IPEC Fundao Oswaldo Cruz Rio de Janeiro Brazil

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IPEC - Fundação Oswaldo Cruz Rio de Janeiro
-Brazil

• Women and Trials in Low and Middle-income
  settings the clinical investigators Perspective
• August 6, 2008
• Beatriz Grinsztejn, MD,Ph.D

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Background

• HIV disproportionately affects women in
  developing countries
• Underrepresented in poor-resource regions
  (McGovern et al, 1994 Allen 1994 Mills et al,
  2006 Kapoor 2004 Zuniga et al, 2007 Wassenaar
  et al, 2007)

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Background

• If women are to benefit from prevention and
  therapeutics interventions, they must participate
  in the trials in a sufficient number to allow
  appropriate gender-specific evaluation of
  efficacy and safety.

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Background

• In general, there is a paucity of clinical trials
  going on in the RLS, where the greatest burden of
  the epidemic exists
• The majority of products in the market were
  developed without adequate representation of RLS
  population in the trials. The generalisability of
  trials results to these populations may be
  compromised
• This affects both men and women. Womens social
  inequality in these societies makes it even worse
  for them

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Women in HIV Clinical Trials

• Willingness to participate, perceptions and
  concerns about clinical trials in poor-resource
  settings
• Studies show that women want to participate in
  clinical trials (qualitative analysis, interviews
  with women participating in prevention studies)
• The two most common motivations for participating
  in a trial were "getting tested for HIV" and
  "doing something good for women's health.
• Repeated, voluntary counseling and testing,
  knowledge of HIV status, and heightened awareness
  of sexual and reproductive health reshaped study
  participants' approaches to sexual relationships
  and AIDS

Tharawan et al, 2001 Coulibaly-Traoré et al,
2003 Stadler et al, 2008
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Recruitment

• HIV-related stigma
• Studies have shown that stigma is a measurable
  barrier to accessing general HIV care thus, it
  would be expected that it may also serve as a
  barrier to participating in a clinical trial.
• Confidentiality issues
• Employment opportunities
• Family relationships
• Social acceptance

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Recruitment-II

• Ability of women to meet the ongoing and multiple
  requirements of trial participation
• Employment issues
• Childcare
• Partner health status
• Disclosure
• Financial resources
• Fertility desires
• Social representation of motherhood

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Recruitment-III

• Investigators fear of occurrency of pregnancy
  during the trial
• Easier to end up enrolling men

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Women enrolled in HPTN ACTG clinical trials
international studies
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IPEC - FIOCRUZ

• 1986 HIV Care service outpatient/inpatient
• 1996 HIV-infected women cohort
• 790 women enrolled
• 25 (197) also participate in clinical trials

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IPEC - FIOCRUZ

• 1999 34 Clinical trials
• Sponsered by
• Pharmaceutical industry 27
• HPTN and ACTG 7
• Patients enrolled
• 678 (total)
• 29 (197) women

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Total of women who participated in clinical
trials - IPEC
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Characteristics of women who participated in
clinical trials IPEC (N197)
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Characteristics of women who participated in
clinical trials IPEC (N197)
SEM Standart error mean
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Pregnancy rates
Time period in which HIV clinical trials have
been conducted in IPEC/FIOCRUZ. Total of women
who participated in HIV clinical trials.
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Factors associated with Womens participation in
clinical trialsIPEC/Fiocruz (1999-2008)
Objective To evaluate the potential factors
associated with womens participation in clinical
trials. Outcome variable Did the woman
participate in clinical trials? Yes or
No. Covariates age, ethnicity, years of formal
education, occupation, monthly familiar income,
lives in her own house, lives as
married//married, partner drugs abuse, partner
HIV serology, receive any support, number of
alive children, children with HIV/AIDS, tobacco
use, alcohol use, drug abuse, sexual abuse
history, domestic violence history, reason to be
HIV tested (sick/HIV family).
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Factors associated with Womens participation in
clinical trialsIPEC/Fiocruz (1999-2008)
Statistical analysis Univariate analysis The ?2
test Variables for which the significance level
was 0.25 and variables of known biologic
importance were considered in the initial
Logistic regression model. Multivariate analysis
Logistic regression We begin with a full model
containing all of the selected variables. The
Wald statistic and Likelihood ratio test were
used to check the importance of each variable
included in the model. The following rules were
used in evaluating if a variable was retained in
the final model 0.7 lt Odds Ratio lt 1.3 p-value
0.1 Odds Ratio 0.7 or Odds Ratio 1.3
p-value 0.2
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Factors associated with Womens participation in
clinical trialsIPEC/Fiocruz (1999-2008)Univariat
e analysis
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Factors associated with Womens participation in
clinical trialsIPEC/Fiocruz (1999-2008)
Univariate analysis
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Factors associated with Womens participation in
clinical trialsIPEC/Fiocruz (1999-2008)
Logistic regression
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Factors associated with Womens participation in
clinical trialsIPEC/Fiocruz (1999-2008)
Logistic regression
Likelihood ratio test for partner serology and
sexual abuse history was 0.05 and 0.20,
respectively.
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Conclusion

• Women with more years of formal education, who
  live in their own home, in marital relationship
  and those who have a non drug use partner are
  more prone to participate in HIV clinical trials.
• Younger women, those who are employed and who
  have a HIV positive partner have a lower chance
  to participate in HIV clinical trials, as well as
  that women who reported drug use and sexual abuse
  history.

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Final Remarks

• More research is needed in order to improve the
  understanding of individual and system barriers
  to clinical trials participation of women in RLS
• Investigators directly involved on the
  recruitment must be sensitized about the
  importance of womens participation in clinical
  trials and potential strategies to overcome this
  barriers must be discussed with the team before
  the start of each study

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Final Remarks

• Strategies of recruitment and retention must be
  individualized considering social and cultural
  aspects of each context
• Involvement of the affected communities since the
  beginning is crucial

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Thank you.