GENDER ISSUES IN CLINICAL TRIALS

1. GENDER ISSUES IN CLINICAL TRIALS Jessie Mbwambo, MUHIMBILI UNIVERSITY COLLEGE OF HEALTH SCIENCES(MUCHS) DAR ES SALAAM, TANZANIA Presented at the HPTN Africa Community Regional Working Group-Lusaka Zambia

2. DISPOSITION • Definition of gender and “gender roles” • Gender roles and the AIDS epidemic • Focus specifically on women and the HIV/AIDS epidemic • Women’s specific vulnerability to HIV infection • Contexts facilitating women’s increased vulnerability to HIV • Women’s vulnerability in VCT, pMTCT and other clinical trials settings • Summary and challenges in including Men as partners

3. GENDER ROLES AND STEREOTYPES • Gender and gender role are widely shared ideas and expectations • about men and women • about masculine and feminine characteristics • Knowledge imparted through socialization and through • families, friends • religious institutions • cultural institutions

4. Traditionally men • Go to towns to work; women stay in villages • Men have other sexual relationships and go back to wives • In this background men expose women to infection as: • men expected to have poor control • women can not question men’s infidelity • when women jealous it is shameful • provided men provides for women should tolerate

5. Traditionally women • Need to be sexually attractive to men • Should be adept at sex • Should pleasure men sexually • Wet sex • Dry sex • Should bear children for men • Other wise should be returned home to her parents as she is “filling the husbands toilet” and not doing what is expected of her • Should remain virgins until they marry versus men who are expected to take multiple premarital partners to get the requisite experience

6. GENDER ROLES AND THE AIDS EPIDEMIC • Interaction and mobility • Urban worse versus rural; epidemic picking up in rural communities. • interaction between local population and migrant workers fuelling epidemic • More young women affected • Blame of the epidemic to young marginalized women makes men not appropriately assess their risk as they do not want to be associated with sex workers • Expectations of men’s behaviours • Traditional structures place women in inferior positions thus they can not question men furthermore female controlled methods looked upon as immoral --will make women have sex with other men

7. Gender roles and AIDS epidemic #2 • Women blamed for STDs and HIV infections • Men blame women for infecting them • Men can become drunk and have risky sex • Men can have natural urges makes them “real men” • Women should remain “pure”? • hide previous relationships therefore do not acknowledge their previous risk • After all they can not even show they had any sexual education as means they were promiscuous otherwise how did they know? • women have relationships (some tribes encourage these but one has to be discreet) • Women lack adequate education to have relevant information and assess risk

8. WHY WOMEN AND HIV/AIDS • The AIDS epidemic is progressing and is especially worse among women • Preventive strategies not working and only selective towards few aspects of epidemic • Abstain • Be faithful • Condomising • Impact not felt among especially women • Epidemic on young women enormous • Women specific vulnerability to HIV due to: • social • physiological • economic

9. Prevention strategies limited? • Do not address women’s • traditional gender roles and stereotypes • roles interfere with her risk assessment • dis-inheritance when partner dies • failure to control their risk of infection • social status • economic status • political power • Do not asses whether methods male or female controlled

10. WOMEN SPECIFIC VULNERABILITY • Age differences in partnerships • exposure of young women to more sexually experienced male partners • risk of traumatic first sexual experience to an immature genital tract • need financial support • Women may have STDs which may go unrecognised thus untreated • even when recognised women may have no money to get treatment for STDs • Men encouraged to get more experience even within permanent partnerships • Questioning men means “you do not trust me” and may result in violence

11. Facilitation of women’s vulnerability • Difficult economic situation • migration • sex for subsistence i.e. money or favours • cannot negotiate safe sex practices • treatment including of STDs • shift of government funding from social services and prevention • Lack of adequate knowledge on exact mechanisms of transmission results in • creative misdiagnosis • shopping for health care therefore deplete meagre resources

12. WOMENS VULNERABILITY IN VCT SETTINGS • Experiences of testing for HIV • Experiences of disclosure of HIV sero-status • Association of HIV and Violence

13. Experiences of testing • Factors influencing women’s decision to test for HIV • Perceptions of benefit • Perceptions of risk • Decision making patterns • Fear of partners reaction • Couple communication

14. Experiences of disclosure of HIV-1 sero-status • Disclosure of HIV-1 sero-status • Overall 79% • HIV+ women 69% • HIV- women 83% • No one 9.8% • Effects on disclosure of sero-status • Overall understanding and supportive • Few have untoward negative effects • Easier to disclose and good outcome indicators if had initially communicated to primary partner

15. The reality: Associations between HIV & Violence • Lifetime experiences with violence, common among all women but significantly more common among HIV+ women • The odds of physical violence among young HIV+ women 10 times higher than among young HIV- women

