424-138	2006	2
		2007	1
	BI 1882.33	2004	2
	CAN 30021	2001	6
	CAN 30024	2001	3
	EPV 2001	2000	6
	HPTN052	2005	19
ART-experienced	A 431-1006	2003	9
	A 431-1022	2005	1
	AI 424-008	2000	7
	AI 424-044	2001	4
	AI 424-045	2002	3
	AI 424-067	2004	5
	BI 1182-48	2003	1
	CROWN	2000	8
	M06-802	2007	3
	M98-888	2000	2
	MK-005	2005	5
	MK-019	2006	1
	PRO 317	2001	6
	TMC114-C215	2004	3
		2005	4
	TMC114-C229	2008	5
	TMC125-C206	2006	6
	TMC125-C217	2005	2
		2008	1
	TMC125-C227	2005	1
	TMC214-C215	2005	1
	VICTOR E-3	2006	7
No ART requirement	FUJISAWA	2002	10
	ML18743	2006	6

Abbreviations: ART, antiretroviral therapy; IPEC-FIOCRUZ, Instituto de Pesquisa Clínica Evandro Chagas – Fundação Oswaldo Cruz.

Table 2 Selected baseline characteristics of women according to participation in clinical trials

Variable	Participated in a clinical trial
	Noa n (%)	Yesa n (%)	Totala
Total number	565	100	665
Ageb
≤35 years	294 (55.1)	33 (33.7)	327 (51.7)
36–45 years	161 (30.1)	48 (49.0)	209 (33.1)
≥46 years	79 (14.8)	17 (17.3)	96 (15.2)
Skin color
White	237 (44.4)	44 (44.9)	281 (44.5)
Non-White	297 (55.6)	54 (55.1)	351 (55.5)
Educationb
>8 years	215 (40.6)	51 (53.1)	266 (42.5)
≤8 years	315 (59.4)	45 (46.9)	360 (57.5)
Employment statusb
Employed	256 (47.9)	34 (35,1)	290 (46.0)
Not employed	278 (52.1)	63 (64.9)	341 (54.0)
Has emotional or financial support?
Yes	320 (60.2)	64 (65.3)	384 (61.0)
No	212 (39.8)	34 (34.7)	246 (39.0)
Lives independentlyb
Yes	342 (65.4)	76 (77.6)	418 (67.3)
No	181 (34.6)	22 (22.4)	203 (32.7)
Married or living as marriedb
Yes	206 (38.6)	49 (50.0)	255 (40.3)
No	328 (61.4)	49 (50.0)	377 (59.7)
Has an HIV-positive partnerb
Yes	214 (40.5)	25 (25.8)	239 (38.2)
No	315 (59.5)	72 (74.2)	387 (61.8)
Has a partner who uses drugsb
Yes	77 (14.4)	5 (5.1)	82 (13.0)
No	457 (85.6)	93 (94.9)	550 (87.0)
Number of living children
None	92 (17.7)	17 (17,3)	109 (17.6)
1–2	298 (57.2)	61 (62.2)	359 (58.0)
>3	131 (25.1)	20 (20.4)	151 (24.4)
Children living with HIV/AIDS
Yes	48 (9.8)	7 (7.3)	55 (9.4)
No	386 (78.8)	74 (77.1)	460 (78.5)
Childless	56 (11.4)	15 (15.6)	71 (12.1)
History of sexual abusec
Yes	109 (20.6)	12 (12.4)	121 (19.3)
No	420 (79.4)	85 (87.6)	505 (80.7)
History of domestic violence
Yes	184 (35.0)	32 (33.3)	216 (34.8)
No	341 (65.0)	64 (66.7)	405 (65.2)
Any alcohol consumptiond
Yes	214 (40.1)	32 (32.7)	246 (38.9)
No	320 (59.9)	66 (67.3)	386 (61.1)
Lifetime illicit drug useb
Yes	152 (28.5)	17 (17.3)	169 (26.7)
No	382 (71.5)	81 (82.7)	463 (73.3)

Notes:

a Total values are not the same for all variables as a consequence of missing values;

b P value < 0.05;

c P value < 0.10;

d P value < 0.25.

Abbreviations: AIDS, acquired immunodeficiency syndrome; HIV, human immunodeficiency virus.

Table 3 Multiple logistic regression for women’s participation in clinical trials, IPEC-FIOCRUZ, Brazila

Variable	Adjusted odds ratio (95% CI)	P-value
Age
≤35 years	0.29 (0.17–0.50)	<0.001
36–45 years	1.00
≥46 years	0.78 (0.39–1.51)	0.475
Education
>8 years	2.28 (1.40–3.76)	0.001
≤8 years	1.00
Employment status
Employed	0.50 (0.30–0.81)	0.006
Unemployed	1.00
Lives independently
Yes	1.69 (1.00–2.98)	0.059
No	1.00
Married or living as married
Yes	1.96 (1.20–3.22)	0.007
No	1.00
Has an HIV-positive partner?
Yes	0.43 (0.25–0.73)	0.002
No	1.00
Lifetime illicit drug use
Yes	0.52 (0.28–0.93)	0.035
No	1.00

a Note: 11.7% (78/665) of women who had a missing value in at least one variable selected from univariable analysis was excluded.

Abbreviations: CI, confidence interval; HIV, human immunodeficiency virus; IPEC-FIOCRUZ, Instituto de Pesquisa Clínica Evandro Chagas – Fundação Oswaldo Cruz.