Novel Biomedical Interventions Help Prevent HIV, Other STIs, and Unintended Pregnancy

Three novel prevention strategies against HIV, other STIs, and unintended pregnancies were presented by researchers in a mini-plenary on September 22 at the Centers for Disease Control and Prevention 2016 STD Prevention Conference in Atlanta, Georgia.

Demetre Daskalakis, MD, MPH, assistant comissioner, HIV/AIDS Prevention and Conrol, The New York City Department of Health and Mental Hygiene, shared his observations about PrEP (Pre-exposure prophylaxis) and his advice for increasing its uptake among people at risk for HIV infection.

An estimated 1.2 million people in the United States are PrEP-eligible or are potential candidates for PrEP, he told the audience.

"Going on PrEP brings people who have never been tested or treated for STIs into the clinic every three to six months or so, improving their sexual health service delivery and quality, including access to contraception," Dr. Daskalakis told Contagion.

"PrEP is actually the gateway to sexual health-focused care for populations that healthcare has not adequately served. PrEP is recommended not as a stand-alone intervention, but as part of a comprehensive HIV prevention package: that means STI screening correctly done; that means risk evaluation and reevaluation," he said in his talk.

In a program in New York City, workers visit the community and discuss key public health messages with people. They take a thorough sexual history from all patients ; screen sexually active patients for STIs based on their sexual history and clinical guidelines; talk about PrEP and PEP (post-exposure prophylaxis) with HIV-negative patients who are at ongoing risk of exposure and HIV-positive patients who may have HIV-negative partners; and prescribe PrEP and PEP according to clinical guidelines or refer patients to sites that provide PrEP.

"The trick is to make the testing as low-threshold as possible. Three-month visits are a lot for some clinical systems…so…create a pathway for express visits…so people can come in and give samples without necessarily seeing you," Dr. Daskalakis said.

"It's not about just pumping drugs out into the community; it's about improving the sexual health of that community and having this be one of the pieces in the toolkit," he advised. "I think PrEP provides an opportunity to reinforce traditional sexual health-prevention messages and…is about customizing your prevention strategy and realizing there are a lot of tools in the toolkit," he said.

"Like [with] injection drug use, we now have harm reduction for sexually active people beyond the condom. Syringe exchange does not prevent heroin overdoses; syringe exchange prevents hepatitis C and HIV. PrEP is syringe exchange for HIV," he added.

Dr. Daskalakis and his colleagues are currently piloting a home-testing STI program.

Clare Coleman, BA, president and CEO of the National Family Planning & Reproductive Health Association, Washington, DC, shared her observations about the impact of technology and policy on contraceptive use and STI screening, as well as the availability of sexual health services in the United States.

"Many of our family planning safety net systems around the country are leading LARC (long-acting reversible contraception) initiatives, but they are really part of a comprehensive strategy under the CDC and the US Office of Population Affairs quality family planning recommendations that came out in April 2014 to look at expanding access to quality family planning services across the board," Coleman told the audience.

LARC use among women in the United States who were between 15 and 44 years of age and were taking contraceptives increased from 2.4% in 2002 to 11.6% in 2012, with 10.3% choosing IUDs and 1.3% having implants. However, "oral contraception is still the absolute dominant method of choice for women across the systems…More than 60% of American women are on oral contraception," she said.

"Prior to 2012, women 21 years and older were encouraged to get an annual Pap test…Now women are told to come less often. Screening intervals have widened depending on the testing, and so, it is absolutely possible that we're going to be screening people less often," she added.

Health centers can increase their screening rates by making screening procedures clear to all staff and dispelling the notion that screening equals pelvic exam, when only a urine sample or vaginal swab are needed, and training staff to screen all appropriate patients regardless of the reason for their visit.

Strategically placing specimen collection materials in the same place in every room can encourage screening, as can using electronic health records to alert clinicians when patients are due to be screened and notifying patients by text messages, phone calls, and postcards.

At the systems level, clinician engagement, training, and buy-in across specialties are essential: making screening available from a variety of providers, having consistent practice patterns across specialties, and comparing practice performance with performance of a peer group.

Coleman used the closed system Kaiser Permanente as an example. "The home office developed and disseminated an STD testing toolkit and guide and it went across the system to all the practices regardless of specialty. It outlined a uniform protocol about how to test and when, and the toolkit was reinforced in the EHR. So, it would prompt clinicians to order STD testing when it was due; it sent that message regardless of practice types."