16. WOMENS VULNERABILITY IN pMTCT SETTINGS • Difficult choices between not fulfilling child bearing obligations and being HIV+ with attendant consequences • …Then my in law came “what type of woman are you?” Your peers now have three children you only have the one. They told my husband come home to marry. I told him you could go but remember we have a Christian marriage. Almost immediately I had another pregnancy and then child. Though the dialogue continued, the tension was reduced. But then my sister in law told my husband, your wife is on OCP. Then he comes asks me are you on OCP?...Woman HIV+ age 34

17. Informed decisions to continue child bearing irrespective of HIV+ sero-status • …I knew all these and I also knew our home situation, if you go back to your parental home you should explain yourself. How will they receive this news, some will hear about this and will just isolate you, they will not drink water in your house, others will just be accepting but then others will say “she is a prostitute you know”…Woman HIV+34 • …the truth is when they saw us come back pregnant for a second time they were unhappy. It was then necessary for us to tell them about our home situation. We are indeed ready to stop having children but when you think I am already HIV infected, if this man returns me back home to my parents what will I have done? … Woman HIV+ age 38

18. Women decide not to follow through interventions as fear inadvertent disclosure of HIV+ status • …nowadays all is know completely [interventions], they know there are these medicines, which increase longevity for those who are HIV infected. They know they are medicines given to pregnant women to help women not give their unborn children infection, this information they have. They also know if one is HIV infected they should not breast feed their new born… • …Mama X how dare you feed your child formula at the cost of Tshs 3000 per tin. If you have all that money why do you not out of this pit to a better room in a better house? Why give this child Tshs 3000. Why do you like to give this child bottled milk all the time? Or what is the problem? This made me do my feeding inside my room…

19. Consequences of disclosure of HIV+ sero-status • Decreased assistance from family and other community members in accessing care and continued support if known to be infected • Denial of services or receive less aggressive treatment • Experience caregivers’ shaming and judgmental attitudes • Fear may be turned away by health workers • Prefer to go to places of care where they think they will be well treated --research sites--: • Travel further, wait longer, & incur greater costs to seek non-stigmatizing care • Delay seeking care until health problems are severe

20. WOMENS VULNERABILITY IN OTHER SETTINGS-MICROBICIDES • Microbicides are biological or chemical substances capable of killing or neutralizing viruses present in ejaculate or cervical or vaginal secretions • Maybe gel, cream film or suppository (for rectal applications) • Hoped that would give women power to protect women from STDs and HIV • Newer developments may also give women choice to regulate child bearing • Aim to develop substances that would not disrupt the outer membranes of cells thus facilitating transmission of STD/HIV

21. Good products but maybe barriers to their use • Still under development and the pharmaceutical industries still not very interested in their production due to presumed low financial returns and/or fear of liabilities • Women may use products by themselves without partner involvement but partners maybe aware of their use during intercourse • Women may not hide the use of microbicide to their partners as they may consider it to be risky

22. Good products but…. • Use of microbicides may not be optimal in settings where dry sex is practiced • Men say they will be angry if women used any products without their consent • Though men may prefer microbicides as appear to be more appealing than condoms, women’s use of microbicides without consent of the partner (especially if has spermicidal properties) will be viewed very suspiciously • Successes in microbicide trials will depend on explanation of use to couples and not women only • Inclusion of partners will minimize partner conflict

23. SUMMARY • Women are more at risk to HIV-1 infection by right of their social, physical and economic vulnerability • Women’s choices in prevention from HIV-1 infection are limited by their “inferior positions” in society • Women’s fear of violence limits their attempt to take preventive measures • Women who have history of violence are more likely • to be positive for HIV • experience negative outcomes on disclosure of sero-status

24. Summary#2 • Women make informed choices as to what interventions to take and this is guided by their risk perception and fear of negative outcomes • Partners of women in clinical trials need to be involved in the research process—lest they become angry and suspicious of women’s intention • Calls for more comprehensive role in HIV interventions where both voices need to be heard • Infrastructure seem to further compound failure to include Men as Partners (MAP) in integrated STD/HIV prevention and family planning services • Time men can visit • Predominantly children and women domains

25. Summary #3 • Infrastructure for inclusion of MAP#2 • Staff--both research and non research--a main barrier in inclusion of MAP as do not have requisite skills level to confidently work with men • May need to revisit the socio-cultural expectations and norms in sexuality related issues among the genders better addressed through working with young men e.g. Profamilia • Community involvement right at the offset to allow for support for women who access Clinical Trials • “the community has eyes with microscopes”

26. CONCLUSION • In dealing with the HIV-1 epidemic more comprehensive strategies involving both the genders right from community level through to the research and national levels are the mainstay to adoption and sustainability of interventions

27. FINALLY Thank you for listening