What Do People Who Practice Anal Sex Desire for Preventing HIV?
“We are entering a new era of HIV prevention in which we are beginning to acknowledge that individual preferences are extremely relevant to actual product use,” said DESIRE (Developing and Evaluating Short-acting Innovations for Rectal Use) study protocol chair José A. Bauermeister, PhD, MPH, Presidential Professor of Nursing and Director of the Program on Sexuality, Technology, & Action Research (PSTAR) at Penn Nursing.
Recognizing the major role personal preferences play in HIV prevention, the National Institutes of Health (NIH)-funded Microbicide Trials Network (MTN) has launched a rectal microbicide study that asks participants to “try on” potential approaches before actual products are developed. The study, DESIRE (Developing and Evaluating Short-acting Innovations for Rectal Use), is the first to systematically examine placebo, or inactive, methods for delivering drugs to help prevent HIV from receptive anal sex.
In DESIRE, study participants will use three placebo products rectally – a douche, a suppository and an insert (fast-dissolving tablet inserted into the rectum) – and report whether they would use the product if proven effective (acceptability and tolerability). Researchers also will assess the safety of each method and will evaluate and compare whether participants used the products correctly and consistently (adherence).
“We are entering a new era of HIV prevention in which we are beginning to acknowledge that individual preferences are extremely relevant to actual product use,” said study protocol chair José A. Bauermeister, PhD, MPH, Presidential Professor of Nursing and Director of the Program on Sexuality, Technology, & Action Research (PSTAR) at Penn Nursing. “We can no longer assume if products work, people will use them. The approach used in DESIRE will instead assess participants’ experiences using different rectal delivery methods before specific products have been developed.”
During DESIRE, study participants will use each rectal delivery modality for a month at a time, with a week-long break in between. They will be asked to use the methods between 30 minutes and 3 hours prior to engaging in receptive anal sex, or once a week for participants who have not engaged in receptive anal sex in a given week. The three delivery methods are a placebo insert approximately two-thirds of an inch in length, a placebo suppository approximately an inch and a half in length, and a commercially available 120 mL douche bottle that participants will be instructed to fill with clean tap or bottled water prior to use.
The study will include 210 HIV-negative cisgender men, transgender men and transgender women who have sex with men at sites in Malawi, Peru, South Africa, Thailand and the United States. In addition to general acceptability, tolerability and adherence, researchers are interested in finding out whether different segments of the study population prefer some rectal delivery methods over others.
“Participants in other studies have indicated that they are excited about the idea of topically applied rectal products for HIV prevention,” said Craig Hendrix, MD, MTN director of rectal microbicide research, and a Professor at Johns Hopkins University School of Medicine. “We also know that rectal douching is a common practice around the time of anal sex. This makes DESIRE an interesting and important study that will directly impact the development of intervention strategies in future rectal microbicide drug trials.”
The study is being conducted at the following trial sites, pending necessary approvals: the Blantyre Clinical Research Site (CRS) in Malawi; the IMPACTA CRS in Lima, Peru; the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa; the Chiang Mai University HIV Prevention CRS in Thailand; and, the University of Pittsburgh CRS, the Bridge HIV CRS in San Francisco, and the University of Alabama at Birmingham CRS in the United States.
The MTN is funded by the National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all part of the NIH. The placebo rectal insert used in the study was developed by CONRAD, a not-for-profit research and development organization located in Arlington, Va.
Rectal microbicides are products – that could take the form of gels, douches, fast-dissolving rectal inserts or suppositories – being developed and tested to reduce a person’s risk of HIV or other sexually transmitted infections through anal sex. This study is part of a larger program at the MTN to test new potential products and delivery methods for HIV prevention for people who practice anal sex.