women’s global health scholars (gwhs) program
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Women’s Global Health Scholars (GWHS) Program. Nancy Padian, PhD, MPH Women’s Global Health Imperative Research Triangle Institute and the University of California. Program Summary. - PowerPoint PPT PresentationTRANSCRIPT
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Women’s Global Health Scholars (GWHS) Program
Nancy Padian, PhD, MPH
Women’s Global Health ImperativeResearch Triangle Institute and the University of California
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Program Summary
• Equip female health scientists from around the world – at doctorate, post-doctorate and junior faculty levels – with the tools, skills and networks needed to advance careers and assume leadership positions
• Special focus on women in academia, and the biases, hierarchies and structures they confront
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Curriculum• Draws from other successful leadership training
models:
– CHESS curriculum of the Association of Commonwealth Universities
– Executive Leadership in Academic Medicine– Public Health Institute’s International Family Planning
Leadership Program
• Through interactive, dynamic process scholars identify barriers in own institutions and settings, and strategies to overcome them
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Program Structure and Content
• Sept. 2006 and Sept. 2007 – 1 week each• Hands-on workshops:
– Strategic career planning– CV organization, strengthening, and maintenance– Writing for publication – Grants development and review– Research administration (including budgeting)– Negotiation skills– Networking with leaders, donors, colleagues– Multidisciplinary collaboration– Navigating academic politics and hierarchies
• Quarterly on-line educational sessions• Monthly peer mentoring conference calls
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Participants
• In 2006 28 women were selected from a competitive pool of nominees to participate in the program
– Africa: Kenya, Malawi, Tanzania, South Africa, Uganda, Zimbabwe, Botswana
– Asia: China, India, Vietnam– Eastern Europe: Turkey, Georgia– Latin America: Brazil, Argentina, Peru
• Multidisciplinary
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Success Indicators
• 8 Competitive grants approved for funding
• 6 Grants completed for submission
• 36 Papers published in peer-reviewed journals
• 24 Papers submitted for publication in peer-reviewed journals
• 2 Young Investigators Awards
• 24 Abstracts accepted for posters and presentations at national and international meetings
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Other Successes
• Replication of training with junior scientists in Argentina
• Ongoing regionally-based peer mentoring support groups
• A cohort of mentors for the next generation of scholars
• Individual life-altering experiences
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Ethical challenges in a randomized controlled trial of diaphragms and gel to prevent
HIV (the MIRA trial)
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MIRA Study Design
All women receive risk reduction counseling, free male condoms and diagnosis and treatment of curable STIs
Women were followed quarterly for 12-24 months
HIV-negativeSexually active
Non-pregnant women
Dia + gel + condoms Male condoms
+
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MIRA Trial Sites
Total n = 5045
UZ-UCSF
Harare, Zimbabwe
n=2502
PHRU
Soweto, South Africa
n=1028
MRC
Durban, South Africa
n=1515
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Main results from ITT (n=4948)
HIV
Incidence rate
Relative Hazard
(95% CI)
All Sites 4.0 1.05 (0.84 – 1.32)
Harare 2.7 1.20 (0.83 – 1.74)
Durban 6.8 0.95 (0.69 – 1.31)
Soweto 3.4 1.05 (0.60 – 1.87)
intention-to-treat, results according to random assignment:
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Three challenges
• Study product distribution during and after the trial
• Nature of the control group: interpretation and generalizability of results
• Standard of care for seroconverters
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Study Product Distribution
• As part of informed consent at entry, women were told “you will receive a diaphragm at the end of the study”
• Two challenging time points
– As individuals exit the study (rolling recruitment), before results were known
– After data were analyzed and results made public
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Pros and Cons of product distribution during the study
Take it back at final visit
•Implicit message that it works for HIV and contraception
– reduce condom use?
•Available outside study
– encourage use with OTC spermicide?
