Call to Action: International Day of Action for Trans Depathologization 2016

This year's International Day of Action for Trans Depathologization is approaching, taking place on Saturday, October 22, 2016.

As in previous years, on this day and in the course of October activist groups throughout the world will organize demonstrations and other actions demanding trans depathologization.

The slogan of the 2016 Call to Action is:

Stop Pathologizing Gender and Bodily Diversity

If you would like to participate in the International Day of Action for Trans Depathologization 2016 and organize an action in your city, please send us a message.

In order to view STP's Call to Action published on August 9, 2016:
http://www.stp2012.info/old/en/news#call_to_action2016

The main objectives of STP are the removal of the classification of gender transition processes as a mental disorder from the diagnostic manuals (DSM of the American Psychiatric Association and ICD of the World Health Organization), access to state-funded trans health care, a change of the trans health care model, from an assessment towards an informed consent approach, legal gender recognition without medical requirements, depathologization of gender diversity in childhood, as well as protection from transphobic violence.

This website aims to visibilize the objectives, manifestos and actions of this Campaign, as well as the list of collective and individual supporters.

Since 2009, STP launches each year the Call to Action for the International Day of Action for Trans Depathologization, with activities being organized in cities all over the world throughout the month of October.

In October 2016, more than 120 actions took place in 47 cities worldwide within the International Day of Action for Trans Depathologization 2016.

Furthermore, at the moment (October 2016), STP counts on the support of 410 activism groups and networks, public institutions and political organizations from Africa, Asia, Europe, Latin America, North America and Oceania.

Apart from the annual call for action in October, during the year STP carries out information, networking and lobbying activities for trans depathologization.

Currently, trans depathologization activism continues to focus on the revision process of the

International Statistical Classification of Diseases and Related Health Problems

(ICD), which is published by the World Health Organization (WHO). The expected approval

date of ICD-11 by the World Health Assembly is 20184

.

As noted in previous press releases5,6,7

, we believe that the removal of trans-specific categories

from the ‘Mental and behavioural disorders’ Chapter and the inclusion of a trans-specific

 1 STP, International Campaign Stop Trans Pathologization. STP launches the Call to Action for the

International Day of Action for Trans Depathologization 2016, August 9, 2016. Available at:

http://www.stp2012.info/old/en/news#call_to_action2016 2 STP, International Campaign Stop Trans Pathologization. Acciones Octubre 2016 / October 2016 Actions.

Available at: http://stp2012.info/old/en/press#october2016_actions

3 STP, International Campaign Stop Trans Pathologization. Support. Available at:

http://stp2012.info/old/en/supports 4 WHO, World Health Organization. The International Classification of Diseases 11th Revision is due by

2018. Available at: http://www.who.int/classifications/icd/revision/en/ 5 GATE, Global Action for Trans* Equality, STP, International Campaign Stop Trans Pathologization. GATE

and STP Press Release: New Developments in the ICD Revision Process, August 19, 2014. Available at:

http://www.stp2012.info/old/en/news#information_ICD_revision_process

6 STP, International Campaign Stop Trans Pathologization. STP Press Release: International Day of Action

for Trans Depathologization 2014. 

Available at:

http://www.stp2012.info/STP_Press_Release_October_2014.pdf

7 STP, International Campaign Stop Trans Pathologization. 

STP Press Release: International Day of Action

for Trans Depathologization 2015. Available at:

http://www.stp2012.info/STP_Press_Release_October2015.pdf

International Study Finds High Levels of Adherence to Use of Rectal Microbicide Gel

Participants as adherent to using gel with sex as taking a daily pill for HIV prevention

CHICAGO, October 20, 2016 – Participants enrolled in a rectal microbicide study were just as likely to follow through using an anti-HIV gel with anal sex as they were to using daily oral pre-exposure prophylaxis (PrEP), according to adherence results presented today at the HIV Research for Prevention conference (HIVR4P). The study, led by the U.S. National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN), was the first extended safety study of a rectal microbicide for prevention of HIV infection from anal sex, which initially reported that the gel was safe in February 2016.

The Phase II study, MTN-017, began in September 2013 and enrolled 195 men who have sex with men (MSM) and transgender women at sites in Peru, Thailand, South Africa and the United States, including Puerto Rico. MTN-017 participants –12 percent of whom were transgender women – cycled through three study regimens which each lasted eight weeks: reduced glycerin tenofovir gel used daily, reduced glycerin tenofovir gel used before and after anal sex, and daily use of the antiretroviral tablet Truvada® (emtricitabine/tenofovir disoproxil fumarate) as PrEP, developed by Gilead Sciences, Inc.