"As LARC has become more possible and more paid for, there has really been an increasing wave of concern about coercion, population targeting, acknowledging the impact of institutional racism across our systems, acknowledging the provider trust issues…We have providers across our network that will not do LARC because they don't think it's safe,” she continued.

"We look really carefully when state health departments tell us that they have a LARC initiative…We are really concerned about LARC initiatives that are focused on low-income people and [we] have been trying to balance what LARC can be for people who choose it and what it ought to be as a part of our broader toolkit,” she explained.

The new [2014] guidelines explicitly state that screening and treatment are to be combined, Coleman pointed out. "At the national level we are engaged in thinking about how can we promote implementation of these expanded recommendations around STD services, and candidly, see it as a business development opportunity. The notion that a family-planning center that's been really focused on women might shift to become a sexual health center of excellence is something that is very intriguing to a number of our systems across the country,” Coleman said.

Jeanne Marrazzo, MD, MPH, professor of medicine and director of the Division of Infectious Diseases, University of Alabama Birmingham, spoke about giving women who are at risk more choices in preventing HIV, STI, and unintended pregnancy.

"This is about keeping you healthy and increasing your choices and increasing your opportunities to address your sexual and reproductive health needs. It's a very new tack for us, because we are very pathogen-focused and specific, and we just need to break that mold," she told the audience.

Dr. Marrazzo and her colleagues were surprised by the results of their recent VOICE study of HIV prevention in 5,029 women of reproductive age in three countries in sub-Saharan Africa. In the phase 2B randomized, double-blind trial, the women were assigned to take one of five products daily: vaginal tenofovir gel, oral tenofovir, oral tenofovir with emtricitabine, vaginal placebo gel, or oral placebo tablet.

But while other large studies of PrEP conducted at the same time were reporting that PrEP worked, none of the drug regimens in Dr. Marrazzo's five were reducing HIV acquisition rates.

"Clearly PrEP did not work in our population," she said. "And through every single measure, people said that they were using the product…But they were lying to us throughout their participation in the study…About one-third of the women were using the product."

"There is a huge disconnect here with their desire to remain in the study and their discomfort with telling us the truth and their distrust in using the products. Clearly, they did not see the products as relevant to their lives," she noted. "This is an issue probably in many prevention studies dealing with healthy people who don't necessarily see themselves as patients, who don't necessarily see themselves as vulnerable to whatever you're trying to prevent."

The idea really is to give people choices that fit with their lifestyles and their unique needs," Dr. Marrazzo advised, adding that research into vaginal rings that contain antiretrovirals and hormonal contraceptives is ongoing. Due to the fact that not everyone will take an oral contraceptive or use a vaginal ring, "we have to keep pushing for a spectrum of products that are available, including on-demand products."

“Women don't always have a voice and can't always necessarily disclose their needs around sexual health. That's very different from what's happening in MSM right now…We really need to have this conversation about what sexual health means for women when it's often very difficult. They are not empowered to necessarily talk about this, particularly with a history of domestic violence and sexual assault…That's the other huge elephant in the room that people don't really talk about,” Dr. Marazzo explained.

Lorraine L. Janeczko, MPH, is a medical science writer who creates news, continuing medical education and feature content in a wide range of specialties for clinicians, researchers and other readers. She has completed a Master of Public Health degree through the Department of Epidemiology of the Johns Hopkins Bloomberg School of Public Health and a Dana Postdoctoral Fellowship in Preventive Public Health Ophthalmology from the Wilmer Eye Institute, the Johns Hopkins University School of Medicine and the Bloomberg School.

SOURCES: 2016 CDC STD Prevention Conference Program pp 71-72: STD Prevention in the Context of Biomedical Interventions to Prevent HIV and Unintended Pregnancy (https://www.cdc.gov/stdconference/2016/STD_Conference_2016_Program_Book.pdf)

(Sources for studies: abstracts, slides, audio recordings, interviews)

Presentations:

Demetre Daskalakis, MD, MPH, assistant commissioner, HIV/AIDS Prevention and Control, The New York City Department of Health and Mental Hygiene, HIV Pre-Exposure Prophylaxis and Sexually Transmitted Infections (Mt. Sinai position, in conference program, is not current.)

Clare Coleman, BA, president and CEO, National Family Planning & Reproductive Health Association, Washington, DC, The Nexus of LARC Use and STD Testing

Jeanne Marrazzo, MD, MPH, professor of medicine and director, Division of Infectious Diseases, University of Alabama Birmingham, Birmingham, AL, Preventing HIV, STI, and Unintended Pregnancy in Women at Risk: Evolving Evidence and Approaches