Let them keep it until data are analyzed
•Women will be disappointed
•Could affect likelihood of coming to final visit and loss to follow-up
•Could send a wrong message to women who continue in the study
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Discussion with CABs, participants, TAB, ethicist
Should we:
• Wait to give a diaphragm and gel to women if and when we have a positive trial result?
OR
• Give them to women at their last visit with significant education and counseling
All women will be given a generous supply of condoms at their last study visit
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Pros and Cons of product distribution after the results were
known (both arms)“Require” that they return the product
•Implicit message that it works for HIV and contraception
– reduce condom use?
•Available outside study
– encourage use with OTC spermicide?
Up to each women
• Would necessitate contacting each participant
• Products do not cause harm
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Community verdict = offer products, don’t require return
• Women are intelligent enough to decide for themselves.
– Patronizing to think otherwise
• Communities and participants would feel betrayed by study if the investigators went back on their promise
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MIRA solution
• As individuals exit, offer study products after an additional informed consent including counseling about efficacy for pregnancy and disease prevention through:
– Close-out consent form with initialed statements– Comprehension quiz
• At the end of study, group meetings to explain and disseminate results; same procedure as exiting during the study
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Close-out consent, sample statements
Replens is a gel used to lubricate the vagina, and it is NOT a spermicide. Using Replens with the diaphragm is NOT a proven method of preventing pregnancy.
Initials: ________
Condoms are currently the only proven way to prevent HIV and other STIs.
Initials: ________
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Diaphragm uptake at closing
Proportion of participants interested in taking a diaphragm home at closing:
•73.5% of diaphragm & gel arm ppts
•47.4% of condom arm ppts
Chi-square for difference highly significant (p<.0001)
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Compared to whom???
Interpretation and generalizability of results
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MIRA bottom line
In the context of a comprehensive HIV prevention package offered to all
participants, the trial found no additional protective benefit against HIV infection from
providing the diaphragm plus lubricant in the intervention arm.
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What MIRA could not assess…
• Whether a diaphragm is as good as a condom
• Whether a diaphragm is better than nothing
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Most vulnerable women
• Majority of women are at risk because their male partners do not use condoms
• Current trial results may not be generalizable to them
• Likely not to participate (male partner participation is implicit)
• Condom use during the study may not reflect “real life”
• How to target, recruit and enroll women whose partners will not use condoms (e.g. sex workers with low levels of condom use with steady partner)
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Sustainability of high levels of condom use beyond a trial
(different comparison during and after)
• Survey of participants enrolled in an RCT of N-9 in Cameroon 14 months after study participation
• Attributable to a change in behavior or in reporting?
During study Post-study
% of acts with condoms 82 - 84 57
% of ppts reporting consistent condom use
64 - 67 35
Source: Wong et al.
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Reconsider standards of condom counseling in the trial (both arms)
and beyond
• Community standard vs. enhanced counseling?
• More difficult to assess the intervention
– Attenuation of power
• Uncouple condom counseling from intervention protocols: e.g. as part of VCT prior to enrollment?
• Consider programs that sustain condom use in the community after the study
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Consider alternative study designs?Consider alternative study designs?
• Head-on comparison of intervention to condom (true equivalence)?
• Condom “run-in”, or otherwise recruit women whose partners will not consistently use condoms
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MIRA SOC program for sero-converters* during the trial• SOC visit by study staff (counseling, support groups, OI
tx, staging, referrals)
• Access to continued psychosocial support and clinical services through referrals or partnerships with community organizations/ facilities
• Transition all MIRA seroconverters into the National ARV Programme in Zimbabwe or South Africa before the end of the trial period
• (*In Zim, HPV sub-study provided screening, care and treatment for infection and disease)
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What happens when the trial is over? (comparable to screening out seropostives at entry)
• Who pays?
• Append to existing programs (state, faith-based, other)
– Quality as high as that which was provided during the program?
– Only conduct trials where such programs exist as a certain level of quality?
• May mean not conducting trials where results most needed
• Other solutions?