Researchers found that most participants were highly adherent during the course of MTN-017, using study products 80 percent of the time or more. Participants were similarly adherent to using gel before and after sex (93 percent) as they were to taking daily oral Truvada (94 percent). They were less adherent when using the gel on a daily basis (83 percent).

“Overall adherence to the three regimens in MTN-017 was high,” said Alex Carballo-Diéguez, Ph.D., HIVR4P abstract co-author and professor of medical psychology, Columbia University. “What we found most remarkable was that even though efficacy of the gel has not been established, its adherence was similar to oral Truvada, which we know is effective. This tells us that rectal microbicide gels, provided they are proven effective, could be a potential alternative for people who don’t want to use daily oral PrEP.”

Adherence in MTN-017 was measured by a combination of responses to daily questions sent by text message, number of returned gel applicators, and blood tests to confirm the presence or absence of drug. Throughout the study, researchers employed real-time pharmacokinetics (PK), in which they regularly tested participants’ blood to assess the presence of drug – a determinant of whether they were using their assigned study products – and shared the results with participants as part of their adherence counseling sessions. These sessions also included convergence interviews, collaborative conversations to engage participants and clarify discrepancies among adherence measures.

In a related HIVR4P poster session (P24.11), Iván C. Balán, Ph.D., assistant professor of clinical psychology, Columbia University, found that convergence interviews conducted in MTN-017, which were aimed at improving the accuracy of adherence data, were feasible and acceptable to both adherence counselors and study participants. They also provided important context to understanding discrepancies in product use assessments and PK results. Engaging study participants as allies in the process was critical to avoid making them feel confronted and thus becoming defensive, noted Dr. Balán.

In addition to Dr. Carballo-Diéguez, abstract co-authors include Dr. Balán, Rebecca Giguere, M.P.H., Curtis Dolezal, Ph.D., Cheng-Shiun Leu, Ph.D., William Brown III, Ph.D., Titcha Ho, Ph.D., Camagu Tuswa-Haynes, M.S., all with the New York State Psychiatric Institute and Columbia University; Javier Lama, M.D., IMPACTA PERU Clinical Trials Unit; Jeanna Piper, M.D., Division of AIDS, National Institute of Allergy and Infectious Diseases (NIAID) at the NIH; Barbra Richardson, Ph.D., University of Washington and Fred Hutchinson Cancer Research Center; Ian McGowan, M.D., Ph.D., University of Pittsburgh; and Ross Cranston, M.D., Microbicide Trials Network.

Dr. Cranston is protocol chair of MTN-017 and Dr. Lama is protocol co-chair.

MTN-017 was funded by NIAID and the National Institute of Mental Health, both components of the NIH. Tenofovir gel was developed by Gilead Sciences, Inc., of Foster City, Calif., which assigned the rights for tenofovir gel to CONRAD, of Arlington, Va., and the International Partnership for Microbicides of Silver Spring, Md., in December 2006. Clinical input and study supplies of reduced glycerin tenofovir gel were provided by CONRAD, with funding from USAID.

# # #

Dr. Carballo-Diéguez’s abstract (QA20.01) is part of the HIV R4P oral presentation session Trust But Verify: Understanding Adherence taking place from 10:30-noon CDT, Wed., October 20. It is one of 22 MTN abstracts being presented at the HIVR4P 2016 conference. Webcasts of all HIVR4P 2016 sessions, along with the conference program and more information on the meeting is available at hivr4p.org.

More information and materials about MTN-017 and rectal microbicides are available athttp://www.mtnstopshiv.org/news/studies/mtn017.



About the Microbicide Trials Network

The Microbicide Trials Network (MTN) is an HIV/AIDS clinical trials network established in 2006 by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. Based at Magee-Womens Research Institute and the University of Pittsburgh, the MTN brings together international investigators and community and industry partners whose work is focused on the development and rigorous evaluation of promising microbicides – products applied inside the vagina or rectum that are intended to prevent the sexual transmission of HIV – from the earliest phases of clinical study to large-scale trials that support potential licensure of these products for widespread use. More information about the MTN is available at www.mtnstopshiv.org.

MTN is funded by the U.S. National Institutes of Health grants UM1AI068633, UM1AI068615 and UM1AI106707.

Click here for PDF version of this document.

African Women Using Anti-HIV Vaginal Ring Say Sex Felt the Same

African women in a study of a vaginal ring used as pre-exposure prophylaxis (PrEP) for the most part said wearing the ring did not affect the physical act of sex. However, for some the worry that their partner would discover they were using the ring reduced the enjoyment of sex. Also, the few women who were burdened by intimate partner violence were much less likely to use the ring.

