Welcome to P-Values, AVAC’s bulletin highlighting advocacy work by our partners and many other stakeholders around the world. “P-value” is a statistical term for the probability that a trial result is a real finding and not the result of chance. As the world faces new challenges and opportunities in prevention research, the global advocacy community isn’t leaving anything to chance. P-Values tracks HIV work on country-and community-level engagement in trials, preparing for results and implementation of new findings. Here’s what you need to know now.
Charting the Course of the First Phase II Rectal Microbicide Trial
Last month the Microbicide Trial Network (MTN), in partnership with AVAC and other groups (see below for full list), held community consultations in Chiang Mai and Bangkok on the planned MTN-017 trial of a rectal formulation of 1% tenofovir gel. These consultations were organized in partnership with advocates who have worked with AVAC on implementing Good Participatory Practice guidelines in Thailand. MTN-017 plans to enroll approximately 216 participants, men who have sex with men and transgender women, at trial sites in South Africa, Peru, Thailand and the United States. Results of the Phase II safety trial will be used to guide decisions on future efficacy trials of the gel as an HIV prevention tool for use during anal sex. At the meetings in Chiang Mai and Bangkok, community stakeholders emphasized the importance of gathering data on rectal use of 1% tenofovir gel among transgender women. As a result of this feedback, the trial team decided to amend the protocol to include transgender women as trial participants—an example of GPP in action!
The full group of collaborators included the International Rectal Microbicide Advocates (IRMA), the Thai Ministry of Public Health – US Centers for Disease Control and Prevention Collaboration and the Thai Research Institute for Health Sciences (RIHES) along with MTN and AVAC. MTN-017 consultations were also held in South Africa in October 2011 and are planned for Peru in March 2012. Contact firstname.lastname@example.org to learn more.
Background facts: The rectal formulation of 1% tenofovir gel was developed to address results from an earlier study, RMP-02/MTN-006, which found that while the vaginal formulation of 1% tenofovir gel used in CAPRISA 004, VOICE and FACTS 001 was generally safe to use in the rectum, side effects were problematic to a few study participants. A rectal formulation of the gel was subsequently developed and tested in MTN-007, the results of which will be reported at CROI in March of this year. To learn more about 1% tenofovir gel—click here.
Yes We Can End the Epidemic: AVAC Fellows Orientation 2012
AVAC’s HIV Prevention Research Advocacy Fellows gathered for an orientation and wrap-up session in Kampala at the end of January. Fellows from 2010, 2011 and eight new fellows from 2012 together with their host organization supervisors gathered in Kampala, Uganda, to take stock of recent accomplishments, plans for the future and take steps to forge an African movement to end the AIDS epidemic. The three-day meeting included debates and discussions about how to prioritize prevention strategies that are available today, such as treatment as prevention and voluntary medical male circumcision (VMMC), and explorations of the agenda for emerging strategies such as PrEP and microbicides and hoped-for interventions like an effective AIDS vaccine. One highlight was an intensive afternoon session on the potential for influencing the Country Operating Plans that guide the President’s Emergency Plan for AIDS Relief (PEPFAR). These “COPs” can be used to leverage additional resources for the pillars of combination prevention—ARV treatment, VMMC and prevention of pediatric infection. In the coming months, advocates will be participating in intensive country-level campaigns.
HIV Risk and Hormonal Contraceptives: Women weigh in
On January 25, more than 40 women—representing HIV prevention advocates, reproductive health service providers and women living with HIV from across Africa—met in Kampala, Uganda to review and discuss the existing data on hormonal contraceptive use and HIV risk. The meeting was convened by the International Community of Women Living with HIV/AIDS East Africa (ICW-EA) and AVAC. Drs. Nelly Mugo and Edith Nakku-Jaloba, of the Partners in Prevention trial team, gave an overview of recent data. Lydia Mulwanyi-Mukombe, a 2012 AVAC HIV Prevention Research Advocacy Fellow, who will be tracking women’s perceptions of and questions on HIV and hormonal contraceptives as part of her fellowship, led an interactive capacity-building exercise on key terms in reproductive health and family planning. One goal of the meeting was to develop a women’s civil society statement, which was presented at a World Health Organization consultation on hormonal contraceptives and HIV risk held January 31-February 2 in Geneva, Switzerland. Lillian Mworeko, head of ICW-EA, Alliance Nikuze, AVAC Fellow 2010, and AVAC Senior Program Manager Deirdre Grant attended and carried women’s voices forward to the discussion. A statement of the meeting outcome is expected in February, and AVAC will hold an advocates’ call to discuss the developments as they emerge. Details of the call will be released on the AVAC Advocates’ Network—subscribe here.
Background facts: Data from one recent trial suggested that injectable contraceptive use increased women’s risk of acquiring or transmitting HIV by twofold, compared to women using non-hormonal methods of family planning. There are mixed data on this issue, and while the most recent data are cause for concern, they are not conclusive. (To learn more visit here.)