Hormonal Contraception & HIV Disease Acquisition: A Limited Review and Reassessment of Findings
A discussion paper Prepared for the Population and Development Program’s Reviving Reproductive Safety Project, Hampshire College, Amherst, MA July 2009 By Nalini Visvanathan
Summary
This paper reviews some of the key studies within the epidemiological literature that examine the relationship between hormonal contraception (HC) use, primarily depot-medroxyprogesterone acetate (DMPA) injectables, and HIV acquisition. The primary objective is to reassess the findings rather than reinterpret them; consequently, it synthesizes the findings and implications published in peer-reviewed scientific journals, and it discusses their translation into preventive actions. Recent publication of findings raises lingering questions about the role of DMPA injectables, administered once in three months, in the transmission of the virus. The vulnerability of young females to infection in the epidemic, a phenomenon as yet not fully understood, and of the women engaged in sex work makes it critical to re-examine and reassess the findings that “overall” there is no association between hormonal contraception (HC) use and HIV disease acquisition.
Emerging and persistent questions about hormonal contraception’s role in disease progression and infectivity (transmission) have also increased the urgency of gaining a fuller and more nuanced understanding of the potential hormonal contraception-HIV relationship, especially because investigators and commentators have noted limitations of their findings. The 2005 WHO Nairobi statement left the Medical Eligibility Criteria for Contraceptive Use (MEC guidelines) unchanged and appears to have sanctioned the continuing use of these contraceptives by all women living in areas where the HIV epidemic is widespread. The WHO statement has been reinforced by reassurance on the website of Family Health International (FHI), a contraceptive research and service agency, that hormonal contraception does not increase the risk of contracting HIV. In scientific publications, FHI researchers acknowledge that age could be a modifier of the association and more research is needed. The researchers’ recommendations for further research and for hormonal contraceptive users to use dual protection, however, are less likely to be mentioned when the principal finding of no “overall” association is cited.
Through synthesis of the findings from two groups of studies that each followed a cohort of women and measured changes in their status over a period of time, the paper highlights important insights and information that have to be disseminated alongside the finding of “no overall association.” It discusses the shortcomings in the HC-HIV study that precipitated the WHO statement, and their implications, and recommends that revised guidelines are instituted to protect, inform and educate all women and particularly the subgroups of women at risk when using hormonal contraception. ~~~~~~~~~~~~~~~~~~~~~~~~ Nalini Visvanathan, Ph.D., MPH is an independent researcher and public health advocate. She has served for three years on the Brigham and Women’s Hospital and Fenway Community Health joint community advisory board, where she became involved with the HIV Prevention Trials Network (HPTN) and later joined the NIH/DAIDS-sponsored working group that recommended guidelines for community involvement in HIV clinical trials. From 2005 through 2006, she was a member of the Harvard Medical and Dental Schools Joint Human Subjects Committee.
Dr Visvanathan is also the co-editor of
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Calls for new policies (see pages 19-21)
We prioritize issues for policy development based on their level of urgency for the vulnerable subgroups of women in the sub-Saharan African region that were discussed in this paper:
A. Policy formulation for immediate action: Development of guidelines for hormonal contraceptive providers and the initiation of educational campaigns in communities. 1) We need policy guidelines that will ensure that women engaged in sex work and those having greater exposure to sexual activity are fully informed and educated about the increased risk for HIV if they choose hormonal methods of contraception, wherever it may be dispensed. (Rationale: The findings of a hormonal contraceptive and HIV acquisition association in the Mombasa study have been explained in terms of the greater sexual exposure to which the women are occupationally subjected, compared to women in the general population. Because this is a biological phenomenon, the findings could have implications for sex workers in other regions of the world.)
2) Providers and counselors must follow a protocol that informs their clients about the need to use a dual protection method when they provide DMPA injectables. (The WHO statement did stress the need for dual protection, “The use of male or female condoms is recommended whenever there is any possibility of exposure to STIs, including HIV. Programmes to promote dual protection should be actively supported.”) While there has been an increase in condom use within the region, it is not clear what is being done in different local contexts.21
3) Adolescent girls and young women (15 24 years) should be counseled to adopt dual protection methods if they choose hormonal contraception. They should be educated and supported in the use of the female condom.22
B. Policy to identify issues for continuing research: Expansion of current research agenda for understanding the hormonal contraception and HIV association. 1) There should be expanded research on the association between hormonal contraception and HIV disease acquisition, progression and transmissibility in the general population of women. The research agenda framed at the 2005 meeting hosted by Gynuity (p. 5) broadly documents areas to address. 2) The research design should incorporate purposive sampling to include large enough samples from subgroups like teenage girls and young women who show marked susceptibility, in order that statistical tests can be performed for this subgroup. 3) We need more studies to explicate the relationship between hormonal contraception and the acquisition of HIV by young women, with attention to changes in the vaginal epithelium and immunity response mechanism.
C. Policies to emphasize the importance of translation research: Creation of regional scientist-lay committees to review and prioritize the scientific findings that have implications for women’s health. 1) The tendency for mass mediated communications to simplify and summarize complex and nuanced scientific findings is a pervasive problem in the translation of new knowledge and its application in clinical settings. In this instance, there seems to be a gap between the nuanced presentation of the findings in a scientific forum and its simplified interpretation in the research literature. We need to examine the diffusion of findings and the threats to the integrity of the information that is relayed both in the mass media and in scientific publications. 2) There is need to set up mechanisms for ensuring that findings with serious implications for women’s health are followed up and public education programs initiated with little loss of time.
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Table of Contents Summary................................................................................................................4 PART 1: Background & Introduction.......................................................................5 Vulnerable Groups in the HIV Epidemic..................................................................6 Methodology...........................................................................................................6 DMPA, Fertility Control and HIV Transmission........................................................7 The Gynuity Meeting...............................................................................................8 The 2005 WHO Nairobi Statement.........................................................................10 PART 2: Disscussion of Key Studies....................................................................12 Mombasa Study.....................................................................................................12 HC-HIV Study / Uganda, Zimbabwe and Thailand Multi-Center Study..................13 Recent Studies......................................................................................................15 Related Issues.......................................................................................................16 Contraceptive Counseling and Dual Protection Method.........................................16 Critical Areas for Follow-up and Action................................................................17 PART 3: Recommendations for Discussion...........................................................19 Endnotes................................................................................................................21 References............................................................................................................23 Appendix: Matrix of Select Principal Studies.........................................................25
~~~~~~~~~~~~~~~~~~~~~~~~ Acknowledgements We would like to thank the reproductive health researchers and practitioners who contributed generously to this paper by providing detailed comments and helping us in the research process. Since institutional policies restrict our ability to include all whose help has been invaluable, we are not listing names, but that does not diminish our sincere gratitude. ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ Contact us if you would like a free hard copy. <
> Nalini Visvanathan, Author Betsy Hartmann, Director, Population and Development Program Elizabeth Barajas-Román, Associate Director, Population and Development Program
Hormonal Contraception & HIV Disease Acquisition: A Limited Review and Reassessment of Findings