At the HIV Research for Prevention (HIVR4P) meeting in Chicago, researchers presented new findings from the MTN-020 study, also known as ASPIRE, of a dapivirine-containing vaginal ring studied as PrEP among 2,629 women 18 to 45 years old in Malawi, South Africa, Uganda and Zimbabwe.

Study results presented at the 21st International AIDS Conference in Durban, South Africa (AIDS 2016), in July showed that on the whole, giving the ring to women reduced their risk of HIV by 27 percent. Women who used the ring with greater frequency had a 56 percent reduced risk, and those who used it consistently had a 75 percent reduced risk of HIV.

To reach the new findings, the researchers interviewed 214 participants who used the ring about their qualitative experiences with it. Most said the ring did not affect the physical act of sex negatively.

However, some women said they fixated on how their male partners would react if they found out about the ring. Consequently, some of them removed the ring before sex, which is not recommended. Others curtailed certain sexual practices they thought would raise the risk of the man finding the ring, including particular sexual positions and receptive oral or digital sex.

Some women reported having greater sexual satisfaction because they believed the ring was protecting them against HIV. But others had the opposite experience because of their worries over their male partners discovering the ring.

Less than 5 percent of the women said they experienced intimate partner-related violence or other related social harms. Those who did were nearly two and a half times more likely to adhere poorly to the ring’s protocol for use (the women received instructions to leave each ring in for a month).

Sixty-four percent of the women told their male partners they were using the ring at the beginning of the study. Thirteen percent never disclosed their use of the ring to their partners.

To read a press release about the study, click here or HERE: Women Report Vaginal Ring for Preventing HIV Had Little Effect on Sexual Intercourse

ASPIRE evaluated whether the ring, which continuously releases the anti-HIV drug dapivirine, could safely reduce HIV infection among 2,629 women aged 18-45 years living in Malawi, South Africa, Uganda and Zimbabwe. Among participants randomized to receive the dapivirine ring, risk of HIV infection fell by 27 percent. A further analysis found that the ring reduced the risk of HIV infection by at least 56 percent among women who used it with greater frequency, and up to 75 percent or higher among those who used it consistently. Further exploration of the ring’s clinical potential began in July 2016 through the large-scale HOPE (HIV Open-Label Prevention Extension) study, also known as MTN-025 (link is external). ASPIRE, HOPE and their ancillary studies were primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The nonprofit International Partnership for Microbicides developed the dapivirine ring and supplied it for the studies.

“Women need an HIV prevention modality that offers safe, effective protection and is practical for use in their daily lives,” said NIAID Director Anthony S. Fauci, M.D. “Women enrolled in the MTN-020/ASPIRE study reported that the experimental vaginal ring generally did not interfere with sexual intercourse, which is an encouraging sign that this product could appeal to a larger group of women at risk for HIV infection.”

The ASPIRE study staff interviewed 214 participants who used the ring to obtain qualitative data about their sexual experiences during the trial. A team led by Nicole Laborde, Ph.D., M.P.H., of RTI International in Research Triangle Park in North Carolina, analyzed the participant responses. While most of these women found that the ring did not negatively affect the physical act of sex, some women said they were continually preoccupied with how their partners would react if they felt or discovered the ring. To address this issue, some women removed the ring before sex, a practice not recommended by study investigators. Other women limited sexual activities that they believed might heighten their partners’ awareness of the ring, such as certain sexual positions and receptive oral or digital sex.

Some women reported greater sexual satisfaction partially due to perceived protection provided by the ring. Other women reported diminished sexual pleasure associated with the worry that their male partners would notice the ring during sex.

Additional analyses of the ASPIRE data revealed other patterns of experience among study participants. Because women who face intimate partner violence and other social harms more often find it difficult to adhere to the clinically proven once-daily antiretroviral drug Truvada as pre-exposure prophylaxis, or PrEP, researchers investigated the connection between consistent use of the ring and these issues. While fewer than 5 percent of all ASPIRE study participants reported incidents of intimate partner-related violence or other social harms, women who did report violence or social harm within a month of the interview were nearly 2.5 times more likely to have low adherence to the ring. Younger age at enrollment, having a new primary partner and not disclosing study participation or ring use to the primary partner were significantly associated with reporting social harms. These findings, reported by a team led by Thesla Palanee-Phillips, M.Med.Sci, Ph.D., M.Sc., at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa, indicate that more research is needed to determine strategies to mitigate low adherence in the context of intimate partner violence and other social harms in future studies of female-controlled prevention methods.